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Integrating Stakeholder Engagement With Claims-Based Research on Health Insurance Design and Bipolar Disorder

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Researchers increasingly recognize that stakeholder involvement enhances research relevance and validity. However, reports of patient engagement in research that relies on administrative records data are rare. The authors' collaborative project combined quantitative and qualitative studies of costs and access to care among U.S. adults with employer-sponsored insurance. The authors analyzed insurance claims to estimate the impacts on enrollee costs and utilization after patients with bipolar disorder were switched from traditional coverage to high-deductible health plans. In parallel, in-depth interviews explored people's experiences accessing treatment for bipolar disorder. Academic investigators on the research team partnered with the Depression and Bipolar Support Alliance (DBSA), a national advocacy organization for people with mood disorders. Detailed personal stories from DBSA-recruited volunteers informed and complemented the claims analyses. Several DBSA audience forums and a stakeholder advisor panel contributed regular feedback on study issues. These multiple engagement modes drew inputs of varying intensity from diverse community segments. Efforts to include new voices must acknowledge individuals' distinct interests and barriers to research participation. Strong engagement leadership roles ensure productive communication between researchers and stakeholders. The involvement of people with direct experience of care is especially necessary in research that uses secondary data. Longitudinal, adaptable partnerships enable colearning and higher-quality research that captures the manifold dimensions of patient experiences.

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Background: Cost-sharing disproportionately affects people with chronic illnesses needing more care. Our qualitative study examined lived experiences navigating insurance benefits and treatment for bipolar disorder, which requires ongoing access to behavioral specialists and psychotropic medications. Methods: Forty semi-structured telephone interviews with individuals with bipolar disorder and employer-sponsored health insurance, or their family caregivers, explored health care needs, coverage details, out-of-pocket (OOP) costs, and perspectives on value. An iterative analytic approach identified salient themes. Results: Most individuals in our sample faced an annual insurance deductible, from $350-$10,000. OOP costs for specialist visits ranged from $0-$450 and for monthly psychotropic medications from $0-$1650. Acute episodes and care for comorbidities, including medication side effects, added to cost burdens. Medication nonadherence due to OOP costs was rare; respondents frequently pointed to the necessity of medications: “whatever it takes to get those”; “it's a life or death situation.” Respondents also prioritized visits to psychiatrist prescribers, though visits were maximally spaced because of cost. Psychotherapy was often deemed unaffordable and forgone, despite perceived need. Interviewees cited limited networks and high out-of-network costs as barriers to specialists. Cost-sharing sometimes led to debt, skimping on nonbehavioral care or other necessities, exacerbated or prolonged mood symptoms, and stress at home. Limitations: Volunteer respondents may not fully represent the target population. Conclusions: Many people with bipolar disorder in US employer-sponsored plans experience undertreatment, hardship, and adverse health consequences due to high cost-sharing. More nuanced insurance benefit designs should accommodate the needs of individuals with complex conditions.
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Background: Rising annual incidence of involuntary hospitalisation have been reported in England and some other higher-income countries, but the reasons for this increase are unclear. We aimed to describe the extent of variations in involuntary annual hospitalisation rates between countries, to compare trends over time, and to explore whether variations in legislation, demographics, economics, and health-care provision might be associated with variations in involuntary hospitalisation rates. Methods: We compared annual incidence of involuntary hospitalisation between 2008 and 2017 (where available) for 22 countries across Europe, Australia, and New Zealand. We also obtained data on national legislation, demographic and economic factors (gross domestic product [GDP] per capita, prevalence of inequality and poverty, and the percentage of populations who are foreign born, members of ethnic minorities, or living in urban settings), and service characteristics (health-care spending and provision of psychiatric beds and mental health staff). Annual incidence data were obtained from government sources or published peer-reviewed literature. Findings: The median rate of involuntary hospitalisation was 106·4 (IQR 58·5 to 150·9) per 100 000 people, with Austria having the highest (282 per 100 000 individuals) and Italy the lowest (14·5 per 100 000 individuals) most recently available rates. We observed no relationship between annual involuntary hospitalisation rates and any characteristics of the legal framework. Higher national rates of involuntary hospitalisation were associated with a larger number of beds (β coefficient 0·65, 95% CI 0·10 to 1·20, p=0·021), higher GDP per capita purchasing power parity (β coefficient 1·84, 0·30 to 3·38, p=0·019), health-care spending per capita (β coefficient 15·92, 3·34 to 28·49, p=0·013), the proportion of foreign-born individuals in the population (β coefficient 7·32, 0·44 to 14·19, p=0·037), and lower absolute poverty (β coefficient -11·5, -22·6 to -0·3, p=0·044). There was no evidence of an association between annual involuntary hospitalisation incidence and any other demographic, economic, or health-care indicator. Interpretation: Variations between countries were large and for the most part unexplained. We found a higher annual incidence of involuntary hospitalisation to be associated with a lower rate of absolute poverty, with higher GDP and health-care spending per capita, a higher proportion of foreign-born individuals in a population, and larger numbers of inpatient beds, but limitations in ecological research must be noted, and the associations were weak. Other country-level demographic, economic, and health-care delivery indicators and characteristics of the legislative system appeared to be unrelated to annual involuntary hospitalisation rates. Understanding why involuntary hospitalisation rates vary so much could be advanced through a more fine-grained analysis of the relationships between involuntary hospitalisation and social context, clinical practice, and how legislation is implemented in practice. Funding: Commissioned by the Department of Health and funded by the National Institute of Health Research (NIHR) via the NIHR Mental Health Policy Research Unit.
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Background: Patient education has taken center stage in successfully shared decision making between patients and health care providers. However, little is known about how patients with bipolar disorder typically obtain information on their illness and the treatment options available to them. Objective: This study aimed to obtain the perspectives of patients with bipolar disorder and their family members on the preferred and most effectively used information channels on bipolar disorder and the available treatment options. Methods: We conducted nine focus groups in Montana, New Mexico, and California, in which we surveyed 84 individuals including patients with bipolar disorder and family members of patients with bipolar disorder. The participants were recruited using National Alliance on Mental Illness mailing lists and websites. Written verbatim responses to semistructured questionnaires were analyzed using summative content analysis based on grounded theory. Two annotators coded and analyzed the data on the sentence or phrase level to create themes. Relationships between demographics and information channel were also examined using the Chi-square and Fisher exact tests. Results: The focus group participants mentioned a broad range of information channels that were successfully used in the past and could be recommended for future information dissemination. The majority of participants used providers (74%) and internet-based resources (75%) as their main information sources. There was no association between internet use and basic demographics such as age or geographical region of the focus groups. Patients considered time constraints and the fast pace in which an overwhelming amount of information is often presented by the provider as major barriers to successful provider-patient interactions. If Web-based channels were used, the participants perceived information obtained through Web-based channels as more helpful than information received in the provider's office (P<.05). Conclusions: Web-based resources are increasingly used by patients with bipolar disorder and their family members to educate themselves about the disease and its treatment. Although provider-patient interactions are frequently perceived to be burdened with time constraints, Web-based information sources are considered reliable and helpful. Future research should explore how high-quality websites could be used to empower patients and improve provider-patient interactions with the goal of enhancing shared decision making between patients and providers.
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Background Health research is evolving to include patient stakeholders (patients, families and caregivers) as active members of research teams. Frameworks describing the conceptual foundations underlying this engagement and strategies detailing best practice activities to facilitate engagement have been published to guide these efforts. Objective The aims of this narrative review are to identify, quantify and summarize (a) the conceptual foundational principles of patient stakeholder engagement in research and (b) best practice activities to support these efforts. Search Strategy, Inclusion Criteria, Data Extraction and Synthesis We accessed a publicly available repository of systematically identified literature related to patient engagement in research. Two reviewers independently screened articles to identify relevant articles and abstracted data. Main Results We identified 990 potentially relevant articles of which 935 (94.4%) were excluded and 55 (5.6%) relevant. The most commonly reported foundational principles were “respect” (n = 25, 45%) and “equitable power between all team members” (n = 21, 38%). Creating “trust between patient stakeholders and researchers” was described in 17 (31%) articles. Twenty‐seven (49%) articles emphasized the importance of providing training and education for both patient stakeholder and researchers. Providing financial compensation for patient stakeholders’ time and expertise was noted in 19 (35%) articles. Twenty articles (36%) emphasized regular, bidirectional dialogue between patient partners and researchers as important for successful engagement. Discussion and Conclusions Engaging patient stakeholders in research as partners presents an opportunity to design, implement and disseminate patient‐centred research. This review creates an overarching foundational framework for authentic and sustainable partnerships between patient stakeholders and researchers.
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Stakeholder engagement is an important component of pragmatic trials seeking to improve mental health care in real-world settings. Models of stakeholder engagement outline the benefits of involving a diverse array of partners in all phases of research. This column describes a stakeholder engagement plan for a comparative-effectiveness pragmatic trial of a care navigator program to increase linkage between emergency departments and outpatient treatment at community mental health centers. Benefits of stakeholder engagement include meaningful input on program design and implementation, insights into balancing the need for flexibility among clinical sites while implementing the program with fidelity, and early discussions about program sustainability and dissemination.
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Introduction: Research has often been viewed as a passive process by which participants enroll in studies developed by researchers. It is becoming clearer that to understand the nuances of mood episodes and how to prevent them, we need to conduct large clinical trials that have the power to investigate moderators and mediators, or catalysts and mechanisms of change. MoodNetwork, the first online, patient-centered research community for individuals with mood disorders, aims to change the way that traditional research has been conducted by involving patients, their caregivers, and advocates in the process of research. The aim of this report is to share lessons learned from developing MoodNetwork. Methods: Participants enroll by completing a demographic survey and consent form. Once enrolled, participants are encouraged to complete optional surveys about their mood disorders and areas of research priority. Stakeholder and advocacy partners developed the website, web-based surveys, and recruitment materials. Results: MoodNetwork has enrolled 4103 participants to date. Of this sample, 96.9% report experiencing depression and 79.7% endorse symptoms of mania or hypomania. Participants rated reducing stigma and alleviating symptoms as their 2 largest research priorities. Recruitment has been slower than expected. Recruiting a diverse sample has been challenging, and this impacts the Network's ability to conduct comparative effectiveness research studies. Discussion: We discuss lessons learned from recruiting individuals with mood disorders to MoodNetwork, an innovative approach to conducting clinical trials. We identify and review 5 strategies for increasing enrollment as well as future directions.
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Plain English summary Including patient and public involvement (PPI) in health research is thought to improve research but it is hard to be clear exactly how it helps. This is because PPI takes many forms, is sometimes only token and is not always reported clearly. This makes it difficult to combine the evidence so that clear conclusions can be reached about the ingredients of successful PPI and what PPI achieves. Previous research that has tried to combine the evidence has led to several guidelines for researchers to use in setting up and reporting PPI. This paper was written jointly by researchers and PPI contributors as a reflection on our experiences. The aim was to add to the evidence, by giving detail about the use of PPI in a large randomised controlled trial and the effect it had. We were guided by published PPI reporting guidelines. The effects on the trial are shown in a table of changes made because of suggestions from the PPI group. A survey was used to ask PPI contributors and researchers about their experience and effects they had noticed. Three themes were noted: impact on the trial, the effect of involvement on individual researchers and group members, and group environment. The PPI work affected the trial in many ways, including changes to documents used in the trial and advice on qualitative data collection methods and analysis. Individuals reported positive effects, including enjoying being in the group, gaining confidence, and learning how to share views. Abstract Background Patient and public involvement (PPI) is believed to enhance health care delivery research, and is widely required in research proposals. Detailed, standardised reporting of PPI is needed so that strategies to implement more than token PPI that achieves impact can be identified, properly evaluated and reproduced. Impact includes effects on the research, PPI contributors and researchers. Using contributor and researcher perspectives and drawing on published guidelines for reporting PPI, we aimed to reflect on our experience and contribute evidence relevant to two important questions: ‘What difference does PPI make?’ and ‘What’s the best way to do it?’ Methods Fourteen people living with multiple long-term conditions (multimorbidity) were PPI contributors to a randomised controlled trial to improve care for people with multimorbidity. Meetings took place approximately four times a year throughout the trial, beginning at grant application stage. Meeting notes were recorded and a log of PPI involvement was kept. At the end of the trial, seven PPI contributors and four researchers completed free-text questionnaires about their experience of PPI involvement and their perception of PPI impact. The responses were analysed thematically by two PPI contributors and one researcher. The PPI group proposed writing this report, which was co-authored by three PPI contributors and two researchers. Results Meeting attendance averaged nine PPI contributors and three to four researchers. The involvement log and meeting notes recorded a wide range of activities and impact including changes to participant documentation, advice on qualitative data collection, contribution to data analysis and dissemination advice. Three themes were identified from the questionnaires: impact on the study, including keeping the research grounded in patient experience; impact on individuals, including learning from group diversity and feeling valued; and an environment that facilitated participation. The size of the group influenced impact. Researchers and PPI contributors described a rewarding interaction that benefitted them and the research. Conclusions PPI was wide-ranging and had impact on the trial, contributors and researchers. The group environment facilitated involvement. Feedback and group interactions benefitted individuals. The insights gained from this study will postitively influence the researchers’ and contributors’ future involvement with PPI.
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Objectives While documented plans for patient and public involvement (PPI) in research are required in many grant applications, little is known about how frequently PPI occurs in practice. Low levels of reported PPI may mask actual activity due to limited PPI reporting requirements. This research analysed the frequency and types of reported PPI in the presence and absence of a journal requirement to include this information. Design and setting A before and after comparison of PPI reported in research papers published in The BMJ before and 1 year after the introduction of a journal policy requiring authors to report if and how they involved patients and the public within their papers. Results Between 1 June 2013 and 31 May 2014, The BMJ published 189 research papers and 1 (0.5%) reported PPI activity. From 1 June 2015 to 31 May 2016, following the introduction of the policy, The BMJ published 152 research papers of which 16 (11%) reported PPI activity. Patients contributed to grant applications in addition to designing studies through to coauthorship and participation in study dissemination. Patient contributors were often not fully acknowledged; 6 of 17 (35%) papers acknowledged their contributions and 2 (12%) included them as coauthors. Conclusions Infrequent reporting of PPI activity does not appear to be purely due to a failure of documentation. Reporting of PPI activity increased after the introduction of The BMJ’s policy, but activity both before and after was low and reporting was inconsistent in quality. Journals, funders and research institutions should collaborate to move us from the current situation where PPI is an optional extra to one where PPI is fully embedded in practice throughout the research process.
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Objectives: As part of a series of Patient-Centered Outcomes Research Institute-funded large-scale retrospective observational studies on bipolar disorder (BD) treatments and outcomes, we sought the input of patients with BD and their family members to develop research questions. We aimed to identify systemic root causes of patient-reported challenges with BD management in order to guide subsequent studies and initiatives. Methods: Three focus groups were conducted where patients and their family members (total n = 34) formulated questions around the central theme, "What do you wish you had known in advance or over the course of treatment for BD?" In an affinity mapping exercise, participants clustered their questions and ranked the resulting categories by importance. The research team and members of our patient partner advisory council further rated the questions by expected impact on patients. Using a Theory of Constraints systems thinking approach, several causal models of BD management challenges and their potential solution were developed with patients using the focus group data. Results: A total of 369 research questions were mapped to 33 categories revealing 10 broad themes. The top priorities for patient stakeholders involved pharmacotherapy and treatment alternatives. Analysis of causal relationships underlying 47 patient concerns revealed two core conflicts: for patients, whether or not to take pharmacotherapy, and for mental health services, the dilemma of care quality vs quantity. Conclusions: To alleviate the core conflicts identified, BD management requires a coordinated multidisciplinary approach including: improved access to mental health services, objective diagnostics, sufficient provider visit time, evidence-based individualized treatment, and psychosocial support.
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Background: The 2012 National Survey of Peer-Run Organizations is one of the first to survey a nationally representative sample of mental health peer-run organizations, nonprofit venues for support and advocacy which are defined by people with psychiatric histories being in positions of authority and control. Objectives: This paper describes data collection methods and demonstrates how participatory strategies to involve people with psychiatric histories intersected with Internet research to achieve study aims. Methods: People with psychiatric histories were involved in designing and implementing a web-based survey to collect data on peer-run organizations' operations and views on national policy. Participatory approaches were used throughout design, data collection analysis, and dissemination. Conclusions: The extensive involvement of people with psychiatric histories in project design and implementation were important strategies that contributed to this study's success.
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Purpose: Since 2012, PCORI has been funding patient-centered comparative effectiveness research with a requirement for engaging patients and other stakeholders in the research, a requirement that is unique among the US funders of clinical research. This paper presents PCORI's evaluation framework for assessing the short- and long-term impacts of engagement; describes engagement in PCORI projects (types of stakeholders engaged, when in the research process they are engaged and how they are engaged, contributions of their engagement); and identifies the effects of engagement on study design, processes, and outcomes selection, as reported by both PCORI-funded investigators and patient and other stakeholder research partners. Methods: Detailed quantitative and qualitative information collected annually from investigators and their partners was analyzed via descriptive statistics and cross-sectional qualitative content and thematic analysis, and compared against the outcomes expected from the evaluation framework and its underlying conceptual model. Results: The data support the role of engaged research partners in refinements to the research questions, selection of interventions to compare, choice of study outcomes and how they are measured, contributions to strategies for recruitment, and ensuring studies are patient-centered. Conclusions: The evaluation framework and the underlying conceptual model are supported by results to date. PCORI will continue to assess the effects of engagement as the funded projects progress toward completion, dissemination, and uptake into clinical decision making.
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Purpose: Engaging patients, caregivers, and other health care stakeholders as partners in planning, conducting, and disseminating research is a promising way to improve clinical decision making and outcomes. Many researchers, patients, and other stakeholders, however, lack clarity about when and how to engage as partners within the clinical research process. To address the need for guidance on creating meaningful stakeholder partnerships in patient-centered clinical comparative effectiveness research, the Patient-Centered Outcomes Research Institute (PCORI) developed the PCORI Engagement Rubric (Rubric). Methods: PCORI developed the Rubric drawing from a synthesis of the literature, a qualitative study with patients, a targeted review of engagement plans from PCORI-funded project applications, and a moderated discussion and review with PCORI's Advisory Panel on Patient Engagement. Results: The Rubric provides a framework for operationalizing engagement to incorporate patients and other stakeholders in all phases of research. It includes: principles of engagement; definitions of stakeholder types; key considerations for planning, conducting, and disseminating engaged research; potential engagement activities; and examples of promising practices from PCORI-funded projects. Conclusions: PCORI designed the Rubric to illustrate opportunities for engagement to researchers interested in applying for PCORI funding and to patients and other stakeholders interested in greater involvement in research. By encouraging PCORI applicants, awardees, and others to apply the rubric, PCORI hopes to shift the research paradigm from one of conducting research on patients as subjects to a pursuit carried out in collaboration with patients and other stakeholders to better reflect the values, preferences, and outcomes that matter to the patient community.
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Plain English summary Involving people in health research is increasingly recognised as being important to make sure that research is focused more on the needs of people who use health services. At present, ideas about what should be researched most often comes from researchers and/or health professionals like doctors and nurses rather than people with a lived experience of mental illness. In this study, we will talk with this group of people from across Wales to explore what they think research into their health services should focus on. The findings from this work will help to influence the work of the National Centre for Mental Health Research Partnership Group; as well as` researchers and health professionals and others who concentrate on mental health research. The Research group is a partnership between people with a lived experience of mental ill health and professionals with an interest in mental ill health. The group plan to take forward the ideas that came from this research and some of the ideas have already been used to increase funding in the area of mental health research. Abstract Background This paper is the result of continued collaboration between members of the Service User and Carer Research Partnership, based in Wales and supported by the National Centre for Mental Health, Health and Care Research Wales, and Hafal. The aim of this study was to explore the research priorities of people with experience of mental health services which include people with a lived experience of mental ill health, their carers, and professionals. Method A nominal group technique was used to gather data. A one-day workshop ‘Getting Involved in Research: Priority Setting’ was held to gather the ideas and suggestions for research priorities from people who have experience of mental health services. Results Twenty-five participants attended the workshop. 5 were mental health professionals, 20 had a lived experience of mental ill health, (of which 3 were also carers). 11 were male and 14 were female. 120 research ideas were generated across 6 ‘Ideas Generating Workstations’. Participants took part in a 3 stage vote to narrow down the ideas to 2 main research priorities. Conclusion The two main research priority areas that were identified:‘Developing the knowledge of mental health issues amongst school-aged children’ as a vehicle to overcome stigma and discrimination, and to support young people to manage their own mental health. ‘Developing education as a tool for recovery’, for example by peer support. In addition, participants engaged in a notable discussion over the research priority: ‘How are carers supported during the recovery of the person for whom they care?’
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Importance: High-deductible health plans (HDHPs) have expanded under the Affordable Care Act and are expected to play a major role in the future of US health policy. The effects of modern HDHPs on chronically ill patients and adverse outcomes are unknown. Objective: To determine the association of HDHP with high-priority diabetes outpatient care and preventable acute complications. Design, setting, and participants: Controlled interrupted-time-series study using a large national health insurer database from January 1, 2003, to December 31, 2012. A total of 12 084 HDHP members with diabetes, aged 12 to 64 years, who were enrolled for 1 year in a low-deductible (≤$500) plan followed by 2 years in an HDHP (≥$1000) after an employer-mandated switch were included. Patients transitioning to HDHPs were propensity-score matched with contemporaneous patients whose employers offered only low-deductible coverage. Low-income (n = 4121) and health savings account (HSA)-eligible (n = 1899) patients with diabetes were subgroups of interest. Data analysis was performed from February 23, 2015, to September 11, 2016. Exposures: Employer-mandated HDHP transition. Main outcomes and measures: High-priority outpatient visits, disease monitoring tests, and outpatient and emergency department visits for preventable acute diabetes complications. Results: In the 12 084 HDHP members included after the propensity score match, the mean (SD) age was 50.4 (10.0) years; 5410 of the group (44.8%) were women. The overall, low-income, and HSA-eligible diabetes HDHP groups experienced increases in out-of-pocket medical expenditures of 49.4% (95% CI, 40.3% to 58.4%), 51.7% (95% CI, 38.6% to 64.7%), and 67.8% (95% CI, 47.9% to 87.8%), respectively, compared with controls in the year after transitioning to HDHPs. High-priority primary care visits and disease monitoring tests did not change significantly in the overall HDHP cohort; however, high-priority specialist visits declined by 5.5% (95% CI, -9.6% to -1.5%) in follow-up year 1 and 7.1% (95% CI, -11.5% to -2.7%) in follow-up year 2 vs baseline. Outpatient acute diabetes complication visits were delayed in the overall and low-income HDHP cohorts at follow-up (adjusted hazard ratios, 0.94 [95% CI, 0.88 to 0.99] for the overall cohort and 0.89 [95% CI, 0.81 to 0.98] for the low-income cohort). Annual emergency department acute complication visits among HDHP members increased by 8.0% (95% CI, 4.6% to 11.4%) in the overall group, 21.7% (95% CI, 14.5% to 28.9%) in the low-income group, and 15.5% (95% CI, 10.5% to 20.6%) in the HSA-eligible group. Conclusions and relevance: Patients with diabetes experienced minimal changes in outpatient visits and disease monitoring after an HDHP switch, but low-income and HSA-eligible HDHP members experienced major increases in emergency department visits for preventable acute diabetes complications.
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Latinos with serious mental illness get sick and die much younger than other adults. In this paper, we review findings of a community based participatory research project meant to identify important healthcare needs, barriers to these needs, solutions to the barriers, and the promise of peer navigators as a solution. Findings from focus groups reflected general concerns of people with mental illness (e.g., insurance, engagement, accessibility) and Latinos with serious mental illness (e.g., immigration, language, and family). Feedback and analyses especially focused on the potential of peer navigators. Implications of these findings for integrated care of Latinos with serious mental illness are discussed.
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Background Among the unique features of the Rare Diseases Clinical Research Network (RDCRN) Program is the requirement for each Consortium to include patient advocacy groups (PAGs) as research partners. This development has transformed the work of the RDCRN and is a model for collaborative research. This article outlines the roles patients and PAGs play in the RDCRN and reports on the PAGs’ impact on the Network’s success. Methods Principal Investigators from the 17 RDCRN Consortia and 28 representatives from 76 PAGs affiliated with these Consortia were contacted by email to provide feedback via an online RDCRN survey. Impact was measured in the key areas of 1) Research logistics; 2) Outreach and communication; and 3) Funding and in-kind support. Rating choices were: 1-very negative, 2-somewhat negative, 3-no impact, 4-somewhat positive, and 5-very positive. Results Twenty-seven of the PAGs (96 %) disseminate information about the RDCRN within the patient community. The Consortium Principal Investigators also reported high levels of PAG involvement. Sixteen (94 %) Consortium Principal Investigators and 25 PAGs (89 %) reported PAGs participation in protocol review, study design, Consortium conference calls, attending Consortium meetings, or helping with patient recruitment. Conclusions PAGs are actively involved in shaping Consortia’s research agendas, help ensure the feasibility and success of research protocols by assisting with study design and patient recruitment, and support training programs. This extensive PAG-Investigator partnership in the RDCRN has had a strongly positive impact on the success of the Network.
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A fundamental feature of community-based participatory research (CBPR) is sharing findings with community members and engaging community partners in the dissemination process. To be truly collaborative, dissemination should involve community members in a two-way dialogue about new research findings. Yet little literature describes how to engage communities in dialogue about research findings, especially with historically marginalized communities where mistrust of researchers may exist because of past or present social injustices. Through a series of interactive community presentations on findings from a longitudinal study, we developed a process for community dissemination that involved several overlapping phases: planning, outreach, content development, interactive presentations, and follow-up. Through this process, we built on existing and new community relationships. Following each interactive presentation, the research team debriefed and reviewed notes to identify lessons learned from the process. Key themes included the importance of creating a flexible dissemination plan, tailoring presentations to each community group, establishing a point person to serve as a community liaison, and continuing dialogue with community members after the presentations. Core strategies for developing trust during dissemination included engaging community members at every step, reserving ample time for discussion during presentations, building rapport by sharing personal experiences, being receptive to and learning from criticism, and implementing input from community members. This process led to a deeper understanding of research findings and ensured that results reached community members who were invested in them.
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BACKGROUND: Despite the rapid growth in the sophistication of research on bipolar disorder (BD), the field faces challenges in improving quality of life (QoL) and symptom outcomes, adapting treatments for marginalized communities, and disseminating research insights into real-world practice. Community-based participatory research (CBPR)-research that is conducted as a partnership between researchers and community members-has helped address similar gaps in other health conditions. This paper aims to improve awareness of the potential benefits of CBPR in BD research. METHODS: This paper is a product of the International Society for Bipolar Disorders (ISBD) Taskforce on Community Engagement which includes academic researchers, healthcare providers, people with lived experience of BD, and stakeholders from BD community agencies. Illustrative examples of CBPR in action are provided from two established centres that specialize in community engagement in BD research: the Collaborative RESearch Team to study psychosocial issues in BD (CREST.BD) in Canada, and the Spectrum Centre for Mental Health Research in the United Kingdom. RESULTS AND DISCUSSION: We describe the philosophy of CBPR and then introduce four core research areas the BD community has prioritized for research: new treatment approaches, more comprehensive outcome assessments, tackling stigma, and enhanced understanding of positive outcomes. We then describe ways in which CBPR is ideal for advancing each of these research areas and provide specific examples of ways that CBPR has already been successfully applied in these areas. We end by noting potential challenges and mitigation strategies in the application of CBPR in BD research. CONCLUSIONS: We believe that CBPR approaches have significant potential value for the BD research community. The observations and concerns of people with BD, their family members, and supports clearly represent a rich source of information. CBPR approaches provide a collaborative, equitable, empowering orientation to research that builds on the diversity of strengths amongst community stakeholders. Despite the potential merits of this approach, CBPR is as yet not widely used in the BD research field, representing a missed opportunity.
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Objective Patient-centered clinical trial design and execution is becoming increasingly important. No best practice guidelines exist despite a key stakeholder declaration to create more effective engagement models. This study aims to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed. Methods Individuals from industry, academic institutions, and patient groups were identified through Clinical Trials Transformation Initiative and Drug Information Association rosters and mailing lists. Objectives, practices, and perceived barriers related to engaging patient groups in the planning, conduct, and interpretation of clinical trials were reported in an online survey. Descriptive and inferential statistical analysis of survey data followed a literature review to inform survey questions. Results Survey respondents (n = 179) valued the importance of involving patient groups in research; however, patient group respondents valued their contributions to research protocol development, funding acquisition, and interpretation of study results more highly than those contributions were valued by industry and academic respondents (all p < .001). Patient group respondents placed higher value in open communications, clear expectations, and detailed contract execution than did non–patient group respondents (all p < .05). Industry and academic respondents more often cited internal bureaucratic processes and reluctance to share information as engagement barriers than did patient group respondents (all p < .01). Patient groups reported that a lack of transparency and understanding of the benefits of collaboration on the part of industry and academia were greater barriers than did non–patient group respondents (all p< .01). Conclusions Despite reported similarities among approaches to engagement by the three stakeholder groups, key differences exist in perceived barriers and benefits to partnering with patient groups among the sectors studied. This recognition could inform the development of best practices for patient-centered clinical trial design and execution. Additional research is needed to define and optimize key success factors.
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Patients and healthcare stakeholders are increasingly becoming engaged in the planning and conduct of biomedical research. However, limited research characterizes this process or its impact. We aimed to characterize patient and stakeholder engagement in the 50 Pilot Projects funded by the Patient-Centered Outcomes Research Institute (PCORI), and identify early contributions and lessons learned. A self-report instrument was completed by researchers between 6 and 12 months following project initiation. Forty-seven principal investigators or their designees (94 % response rate) participated in the study. MAIN MEASURES Self-report of types of stakeholders engaged, stages and levels of engagement, facilitators and barriers to engagement, lessons learned, and contributions from engagement were measured. Most (83 %) reported engaging more than one stakeholder in their project. Among those, the most commonly reported groups were patients (90 %), clinicians (87 %), health system representatives (44 %), caregivers (41 %), and advocacy organizations (41 %). Stakeholders were commonly involved in topic solicitation, question development, study design, and data collection. Many projects engaged stakeholders in data analysis, results interpretation, and dissemination. Commonly reported contributions included changes to project methods, outcomes or goals; improvement of measurement tools; and interpretation of qualitative data. Investigators often identified communication and shared leadership strategies as "critically important" facilitators (53 and 44 % respectively); lack of stakeholder time was the most commonly reported challenge (46 %). Most challenges were only partially resolved. Early lessons learned included the importance of continuous and genuine partnerships, strategic selection of stakeholders, and accommodation of stakeholders' practical needs. PCORI Pilot Projects investigators report engaging a variety of stakeholders across many stages of research, with specific changes to their research attributed to engagement. This study identifies early lessons and barriers that should be addressed to facilitate engagement. While this research suggests potential impact of stakeholder engagement, systematic characterization and evaluation of engagement at multiple stages of research is needed to build the evidence base.
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Inclusion of the patient perspective in research need not, and must not, reduce the rigor of the research. Patient input informs the design of research components that are already a standard part of studies, such as inclusion/exclusion criteria, comparators, and outcomes. The special training and skill set of researchers guide the approaches to study design, data collection, and analysis, just as the experience and perspectives of patients, clinicians, and other stakeholders help to make the research more patient-centered and relevant to health care decisions. Physician input is needed because patient-centered outcomes research is intended to influence clinical practice. There are practical reasons to incorporate patient-centeredness in research, including improved choice of research questions and improved selection and refinement of outcomes through elicitation of stakeholder perspectives, enhanced accrual and participant retention strategies, and more appropriate dissemination and implementation strategies for findings. The promise of speeding implementation is particularly salient for PCORI, which has a legislative mandate to improve practice and reduce practice variation and disparities. PCORI proposals must include an implementation plan. Clinicians have a role in putting results into practice and should be aware of the intention of patient-centered research to enhance relevance and, ideally, trust in results by those who use them.
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The era of big data, loosely defined as the development and analysis of large or complex data sets, brings new opportunities to empower patients and their families to generate, collect, and use their health information for both clinical and research purposes. In 2013 the Patient-Centered Outcomes Research Institute launched a large national research network, PCORnet, that includes both clinical and patient-powered research networks. This article describes these networks, their potential uses, and the challenges they face. The networks are engaging patients, family members, and caregivers in four key ways: contributing data securely, with privacy protected; including diverse and representative groups of patients in research; prioritizing research questions, participating in research, and disseminating results; and participating in the leadership and governance of patient-powered research networks. If technical, regulatory, and organizational challenges can be overcome, PCORnet will allow research to be conducted more efficiently and cost-effectively and results to be disseminated quickly back to patients, clinicians, and delivery systems to improve patient health.
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OBJECTIVES We conducted a review of the peer-reviewed literature since 2003 to catalogue reported methods of stakeholder engagement in comparative effectiveness research and patient-centered outcomes research. METHODS AND RESULTS We worked with stakeholders before, during and after the review was conducted to: define the primary and key research questions; conduct the literature search; screen titles, abstracts and articles; abstract data from the articles; and analyze the data. The literature search yielded 2,062 abstracts. The review was conducted on 70 articles that reported on stakeholder engagement in individual research projects or programs. FINDINGS Reports of stakeholder engagement are highly variable in content and quality. We found frequent engagement with patients, modestly frequent engagement with clinicians, and infrequent engagement with stakeholders in other key decision-making groups across the healthcare system. Stakeholder engagement was more common in earlier (prioritization) than in later (implementation and dissemination) stages of research. The roles and activities of stakeholders were highly variable across research and program reports. RECOMMENDATIONS To improve on the quality and content of reporting, we developed a 7-Item Stakeholder Engagement Reporting Questionnaire. We recommend three directions for future research: 1) descriptive research on stakeholder-engagement in research; 2) evaluative research on the impact of stakeholder engagement on the relevance, transparency and adoption of research; and 3) development and validation of tools that can be used to support stakeholder engagement in future work.
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Objective: In January 2006 insurance coverage for medications shifted from Medicaid to Medicare Part D private drug plans for the six million individuals enrolled in both programs. Dual beneficiaries faced new formularies and utilization management policies. It is unclear whether Part D, compared with Medicaid, relaxed or tightened psychiatric medication management, which could affect receipt of recommended pharmacotherapy, and emergency department use related to treatment discontinuities. This study examined the impact of the transition from Medicaid to Part D on guideline-concordant pharmacotherapy for bipolar I disorder and emergency department use. Methods: Using interrupted-time-series analysis and Medicaid and Medicare administrative data from 2004 to 2007, the authors analyzed the effect of the coverage transition on receipt of guideline-concordant antimanic medication, guideline-discordant antidepressant monotherapy, and emergency department visits for a nationally representative continuous cohort of 1,431 adults with diagnosed bipolar I disorder. Results: Sixteen months after the transition to Part D, the proportion of the population with any recommended use of antimanic drugs was an estimated 3.1 percentage points higher than expected once analyses controlled for baseline trends. The monthly proportion of beneficiaries with seven or more days of antidepressant monotherapy was 2.1 percentage points lower than expected. The number of emergency department visits per month temporarily increased by 19% immediately posttransition. Conclusions: Increased receipt of guideline-concordant pharmacotherapy for bipolar I disorder may reflect relatively less restrictive management of antimanic medications under Part D. The clinical significance of the change is unclear, given the small effect sizes. However, increased emergency department visits merit attention for the Medicaid beneficiaries who continue to transition to Part D.
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Involving service users in research improves its quality and relevance. Many research organizations funding and supporting research now ask researchers about involvement as part of their application process. Some researchers are facing challenges in taking forward involvement as the research infrastructure is not always facilitative. Researchers need greater reward and recognition for carrying out good quality involvement to encourage more effective processes.
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This column describes a process for adapting an evidence-based practice in community clinics in which researchers and community providers participated and the resulting framework for implementation of the practice-Replicating Effective Programs-Facilitation. A two-day meeting for the Recovery-Oriented Collaborative Care study was conducted to elicit input from more than 50 stakeholders, including community providers, health care administrators, and implementation researchers. The process illustrates an effective researcher-community partnership in which stakeholders worked together not only to adapt the evidence-based practice to the needs of the clinical settings but also to develop the implementation strategy.
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Community-based research in public health focuses on social, structural, and physical environmental inequities through active involvement of community members, organizational representatives, and researchers in all aspects of the research process. Partners contribute their expertise to enhance understanding of a given phenomenon and to integrate the knowledge gained with action to benefit the community involved. This review provides a synthesis of key principles of community-based research, examines its place within the context of different scientific paradigms, discusses rationales for its use, and explores major challenges and facilitating factors and their implications for conducting effective community-based research aimed at improving the public's health.
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Objective: High-deductible health plans (HDHPs) require substantial out-of-pocket spending for most services, although medications may be subject to traditional copayment arrangements. This study examined effects of HDHPs on medication out-of-pocket spending and use and quality of care among individuals with bipolar disorder. Methods: This quasi-experimental study used claims data (2003-2014) for a national sample of 3,532 members with bipolar disorder, ages 12-64, continuously enrolled for 1 year in a low-deductible plan (≤$500) and then for 1 year in an HDHP (≥$1,000) after an employer-mandated switch. HDHP members were matched to 18,923 contemporaneous individuals in low-deductible plans (control group). Outcome measures were out-of-pocket spending and use of bipolar disorder medications, psychotropics for other disorders, and all other medications and appropriate laboratory monitoring for psychotropics. Results: Relative to the control group, annual out-of-pocket spending per person for bipolar disorder medications increased 20.8% among HDHP members (95% confidence interval [CI]=14.9%-26.7%), and the absolute increase was $36 (95% CI=$25.9-$45.2). Specifically, out-of-pocket spending increased for antipsychotics (27.1%; 95% CI=17.4%-36.7%) and anticonvulsants (19.2%; 95% CI=11.9%-26.6%) but remained stable for lithium (-3.7%; 95% CI=-12.2% to 4.8%). No statistically significant changes were detected in use of bipolar disorder medications, other psychotropics, or all other medications or in appropriate laboratory monitoring for bipolar disorder medications. Conclusions: HDHP members with bipolar disorder experienced a moderate increase in out-of-pocket spending for medications but preserved bipolar disorder medication use. Findings may reflect individuals' perceptions of the importance of these medications for their functioning and well-being.
Article
Background: Cost-sharing disproportionately affects people with chronic illnesses needing more care. Our qualitative study examined lived experiences navigating insurance benefits and treatment for bipolar disorder, which requires ongoing access to behavioral specialists and psychotropic medications. Methods: Forty semi-structured telephone interviews with individuals with bipolar disorder and employer-sponsored health insurance, or their family caregivers, explored health care needs, coverage details, out-of-pocket (OOP) costs, and perspectives on value. An iterative analytic approach identified salient themes. Results: Most individuals in our sample faced an annual insurance deductible, from $350-$10,000. OOP costs for specialist visits ranged from $0-$450 and for monthly psychotropic medications from $0-$1650. Acute episodes and care for comorbidities, including medication side effects, added to cost burdens. Medication nonadherence due to OOP costs was rare; respondents frequently pointed to the necessity of medications: “whatever it takes to get those”; “it's a life or death situation.” Respondents also prioritized visits to psychiatrist prescribers, though visits were maximally spaced because of cost. Psychotherapy was often deemed unaffordable and forgone, despite perceived need. Interviewees cited limited networks and high out-of-network costs as barriers to specialists. Cost-sharing sometimes led to debt, skimping on nonbehavioral care or other necessities, exacerbated or prolonged mood symptoms, and stress at home. Limitations: Volunteer respondents may not fully represent the target population. Conclusions: Many people with bipolar disorder in US employer-sponsored plans experience undertreatment, hardship, and adverse health consequences due to high cost-sharing. More nuanced insurance benefit designs should accommodate the needs of individuals with complex conditions.
Article
Objectives: To determine the impact of high-deductible health plans (HDHPs) on health care use among individuals with bipolar disorder. Study design: Interrupted time series with propensity score-matched control group design, using a national health insurer's claims data set with medical, pharmacy, and enrollment data. Methods: The intervention group was composed of 2862 members with bipolar disorder who were enrolled for 1 year in a low-deductible (≤$500) plan and then 1 year in an HDHP (≥$1000) after an employer-mandated switch. HDHP members were propensity score matched 1:3 to contemporaneous controls in low-deductible plans. The main outcomes included out-of-pocket spending per health care service, mental health-related outpatient visits (subclassified as visits to nonpsychiatrist mental health providers and to psychiatrists), emergency department (ED) visits, and hospitalizations. Results: Mean pre- to post-index date out-of-pocket spending per visit on all mental health office visits, nonpsychiatrist mental health provider visits, and psychiatrist visits increased by 21.9% (95% CI, 15.1%-28.6%), 33.8% (95% CI, 2.0%-65.5%), and 17.8% (95% CI, 12.2%-23.4%), respectively, among HDHP vs control members. The HDHP group experienced a -4.6% (95% CI, -11.7% to 2.5%) pre- to post change in mental health outpatient visits relative to controls, a -10.9% (95% CI, -20.6% to -1.3%) reduction in nonpsychiatrist mental health provider visits, and unchanged psychiatrist visits. ED visits and hospitalizations were also unchanged. Conclusions: After a mandated switch to HDHPs, members with bipolar disorder experienced an 11% decline in visits to nonpsychiatrist mental health providers but unchanged psychiatrist visits, ED visits, and hospitalizations. HDHPs do not appear to have a "blunt instrument" effect on health care use in bipolar disorder; rather, patients might make trade-offs to preserve important care.
Article
Participatory research, in which people with lived experience of the study phenomenon are involved as collaborators, has been conducted for decades; however, these innovations have struggled to take hold in mental health settings—until recently. The slow uptake of community partnered research in mental health has been unfortunate, especially because this field already suffers from poor community relations, pervasive community mistrust, and racial and ethnic disparities. But now, people with lived experience of severe mental illness—long considered to be “incapable” of functioning as co-researchers—are beginning to be included on research teams. However, training and opportunities for conducting such work are still lacking. This report describes a two-year initiative to improve the quality and quantity of participatory research being conducted in a department of psychiatry at a large medical school, which culminated in an innovative training program for both researchers and patients, developed in direct collaboration with stakeholders. In addition to detailing this program, we also discuss the deep legacy of mental health mistrust and our own efforts to address issues of social justice and health equity.
Article
Background: Mood disorders (MDs) are pervasive and debilitating psychiatric conditions. Many helpful psychological and psychopharmacological treatments exist, but MD's prevalence and chronicity often means relying purely on professional care can create financial strain on individuals and healthcare systems. Also, many individuals respond only partially to professionally-delivered medical/pharmacological interventions or are unable to tolerate or adhere to them. Peer-led mutual-help organizations (MHOs) have emerged and grown in the U.S. to extend and potentiate professional efforts or otherwise address needs unmet by professional care. The Depression and Bipolar Support Alliance (DBSA) is the largest of these, but beyond observational evidence, little is known about participation or benefits. Greater knowledge could inform the field regarding clinical and public health utility of peer-driven efforts. Method: Community-based cross-sectional comparative investigation of MD individuals attending (N = 202) or not attending (N = 105) DBSA. Measures included demographics, clinical characteristics and clinical service use, and indices of symptomatology, functioning, quality of life (QOL), and psychological well-being. Results: Compared to non-DBSA participants, DBSA participants were more likely to be male and white and trended toward greater religious affiliation (p = 0.05). DBSA participants attended meetings about twice per month with two-thirds attending for more than one year. The DBSA cohort had a much higher proportion with bipolar I disorder and reported more lifetime and past 90-day use of acute, intensive, medical services and medications. There were no between-group differences on indices of QOL or psychological well-being, but within the DBSA group, greater DBSA attendance and involvement was associated with greater QOL and well-being, and less functional impairment. Limitations: Cross-sectional design and regional sampling frame with unknown generalizability to national DBSA membership. Conclusion: Given the grave impact of MDs and that DBSA is freely available it may fill an important clinical and public health need by attracting and engaging MD individuals with greater functional instability and impairment. The positive association found between greater active DBSA participation and improvements in functioning and well-being, while promising, requires longitudinal investigation to formally establish the causal direction of effects.
Article
Objective: Patient-powered research networks (PPRNs) are a valuable source of patient-generated information. Diagnosis code-based algorithms developed by PPRNs can be used to query health plans' claims data to identify patients for research opportunities. Our objective was to implement privacy-preserving record linkage processes between PPRN members' and health plan enrollees' data, compare linked and nonlinked members, and measure disease-specific confirmation rates for specific health conditions. Materials and methods: This descriptive study identified overlapping members from 4 PPRN registries and 14 health plans. Our methods for the anonymous linkage of overlapping members used secure Health Insurance Portability and Accountability Act-compliant, 1-way, cryptographic hash functions. Self-reported diagnoses by PPRN members were compared with claims-based computable phenotypes to calculate confirmation rates across varying durations of health plan coverage. Results: Data for 21 616 PPRN members were hashed. Of these, 4487 (21%) members were linked, regardless of any expected overlap with the health plans. Linked members were more likely to be female and younger than nonlinked members were. Irrespective of duration of enrollment, the confirmation rates for the breast or ovarian cancer, rheumatoid or psoriatic arthritis or psoriasis, multiple sclerosis, or vasculitis PPRNs were 72%, 50%, 75%, and 67%, increasing to 91%, 67%, 93%, and 80%, respectively, for members with ≥5 years of continuous health plan enrollment. Conclusions: This study demonstrated that PPRN membership and health plan data can be successfully linked using privacy-preserving record linkage methodology, and used to confirm self-reported diagnosis. Identifying and confirming self-reported diagnosis of members can expedite patient selection for research opportunities, shorten study recruitment timelines, and optimize costs.
Article
Objective: To evaluate patient-reported determinants of treatment effectiveness and tolerability amongst persons with major depressive or bipolar disorders. Methods: The Depression and Bipolar Support Alliance (DBSA) conducted an online survey February 2016-April 2016 asking participants about which outcomes are most important in determining subjective treatment effectiveness and tolerability. Results: In total, 896 participants completed the survey [49.9% unipolar depression (n = 447) and 50.1% bipolar depression (n = 449)]. Survey respondents reported several previous medication trials with the minority (25% of depression and 29% of bipolar group) of respondents reporting that their current treatment plan was completely effective. When asked how they know that the treatment is working, for both groups, the highest rated response was, "I don't feel overly anxious, agitated or irritable." Weight gain was the adverse effect that most commonly led respondents to discontinue a medication. Lethargy, emotional blunting, shaking/trembling and anxiety were also identified as common treatment-emergent experiences leading to medication discontinuation in greater than one-third of respondents. The bipolar group more frequently identified several signs that suggested treatment was working (e.g., improved neurocognitive function, improved sleep), as well as more frequently reported several reasons to discontinue medications (e.g., weight gain, trembling). Conclusion: Numerous factors emerged as important to patients when evaluating treatment effectiveness and tolerability. Some of these factors are inadequately assessed by current standard clinical trial outcome measures. Considering these important patient-centred outcomes in future clinical trials, treatment guidelines and direct patient care may serve to improve patient satisfaction, quality of life and the therapeutic alliance.
Article
Objective: This study examined the association between a Medicaid prior-authorization policy for second-generation antipsychotic and anticonvulsant agents and medication discontinuation and health service use by patients with bipolar disorder. Methods: A pre-post design with a historical comparison group was used to analyze Maine Medicaid and Medicare claims data. A total of 946 newly treated patients were identified during the eight-month policy (July 2003-February 2004), and a comparison group of 1,014 was identified from the prepolicy period (July 2002-February 2003). Patients were stratified by number of visits to community mental health centers (CMHCs) before medication initiation (proxy for illness severity): CMHC attenders, at least two visits; nonattenders, fewer than two. Changes in rates of medication discontinuation and outpatient, emergency room, and hospital visits were estimated. Results: Compared with nonattenders, at baseline CMHC attenders had substantially higher rates of comorbid mental disorders and use of medications and health services. The policy was associated with increased medication discontinuation among attenders and nonattenders, reductions in mental health visits after discontinuation among attenders (-.64 per patient per month; p<.05), and increases in emergency room visits after discontinuation among nonattenders (.16 per patient per month; p<.05). During the eight-month policy period, the policy had no detectable impact on hospitalization risk. Conclusions: The prior-authorization policy was associated with increased medication discontinuation and subsequent changes in health service use. Although small, these unintended effects raise concerns about quality of care for a group of vulnerable patients. Long-term consequences of prior-authorization policies on patient outcomes warrant further investigation.
Article
Research increasingly means that patients, caregivers, health professionals, other stakeholders, and academic investigators work in partnership. This requires effective collaboration rooted in mutual respect, involvement of all participants, and good communication. Having conducted such partnered research over multiple projects, and having recently completed a project together funded by the Patient-Centered Outcomes Research Institute, we collaboratively developed a list of 12 lessons we have learned about how to ensure effective research partnerships. To foster a culture of mutual respect, hold early in-person meetings, with introductions focused on motivation, offer appropriate orientation for everyone, and maintain awareness of individual and project goals. To actively involve all team members, it is important to ensure sufficient funding for everyone's participation, to ask for and recognize diverse contributions, and to seek the input of quiet members. To facilitate good communication, teams should carefully consider labels, avoid jargon and acronyms, judiciously use homogeneous and heterogeneous subgroups, and keep progress visible. In offering pragmatic, actionable lessons we have learned through our separate and shared experiences, we hope to help foster more patient-centered research via productive and enjoyable research collaborations.
Article
Objective: The impact of a peer navigator program (PNP) on efforts to address the health needs of Latinos with serious mental illness was examined in a randomized controlled trial. Methods: Latinos with a serious mental illness (N=110) were randomly assigned to the PNP (integrated care with a peer navigator [PN]) or to a treatment-as-usual control group (integrated care without a PN) for one year. Data on service engagement (scheduled and received appointments) were assessed weekly, and self-reports of recovery, empowerment, and quality of life were collected at baseline and at four, eight, and 12 months. Results: Findings from group × trial analyses of covariance (ANCOVAs) found main and interaction effects for scheduled and achieved appointments, showing better engagement for the PNP group compared with the control group over the course of the study. Significant interactions were found for recovery, empowerment, and quality of life, showing greater improvement for the PNP group compared with the control group over year 1 of the study (multivariate ANCOVA; F=3.27, df=9 and 98, p<.01). Conclusions: In-the-field navigation by peers seems to enhance service engagement, recovery, and quality of life. Whether these results occurred because navigators helped overcome barriers to treatment-regardless of whether they were peers per se-needs to be examined in future research.
Article
In this commentary, we discuss the science of stakeholder engagement in research. We propose a classification system with definitions to determine where projects lie on the stakeholder engagement continuum. We discuss the key elements of implementation and evaluation of stakeholder engagement in research posing key questions to consider when doing this work. We commend and critique the work of Hamilton et al. in their multilevel stakeholder engagement in a VA implementation trial of evidence-based quality improvement in women’s health primary care. We also discuss the need for more work in this area to enhance the science of stakeholder engagement in research.
Article
Background: The aim of patient-centered comparative effectiveness research is to conduct stakeholder-driven investigations that identify which interventions are most effective for which patients under specific circumstances. Conducting this research in real-world settings comes with unique experiences and challenges. We provide the study design, challenges confronted, and the solutions we devised for Optimal Health, a stakeholder-informed patient-centered comparative effectiveness study focused on the needs of seriously mentally ill individuals receiving case management services in community mental health centers across Pennsylvania. Methods: Optimal Health, supported by the Patient-Centered Outcomes Research Institute, is a cluster-randomized trial of two evidence-based interventions for improving health and wellness across 11 provider sites. Participants were followed for 18-24 months, with repeated measurements of self-reported health status and activation in care and administrative measurements of primary and specialty health service utilization. Health-related quality of life, engagement in care, and service utilization are to be compared via random effects mixed models. Stakeholders were, and continue to be, engaged via focus groups, interviews, and stakeholder advisory board meetings. A learning collaborative model was used to support shared learning and implementation fidelity across provider sites. Results: From 1 November 2013 through 15 July 2014, we recruited 1229 adults with serious mental illness, representing 85.1% of those eligible for study participation. Of these, 713 are in the Provider-Supported arm of the study and 516 in Patient Self-Directed Care. Across five data collection time points, we retained 86% and 83% of the participants in the Provider-Supported and Self-Directed arms, respectively. Lessons learned: Lessons learned relate to estimation of the size of our study population, the value of multiple data sources, and intervention training and implementation. The use of historical claims data can lead to an overestimation of eligible participants and, subsequently, a reduced study sample and an imbalance between intervention arms. Disruptions in continuity of care in real-world settings can pose challenges to on-site self-report data collection, although the inclusion of multiple data sources in study design can improve data completeness. Geographic dispersion of rural provider sites and staff turnover can lead to training and intervention fidelity challenges that can be overcome with the use of a "train-the-trainer" model, "wellness champions," and the use of a Learning Collaborative approach. Stakeholder engagement in mitigating these challenges proved to be critical to study progress. Conclusion: Conducting real-world patient-centered comparative effectiveness research in healthcare systems that care for seriously mentally ill persons is an important yet challenging undertaking, one which requires flexibility in identifying potential adaptations within all major study phases. Advice from a wide range of stakeholders is critical in development of successful strategies.
Article
People with mental illness use more health care and have worse outcomes than those without such illnesses. In response to incentives to reduce spending, accountable care organizations (ACOs) may therefore attempt to improve their management of mental illness. We examined changes in mental health spending, utilization, and quality measures associated with ACO contracts in the Medicare Shared Savings Program and Pioneer model for beneficiaries with mental illness, using Medicare claims for the period 2008-13 and difference-in-differences comparisons with local non-ACO providers. Pioneer contracts were associated with lower spending on mental health admissions in the first year of the contract, an effect that was attenuated in the second year. Otherwise, ACO contracts were associated with no changes in mental health spending or readmissions, outpatient follow-up after mental health admissions, rates of depression diagnosis, or mental health status. These results suggest that ACOs have not yet focused on mental illness or have been largely unsuccessful in early efforts to improve their management of it.
Article
Background: The transition from Medicaid-only to dual Medicare/Medicaid coverage has the potential to reduce financial barriers to health care for patients with serious mental illness through increased coverage or expanded access to clinicians as their reimbursement increases. Aims: To estimate the effect of dual coverage after Medicaid enrollment during the required waiting period among adults with serious mental illness on health care use, overall and related to mental health and substance use disorders (MHSUD). Methods: Data include enrollment and claims from Medicaid and Medicare in Missouri and South Carolina, from January 2004 to December 2007. We used an interrupted time-series design to estimate the effect of dual coverage on average use of outpatient, emergency department (ED), and inpatient care/month. Results: After 12 months of dual coverage, the probability of outpatient care use increased in both states from 4% to 9%. In Missouri, the mean probability and frequency of ED visits, total and MHSUD related, increased by 21%-32%; the probability of all-cause and MHSUD-related inpatient admissions increased by 10% and 19%, respectively. In South Carolina, the mean probability of any inpatient admission increased by 27% and of any MHSUD-related inpatient admission by 42%. Discussion: The increase in use of outpatient care is consistent with the expected increase in coverage of, and payment for, outpatient services under dual coverage relative to Medicaid-only. Sustained increases in ED and inpatient admissions raise questions regarding the complexity of obtaining care under 2 programs, pent-up demand among beneficiaries pretransition, and the complementarity of outpatient and inpatient service use.
Article
Background: Little is known about the effect of the Affordable Care Act's (ACA) elimination of out-of-pocket costs for preventive services. This policy likely reduced out-of-pocket colonoscopy costs most for high-deductible health plan (HDHP) members. Objectives: Determine the ACA's impact on colorectal cancer screening among HDHP members. Research design: Pre-post with comparison group, constructed before and after the ACA. Subjects: We studied 2003-2012 administrative claims data of a large national health insurer. HDHP members had 1 year of low-deductible (≤$500) plan enrollment followed by 1 year of HDHP (≥$1000) enrollment after an employer-mandated switch; HDHP enrollment occurred fully after the ACA for 21,605 members and fully before the ACA for 106,609 members. We propensity score-matched contemporaneous low-deductible (≤$500) control group members to both the before-ACA and after-ACA HDHP groups. We examined the 1-year impact of the HDHP switch separately in the before-ACA and after-ACA study cohorts, then compared these changes to estimate ACA effects. Measures: Overall colorectal cancer screening, colonoscopy, and fecal-occult blood testing annual rates. Results: Before the ACA, colorectal cancer screening tests declined by 37/10,000 (-71, -4) among HDHP members versus controls; after the ACA, HDHP members experienced a nonsignificant increase in screening [+52/10,000 (-19,124)]. Corresponding changes in colonoscopy were -55/10,000 (-81, -29) before and +20/10,000 (-38, 78) after the ACA. Thus, the ACA was associated with increased colorectal cancer screening rates [+89/10,000 (11, 168); relative: +9.1% (0.5-17.8)] and screening colonoscopies [+75/10,000 (12-139); relative: +16.4% (2.5-30.3)] among HDHP members. Conclusion: The ACA was associated with improved colorectal cancer screening among HDHP members.
Article
In developing the interview guide for the focus groups and the issue book for the forums, we sought input from our Community Advisory Board (CAB), a 12-member group consisting of community advocates, members of the clergy, community-based clinicians, local college students, and persons living with mental illness. We asked the CAB to help us write a definition of mental illness that would be understood by community members. CAB members told us we needed to step back and consider the term mental illness itself. CAB members considered mental illness a negative term and preferred the more positive term emotional wellness. CAB members pointed out that mental carries a negative, stigmatizing connotation, even when used to refer to good mental health. The CAB felt that emotional wellness implied a more holistic state of health that could speak to the community’s view of physical, spiritual, and mental health as interconnected. After engaging in this discussion and agreeing on a common terminology, we then were able to move on to define the term emotional un-wellness. Had we not understood and been sensitive to the language of the community, we would have risked alienating rather than engaging community members. From this pilot study, we learned that community members and leaders 1) understand that stress from poverty and racism are directly related to mental health, 2) are concerned about widespread stigma with mental illness, and 3) feel that community members do not effectively identify mental health problems requiring treatment.
Article
This Viewpoint describes the role of stakeholders in developing research questions, reviewing research applications, and conducting research as part of the Patient-Centered Outcomes Research Institute research enterprise.The US Congress authorized the Patient-Centered Outcomes Research Institute (PCORI) in 2010 to fund comparative clinical effectiveness research (CER) “to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions.”1 This charge is unique. No other health research funding agency is restricted to funding CER, defined as “comparing health outcomes and the clinical effectiveness, risks, and benefits of 2 or more medical treatments, services….”1 No other funding agency must address the research needs of the entire range of stakeholders in the health care enterprise. To respond to these mandates, PCORI’s board of governors, methodology committee, and staff have built a novel “stakeholder-driven” approach to doing CER. The premise: research is more likely to improve the care of patients if they and other key stakeholders are involved in all aspects of the research.
Article
The Patient-Centered Outcomes Research Institute has accelerated conversations about the importance of actively engaging stakeholders in all aspects of comparative effectiveness research (CER). Other scientific disciplines have a history of stakeholder engagement, yet few empirical examples exist of how these stakeholders can inform and enrich CER. Here we present a case study which includes the methods used to engage stakeholders, what we learned from them, and how we incorporated their ideas in a CER project. We selected stakeholders from key groups, built relationships with them and collected their feedback through interviews, observation and ongoing meetings during the four research process phases: proposal development, adapting study methods, understanding the context and information technology tool design and refinement.
Article
More than 1 in 5 disabled people with dual Medicare-Medicaid enrollment have schizophrenia or a bipolar disorder (ie, a serious mental illness). The effect of their transition from Medicaid drug coverage, which varies in generosity across states, to the Medicare Part D drug benefit is unknown. Many thousands make this transition annually. To determine the effect of transitioning from Medicaid drug benefits to Medicare Part D on medication use by patients with a serious mental illness and to determine the influence of Medicaid drug caps. In time-series analysis of continuously enrolled patient cohorts (2004-2007), we estimated changes in medication use before and after transitioning to Part D, comparing states that capped monthly prescription fills with states with no prescription limits. We used Medicaid and Medicare claims from a 5% national sample of community-dwelling, nonelderly disabled dual enrollees with schizophrenia (n = 5554) or bipolar disorder (n = 3675). Psychotropic treatments included antipsychotics for schizophrenia and antipsychotics, anticonvulsants, and lithium for bipolar disorder. We measured monthly rates of untreated illness, intensity of treatment, and overall prescription medication use. Prior to Part D, the prevalence of untreated illness among patients with a bipolar disorder was 30.0% in strict-cap states and 23.8% in no-cap states. In strict-cap states, the proportion of untreated patients decreased by 17.2% (relatively) 1 year after Part D, whereas there was no change in the proportion of untreated patients in no-cap states. For patients with schizophrenia, the untreated rate (20.6%) did not change in strict-cap states, yet it increased by 23.3% (from 11.6%) in no-cap states. Overall medication use increased substantially after Part D in strict-cap states: prescription fills were 35.5% higher among patients with a bipolar disorder and 17.7% higher than predicted among schizophrenic patients; overall use in no-cap states was unchanged in both cohorts. The effects of transitioning from Medicaid to Medicare Part D on essential treatment of serious mental illness vary by state. Transition to Part D in states with strict drug benefit limits may reduce rates of untreated illness among patients with bipolar disorders, who have high levels of overall medication use. Access to antipsychotic treatment may decrease after Part D for patients with a serious mental illness living in states with relatively generous uncapped Medicaid coverage.
Article
Objective: The Mental Health Parity and Addiction Equity Act requires insurance parity for mental health/substance use disorder and general medical services. Previous research found that parity did not increase mental health/substance use disorder spending and lowered out-of-pocket spending. Whether parity's effects differ by diagnosis is unknown. The authors examined this question in the context of parity implementation in the Federal Employees Health Benefits (FEHB) Program. Method: The authors compared mental health/substance use disorder treatment use and spending before and after parity (2000 and 2002, respectively) for two groups: FEHB enrollees diagnosed in 1999 with bipolar disorder, major depression, or adjustment disorder (N=19,094) and privately insured enrollees unaffected by the policy in a comparison national sample (N=10,521). Separate models were fitted for each diagnostic group. A difference-in-difference design was used to control for secular time trends and to better reflect the specific impact of parity on spending and utilization. Results: Total spending was unchanged among enrollees with bipolar disorder and major depression but decreased for those with adjustment disorder (-$62, 99.2% CI=-$133, -$11). Out-of-pocket spending decreased for all three groups (bipolar disorder: -$148, 99.2% CI=-$217, -$85; major depression: -$100, 99.2% CI=-$123, -$77; adjustment disorder: -$68, 99.2% CI=-$84, -$54). Total annual utilization (e.g., medication management visits, psychotropic prescriptions, and mental health/substance use disorder hospitalization bed days) remained unchanged across all diagnoses. Annual psychotherapy visits decreased significantly only for individuals with adjustment disorders (-12%, 99.2% CI=-19%, -4%). Conclusions: Parity implemented under managed care improved financial protection and differentially affected spending and psychotherapy utilization across groups. There was some evidence that resources were preferentially preserved for diagnoses that are typically more severe or chronic and reduced for diagnoses expected to be less so.
Article
With the increased popularity of qualitative research, researchers in counseling psychology are expanding their methodologies to include mixed methods designs. These designs involve the collection, analysis, and integration of quantitative and qualitative data in a single or multiphase study. This article presents an overview of mixed methods research designs. It defines mixed methods research, discusses its origins and philosophical basis, advances steps and procedures used in these designs, and identifies 6 different types of designs. Important design features are illustrated using studies published in the counseling literature. Finally, the article ends with recommendations for designing, implementing, and reporting mixed methods studies in the literature and for discussing their viability and continued usefulness in the field of counseling psychology. (PsycINFO Database Record (c) 2012 APA, all rights reserved)
Article
Prior authorization policies (PA) are widely used to control psychotropic medication costs by state Medicaid programs and Medicare Part D plans. The objective of this study was to examine the impact of a Maine Medicaid PA policy on initiation and switching of anticonvulsant and atypical antipsychotic treatments among patients with bipolar disorder. We obtained Maine and New Hampshire (comparison state) Medicaid and Medicare claims data for 2001 to 2004; the Maine PA policy was implemented in July 2003. Among continuously enrolled patients with bipolar disorder (Maine: n = 5336; New Hampshire: n = 1376), we used an interrupted times series with comparison group design to estimate changes in rates of initiating new episodes of bipolar treatment and generalized estimating equations models to examine rates of switching therapies among patients under treatment. The Maine PA policy was associated with a marked decrease in rates of initiation of bipolar treatments; a relative reduction of 32.3% (95% CI: 24.8, 39.9) compared with expected rates at 4 months after policy implementation. This decrease was driven primarily by reductions in the initiation of nonpreferred agents. The policy had no discernable impact on rates of switching therapy among patients currently on treatment (RR: 1.03; 95% CI: 0.76, 1.39). The findings of this study provide evidence that PA implementation can be a barrier to initiation of nonpreferred agents without offsetting increases in initiation of preferred agents, which is a major concern. There is a critical need to evaluate the possible unintended effects of PA policies to achieve optimal health outcomes among low-income patients with chronic mental illness. In addition, more research is needed to understand how these barriers arise and whether specific seriously mentally ill populations or drug classes should be exempted from PA policies.
Article
We examined the effects of a three-prescription monthly payment limit (cap) on the use of psychotropic drugs and acute mental health care by noninstitutionalized patients with schizophrenia. We hypothesized that reducing access to such drugs would increase the use of emergency mental health services and the rate of partial hospitalizations (full-day or half-day treatment programs) and psychiatric-hospital admissions. We linked Medicaid claims data for a period of 42 months with clinical records from two community mental health centers (CMHCs) and the single state psychiatric hospital in New Hampshire, where Medicaid imposed a three-prescription limit on reimbursement for drugs during 11 months (months 15 through 25) of the study. For comparison, we used Medicaid claims for a period of 42 months in New Jersey, which had no limit on drug reimbursement. The study patients (n = 268) and the comparison patients (n = 1959) were permanently disabled, noninstitutionalized patients with schizophrenia, 19 through 60 years of age, who were insured by Medicaid. We conducted interrupted time-series regression analyses to estimate the effects of the cap on the use of medications and mental health services. The cap resulted in immediate reductions (range, 15 to 49 percent) in the use of antipsychotic drugs, antidepressants and lithium, and anxiolytic and hypnotic drugs (P < 0.01). It also resulted in coincident increases of one to two visits per patient per month in visits to CMHCs (range of increase, 43 to 57 percent; P < 0.001) and sharp increases in the use of emergency mental health services and partial hospitalization (1.2 to 1.4 episodes per patient per month), but no change in the frequency of hospital admissions. After the cap was discontinued, the use of medications and most mental health services reverted to base-line levels (measured in the first 14 months of the study). The estimated average increase in mental health care costs per patient during the cap ($1,530) exceeded the savings in drug costs to Medicaid by a factor of 17. Limits on coverage for the costs of prescription drugs can increase the use of acute mental health services among low-income patients with chronic mental illnesses and increase costs to the government, even aside from the increases caused in pain and suffering on the part of patients.