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Pilot and Feasibility Studies
Developing andtesting aproduce
prescription implementation blueprint
toimprove food security inaclinical setting:
apilot study protocol
Hannah E. Frank1* , Linda E. Guzman1, Shivani Ayalasomayajula2, Ariana Albanese1, Brady Dunklee3,4,
Matthew Harvey3,4, Kelly Bouchard2, Maya Vadiveloo5, Amy L. Yaroch6, Kelli Scott1,2,7 and Alison Tovar2
Abstract
Background Food insecurity is common in the United States, especially in Rhode Island, where it affects up to 33%
of residents. Food insecurity is associated with adverse health outcomes and disproportionally affects people
from minoritized backgrounds. Produce prescription programs, in which healthcare providers write “prescriptions”
for free or reduced cost vegetables, have been used to address food insecurity and diet-related chronic disease.
Although there is growing evidence for the effectiveness of produce prescription programs in improving food secu-
rity and diet quality, there have been few efforts to use implementation science methods to improve the adoption
of these programs.
Methods This two-phase pilot study will examine determinants and preliminary implementation and effectiveness
outcomes for an existing produce prescription program. The existing program is funded by an Accountable Care
Organization in Rhode Island and delivered in primary care practices. For the first phase, we conducted a formative
evaluation, guided by the Consolidated Framework for Implementation Research 2.0, to assess barriers, facilitators,
and existing implementation strategies for the produce prescription program. Responses from the formative evalu-
ation were analyzed using a rapid qualitative analytic approach to yield a summary of existing barriers and facilita-
tors. In the second phase, we presented our formative evaluation findings to a community advisory board consist-
ing of primary care staff, Accountable Care Organization staff, and staff who source and deliver the vegetables. The
community advisory board used this information to identify and refine a set of implementation strategies to support
the adoption of the program via an implementation blueprint. Guided by the implementation blueprint, we will
conduct a single-arm pilot study to assess implementation antecedents (i.e., feasibility, acceptability, appropriateness,
implementation climate, implementation readiness), implementation outcomes (i.e., adoption), and preliminary pro-
gram effectiveness (i.e., food and nutrition security). The first phase is complete, and the second phase is ongoing.
Discussion This study will advance the existing literature on produce prescription programs by formally assessing
implementation determinants and developing a tailored set of implementation strategies to address identified barri-
ers. Results from this study will inform a future fully powered hybrid type 3 study that will use the tailored implemen-
tation strategies and assess implementation and effectiveness outcomes for a produce prescription program.
*Correspondence:
Hannah E. Frank
Hannah_Frank@brown.edu
Full list of author information is available at the end of the article
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Page 2 of 13
Franketal. Pilot and Feasibility Studies (2024) 10:51
Trial registration Clinical trials: NCT05 941403, Registered June 9, 2023.
Keywords Food insecurity, Produce prescriptions, Implementation science, Implementation blueprint, Protocol
Background
e COVID-19 pandemic ended years of declining rates
of food insecurity in the United States [1]. Food insecu-
rity, which refers to unreliable access to sufficient and
adequate food to meet one’s needs [2], is at an all-time
high with 10.2% of the population living with food inse-
curity nationally [3]. Food insecurity is associated with
suboptimal diets [4], increased risk for cardiovascular
morbidity and mortality, and behavioral health prob-
lems [5, 6]. People with minoritized racial/ethnic identi-
ties and people with lower levels of socioeconomic status
have been particularly impacted by food insecurity, as
well as greater COVID-19 symptom severity and hospi-
talization [7]. Additionally, individuals with diet-related
diseases associated with food insecurity (e.g., diabetes,
obesity) were more likely to experience severe outcomes
of COVID-19, including increased hospitalization [8]. It
is worth noting that the term nutrition security has been
brought to the forefront in recent years to highlight the
importance of food quality in addition to food access.
Nutrition security considers the nutritional value, afford-
ability, accessibility, and safety of foods that promote
well-being, with a focus on equity. While the pandemic
exacerbated food and nutrition security, it also led to
greater recognition of how local food systems could be
leveraged in creative ways to get food to households [9,
10], especially among minoritized communities. Alleviat-
ing food and nutrition insecurity will require tackling the
correlates of poverty while designing sustainable inter-
ventions that increase access and availability to nutrient-
rich foods (e.g., vegetables) that are culturally informed.
ere is growing evidence and increased attention
with the recent White House Conference on Hunger,
Nutrition, and Health on the importance of using “food
as medicine” approaches to address food and nutrition
insecurity, prevent associated negative health outcomes,
and reduce healthcare costs [11, 12]. One such program
involves the use of produce prescriptions that enable
healthcare providers to identify patients at risk for food
insecurity and/or cardio-metabolic disease and write
prescriptions for vegetables [6]. is model has quickly
grown, partly due to the Gus Schumacher Nutrition
Incentive Program (GusNIP), which was authorized in
the 2018 Farm Bill and formally funded produce prescrip-
tion programs for the first time [13]. e predecessor to
GusNIP, the Food Insecurity Nutrition Incentive (FINI)
Program, funded nutrition incentive (but not produce
prescription) programs. ere is increasing evidence that
produce prescriptions reduce food and nutrition inse-
curity and promote diet quality and health outcomes in
minoritized populations [14–16]. A 2023 study of 22 pro-
duce prescription programs in the United States found
that participation in such programs was associated with
improvements in fruit and vegetable intake, food insecu-
rity, and self-reported health status among both adults
and children [17]. Adult participants with poor cardio-
metabolic health also experienced improvements in gly-
cated hemoglobin, blood pressure, and body mass index
[18].
Despite the growing evidence, there is variability in
the effectiveness of produce prescription programs, and
many barriers remain to successful scale-up across set-
tings [19]. For example, many programs require par-
ticipants to pick up the produce at a specific location,
leading to transportation challenges [20]. Given that
many of the beneficiaries of these programs are from
low-income and culturally diverse backgrounds, it is pos-
sible that participants vary in their knowledge and use of
certain vegetables. Such realities lead to decreased reach
and participation of patient populations, especially those
from underserved communities that stand to benefit
from these programs. Healthcare staff also report hav-
ing limited time to receive training, deliver screenings,
and make patient referrals to produce prescription pro-
grams, resulting in variable implementation in healthcare
settings [21–23]. Some programs are paired with nutri-
tion education to improve health outcomes; however,
these educational components fail to overcome these key
transportation and time barriers. A recent report high-
lighted key research recommendations to support the
expansion of produce prescriptions nationally, including
the need for studies that involve key community mem-
bers and assess both implementation and program effec-
tiveness outcomes [24].
A produce prescription program inRhode Island
In the state of Rhode Island, food insecurity is preva-
lent (up to 33% of the population) [25]. Integra Com-
munity Care Network (Integra) is the Accountable Care
Organization (ACO) of Care New England Health, Rhode
Island Primary Care Physicians Corporation, and South
County Health. Integra represents a network of more
than 100 primary care practices. In 2019, Integra sub-
mitted an initial proposal for funding to support a pro-
duce prescription (VeggieRx) program in Rhode Island in
response to the high rates of food insecurity; the program
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Franketal. Pilot and Feasibility Studies (2024) 10:51
first launched in 2020. e program requires practice
staff and providers to identify families with food inse-
curity and/or diet-related illnesses during primary care
appointments using clinical judgment or with a 12-item
screener that assesses health-related social needs includ-
ing food insecurity. Identified patients complete an
intake with practice staff to determine eligibility. Eligible
patients are then referred to Southside Community Land
Trust (SCLT), a local nonprofit that aggregates and packs
produce from gardeners and small farmers who grow
vegetables in environmentally sustainable ways on SCLT-
managed land. SCLT also manages the format of deliv-
ery, including pickup or delivery. e VeggieRx program
takes place biweekly from July to November of each year.
Each bagged share contained 5–6 varieties of vegetables
and herbs, weighing approximately 3–6 pounds, with an
enrolled member of a household receiving one bagged
share per delivery. Table1 shows the number of partici-
pants, households, and practices involved in the program
each year since the program’s initiation in 2020. Despite
the program’s success in reaching a yearly average of
approximately 34 households experiencing food insecu-
rity, the program aims to continue to grow, with a goal of
reaching approximately 50 households in 2023.
Since its initiation, the program has been perceived
positively by patients but also has faced challenges in
achieving broader adoptionincluding consistentscreen-
ing and referrals by providers and clinical staffto ensure
that eligible patients are offered the program. Imple-
mentation science focuses on identifying and addressing
barriers to delivering an intervention in a clinical setting
through research-supported implementation strategies
[26]. us, consistent with an implementation science
approach, a crucial next step in scaling up the VeggieRx
program is to formally evaluate the barriers and facili-
tators that impact successful adoption and the optimal
implementation strategies needed to enhance scale-
up and retention. We do this by referencing the Con-
solidated Framework for Implementation Research 2.0
(CFIR 2.0 [27]). As a determinant framework [28], the
CFIR 2.0 helps elucidate factors that influence implemen-
tation outcomes. e CFIR 2.0 assesses characteristics of
the intervention, the inner setting in which the interven-
tion is implemented (i.e., the primary care practices), and
the outer setting in which the intervention resides (e.g.,
state policies). e development and preliminary testing
of implementation strategies are needed to bolster the
VeggieRx program’s adoption and impact in real-world
settings, which is expected to ultimately impact partici-
pant health outcomes.
Study aims
e specific aims of this pilot study [29] are as follows:
1. Phase 1: Engage in a formative evaluation to identify,
using an implementation science determinant frame-
work (the CFIR 2.0), barriers, facilitators, and current
implementation strategies for the existing VeggieRx
program with participating patients and providers/
staff.
2. Phase 2: In response to identified barriers and facili-
tators, and together with community advisory board
partners, develop a set of implementation strategies
(i.e., an implementation blueprint) guided by the
Expert Recommendations for Implementing Change
Project (ERIC [30]) to support uptake of the Veggi-
eRx program.
3. Phase 2: Conduct a pilot VeggieRx implementation
study to assess both implementation outcomes (pri-
mary outcome: adoption; secondary outcomes: feasi-
bility, acceptability, appropriateness, implementation
climate, implementation readiness) and preliminary
program effectiveness outcomes (primary outcome:
food security; secondary outcome: depression symp-
toms).
is two-phase study will consider perspectives from
VeggieRx providers/staff and patient recipients to modify
implementation practices. e first phase includes Aim 1
and focused on formative evaluation of existing VeggieRx
practices. e second phase includes Aims 2 and 3 and
involves the development and piloting of an implemen-
tation blueprint to improve implementation of the Veg-
gieRx program.
Methods
Study design
is two-phase study will: (1) develop an implementation
blueprint of community advisory board (CAB)-informed
strategies designed to address current barriers to imple-
mentating a produce prescription program (VeggieRx)
and (2) conduct a pilot trial of these implementation
Table 1 VeggieRx enrollment by year
2020 2021 2022
Pickup/delivery Pickup only Home
delivery
only
Home
delivery
only
Total vegetable shares delivered
(N)587 602 705
Individuals receiving vegetables
(N)119 147 144
Households receiving vegetables
(N)28 38 37
Practices referring patients (N)1 3 4
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Franketal. Pilot and Feasibility Studies (2024) 10:51
strategies. Pilot outcomes will include adoption, fea-
sibility, acceptability, and appropriateness of the Veg-
gieRx program, as well as implementation climate and
implementation readiness. We will also assess prelimi-
nary program effectiveness. ese findings will inform a
future hybrid type 3 effectiveness-implementation study.
We use the Lancaster and abane guidelines [31] for
reporting non-randomized pilot and feasibility studies,
which represent an adapted version of the Consolidated
Standards of Reporting Trials (CONSORT) [32, 33],
as well as the Standards for Reporting Implementation
Studies (STaRI) [34]. All study procedures and materials
have been approved by Brown University’s Institutional
Review Board.
Setting
Our research team established a partnership with Inte-
gra, who oversees the VeggieRx program, and with SCLT,
who provides fresh produce and manages the VeggieRx
program food delivery. Currently, four Integra primary
care practices are involved in the VeggieRx program;
these include internal medicine, family medicine, and
pediatric practices. e participating practices reach
households from varying socioeconomic, racial, and
ethnic backgrounds. In Phase 1, the four practices that
most recently participated in the VeggieRx program were
invited to participate. New practices that elected to par-
ticipate in the 2023 VeggieRx program were also invited
to participate in Phase 2 of the study. All practices were
informed of plans for data collection, including contact-
ing patients and individual clinicians to complete quali-
tative interviews and quantitative surveys (Phase 1), as
well as newly developed VeggieRx implementation strat-
egies (Phase 2). Participation in the VeggieRx program
for practices and patients was not contingent on study
participation.
Phase 1 (Aim 1: formative evaluation toidentify barriers,
facilitators, andcurrent VeggieRx implementation
strategies)
Phase 1: formative evaluation participants
Healthcare providers and staff at practices participating
in the VeggieRx program (N = 5) and patients who par-
ticipated in the VeggieRx program (N= 9) were selected
as the target populations for this study. Our sampling of
five or more participants per informant category is in line
with recommendations for achieving thematic satura-
tion [35]. Healthcare providers and staff included anyone
employed by each practice and involved in patient care,
including physicians, nurses, medical assistants, and
other members of the clinical team. Participants were
eligible to participate if they were: (1) 18 years of age
or older, (2) a healthcare provider or staff member in a
practice participating in VeggieRx (regardless of whether
they actually referred patients) or a recipient of VeggieRx,
and (3) fluent in English and/or Spanish. Inclusion crite-
ria were minimal to maximize the number and variability
of participants. Patients who participate in the VeggieRx
program were identified by their providers as eligible for
the program as described above.
Community Advisory Board (CAB) A group of commu-
nity partners formed a CAB to provide input throughout
the study. e CAB was initially convened during Phase
1 and played a central role in developing the imple-
mentation blueprint (Phase 2 Aim 2). CAB members
were eligible but not required to provide data through
completion of interviews in Phase 1 and/or surveys in
Phase 2. e CAB (N = 6 members) consisted of Integra
ACO staff, staff from SCLT, and staff from participat-
ing practices. ree study research team members also
attended CAB meetings. Four of the CAB members were
also research participants and completed interviews in
Phase 1. Aligned with best practices [36], CAB members
met with the research team to review roles, expectations,
and communication plans for CAB participation. CAB
meetings occurred three times over the course of the
study, as described in more detail in the procedures sec-
tion below.
Phase 1: recruitment
Providers and administrative staff members were primar-
ily recruited through Integra. An Integra representative
briefed on the study’s eligibility criteria contacted indi-
viduals affiliated with the care network to inform them
about the study and collected contact information from
those who expressed interest in participating and who
verbally agreed to be contacted.
Patients enrolled in the VeggieRx program were
recruited with the aid of SCLT staff who communicated
with patients about their vegetable shares. SCLT staff
shared study information with patients via text messages,
including a link where they could sign up to participate.
Recruitment flyers were printed and packaged with pro-
duce deliveries. e text messages and flyers were avail-
able in English and Spanish and distributed according to
patients’ known language preference.
Phase 1: measures
A summary of the schedule of study measures and time
points is provided in Table2.
Qualitative interviews Semi-structured interview
guides were used to collect formative evaluation data.
Interviews took place at the end of the 2022 VeggieRx
delivery season (i.e., October-December 2022) and lasted
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Franketal. Pilot and Feasibility Studies (2024) 10:51
20–30min. e interview guides consisted of questions
that assessed barriers and facilitators to implementation
of VeggieRx across the five domains of the CFIR 2.0, and
an implementation science framework focused on deter-
minants of new practice implementation, including the
following: (1) the VeggieRx intervention; (2) the indi-
viduals involved in VeggieRx implementation, including
VeggieRx recipients; (3) the inner setting of the practices
where VeggieRx is implemented; (4) the outer setting in
which VeggieRx is implemented; and (5) the VeggieRx
implementation process. Semi-structured interviews
also included questions about current VeggieRx imple-
mentation strategies and provider/patient perceptions of
each strategy’s effectiveness. See Additional file1 for the
patient and staff interview guides.
Quantitative measures Qualitative interview data
were supplemented by quantitative surveys. Providers
and staff completed reliable measures that assessed pro-
vider attitudes and implementation climate, including
the Evidence-Based Practice Attitudes Scale (EBPAS;
15-items, Cronbach’s α = 0.59–0.9) [37] and the Imple-
mentation Climate Scale (ICS; six items, Cronbach’s
α = 0.89) [38], as well as a brief demographics question-
naire. ese measures were selected to provide descrip-
tive information about the characteristics of individuals
(i.e., providers’ attitudes) and inner setting (i.e., imple-
mentation climate) domains of the CFIR 2.0. e sur-
vey for patients contained brief demographic questions
concerning their background and participation in the
VeggieRx program, including two items that assessed
food insecurity [39] and four items that assessed nutri-
tion security [40]. We opted to assess food insecurity
and nutrition insecurity in addition to participant demo-
graphics to better understand the food and nutrition
characteristics of our sample and to assess whether the
VeggieRx program was reaching the population it was
intended to serve. Surveys took 5–10min to complete
and were administered immediately after the qualitative
Table 2 Study measures
All measures will be available in Spanish and English
Abbreviations: Pt patient, Pr provider/sta, St study team
a Demographics questionnaires in Phase 1 included two items about food insecurity and four items about nutrition security
Measure CFIR 2.0 Outcomes Addendum Construct Study period
Phase 1 Phase 2:
baseline
assessment
Phase 2:
6-month
follow-up
assessment
Demographics
(Pt, Pr) N/A XaX
Implementation determinantsand outcomes
Acceptability of intervention
measure (Pr) Acceptability X X
Evidence-Based Practice Attitudes Scale (Pr) Acceptability (attitudes) X X
Patient engagement (Pt) Acceptability X (biweekly)
Number of patients enrolled in VeggieRx (St) Adoption X X
Intervention appropriateness measure (Pr) Appropriateness X X
Qualitative interviews (Pt/Pr) Determinants X
Open-ended written response question Feasibility and acceptability X (Pr only)
Feasibility of Intervention Measure (Pr) Feasibility X X
Participant enrollment (St) Feasibility X X
Implementation Climate Scale (Pr) Implementation climate X X
Organizational Readiness for Implementing Change (Pr) Implementation readiness X X
Innovation (eectiveness) outcomes
USDA measure (Pt) Effectiveness:
Food security X X
Nutrition security measure (Pt) Effectiveness:
Nutrition security X X
Dietary Screener Guide (Pt) Effectiveness: Fruit and vegetable intake X X
Patient Health Questionnaire-2 (Pt) Effectiveness:
Depression X X
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Franketal. Pilot and Feasibility Studies (2024) 10:51
interviews. Results of the surveys will be presented in a
separate manuscript.
Phase 1: procedures
Aim 1: formative evaluation Prior to completing inter-
views, participants provided verbal consent to participate
in study procedures. Trained research assistants who are
fluent in English or Spanish were assigned to interview
participants (providers/staff and patients) based on the
participants’ language preference. Once study eligibility
was confirmed, research assistants scheduled a time and
date for the interview and brief post-interview quantita-
tive measures. Participants were given the option of com-
pleting qualitative interviews via Zoom or in person, and
all interviews were video- and audio-recorded via Zoom.
Immediately following completion of interviews, par-
ticipants were asked to complete quantitative measures
via Qualtrics (self-report or interviewer administered,
depending on participant literacy level and preference).
Participants were compensated with a US $50 gift or
debit card for their time.
Phase 1: Analytic plan
Quantitative Descriptive statistics for the provider-
level quantitative measures, including the EBPAS and
the ICS, were calculated, including means, standard
deviations, ranges, frequencies, and percentages. ICS
scores were reported at individual and practice levels,
assuming that practices had at least three providers or
staff per practice completing the measure to maintain
confidentiality.
Qualitative Audio recordings of the interviews were
transcribed and translated to English from Spanish to
facilitate data analysis. Interviews were coded using a
rapid analytic approach [41], in which a templated sum-
mary table was developed to summarize transcripts. e
templated summary table included one column for each
CFIR 2.0-informed interview guide question, includ-
ing required probes, and one column for key points and
exemplar quotes. Barriers and facilitators were coded
using a priori deductive codes representing each of the
CFIR 2.0 domains. ese codes were described in a code-
book that included a summary of each domain, a list of
potentially relevant constructs, and specific examples
from study interviews added in the early stages of cod-
ing. Within the templated summary table, there was one
cell where coders could summarize barriers and facili-
tators for each CFIR 2.0 domain. Initial transcript sum-
maries were generated by members of the analytic team;
the study principal investigator conducted a secondary
review of all summaries and discussed them with the ana-
lytic team to make any needed modifications and ensure
consistency across coders. Final summaries were con-
solidated into matrices by participant type (i.e., patients
and providers). e analytic team generated an exhaus-
tive list of barriers and facilitators for the modified con-
joint analysis method to be employed in Phase 2. In addi-
tion, the coding team reviewed matrices collaboratively
and iteratively to identify themes and sub-themes across
interviews, consistent with the framework method [42].
Weekly analytic team meetings provided an opportunity
for discussion of coding and analysis to ensure consist-
ency across team members. Discussion and consensus
were used to resolve any questions and discrepancies in
coding. Results were shared with the study team and par-
ticipating sites.
Phase 2 (Aims 2 and3: developing andpiloting
animplementation blueprint forVeggieRx)
Phase 2: procedures
Aim 2: developing the implementation blueprint Fol-
lowing the methods described by Lewis and colleagues
[43], we developed an implementation blueprint using
modified conjoint analysis. Conjoint analysis [44] is a
method frequently employed in marketing to evaluate
consumer preferences and priorities for specific prod-
uct attributes. is method is particularly applicable to
implementation blueprint development as it enables the
prioritization and consideration of trade-offs for differ-
ent implementation strategies [45]. Qualitative data from
Aim 1 informed our understanding of VeggieRx imple-
mentation determinants, and we worked with our CAB
to prioritize determinants and to assess matching imple-
mentation strategies. Specifically, in our first CAB meet-
ing, we shared results from the qualitative interviews and
asked CAB members to rate each barrier on feasibility to
change (i.e., “high” or “low” feasibility) and importance
to address (i.e., “high” or “low” importance). Prior to the
second CAB meeting, the research team and representa-
tives from Integra generated a list of implementation
strategies drawn from the well-established ERIC project
[30] and informed by existing literature [46] that could
address the high feasibility and high importance barriers.
is list of strategies was presented to the CAB at the sec-
ond meeting for rating on feasibility (i.e., “high” or “low”
feasibility of strategy use given existing resources). CAB
members were then asked to rate each strategy in terms
of its impact on VeggieRx progress success on a scale of
“1 — low impact” to “3 — high impact.” Strategies were
selected for inclusion in the blueprint if they were rated
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Franketal. Pilot and Feasibility Studies (2024) 10:51
as high impact on fidelity (i.e., rating of 3), high feasibility,
or both. After identifying strategies using this method,
final strategies were selected and operationalized through
discussion with CAB members in a third meeting. e
list and operationalization of the final strategies selected
for inclusion are provided in Table 3. ese strategies
were organized into a step-by-step blueprint document
with strategies designated as supporting pre-implemen-
tation, implementation, and/or sustainment [47]. e
fourth and final CAB meeting will involve receiving input
from the CAB on pilot trial results (“member checking”)
and planning for dissemination of findings.
Aim 3: pilot study Four primary care practices have
committed to participate in this study and carry out
implementation strategies identified in the implemen-
tation blueprint. Individual participants will complete
informed consent procedures prior to participating.
Patients (N = 10–15) and providers/staff (N = 10–15) will
complete baseline surveys at the start of the 2023 vege-
table delivery season, which begins in July, and again at
6-month follow-up. Patient baseline and follow-up meas-
ures (listed in Table2) are each expected to take approxi-
mately 30min and can either be completed via self-report
or via interviewer. A biweekly measure of patient engage-
ment will take approximately 2min each time and will be
sent via text message or email depending on participants’
preferences throughout the duration of the 6-month Veg-
gieRx delivery period. All participants will be compen-
sated by the study team with a US $50 gift or debit card
for their completion of measures at baseline and US $75
at follow-up. Patient participants will receive compensa-
tion of US $3 for each week they answer the text or email
survey, which will be paid at the end of the 6-month Veg-
gieRx delivery period.
Implementation strategies e “core components” [48]
of the VeggieRx program, including primary care refer-
rals to the program and patients receiving pre-packaged
vegetables on a biweekly basis, will remain unchanged.
However, implementation strategies [49] will focus on
improving the extent to which VeggieRx is adopted,
implemented, and sustained. Implementation strategies
for this study will involve making changes to the adapt-
able components (“adaptable periphery”) [48] of the
intervention (e.g., switching to delivery only) to improve
its fit for the intended population and will also involve
changes to the operations of the program (e.g., stream-
lining the referral process). With support from the study
team, key players in the VeggieRx program (i.e., practices,
Integra, SCLT) will begin to employ the implementa-
tion strategies defined by the implementation blueprint
developed in Aim 2. For a 6-month period from baseline
through follow-up, study staff will check in biweekly with
staff at participating practices, SCLT, and Integra to col-
lect details of implementation strategies being used. We
will collect detailed information on individuals responsi-
ble for each strategy, specifics of strategies used, strategy
targets (i.e., for whom the strategy was intended), time-
line, and dose/frequency of strategy use. is approach to
tracking implementation strategies aligns with the meth-
ods described by Rudd and colleagues and also includes
identification of hypothesized mechanisms for each
strategy [50]. Biweekly meetings with Integra will include
consultation on the deployment of the strategies deline-
ated in the implementation blueprint.
Phase 2: pilot participants
Healthcare providers and staff (N = 10–15) and patients
(N = 10–15) will be recruited from the four practices
to complete surveys asking about implementation and
effectiveness outcomes. Inclusion criteria and sample
size justification (i.e., likelihood of achieving saturation
on qualitative interviews) for both types of participants
are the same as in Phase 1. Patients and providers/staff
who participated in Phase 1 will also be eligible to par-
ticipate in Phase 2; additional participants will also be
recruited to account for patient/staff turnover and to
achieve planned recruitment numbers.
Phase 2: pilot recruitment
e same recruitment methods used in Phase 1 will be
used in Phase 2 (see Phase 1 Recruitment section above).
Patients who participated in Phase 1 will be eligible to
participate in Phase 2, but we anticipate also recruiting
new participants for this phase.
Phase 2: pilot measures
Study measurement will be guided by the CFIR 2.0 Out-
comes Addendum [51], which delineates both imple-
mentation and innovation (effectiveness) outcomes. In
addition, the Outcomes Addendum specifies several
antecedent assessments or implementation determinants
that have been shown to predict anticipated or actual
implementation outcomes. ese include acceptabil-
ity, appropriateness, feasibility, implementation climate,
and implementation readiness. In the present study, we
intend to measure all five of these implementation deter-
minants, as well as one preliminary implementation out-
come (adoption), and three innovation (effectiveness)
outcomes, as described below and shown in Table2.
Antecedent assessments Acceptability of the VeggieRx
intervention will be measured with providers/staff at
each site using the acceptability of intervention measure
(AIM; four items, Cronbach’s α = 0.85) [52]. Additionally,
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Franketal. Pilot and Feasibility Studies (2024) 10:51
Table 3 CAB-informed ERIC implementation strategies
Barrier, identied by CFIR 2.0 qualitative interviews; Action, statements specifying discrete observable behaviors that encompass the implementation strategy; Justication, empirical, theoretical, or pragmatic justication
for the choice of implementation strategies
Abbreviations: ERIC Expert Recommendations for Implementing Change,SDOHSocial Determinants of Health
Barrier ERIC Action Justication
Category Strategy
Logistical challenges Provide interactive assistance Provide local technical assistance Integra develop and finalize referral pro-
cesses and address logistical challenges Integra ACO will run the VeggieRx program
long term
Capacity Adapt and tailor to context Promote adaptability Provide delivery of vegetables to all
patients via 3rd party vendor (Cart-
wheelRI)
Patients would find VeggieRx more accept-
able and appropriate if VeggieRx offered
delivery
Provider awareness Train and educate stakeholders Conduct educational meetings Integra to conduct meetings with staff
who facilitate program referrals to orient
them to the referral process
Integra will facilitate the referral process,
providing practices with updates
User-friendliness of vegetables/
Spanish language Distribute educational materials Distribute materials to patients (in English
and Spanish) about VeggieRx and referral
process
Patients receive a card or email with Veg-
gieRx information
Provider awareness Distribute educational materials Distribute materials to providers
about VeggieRx and how to make referrals Distributing educational materials will help
providers and staff learn about VeggieRx
User-friendliness of vegetables/
Spanish language Develop educational materials Add tips about vegetable shelf-life, stor-
age, and preparation to existing materials
in both English and Spanish; include links
to online videos/resources
Patients identified lack of familiarity
with certain vegetables
Logistical challenges Provide ongoing consultation (track
strategies) Schedule regular check-ins on the use
of implementation strategies and trou-
bleshoot/answer questions about chal-
lenges that arise related to employing
the blueprint
Tracking implementation strategy usage
is a critical component of implementation
measurement
Provider awareness Support clinicians Remind clinicians Champions to provide prompts to provid-
ers to screen patients for program Providers may need prompts/reminders
to ensure they remember to refer appropri-
ate patients to the VeggieRx program
Logistical challenges Engage consumers Intervene with patients/consumers
to enhance uptake and adherence During intake process, assess patients’
needs related to social determinants
of health (SDOH) and make referrals
to resources that can address these needs
Ensure that patients receiving vegetable
delivery appropriately and satisfactorily
address their SDOH needs
Logistical challenges Change infrastructure Change record systems Change to two-part referral system
with integra relaying all patient informa-
tion to southside
Methods to improve referral systems will
likely help providers more easily make refer-
rals to (adopt) the program
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Franketal. Pilot and Feasibility Studies (2024) 10:51
acceptability will be measured with two open-ended writ-
ten response questions that ask about providers’ percep-
tions of the feasibility and acceptability of selected imple-
mentation strategies. e use of open-ended response
items was selected due to feasibility concerns related to
scheduling qualitative interviews with providers and
the importance of eliciting their feedback. Providers’
general attitudes toward evidence-based practices will
be measured by the Evidence-Based Practice Attitudes
Scale (EBPAS; 15 items, Cronbach’s α = 0.59–0.9) [37].
Biweekly surveys of engagement with the intervention
will measure patient acceptability. Specifically, partici-
pants will receive a text message or phone call from study
staff (based on their preferred method of communica-
tion) within a week of receiving each vegetable delivery.
e survey will take approximately 2min and ask the fol-
lowing questions: (1) Did you receive your vegetables last
Friday? (yes/no); (2) Did you know how to use the vegeta-
bles? (yes/no with recipes included with the delivery); (3)
How much did you like the vegetables included in your
most recent delivery? (Likert scale: 1 did not like at all to
5 liked very much); (4) How many of the vegetables did
you and your family eat? (Likert scale: 1 used none to 5
used all the vegetables); and (5) How much do the veg-
etables fit with the types of food your family eats? (Likert
scale: 1 not at all to 5 very much). Appropriateness will
be measured with providers/staff at each site using the
intervention appropriateness measure (IAM; four items,
Cronbach’s α = 0.91) [38]. Feasibility will be measured
with the Feasibility of Intervention Measure (FIM; four
items, Cronbach’s α = 0.89) [52]. We will also assess feasi-
bility in terms of participant enrollment in the study and
number of measures completed at each time point.
Implementation climate We will assess the innovation-
specific organizational climate for implementing produce
prescription programs using the six-item Implementa-
tion Climate Scale developed by Weiner and colleagues
(Cronbach’s α = 0.91) [38].
Implementation readiness We will assess organizations’
(primary care practices’) readiness for implementing
change using the Organizational Readiness for Change
Scale (ORIC; 12 items; Change Commitment Scale
Cronbach’s α = 0.91; Change Efficacy Scale Cronbach’s
α = 0.89) [53].
Implementation outcome Adoption of VeggieRx will
be measured from the web form used to enroll par-
ticipants in the VeggieRx program. Specifically, we will
assess patient adoption by measuring the number of
patients enrolled in VeggieRx during the 6-month pro-
gram period. We will assess provider adoption by noting
the role/title of the person making each referral and the
practice from which each referral was made. We will also
assess practice-level adoption by noting the percentage of
providers at each practice who referred patients at least
once.
Innovation (effectiveness) outcomes Behavioral/health
outcomes will include the following: (1) food and nutri-
tion security, (2) fruit and vegetable intake, and (3)
depression symptoms. Food security will be measured
by six-item USDA measure, and nutrition securitywill be
measured by the four-item nutrition security measure
[40]. Fruit and vegetable intakewill be measured with
the 10-item Dietary Screener Guide [54]. Finally, we will
assess depressionvia the Patient Health Questionnaire-2
[55]. We will also administer a demographic survey to
collect information on participants’ age, sex, race/ethnic-
ity, number of members in the household, and zip code.
Phase 2: analytic plan
Quantitative Descriptive statistics will be calculated
(means, standard deviations, ranges, frequencies, per-
centages) for all outcome variables, including imple-
mentation (i.e., acceptability, adoption, appropriateness,
feasibility, implementation climate, implementation
readiness) and effectiveness (i.e., food security, body
mass index, and depression). In addition to calculating
descriptive statistics for standardized measures of imple-
mentation and effectiveness outcomes, we will also assess
feasibility of study procedures based on participant
enrollment. Specifically, we will assess the proportion
of participants enrolled in the study relative to the total
number of patients receiving VeggieRx, the proportion
of participants enrolled in the study relative to the num-
ber approached to enroll in the study, and the proportion
of participants who consent relative to the number who
express interest in the study. Unadjusted effect sizes for
differences from pre to post (e.g., differences in means,
proportions) will be estimated for preliminary imple-
mentation (adoption) and effectiveness (food security,
dietary quality, body mass index, depression) outcomes
between baseline and follow-up. We will assess pre-post
differences in adoption by comparing the number of veg-
etables shares provided, households served, and miss
rates for pickups/deliveries in past years (2020, 2021, and
2022) and in the current year (2023).
Qualitative Open-ended written response questions
that assess the feasibility and acceptability of selected
implementation strategies will be analyzed using a the-
matic framework analysis approach [42]. We will create
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Franketal. Pilot and Feasibility Studies (2024) 10:51
one column for each question (i.e., one for feasibility
and one for acceptability) and rows for each participant.
Consistent with the example of data interpretation pro-
vided by Gale and colleagues [42, 56], we will use memo-
ing to summarize the data in each column, and themes
will be developed inductively based on provider and staff
responses to each question.
Power analysis
We did not conduct power analyses for this study given
recommendations that power analyses are not appropri-
ate for pilot studies that do not propose inferential tests
[57]. Our sample size was determined based on the prag-
matics of recruitment (i.e., including all sites currently
involved with the VeggieRx program). Analyses instead
focus on exploring descriptive data and examining the
feasibility and acceptability of implementation strategies.
Trial status
e Brown University Institutional Review Board has
approved all study procedures. Phase 2 of the study is
registered on ClinicalTrials.gov. Phase 2 participant
recruitment began in June 2023 and is currently ongoing.
Discussion
Despite the proliferation of produce prescription pro-
grams as a method for addressing food insecurity and
diet-related illness [20, 58–61] and the evidence for their
impact on vegetable intake and health-related outcomes
[62], there is a need for additional research that explic-
itly examines methods to improve their implementation.
Although some studies have begun to identify promising
implementation strategies [46], few studies have explic-
itly developed tailored implementation strategies and
examined implementation outcomes for a produce pre-
scription program. Furthermore, few studies have mean-
ingfully integrated community members’ perspectives
in the implementation process [63]. In response to these
needs, this study aims to assess existing determinants of
VeggieRx implementation in primary care settings and
use this information to inform the development of an
implementation blueprint to improve implementation.
Results will inform a future fully powered hybrid type 3
effectiveness-implementation study that will assess Veg-
gieRx’s effectiveness for improving food insecurity and
how successfully it can be scaled up in clinical practice
settings.
is study has multiple strengths that directly address
the limitations of the existing literature. Consistent with
the 2022 Food is Medicine Action Plan’s [12] recommen-
dation for research that seeks out perspectives and part-
nerships with community-based organizations, we will
partner with multiple community organizations and con-
vene a community advisory board to inform the develop-
ment of an implementation blueprint. Implementation
strategies will be developed using a systematic process
responsive to identified barriers and tailored with input
from our community advisory board. In addition, we
will collect qualitative and quantitative data from multi-
ple sources to understand implementation determinants
(Phase 1) and to assess preliminary implementation and
effectiveness outcomes (Phase 2). Data will be collected
from patients, providers, staff, and our partners at South-
side Community Land Trust to ensure that we consider a
broad range of perspectives. Finally, our study is guided
by a well-established implementation framework (the
CFIR 2.0) to ensure that our implementation efforts con-
sider determinants at multiple levels, ranging from indi-
vidual to outer setting factors.
Despite these strengths, this study also has limitations.
All sites will receive the same implementation strategies
at the same time. Sites will not be randomized to receive
strategies given the small number of sites involved at this
time (N = 4). e goal of this study is to pilot the iden-
tified implementation strategies and assess preliminary
effectiveness and implementation outcomes in prepara-
tion for a larger trial. Related to the small sample size and
the scope of this pilot study, we will not have sufficient
statistical power to conclude whether implementation
strategies are effective; instead, we will examine means
and effect sizes to assess whether our selected strategies
are feasible and promising to address identified barriers.
In addition, we are relying on self-report patient and pro-
vider data, which may be less accurate than observational
or objective data. While there is a need to collect data
from electronic health records on patient outcomes (e.g.,
BMI, blood pressure) and provider behavior (e.g., session
notes), it was deemed to be unfeasible within the context
of this study. We hope to develop infrastructure to use
electronic health record data in future work. is study
will focus on one specific produce prescription program
in the state of Rhode Island; our hope is that findings
from this study will generalize to other programs in the
state and throughout the country; however, some of our
findings may be specific to this program and our commu-
nity partners.
In summary, this project will enhance the existing lit-
erature about implementation determinants of produce
prescription programs by identifying barriers and facili-
tators to existing implementation and testing commu-
nity-informed implementation strategies. Results from
this study have the potential to have a larger health
impact, especially on issues related to food insecurity and
diet-related illness, by improving the reach and scalability
of produce prescription programs. In addition, the Rhode
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Page 11 of 13
Franketal. Pilot and Feasibility Studies (2024) 10:51
Island Food Policy Council is convening all produce pre-
scription programs in the state to better communicate
and collaborate so that our future work can include state-
wide programs and compare enhanced implementation
to implementation as usual.
Abbreviations
ACO Accountable Care Organization
CAB Community Advisory Board
SCLT Southside Community Land Trust
VeggieRx Vegetable prescription
Supplementary Information
The online version contains supplementary material available at https:// doi.
org/ 10. 1186/ s40814- 024- 01467-7.
Additional le1. Patient and staff interview guide.
Acknowledgements
We appreciate the support and partnership of the many people who have
made this VeggieRx program possible, including Southside Community Land
Trust and the primary care practices who are implementing the program.
Authors’ contributions
KS and AT conceived of and designed the research study; HEF helped design
the research study and carry out study activities. MV and ALY provided
consultation on the design of study. SA and KB assisted in carrying out study
activities. LG, SA, AA, BD, MH, MV, and ALY substantially revised the manuscript.
All authors approved the submitted version, have agreed to be accountable
for the contributions, and attest to the accuracy and integrity of the work,
even aspects for which the authors were not personally involved.
Funding
Funding for this study was provided by a grant from the Peter G. Peterson
Foundation Pandemic Response Policy Research Fund. The study sponsor did
not have any role in study design or writing of this report.
Availability of data and materials
The qualitative dataset generated and analyzed during the current study is
not publicly available due to the highly sensitive nature of interview transcript
data. Publication of entire transcripts risk identifying research participants.
Given the small dataset, quantitative data will not be made publicly available.
However, de-identified quantitative data will be made available to individual
investigators following a written request to the study principal investigators.
Declarations
Ethics approval and consent to participate
All procedures were approved by the Brown University (Protocol no.
2022003452 and STUDY00000018) Institutional Review Boards. All participants
will provide verbal consent to participate in our research study.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Author details
1 Department of Psychiatry and Human Behavior, The Warren Alpert Medical
School of Brown University, Providence, RI, USA. 2 Department of Behavioral
and Social Sciences, Brown University School of Public Health, Providence, RI,
USA. 3 Integra Community Care Network, Providence, RI, USA. 4 Care New Eng-
land Health System, Providence, RI, USA. 5 Department of Nutrition and Food
Science, University of Rhode Island, Kingston, RI, USA. 6 Gretchen Swanson
Center for Nutrition, Omaha, NE, USA. 7 Department of Medical Social Sciences,
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Received: 23 August 2023 Accepted: 16 February 2024
References
1. U.S. Department of Agriculture. USDA Actions on Nutrition Security. 2022.
2. Barrett CB. Measuring food insecurity. Science. 2010;327(5967):825–8.
https:// doi. org/ 10. 1126/ scien ce. 11827 68.
3. Coleman-Jensen A, Rabbitt MP, Gregory CA, Singh A. Household Food
Security in the United States in 2021. U.S. Department of Agriculture.
2022. https:// www. ers. usda. gov/ publi catio ns/ pub- detai ls/? pubid=
104655.
4. Bank RICF. Hunger facts & resources https:// rifoo dbank. org/ what- we- do/
hunger- facts- resou rces/ 2021.
5. Gundersen C, Ziliak JP. Food insecurity and health outcomes. Health Aff.
2015;34(11):1830–9. https:// doi. org/ 10. 1377/ hltha ff. 2015. 0645.
6. Sun Y, Liu B, Rong S, Du Y, Xu G, Snetselaar LG, Wallace RB, Bao W. Food
insecurity is associated with cardiovascular and all-cause mortality
among adults in the United States. J Am Heart Assoc. 2020;9(19):e014629.
https:// doi. org/ 10. 1161/ jaha. 119. 014629.
7. U.S. Department of Agriculture. Food and Nutrition Security. 2021. Avail-
able from: https:// www. usda. gov/ nutri tion- secur ity.
8. Al-Sabah S, Al-Haddad M, Al-Youha S, Jamal M, Almazeedi S. COVID-
19: impact of obesity and diabetes on disease severity. Clin Obes.
2020;10(6):e12414. https:// doi. org/ 10. 1111/ cob. 12414.
9. Diallo AF, Falls K, Hicks K, McQueen Gibson E, Obaid R, Slattum P, Zanjani
F, Price E, Parsons P. The Healthy Meal Program: a food insecurity screen-
ing and referral program for urban dwelling older adults. Public Health
Nurs. 2020;37(5):671–6. https:// doi. org/ 10. 1111/ phn. 12778.
10. Garba NA, Sacca L, Clarke RD, Bhoite P, Buschman J, Oller V, Napolitano N,
Hyppolite S, Lacroix S, Archibald A, Hamilton O, Ash T, Brown DR. Address-
ing food insecurity during the COVID-19 pandemic: intervention out-
comes and lessons learned from a collaborative food delivery response in
South Florida’s underserved households. Int J Environ Res Public Health.
2022;19(13). https:// doi. org/ 10. 3390/ ijerp h1913 8130.
11. Biden-Harris Administration. White House Conference on Hunger, Nutri-
tion, and Health. Washington, DC. 2022.
12. Downer S, Berkowitz SA, Harlan TS, Olstad DL, Mozaffarian D. Food is
medicine: actions to integrate food and nutrition into healthcare. BMJ.
2020;369:m2482. https:// doi. org/ 10. 1136/ bmj. m2482.
13. Gretchen Swanson Center for Nutrition. Gus Schumacher Nutrition Incen-
tive Program Training, Technical Assistance, Evaluation, and Information
Center (GusNIP NTAE): impact findings. 2021.
14. Herman DR, Harrison GG, Jenks E. Choices made by low-income women
provided with an economic supplement for fresh fruit and vegetable
purchase. J Am Diet Assoc. 2006;106(5):740–4. https:// doi. org/ 10. 1016/j.
jada. 2006. 02. 004.
15. Jones LJ, VanWassenhove-Paetzold J, Thomas K, Bancroft C, Ziatyk EQ,
Kim LS, Shirley A, Warren AC, Hamilton L, George CV, Begay MG, Wilmot T,
Tsosie M, Ellis E, Selig SM, Gall G, Shin SS. Impact of a Fruit and Vegetable
Prescription Program on health outcomes and behaviors in young Navajo
children. Curr Dev Nutr. 2020;4(8):nzaa109. https:// doi. org/ 10. 1093/ cdn/
nzaa1 09.
16. Trapl ES, Smith S, Joshi K, Osborne A, Benko M, Matos AT, Bolen S. Dietary
impact of produce prescriptions for patients with hypertension. Prev
Chronic Dis. 2018;15:E138. https:// doi. org/ 10. 5888/ pcd15. 180301.
17. Volpp KG, Berkowitz SA, Sharma SV, Anderson CAM, Brewer LC, Elkind
MSV, Gardner CD, Gervis JE, Harrington RA, Herrero M, Lichtenstein AH,
McClellan M, Muse J, Roberto CA, Zachariah JPV, American Heart Associa-
tion. Food is medicine: a presidential advisory from the American Heart
Association. Circulation. 2023;148(18):1417–39. https:// doi. org/ 10. 1161/
CIR. 00000 00000 001182.
18. Hager K, Du M, Li Z, Mozaffarian D, Chui K, Shi P, Ling B, Cash SB, Folta SC,
Zhang FF. Impact of produce prescriptions on diet, food security, and
cardiometabolic health outcomes: a multisite evaluation of 9 produce
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 12 of 13
Franketal. Pilot and Feasibility Studies (2024) 10:51
prescription programs in the United States. Circ Cardiovasc Qual Out-
comes. 2023;16(9):e009520. https:// doi. org/ 10. 1161/ CIRCO UTCOM ES. 122.
009520.
19. Newman T, Lee JS. Strategies and challenges: qualitative lessons learned
from Georgia produce prescription programs. Health Promot Pract.
2022;23(4):699–707. https:// doi. org/ 10. 1177/ 15248 39921 10285 58.
20. Newman T, Lee JS, Thompson JJ, Rajbhandari-Thapa J. Current land-
scape of produce prescription programs in the US. J Nutr Educ Behav.
2022;54(6):575–81. https:// doi. org/ 10. 1016/j. jneb. 2022. 02. 011.
21. Schoendorfer N, Gannaway D, Jukic K, Ulep R, Schafer J. Future doctors’
perceptions about incorporating nutrition into standard care practice. J
Am Coll Nutr. 2017;36(7):565–71. https:// doi. org/ 10. 1080/ 07315 724. 2017.
13339 28.
22. Wynn K, Trudeau JD, Taunton K, Gowans M, Scott I. Nutrition in primary
care: current practices, attitudes, and barriers. Can Fam Physician.
2010;56(3):e109–16.
23. Stotz SA, Budd Nugent N, Ridberg R, Byker Shanks C, Her K, Yaroch AL,
Seligman H. Produce prescription projects: challenges, solutions, and
emerging best practices - perspectives from health care providers. Prev
Med Rep. 2022;29:101951. https:// doi. org/ 10. 1016/j. pmedr. 2022. 101951.
24. Garfield K, Scott E, Sukys K, Downer S, Landauer R, Orr J, Friedman R,
Dushko M, Leib EB, Greenwald R. Mainstreaming produce prescriptions: a
policy strategy report. 2021.
25. Rhode Island Community Food Bank. 2022 status report on hunger in
Rhode Island. 2022.
26. Bauer MS, Kirchner J. Implementation science: what is it and why should I
care? Psychiatry Res. 2020;283:112376. https:// doi. org/ 10. 1016/j. psych res.
2019. 04. 025.
27. Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated
Consolidated Framework for Implementation Research based on
user feedback. Implement Sci. 2022;17(1). https:// doi. org/ 10. 1186/
s13012- 022- 01245-0.
28. Nilsen P. Making sense of implementation theories, models and
frameworks. Implement Sci. 2015;10(1). https:// doi. org/ 10. 1186/
s13012- 015- 0242-0.
29. Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Cole-
man CL, Bond CM. Defining feasibility and pilot studies in preparation for
randomised controlled trials: development of a conceptual framework.
PLoS One. 2016;11(3):e0150205. https:// doi. org/ 10. 1371/ journ al. pone.
01502 05.
30. Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu
MM, Proctor EK, Kirchner JE. A refined compilation of implementation
strategies: results from the Expert Recommendations for Implementing
Change (ERIC) project. Implement Sci. 2015;10(1):21. https:// doi. org/ 10.
1186/ s13012- 015- 0209-1.
31. Lancaster GA, Thabane L. Guidelines for reporting non-randomised pilot
and feasibility studies. Pilot Feasibility Stud. 2019;5(1). https:// doi. org/ 10.
1186/ s40814- 019- 0499-1.
32. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L,
Lancaster GA. CONSORT 2010 statement: extension to randomised pilot
and feasibility trials. Bmj. 2016;355:i5239. https:// doi. org/ 10. 1136/ bmj.
i5239.
33. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated
guidelines for reporting parallel group randomised trials. BMJ.
2010;340:c332. https:// doi. org/ 10. 1136/ bmj. c332.
34. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths
CJ, Rycroft-Malone J, Meissner P, Murray E, Patel A, Sheikh A, Taylor SJC.
Standards for Reporting Implementation Studies (StaRI) statement. BMJ.
2017:i6795. https:// doi. org/ 10. 1136/ bmj. i6795.
35. Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research:
a systematic review of empirical tests. Soc Sci Med. 2022;292:114523.
https:// doi. org/ 10. 1016/j. socsc imed. 2021. 114523.
36. Newman SD, Andrews JO, Magwood GS, Jenkins C, Cox MJ, Williamson
DC. Community advisory boards in community-based participatory
research: a synthesis of best processes. Prev Chronic Dis. 2011;8(3):A70.
37. Aarons GA. Mental health provider attitudes toward adoption of evi-
dence- based practice: the Evidence-Based Practice Attitude Scale. Ment
Health Serv Res. 2004;6(2):61–74.
38. Weiner BJ, Belden CM, Bergmire DM, Johnston M. The meaning and
measurement of implementation climate. Implement Sci. 2011;6(1):78.
https:// doi. org/ 10. 1186/ 1748- 5908-6- 78.
39. Hager ER, Quigg AM, Black MM, Coleman SM, Heeren T, Rose-Jacobs R,
Cook JT, Ettingerdecuba SA, Casey PH, Chilton M, Cutts DB, Meyers AF,
Frank DA. Development and validity of a 2-item screen to identify families
at risk for food insecurity. Pediatrics. 2010;126(1):e26–32. https:// doi. org/
10. 1542/ peds. 2009- 3146.
40. Calloway EE, Carpenter LR, Gargano T, Sharp JL, Yaroch AL. Development
of new measures to assess household nutrition security, and choice in
dietary characteristics. Appetite. 2022;179:106288. https:// doi. org/ 10.
1016/j. appet. 2022. 106288.
41. Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder
LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic
methods from a process evaluation of academic detailing in the Veterans
Health Administration. Implement Sci. 2019;14(1). https:// doi. org/ 10.
1186/ s13012- 019- 0853-y.
42. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework
method for the analysis of qualitative data in multi-disciplinary health
research. BMC Med Res Methodol. 2013;13(1):117. https:// doi. org/ 10.
1186/ 1471- 2288- 13- 117.
43. Lewis CC, Scott K, Marriott BR. A methodology for generating a tailored
implementation blueprint: an exemplar from a youth residential setting.
Implement Sci. 2018;13(1):68. https:// doi. org/ 10. 1186/ s13012- 018- 0761-6.
44. Green PE, Srinivasan V. Conjoint analysis in marketing: new developments
with implications for research and practice. J Mark. 1990;54(4):3–19.
https:// doi. org/ 10. 1177/ 00222 42990 05400 402.
45. Powell BJ, Beidas RS, Lewis CC, Aarons GA, McMillen JC, Proctor EK, Man-
dell DS. Methods to improve the selection and tailoring of implementa-
tion strategies. J Behav Health Serv Res. 2017;44(2):177–94. https:// doi.
org/ 10. 1007/ s11414- 015- 9475-6.
46. Joshi K, Smith S, Bolen SD, Osborne A, Benko M, Trapl ES. Implementing
a produce prescription program for hypertensive patients in safety net
clinics. Health Promot Pract. 2019;20(1):94–104. https:// doi. org/ 10. 1177/
15248 39917 754090.
47. Kilbourne AM, Goodrich DE, Miake-Lye I, Braganza MZ, Bowersox NW.
Quality enhancement research initiative implementation roadmap. Med
Care. 2019;57(Suppl 3):S286–93. https:// doi. org/ 10. 1097/ mlr. 00000 00000
001144.
48. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC.
Fostering implementation of health services research findings into prac-
tice: a consolidated framework for advancing implementation science.
Implement Sci. 2009;4(1):50. https:// doi. org/ 10. 1186/ 1748- 5908-4- 50.
49. Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recom-
mendations for specifying and reporting. Implement Sci. 2013;8(1):139.
https:// doi. org/ 10. 1186/ 1748- 5908-8- 139.
50. Rudd BN, Davis M, Beidas RS. Integrating implementation science in
clinical research to maximize public health impact: a call for the reporting
and alignment of implementation strategy use with implementation
outcomes in clinical research. Implement Sci. 2020;15(1). https:// doi. org/
10. 1186/ s13012- 020- 01060-5.
51. Damschroder LJ, Reardon CM, Opra Widerquist MA, Lowery J. Concep-
tualizing outcomes for use with the Consolidated Framework for Imple-
mentation Research (CFIR): the CFIR Outcomes Addendum. Implementa-
tion Science. 2022;17(1). https:// doi. org/ 10. 1186/ s13012- 021- 01181-5.
52. Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton
MH, Halko H. Psychometric assessment of three newly developed imple-
mentation outcome measures. Implement Sci. 2017;12(1):108. https://
doi. org/ 10. 1186/ s13012- 017- 0635-3.
53. Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational
readiness for implementing change: a psychometric assessment of
a new measure. Implement Sci. 2014;9(1):7. https:// doi. org/ 10. 1186/
1748- 5908-9-7.
54. Thompson FE, Midthune D, Kahle L, Dodd KW. Development and evalu-
ation of the National Cancer Institute’s Dietary Screener Questionnaire
Scoring Algorithms. J Nutr. 2017;147(6):1226–33. https:// doi. org/ 10. 3945/
jn. 116. 246058.
55. Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2:
validity of a two-item depression screener. Med Care. 2003;41:1284–92.
56. Heath G, Cameron E, Cummins C, Greenfield S, Pattison H, Kelly D, Red-
wood S. Paediatric ‘care closer to home’: stake-holder views and barriers
to implementation. Health Place. 2012;18(5):1068–73. https:// doi. org/ 10.
1016/j. healt hplace. 2012. 05. 003.
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 13 of 13
Franketal. Pilot and Feasibility Studies (2024) 10:51
57. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot stud-
ies in clinical research. J Psychiatr Res. 2011;45(5):626–9. https:// doi. org/
10. 1016/j. jpsyc hires. 2010. 10. 008.
58. Marcinkevage J, Auvinen A, Nambuthiri S. Washington State’s Fruit and
Vegetable Prescription Program: improving affordability of healthy foods
for low-income patients. Prevent Chronic Dis. 2019;16:E91.
59. Goddu AP, Roberson TS, Raffel KE, Chin MH, Peek ME. Food Rx: a commu-
nity-university partnership to prescribe healthy eating on the South Side
of Chicago. J Prev Interv Community. 2015;43(2):148–62. https:// doi. org/
10. 1080/ 10852 352. 2014. 973251.
60. Izumi BT, Higgins CE, Baron A, Ness SJ, Allan B, Barth ET, Smith TM, Pranian
K, Frank B. Feasibility of using a community-supported agriculture
program to increase access to and intake of vegetables among federally
qualified health center patients. J Nutr Educ Behav. 2018;50(3):289–96.e1.
https:// doi. org/ 10. 1016/j. jneb. 2017. 09. 016.
61. Trapl ES, Joshi K, Taggart M, Patrick A, Meschkat E, Freedman DA. Mixed
methods evaluation of a produce prescription program for pregnant
women. J Hunger Environ Nutr. 2017;12(4):529–43. https:// doi. org/ 10.
1080/ 19320 248. 2016. 12277 49.
62. Bhat S, Coyle DH, Trieu K, Neal B, Mozaffarian D, Marklund M, Wu JHY.
Healthy food prescription programs and their impact on dietary behavior
and cardiometabolic risk factors: a systematic review and meta-analysis.
Adv Nutr. 2021;12(5):1944–56. https:// doi. org/ 10. 1093/ advan ces/ nmab0
39.
63. Friedman DB, Freedman DA, Choi SK, Anadu EC, Brandt HM, Carvalho N,
Hurley TG, Young VM, Hébert JR. Provider communication and role mode-
ling related to patients’ perceptions and use of a federally qualified health
center-based farmers’ market. Health Promot Pract. 2014;15(2):288–97.
https:// doi. org/ 10. 1177/ 15248 39913 500050.
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