Patient perspectives on, and effects of, medication management in geriatric fallers (the EMMA study): protocol for a mixed-methods pre-post study

Abstract

Introduction
Pharmacotherapy is critical in geriatric fallers owing to the vulnerability of this population. Comprehensive medication management can be an important strategy to reduce the medication-related risk of falling in this patient group. Patient-specific approaches and patient-related barriers to this intervention have rarely been explored among geriatric fallers. This study will focus on establishing a comprehensive medication management process to provide better insights into patients’ individual perceptions regarding their fall-related medication as well as identifying organisational and medical-psychosocial effects and challenges of this intervention.

Methods and analysis
The study design is a complementary mixed-methods pre-post study which follows the approach of an embedded experimental model. Thirty fallers aged at least 65 years who were on five or more self-managed long-term drugs will be recruited from a geriatric fracture centre. The intervention consists of a five-step (recording, reviewing, discussion, communication, documentation) comprehensive medication management, which focuses on reducing the medication-related risk of falling. The intervention is framed using guided semi-structured pre-post interventional interviews, including a follow-up period of 12 weeks. These interviews will assess patients’ perceptions of falls, medication-related risks and gauge the postdischarge acceptability and sustainability of the intervention. Outcomes of the intervention will be measured based on changes in the weighted and summated Medication Appropriateness Index score, number of fall-risk-increasing drugs and potentially inadequate medication according to the Fit fOR The Aged and PRISCUS lists. Qualitative and quantitative findings will be integrated to develop a comprehensive understanding of decision-making needs, the perspective of geriatric fallers and the effects of comprehensive medication management.

Ethics and dissemination
The study protocol was approved by the local ethics committee of Salzburg County, Austria (ID: 1059/2021). Written informed consent will be obtained from all patients. Study findings will be disseminated through peer-reviewed journals and conferences.

Trial registration number
DRKS00026739.

Full text

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BucheggerS, etal. BMJ Open 2023;13:e066666. doi:10.1136/bmjopen-2022-066666
Open access
Patient perspectives on, and effects of,
medication management in geriatric
fallers (the EMMA study): protocol for a
mixed- methods pre- post study
Stephanie Buchegger ,1,2 Bernhard Iglseder,3 Reinhard Alzner,3
Magdalena Kogler,4 Olaf Rose,5 Patrick Kutschar ,6 Simon Krutter ,6
Christina Dückelmann,1,4 Maria Flamm,2,7 Johanna Pachmayr1,2
To cite: BucheggerS,
IglsederB, AlznerR, etal.
Patient perspectives on,
and effects of, medication
management in geriatric
fallers (the EMMA study):
protocol for a mixed- methods
pre- post study. BMJ Open
2023;13:e066666. doi:10.1136/
bmjopen-2022-066666
►Prepublication history and
additional supplemental material
for this paper are available
online. To view these les,
please visit the journal online
(http://dx.doi.org/10.1136/
bmjopen-2022-066666).
Received 17 July 2022
Accepted 03 February 2023
For numbered afliations see
end of article.
Correspondence to
Stephanie Buchegger;
stephanie. buchegger@ pmu.
ac. at
Protocol
© Author(s) (or their
employer(s)) 2023. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by
BMJ.
ABSTRACT
Introduction Pharmacotherapy is critical in geriatric
fallers owing to the vulnerability of this population.
Comprehensive medication management can be an
important strategy to reduce the medication- related risk
of falling in this patient group. Patient- specic approaches
and patient- related barriers to this intervention have rarely
been explored among geriatric fallers. This study will focus
on establishing a comprehensive medication management
process to provide better insights into patients’ individual
perceptions regarding their fall- related medication as well
as identifying organisational and medical- psychosocial
effects and challenges of this intervention.
Methods and analysis The study design is a
complementary mixed- methods pre- post study which
follows the approach of an embedded experimental model.
Thirty fallers aged at least 65 years who were on ve or
more self- managed long- term drugs will be recruited from
a geriatric fracture centre. The intervention consists of a
ve- step (recording, reviewing, discussion, communication,
documentation) comprehensive medication management,
which focuses on reducing the medication- related risk
of falling. The intervention is framed using guided semi-
structured pre- post interventional interviews, including a
follow- up period of 12 weeks. These interviews will assess
patients’ perceptions of falls, medication- related risks and
gauge the postdischarge acceptability and sustainability
of the intervention. Outcomes of the intervention will
be measured based on changes in the weighted and
summated Medication Appropriateness Index score,
number of fall- risk- increasing drugs and potentially
inadequate medication according to the Fit fOR The Aged
and PRISCUS lists. Qualitative and quantitative ndings will
be integrated to develop a comprehensive understanding
of decision- making needs, the perspective of geriatric
fallers and the effects of comprehensive medication
management.
Ethics and dissemination The study protocol was
approved by the local ethics committee of Salzburg
County, Austria (ID: 1059/2021). Written informed consent
will be obtained from all patients. Study ndings will
be disseminated through peer- reviewed journals and
conferences.
Trial registration number DRKS00026739.
INTRODUCTION
Falls are an increasing public health problem.
Approximately 30% of community- dwelling
people aged 65 years or older suffer from
falls.1 Approximately 5% of all fall events result
in serious injuries requiring hospitalisation.2
Most hospital admissions are due to hip frac-
tures, fractures of the arm and head injuries.3
In addition to serious physical injuries, patients
often suffer from loss of quality of life,4 5 fear of
falling,6 increased risk for institutionalisation7 8
and enhanced rates of morbidity and mortality.9
In Western Europe, the burden of disease after
a fall represents 1.4 million disability- adjusted
life- years and >50 000 geriatric patients die due
to falls annually.10
The individual burden of geriatric fallers
is complex and multifactorial.11 Geriatric
patients are frequently exposed to age- related
changes in body function and composition,
multimorbidity and polypharmacy, which
increase the risk of adverse events such as
falling.12 13 Medication is a modifiable risk
factor for falls and fall- related injuries.14
Prescription and monitoring of drug therapy
STRENGTHS AND LIMITATIONS OF THIS STUDY
⇒In- depth understanding of geriatric fallers’ percep-
tions and experiences of medication- related risks.
⇒Implementation of an embedded quasi- experimental
design in mixed- methods exploring patient- centred
and organisational barriers when conducting a com-
prehensive medication management process.
⇒Qualitative and quantitative measures analysing co-
management of care for geriatric fallers carried out
in a geriatric fracture centre.
⇒Mixed- methods approach complementing pre- post
geriatric fallers’ perceptions on medication- related
risks with comprehensive medication management.
⇒Reduced time span and number of participants may
limit the external validity of the study.
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in older patients is challenging for all involved health-
care professionals and requires a proper balance between
optimising control of chronic diseases and minimising
the risks of polypharmacy.15 16 Furthermore, evidence
regarding medical treatment of multimorbid patients
is scarce.17 18 Patients with complex healthcare needs
frequently suffer because of fragmented and incomplete
healthcare.19 In Austria, similar to other European coun-
tries, regular reviews and adjustment of medication have
rarely been established in hospital care.20 21 Comprehen-
sive medication management (CMM) defines a medica-
tion review process with a collaborative approach to assess
patients’ medication regimen and optimise medication
therapy.22 Collaboration with pharmacists can contribute
to safe medication use and prevention of drug- related
problems.23 Several studies have investigated the impact
of medication review to reduce the risk of falling, but
outcome measures are heterogeneous, and results vary
widely.23–29 Furthermore, fall prevention programmes
have been unsuccessful in the past because of the discrep-
ancy between the perspectives of healthcare providers
and those of their patients regarding individual fall risk
assessments.30
Therefore, new approaches are required for this purpose.
This study will address geriatric fallers’ perceptions and
experiences when implementing a CMM intervention to
contribute to a patient- centred approach in fall prevention.
Study aim and objectives
The aims of this mixed- methods pre- post study are to (1)
obtain an in- depth understanding of perceptions and expe-
riences of medication- related risk of falling among hospital-
ised geriatric patients and (2) identify organisational and
medical- psychosocial factors which facilitate or hamper the
outcome of a CMM with a focus on reducing falls.
The objectives of this study are to explore the following
research questions:
►How do geriatric fallers experience their falls, and
how do they link the associated feelings and condi-
tions to their medication?
►What are the patient- related and medication- related
challenges that can affect the implementation of
CMM?
►To what extent can the patients’ medication be opti-
mised using CMM while considering the medica-
tion appropriateness according to the weighted and
summated Medication Appropriateness Index (MAI)
score, reducing fall- risk increasing drugs (FRID) and
potential inappropriate medication (PIM)?
►What are the medical- psychosocial and organisational
factors that may facilitate or hamper the acceptability,
feasibility and sustainability of CMM?
METHODS AND ANALYSIS
Study design
The Medical Research Council (MRC) guidance will
serve as the overarching framework for this study. The
MRC network focuses on developing and evaluating
complex interventions and helps making appropriate
methodological and practical choices.31 32 Using a
mixed- methods approach in intervention research can
address more questions which provide implications for
decision makers.33 The EMMA (Effects of, Medication
Management in geriatric fAllers) study is designed as
a mixed- methods pre- post study consisting of qualita-
tive semi- structured patient interviews and quantitative
medication- related data in a complementary approach.
Specifically, the mixed- methods approach follows the
design of an embedded experimental model according
to Creswell, with the qualitative part framing the
quantitative part in a two- phase sequential approach
collecting qualitative data before and after the inter-
vention.34 Recommendations for interventional trials
(Standard Protocol Items: Recommendations for Inter-
ventional Trials 2013) were used to develop the study
protocol and are shown in the online supplemental file
1.35 Regarding the research question, a single popu-
lation, intervention, comparison, outcome and study
type (PICOS) question was generated.36 The PICOS
question is based on:
►Population: community- dwelling patients aged ≥65
years receiving polypharmacy (taking ≥five medi-
cines) and admitted to a geriatric fracture centre
(GFC) after an injurious fall.
►Intervention: five- step CMM intervention.
►Comparison: pre- post interventional comparison of
patient perspectives.
►Outcomes: individual pre- post perceptions of patients
regarding medication- related risks of falling and the
medical- psychosocial effects of CMM (qualitative).
Changes in weighted and summed MAI scores, FRID
and PIM (quantitative).
►Study type: prospective, monocentric, single- arm,
longitudinal mixed- methods pre- post interventional
study using a complementary approach based on an
embedded quasi- experimental model.
The rationale of the study design was set out as follows:
In the first step, the complementary approach, also
defined as ‘additional coverage’, aims to provide a better
illustration and extension of understanding the findings
of patients’ perceptions and their medical character-
istics as different types of data produce different types
of knowledge.37 38 Furthermore, the complementary
approach contributes to a more comprehensive answer to
the research questions.37
Second, the embedded experimental approach allows
the analysis of qualitative information in a pre- post inter-
ventional process which enhances the comparability of
patients’ views. To strengthen the pre- post approach and
avoid an increased risk of treatment bias in light of the
CMM intervention, no during- interventional qualitative
phase will take place.
Third, the embedded experimental model specif-
ically follows the design of a quasi- experimental
approach, including a non- randomised allocation to
strengthen the balance between internal (in- depth
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patients’ perceptions) and external (exploration of
CMM in a real- life clinical setting among geriatric
fallers) validity.39 40
Fourth, the mixed- methods approach is beneficial
for providing a holistic picture of the impact of patient-
centred interventions.41
Finally, using a mixed- methods approach enables
the exploration of whether the implementation of
the CMM intervention is feasible to contribute to a
better outcome in reducing the medication- related
risk of falling by strongly focusing on patient- centred
care.42 The Consolidated Framework for Implemen-
tation Research (CFIR) will underpin the study when
investigating interventional barriers and facilitators to
improve understanding.43 Proctor et al present a model
to distinguish implementation outcomes (eg, feasibility
measures) and programme outcomes (eg, service- level
outcomes and patient- level outcomes), emphasising
that a programme is only effective when it is well
implemented.44 The CFIR is combined with concep-
tual model of implementation research by Proctor et
al to better represent outcomes (both implementation
and programme outcomes).45 Findings could help to
plan and execute a larger study and to investigate the
effectiveness of an optimised CMM process in geriatric
fallers and contribute to the development of recom-
mendations on fall prevention and drug therapy safety
in a geriatric fracture practice setting.
The study starts with the qualitative arm to explore
the phenomenon of the participants’ fall events and
perspectives on their medication by conducting guided,
semi- structured, pre- interventional interviews. The inter-
views will be arranged as face- to- face interviews lasting
approximately 45 min. Next, the quantitative, inter-
ventional phase, that is, CMM, with the overall aim of
enhancing the quality of medication will be conducted.
Continuing the sequence, qualitative, postinterventional
interviews in a guided semi- structured approach will be
conducted at three time points (2, 6 and 12 weeks) after
discharge. Interviews will be conducted remotely via tele-
phone to assess the acceptability, feasibility and sustain-
ability of the CMM, including the reoccurrence of falling.
Telephone interviews are intended to last approximately
25 min. Retention of participants will be promoted by
an appointment card reminding them of upcoming
follow- up telephone interviews. With the participants’
consent, interviews will be audio recorded. All answers
will be de- identified by using an eight- digit code which
allows linking of qualitative and quantitative data. The
interviews will be held by a trained researcher (SB). Both
interview flows, pre- post interventional, are displayed in
figure 1 and are explained below.
Development of patient interviews
Two interview guides (pre- interventional face- to- face
interview questions and postinterventional telephone
interview questions) were created and are shown
in online supplemental files 2 and 3. Based on the
research questions, a focused review using PubMed and
Google Scholar was initiated to determine the themes.
Recommendations from Bolderston were considered
as a quality guide to optimise interview questions.46
The plausibility and face validity of the questions were
scrutinised by clinical experts, including geriatricians,
orthopaedists/traumatologists, pharmacists, nurses,
social researchers and members of the project team.
Figure 1 Patient interview ow (created with Servier Medical Art).106 CMM, comprehensive medication management.
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To test comprehensibility, interview questions will be
piloted with patients.46
Pre-interventional face-to-face semi-structured interviews
General questions about the patients’ fall experience/fall event and
about possible relations to medication
Questions in this category will have a strong focus on the
evaluation of the patients’ fall events, estimated causes
of the fall and any possible, subjective connection with
the individual medication.47 Furthermore, participants’
history of falling and how they perceive the importance
of fall prevention strategies will be evaluated.48
Guiding questions about the patients’ individual medication
management and knowledge regarding their medication
Guiding questions will be asked to assess the participants’
knowledge of their medication related to indication.
Patients’ individual medication management (medication
plan, help in taking medication and why help is needed),
as well as the latest changes in their medication, will be
administered.49 50 Furthermore, participants will be asked
how they enquire about their medication information.51
Planned follow-up questions about the patients’ views on
polypharmacy and on discontinuing drugs
At this point, the participants will be asked about their
satisfaction with the number of medications. Another
focus is on determining the extent to which patients are
generally willing to reduce the dosage or discontinue any
inappropriate medication by physicians.52
Closed-ended questions to assess patients’ adherence to therapy
Questions with a closed- ended character will be asked
to explore the participants’ behaviour in taking their
medication corresponding to the recommendations for
medication use. Based on Likert- type scale questions, the
frequency of how often the participants forget to take
their medication and whether they discontinue their
medication on feeling better will be gauged.53 54 Since
questions about the patients’ adherence represent a very
sensitive topic and are more likely to be discovered once a
patient’s relationship has been built up during the inter-
view, this category will be chosen for the later parts of the
interview.55
Sociodemographics
Lastly, study participants will be asked questions regarding
sociodemographic factors, including age, sex and highest
education level. This category will also assess the partici-
pants’ social situation.
Postinterventional semi-structured telephone interviews
Guiding questions on patients’ health condition and reoccurrence
of falling
In this section, a 5- type Likert scale question (from poor to
excellent) will be asked to categorise the patients’ health
status after hospital discharge.56 57 Furthermore, patients
will be asked about further falls events. The subquestions
of this category will be strongly designed according to the
questions regarding fall occurrence in face- to- face inter-
views to enable a comparison.
Guiding questions on the patients’ medication status
To assess the acceptability, feasibility and sustainability of
CMM, patients will be asked about the current status of
their medication. For each changed/newly prescribed/
discontinued drug in the hospital, patients will be asked
how they feel about the change and if further changes (eg,
newly prescribed drugs) occur after discharge. If further
changes occur, patients will be asked about the reason
and the prescriber (eg, general practitioner, specialists).
Furthermore, patients will be asked if they are satisfied
with their medications.58
Questions to assess the patients’ satisfaction with the CMM
service
The interview will be closed with a general, binary
question about the patients’ satisfaction with the CMM
included in the clinical routine care procedure.56 Hereby,
an important question will be the patients’ perspectives
on improvement suggestions. This question will only be
asked during the telephone interview at T5, as this will be
the first interview after hospital discharge.
Data collection
Data will be collected at eight different time points
to describe the process and measure the outcomes.
Following the mixed- methods approach in an embedded
experimental design, data collection will include both
qualitative and quantitative sources. The parameters
listed in figure 2 will be recorded to explore patients’
perspectives and the effects of CMM.
Setting
Participating individuals suffering from a fall will be
recruited by the geriatrician (RA) of the GFC of a tertiary
care, academic hospital in Austria.59 The GFC is certifi-
cated according to the German Trauma Society’s guide-
lines with the aim to improve geriatric trauma care.60
Between planning and implementing this study, the
COVID- 19 pandemic has had profound clinical and
social repercussions for geriatric patients. Nevertheless,
it is important to continue and include older adults in
non COVID- 19- related research.61 All relevant COVID- 19
measures will be considered while conducting this study.
Recruitment commenced in May 2021 with anticipated
completion by May 2023.
Participants
Recruitment and sampling
Recruitment of patients is based on a criterion sampling
strategy by eligibility criteria with the aim to achieve
maximum variation sampling in participants regarding
the patients’ experiences of their fall and subsequent
medication changes and in demographic characteristics
(ie, age, sex) and living situation.62 63 Approximately 30
geriatric patients will be recruited. The target sample size
was inspired by other mixed- methods studies, which were
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Figure 2 Data collection following the mixed- methods approach in an embedded experimental design (created with
Servier Medical Art).106 CMM, comprehensive medication management; FRID, fall- risk increasing drugs; MAI. Medication
Appropriateness Index; PIM, potential inappropriate medication.
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initiated to investigate interventional effects through
patient perspectives.64–66 Furthermore, according to
Morse, the number of participants was determined by
considering the intensity of interviews, the qualitative
method (semi- structured interviews) and the general
study design (longitudinal mixed- methods pre- post study;
embedded experimental design).67 The study enrolment
will take place during hospital admission. Individuals
who may be interested and eligible to participate will
be approached by their consultant geriatrician (RA),
who will explain the background, purpose and scope of
the project. If a patient is willing to participate, written
informed consent will be obtained. It will be pointed out
that, even if consented, participation is free to withdraw
from the study at any time without any consequences.
Once informed consent is obtained, face- to- face pre-
interventional interview will be conducted.
Eligibility criteria
Eligible patients are 65 years or older, present to the GFC
after an injurious fall, take five or more long- term medi-
cations, speak German and are able to provide written
informed consent. Patients must be community- dwelling
or live in assisted or independent living communities.
Eligible participants must manage their medication
independently in order to be able to provide sufficient
information about the medication and must be mentally
capable participating an interview. The cognitive status
will be measured by the Salzburg Dementia Test Prediction
(SDTP).68 Here, a predicted Mini- Mental State Examina-
tion with a cut- off of >25/30 (=no cognitive impairment)
is targeted. To explore medication- related risks of falling,
patients with falls out of bed or wheelchair as well as falls
caused by collision with vehicles are excluded.
Professional groups cover geriatricians, orthopaedists/
traumatologists and pharmacists at the GFC.
Intervention
The rationale of the CMM intervention is based on the
statements of the International Pharmaceutical Federa-
tion which describes a model of Collaborative Pharmacy
Practice with advancing models that facilitate interpro-
fessional collaboration and greater pharmacist account-
ability.69 The intervention will consist of a five- step CMM
practice by reviewing medication appropriateness,
including PIM and FRID. Results of a focused review will
be used to identify FRID. Screening tools of the MAI,
PRISCUS list and Fit fOR The Aged (FORTA) list will
be used to assess medication use. The MAI represents
a reliable and valid measure of medication appropri-
ateness and appears to be a useful tool for research
studies, quality improvement studies and patient care
programmes.70 71 The FORTA list was recently updated
in 2021 and comprises four categories classified by an
expert Delphi panel.72 The PRISCUS list was developed
for the German market and includes inappropriate
substances comprising antidepressants, antihyper-
tensives and hypnotics/sedatives which are linked to
increased risk of falling.73–75 Identified drug- related
problems, recommendations and acceptance will be
documented by the Pharmaceutical Care Network
Europe V.9.1 classification system.76 Final clinical deci-
sions on medication optimisation will be based on clin-
ical expertise, patients’ perceptions and ultimately by
the geriatrician as the approving authority. CMM inter-
ventions and a digitally created medication plan will be
included in the patients’ letters of discharge (process
results from T2 and T3). The medication plan includes
medication (name, dose, frequency) and start/stop
dates. Orthopaedists/Traumatologists prepare the infor-
mation (digital and printed) at T4 to enable availability
for patients and physicians at the inpatient and outpa-
tient care sector. The five- step CMM process consists of
recording, reviewing, discussion, communication and
documentation. Core elements of a Medication Therapy
Management Service of the American Pharmacists Asso-
ciation and National Association of Chain Drug Stores
Foundation inspired the design of the process which
underwent setting- specific adaption.77 The five interven-
tional steps are shown in figure 3.
Outcomes
Two different methodological approaches will be used
for measuring outcomes: patient- reported outcomes
(primary outcomes) will be investigated qualitatively by
means of guided semi- structured patient interviews; clin-
ical and organisational outcomes of the CMM interven-
tion (secondary outcomes) will be assessed quantitatively.
Primary outcomes
T1 (pre-interventional interview)
►Symptoms, conditions and feelings before the fall.47
►Reason(s) of the fall. Can potential causes be linked
to medication?47
►Knowledge on medication indication.49
►Views on polypharmacy and willingness of discontin-
uing drugs.52
►Adherence to medication.54
T5, T6, T7 (postinterventional interviews)
►Changes in patients’ individual medication status
including reasons and drugs (acceptability, feasibility
and sustainability of the intervention) (=programme
outcomes according to CFIR and Proctor et al).44 78
►Reoccurrence of falling including why/how and
correlation to pre- interventional fall events (compar-
ison of patients’ previous fall description).47
►Satisfaction with the CMM service including sugges-
tions for improvement56 (=programme outcome
assessed only at T5).44 78
Categories regarding falls and medication will be
compared pre- interventional and postinterventional (T1
vs T5, T6, T7). To illustrate the condensed findings, the
outcomes will be underpinned by quotations of partici-
pants’ terminology.
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Secondary outcomes
T2 versus T4 (intervention)
►Medication optimisation, measured by changes in
medication appropriateness according to the MAI
sum score and changes in the number of FRID and
PIM.70 72 79
►Medication change rate, measured by changes in
medication (reduced dosage, discontinued, newly
prescribed)80 and pill burden (total number of doses
per day including over- the- counter products).81
►Pharmacological subgroups of patients’ medication
(Anatomical Therapeutic Chemical Classification
(ATC)).82
T3, T4 (implementation)
►Acceptance rate of pharmaceutical interventions by
physicians77 and transfer of the optimised medica-
tion plan by orthopaedists/traumatologists into the
patients’ letters of hospital discharge according to
CFIR and Proctor et al.44 45
►Lengths of hospital stay (in days).60
T0, T1 (patient characteristics)
►Morbidity (Charlson Comorbidity Index).83
►Cognitive performance (SDTP).68
►Fracture/Type of injury.
►Sociodemographic data (age, sex, highest level of
education and social situation).
Data analysis
Qualitative analysis
Recordings of patients’ interviews will be transcribed
verbatim and then analysed by qualitative content anal-
ysis according to Mayring.84 Particularly, the technique
of ‘structuration’ with the aim of assessing the material
based on categories (inductive- deductive categories) will
be chosen. In the coding process, transcription passages
will be assigned to categories and subcategories. During
the process, inductive categories will be formed. A corpus
of the data will be created by abstraction, including
quotations of the participants.84 85 Main categories are
consistent across data which enables crosschecking. The
corpus allows the distinction between simple category
lists (nominal scale level) and ordinal category systems
(eg, 5- type Likert scale). Formed categories can then
be integrated in the synthesis of qualitative and quanti-
tative data of the mixed- methods design. The analytical
Figure 3 Five- step interventional CMM process as conducted in the EMMA study (created with BioRender and Servier Medical
Art).106 107 CMM, comprehensive medication management; FRID, fall- risk increasing drugs; GFC, geriatric fracture centre; MAI.
Medication Appropriateness Index; PIM, potential inappropriate medication.
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process provides a practical, transparent summarisation
of large data material which is strictly rule- governed and
thus strongly intersubjectively verifiable.85 To ensure the
credibility, results will be discussed in the research team.
The qualitative software package MAXQDA 2022 (VERBI
Software) will be used to assist the analysis.86 Standards
for Reporting Qualitative Research (SRQR) are used as
a checklist in manuscript preparation and in providing
transparency when writing up the study findings.87
Quantitative analysis
Patients’ medication will be analysed through
a. medication appropriateness by using the weighted and
summated MAI according to Samsa et al receiving a fi-
nal range up to 18 for each medication.70 Not appli-
cable or not assessable items will be scored 0 for each
item;
b. PIM by using the FORTA and PRISCUS lists;72 79
c. FRID by using results of a focused review.
Results of medication optimisation (eg, reducing
FRID) will be reported stratified by subgroups using ATC
codes.82
Statistical analysis will be of a descriptive nature with
a complementary approach to qualitative data. Basic
exploratory analysis will be used to investigate correla-
tions between scores on the weighted and summated MAI
scores and further secondary outcome measures by using
non- parametric tests and will be stratified according to
age- related groups and sex.
Mixed-methods analysis
Data integration of the qualitative and quantitative arms
represents the key to the EMMA study. Different types of
data will be analysed separately and subsequently inte-
grated at the ‘results point of integration’. Integration
will be facilitated by a visual joint display which can be
achieved by arranging related data in a figure, table,
matrix or graph.37 88–90 Meaningful integration facilitates
the synthesis of results by creating a whole beyond the
sum of the individual parts.91 The integration process
will be justified through the mixed- methods purpose of
complementation by seeking a better understanding and
holistic picture of the study findings. Qualitative findings
will be used to identify unexpected effects and perspec-
tives which are not covered by quantitative data.92
Missing data
Missing data (clinical data, patient- reported data) are
anticipated and will be indicated on their exact number
and reasons. Multiple imputations will be used to treat
missing data under a ‘missing at random’ assumption.93
Regarding the qualitative part of the study, missing data
are limited to no more than ≤20% attrition (dropout by
design, loss to follow- up, study withdrawal) of the first and
the last follow- up time points (T5, T7). For the quantita-
tive part (T2, T3, T4), the dropout rate must not exceed
≤5%.94
Patient and public involvement
Patients were involved in the development of the inter-
views. Patients were asked to participate in a pretest of both
interview guides to improve the feasibility of the process.
According to patients’ suggestions, interview questions
were adapted in wording which increased comprehensi-
bility and clarity. The results of the optimised medication
due to CMM will be communicated with patients during
the study. Additional study materials (ie, pharmaceutical
interventions and medication- related information) and
published outcomes will be made available to the partici-
pants on request.
ETHICS AND DISSEMINATION
Ethical considerations
This mixed- methods pre- post study protocol is in accor-
dance with the ethical principles of the Declaration of
Helsinki and current Good Clinical Practice. Moreover,
the study protocol was approved on 3 May 2021 by the
local ethics committee of Salzburg County, Austria (ID:
1059/2021). After obtaining the participant’s consent,
interviews will be recorded on an audio device, transcribed
verbatim and deleted afterwards. Patient information will
be stored in locked file cabinets. All data will be pseud-
onymised (using the code number of each respondent)
and generalised in data sheets. The research data will be
stored separately from personal identifiable information.
The principal investigator (BI), study physician (RA)
and pharmacists (MK, SB, CD) will be provided access
to the cleaned data files. To ensure confidentiality, data
dispersed to the project team members will be delinked
from any identifying patient information. A descriptive
analysis of the quantitative data will be performed after
checking the database. Before the formal phase of qual-
itative research is conducted, pretest interviews will be
conducted to assess the rigour of the instrumentation.
There is no need for a data monitoring committee
because expected study risks are minimal.95 Patients can
contact responsible study physicians at any time. Any
concerns regarding patients’ medication will be actively
listened to. According to the type of concern, patients will
receive education, counselling or an appointment when-
ever needed. Adverse events will be reported to the rele-
vant groups (sponsor and research ethics committee).
Dissemination
The participants will receive a verbal summary in lay
terms of the preliminary research findings at the end of
the last telephone interview. Another aim of this study
is to disseminate findings to patients suffering from
falls (beyond study participants) through talks. Under-
standing patients’ opinions on their medication should
contribute to developing recommendations for fall
prevention and drug therapy safety. Therefore, the find-
ings of this study will be disseminated in peer- reviewed
journals and conference presentations. Furthermore, the
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BucheggerS, etal. BMJ Open 2023;13:e066666. doi:10.1136/bmjopen-2022-066666
Open access
results are intended to provide assistance and improve-
ments for further roll- out of CMM service at a GFC.
DISCUSSION
The EMMA study protocol uses a mixed- methods pre-
post approach to examine the medical- psychosocial and
organisational effects and challenges when implementing
a CMM intervention for geriatric patients after a fall.
Evidence of patient- centred interventions in reducing
falls is scarce, and previous approaches of CMM are incon-
sistent.96–98 Findings from these previous studies demon-
strate that: (a) drug therapy optimisation can reduce
inappropriate prescribing96 but does not reduce drug-
related hospitalisations, that is, risk of falling97 and (b)
withdrawing FRID as a single intervention is not effective
in reducing the risk of falling.98 However, these studies
did not explore patients’ perceptions, needs and organ-
isational implications regarding the CMM. The EMMA
study is innovative for the following reasons:
1. Application of an embedded experimental design
according to Creswell and Clark in mixed- methods
represents a strategic method to reveal effects and
challenges of CMM for geriatric fallers.34 As such, the
design allows for pre- post comparison and providing
information on the intervention as well as on accept-
ability, sustainability and on reoccurrence of falling.
The integration of qualitative and quantitative data at
the end of the study helps to create a clearer and more
holistic picture of the results.92
2. Exploring the perspective of geriatric fallers at differ-
ent time points provides an in- depth understanding of
the medication- related risk of falling and helps assess
the needs of patients within the CMM. Shuman et al99
used an exploratory qualitative design to investigate
patient perceptions at two different time points (in-
hospital and postdischarge) to obtain perceptions of
fall risks, fall prevention interventions and fall- related
discharge instructions. They found that patients did
not perceive their risk of falling and that there was a
high need for healthcare providers to engage patients
and their families in understanding fall prevention (eg,
due to conversations). However, this study was limited
by a follow- up period of 8 days postdischarge and did
not investigate the medication- related risk of falling.
3. The EMMA study is the first of its kind to be conduct-
ed in a GFC. This setting supports the development of
new solutions to geriatric falls. While previous studies
have explored patients’ perceptions of falls and fall
prevention programmes in community care settings,
little evidence describes this issue in an inpatient care
setting.100–104 Radecki et al105 interviewed 12 hospital-
ised patients to understand the individual fall risks and
fall prevention interventions implemented by nursing
staff. They found that fall risk factors (eg, laboratory
values and medication changes) may not be tangi-
ble to patients. However, this study did not explore
perceptions and experiences of medication- related
interventions to improve fall prevention efforts.
Therefore, there is a strong need to develop and im-
plement patient- centred fall prevention programmes
with true patient involvement.
Despite being an innovative approach, the study
design hides several limitations. Some of these include
potential risks of recall bias, such as under- reporting or
over- reporting experiences which could affect the clas-
sification of categories in the analysis. Patients with pre-
existing osteoporosis are prone to be included into the
study. There is an absence of controls; thus, researchers
should be cautious when interpreting the results. The
sample size of 30 geriatric fallers undergoing CMM at a
single medical centre is limited. While this study does not
provide generalisable outcomes, the findings can help to
modify future CMMs for better results in patient- centred
care, facilitating fall prevention and drug therapy safety.
A qualitative investigation of CMM focusing on pharma-
cist and physician experiences and outcomes is planned
in the future.
Author afliations
1Institute of Pharmacy, Pharmaceutical Biology and Clinical Pharmacy, Paracelsus
Medical University Salzburg, Salzburg, Austria
2Center of Public Health and Health Services Research, Paracelsus Medical
University Salzburg, Salzburg, Austria
3Department of Geriatric Medicine, University Hospital Salzburg—Christian Doppler
Hospital, Salzburg, Austria
4Department of Clinical Pharmacy and Drug Information, Hospital Pharmacy,
Landesapotheke Salzburg, Salzburg, Austria
5Department of Research in Pharmacotherapy, Impac2t, Münster, Germany
6Institute of Nursing Science and Practice, Paracelsus Medical University Salzburg,
Salzburg, Austria
7Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus
Medical University Salzburg, Salzburg, Austria
Acknowledgements We would like to thank Professor Dr Thomas Freude and
Dr Andreas Hartmann for their permission to conduct this study at the GFC of the
University Hospital Salzburg. We express our gratitude to Dr Martin Wolkersdorfer
for organising the pharmaceutical personnel. We thank all participants for their
support in this study. We would like to thank Editage ( www. editage. com) for English
language editing.
Contributors SB established the study protocol and organised the application for
ethical approval under the supervision of BI and JP. BI implemented the project
and coordinated the study. SB designed the study and provided the guided semi-
structured interviews. PK and SK are responsible for methodological expertise. RA
and MK will deliver interventions (medical and pharmaceutical, respectively). SB
is responsible for conducting patient interviews, collecting data and performing
research assessments. OR, CD and MF are part of the project team and participated
in the drafting of the manuscript. All authors have read and approved the nal
manuscript.
Funding The authors have not declared a specic grant for this research from any
funding agency in the public, commercial or not- for- prot sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the
design, or conduct, or reporting, or dissemination plans of this research. Refer to
the 'Methods' section for further details.
Patient consent for publication Not applicable.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has
not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been
peer- reviewed. Any opinions or recommendations discussed are solely those
of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and
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10 BucheggerS, etal. BMJ Open 2023;13:e066666. doi:10.1136/bmjopen-2022-066666
Open access
responsibility arising from any reliance placed on the content. Where the content
includes any translated material, BMJ does not warrant the accuracy and reliability
of the translations (including but not limited to local regulations, clinical guidelines,
terminology, drug names and drug dosages), and is not responsible for any error
and/or omissions arising from translation and adaptation or otherwise.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non- commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non- commercial. See:http://creativecommons.org/licenses/by-nc/4.0/.
ORCID iDs
StephanieBuchegger http://orcid.org/0000-0002-8788-9329
PatrickKutschar http://orcid.org/0000-0002-2029-2552
SimonKrutter http://orcid.org/0000-0001-5788-9574
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