Multimorbidity in Primary Care
Multimorbidity in Primary Care
Multimorbidity in Primary Care
com
Open Access
the number of investigations, number of pills to take and the GP’s prioritisation. Concordance was lower
each day, number of injections to take, number of among patients who reported poor health status.18
check-ups or preventive measures, and other care (eg, Our aim is to assess the burden related to multimor-
education or physiotherapy). For instance, an estimated bidity and to describe prioritisation in the management
20% of older adults in the US population take more of multiple chronic conditions in the context of primary
than 10 different medications each week.15 16 Owing to care practice, taking patients’ and GPs’ perspectives into
the importance of the disease-related burden and account.
burden of treatment, primary care for people with multi-
morbidity must address disease-specific issues in the
context of coexisting chronic medical conditions and METHODS AND ANALYSES
the patient’s psychosocial environment. This implies Study objectives
complex, patient-centered care involving patient–pro- Primary objective 1: Burden related to multimorbidity—We will
vider concordance, effective communication and shared assess the importance of the burden related to multi-
decision-making.17 18 One of the main difficulties GPs morbidity (ie, disease-related burden and burden of
face is the challenge of following guidelines that are typ- treatment) among patients in a primary care setting,
ically developed for single diseases.19–21 Sinnott et al22 identify the determinants of an increased burden
synthesised qualitative research on the perception that related to multimorbidity, and examine the agreement
GPs and other primary care practitioners have of the between patients’ and GPs’ perceptions of this burden.
management of multimorbidity. Ten studies conducted Primary objective 2: Prioritisation of care—We want to evalu-
in seven countries (Belgium, England, Germany, ate the concordance between the problems related to the
Ireland, Scotland, the Netherlands and the USA), prioritisation of treatment for multiple chronic conditions
including 275 GPs, were considered. The synthesis as assessed by GPs and as perceived by patients. We will
emphasised that difficulties in the care of people with assess prioritisation established by patients and by GPs in
multimorbidity mainly arise from disorganisation and the handling of chronic conditions among multimorbid
fragmentation of healthcare, inadequacy of guidelines patients in primary care, and identify patient-related or
and evidence-based medicine, and challenges to patient- GP-related determinants that influence this prioritisation
centered care and shared decision-making.22 achieved by patients and GPs, respectively.
Secondary objective: Gender study—We will examine
Prioritisation of care whether the gender of GPs or patients is a determinant
Prioritisation of illnesses and care for specific diseases of variations in patients’ and GPs’ perceived burden in
should be concordant between patients and their GPs, relation to multimorbidity, and its related treatment in
but may not always be. To date, few studies have primary care.
addressed prioritisation of care in multimorbid
patients.18 23 We identified a single study that examined
Study design
the prioritisation of care in multimorbid patients from
This is an observational study with a cross-sectional
the patients’ perspective and without an index condi-
design.
tion.23 Health outcome priorities (staying alive, main-
taining independence, reducing/eliminating pain and
reducing/eliminating symptoms) were evaluated. Study population
Maintaining independence was ranked as the most Participants: The study will involve GPs throughout
important factor by 76% of the patients. Among those Switzerland and their multimorbid patients. We will enrol
who ranked maintaining independence as the primary 1000 patients through a convenience sample of 100 GPs in
factor, 67% ranked symptoms relief as the second. private practice. Each participating Institute of Family
Among those who ranked staying alive as their first Medicine will organise the recruitment of 20 GPs from
concern (11%), 66% ranked maintaining independence small or large practices in both urban and rural settings, in
as their second concern. A single prospective study their respective regions of Switzerland (figure 1). As no
including 92 providers and 1004 US veterans examined Institute of Family Medicine exists in the Italian-speaking
the correlation between GPs’ and patient’s prioritisation part of the country, we restricted our study to the
of health conditions.18 Patients and GPs provided the French-speaking and German-speaking regions.
three most important concerns among a list of nine con- Eligibility: All multimorbid patients visiting a participat-
ditions chosen based on their prevalence (symptomatic ing GP during the inclusion period and meeting the
chronic conditions: pain, depression, breathing difficul- inclusion criteria are eligible. We considered three
ties; and asymptomatic chronic conditions: hyperten- chronic conditions as the minimum number of condi-
sion, diabetes, hyperlipidaemia, heart disease or heart tions for which a prioritisation of care could be necessary.
failure, obesity and tobacco use). In 72% of cases, the Inclusion criteria
patient’s most important concern was represented in the ▸ To be aged 18 years or older;
GP’s list of three most important concerns. In 60% of ▸ To have been followed by the GP for at least
the cases, there was a concordance between the patient’s 6 months before the index encounter;
Open Access
Figure 1 Schematic representation of the regions of Switzerland covered by each Institute of Family Medicine. Each Institute of
Family Medicine (Geneva, Lausanne, Bern, Basel, Zürich) will organise the enrolment of 20 general practitioners (GPs) located
within its region.
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Figure 2 General practitioners’ (GPs’) and patients’ recruitment process and general study procedure.
the GP includes the patient of this consultation if he/ to participate, their date of birth, sex and reason for
she meets the inclusion criteria. If the randomised refusing participation will be documented.
patient does not meet the inclusion criteria, the next Procedure (figure 2): Once the GP agrees to participate,
patient who fulfils the inclusion criteria is eligible. If no he/she will be trained by a research assistant or an inves-
patient is included at the end of the half-day, the recruit- tigator to ensure the aim of the study and data collection
ment process will be postponed to the next half-day of processes are clearly understood. Training will include
consultations. The patient will be asked to consent to detailed information on the procedure to follow, include
participate to a telephone interview questionnaire that patients using the randomisation calendar, and the list
will take place within 48 h after the visit to the GP. The of 75 conditions provided. GPs will also be instructed on
patient’s name and phone number will then be transmit- the data collection process using the questionnaires.
ted to a research assistant. If an eligible patient refuses Data collection from GPs will take place at the GPs’
Open Access
private practices using paper-based questionnaires. For GP and if they agree to take part, they will provide
patients, we will use delayed phone interview question- written informed consent. Enrolled patients will com-
naires. Each GP will first complete a survey providing plete a 25 min telephone-based questionnaire. For each
demographic and practice-related data. Patient enrol- patient who is enrolled, the GP will complete a 20 min
ment will take place during a visit to the GP. Randomly paper-based questionnaire. All data will be coded during
identified patients will be informed of the study by their the data collection process. Patients’ names and phone
Open Access
numbers will be destroyed after data collection is com- resulting in the computation of a cumulative score that
pleted. Research assistants will conduct all patients’ tele- represents the degree of impairment to the whole
phone interviews, in French or German, from the person. The CIRS has been used in studies involving
Institute for Family Medicine in Lausanne. The research multimorbid patients and been validated for use in
team in Lausanne will train the research assistants to primary care.27–30
conduct the telephone interviews and to collect the Current treatment: The GP will provide a list of all medi-
data, in collaboration with the Pedagogical Unit of the cations, preventive measures and rehabilitative measures
Faculty of Biology and Medicine of Lausanne. Training prescribed. The actual treatment will be considered.
will include conducting and handling phone interviews, Renouncement of treatment: The GP will provide a list of
including the management of negative emotions that conditions for which he/she consider the treatment as
may arise during the interview. A patient-actor will par- suboptimal, because it had to be adapted due to poten-
ticipate in this training. The training will include learn- tial drug interaction, treatment burden or lack of com-
ing to ask questions exactly as written on the pliance from the patient or following a shared decision
questionnaires to ensure homogeneity of the data collec- with the patient.
tion between patients and between research assistants. Patient-related variables assessed through the patients’
Research assistants will also be trained to record data survey include prioritisation, quality of life, SES, health
using the Epidata V.3.1 software. literacy and treatment burden.
Prioritisation: We will assess the prioritisation of chronic
Variables conditions from the patient’s perspective by asking if
We will collect GP-related and patient-related variables he/she had the power to remove one health condition,
(table 2). We describe the more complex variables which one he/she would choose first and then second.
below. All questionnaires for which a German or French It is possible that one or both answers to this question
version did not exist were translated using a translation/ will not refer to chronic conditions; however, we expect
back-translation procedure. this to be the case only for a restricted number of
Patient-related variables assessed through the GP patients.
survey include the number and list of chronic condi- Quality of life: We will evaluate the burden related to
tions, severity of each chronic condition, current treat- multimorbidity from the patient’s perspective using the
ment and renouncement of treatment. EQ-5D-3L quality-of-life scale.31–33 The EQ-5D-3L is a
Number and list of chronic conditions: The International short, validated questionnaire for the self-assessment of
Classification of Primary Care, V.2 (ICPC-2), is a classifi- quality of life for which population reference values are
cation of symptoms and diagnostics specifically designed available for Switzerland.34 35
for use in primary care.24 We will employ a list of 75 SES: The SES of enrolled patients will be assessed
chronic conditions identified in the ICPC-2 following a using the deprivation in primary care questionnaire
methodology described elsewhere (N’Goran et al, in (DipCare), which was developed and validated in the
preparation). Briefly, we conducted a nationwide survey French-speaking part of Switzerland36 and translated
of GPs using a modified Delphi method.25 We used into German. An overall score of deprivation will be
experts from five different regions: Basel, Bern, Geneva, then computed.
Vaud and Zürich. We started with all 686 items of the Health literacy: We will use the six-item questionnaire
ICPC-2 and proceeded to a step-by-step elimination. from the European Health Literacy Survey project
First, a focus group of five experts removed from the (HLS-EU 6) to assess health literacy.37 These items were
ICPC-2 items that were irrelevant in the context of selected based on content and difficulty experienced
chronic conditions. Then, three rounds of online survey from the 47-question survey (HLS-EU 47).37 38 The
were conducted: experts had to score the chronic aspect HLS-EU 6 was developed on a random subsample of the
of each remaining item first as chronic, not chronic or HLS-EU 47 survey (N=3411), and cross-validated with
in between, and second on a scale of 1–9 (2 rounds); another random subsample (N=3383) (HLS-EU consor-
and then assess the relevance of the chronic items in tium, personal communication, 2014). Answers to each
the context of multimorbidity (1 round). To analyse question from the HLS-EU 6 are given in the form of a
data, we used the median values and the inter-percentile four-point Likert scale (1=very difficult, 2=fairly difficult,
range adjusted for symmetry (IPRAS) for agreement/ 3=fairly easy, 4=very easy). Although no population-based
disagreement between experts.25 Items reaching a data exist for Switzerland, data do exist for neighbouring
median value of 6 and agreement between experts were countries.
retained in the final list. Treatment burden: The treatment burden questionnaire
Severity of each chronic condition: For each patient (TBQ) was developed recently to assess the overall
enrolled, the GP will provide a quantitative estimate of burden related to the treatment of chronic conditions.39
impairment for each organ area using the cumulative It consists of 13 questions whose answers are each scored
illness rating scale (CIRS).26 The CIRS involves rating from 0 to 10, with 0 corresponding to no burden and 10
the impairment of 14 organs or systems. Medical pro- to a very important/considerable burden. The global
blems are compiled and quantified by organ system, (summed) score of treatment burden ranges from 0 to
Open Access
130. No Swiss population-based data exist for this ▸ To identify the patient-related or GP-related determi-
questionnaire. nants that have an influence on concordance in the
prioritisation achieved by patients and GPs,
Planned analyses respectively.
Primary objective 1: Burden related to multimorbidity Secondary objective: Gender study
▸ To identify patient-related or GP-related determinants ▸ To examine whether gender of patients or GPs influ-
that influence the disease-related burden (number of ences the TBQ or the GPs’ evaluation of the burden
chronic conditions, CIRS and EQ-5D-3L) or TBQ of treatment
▸ To analyse the relationship between the perceptions ▸ To examine whether gender influences the concord-
of patients and the GPs regarding the burden related ance between GPs’ and patients’ prioritisations of
to multimorbidity using the number of chronic con- chronic conditions
ditions identified, the CIRS and the EQ-5D-3L
questionnaire Statistics
▸ To assess the burden of treatment in terms of the Patients’ sample size: The sample size estimation is based
number of pills prescribed per day, and to test on reported proportions of patients with different
whether it relates to the patients’ evaluation using the numbers of chronic conditions from studies conducted
TBQ, and to GPs’ evaluation of the burden of in primary care. We evaluated the number of patients
treatment whom we would include with different numbers of
▸ To assess whether the number of conditions treated is chronic conditions, given possible sample sizes of 500,
related to TBQ scores using univariate and multivari- 750 and 1000 patients, if the repartition of patients was
ate models similar to that in any of the three studies considered.
Primary objective 2: Prioritisation of care Based on this data, a sample size of 1000 is enough to
▸ To evaluate whether in multimorbid patients some allow for potential subgroup analyses. The estimates are
chronic conditions are left untreated by comparing reported in table 3. This sample size is also coherent
the list of chronic conditions diagnosed with the list considering that a statistical model requires approxi-
of treatments prescribed. mately 15 patients per variable.
▸ To describe the subgroup of patients with conditions Descriptive statistics: Descriptive statistics will be per-
left voluntarily untreated or suboptimally treated, and formed to describe the sample of GPs and the sample of
compare it to the group of patients in which no con- patients. All collected measures and derived variables
ditions were left untreated will be summarised using usual descriptive statistics and
▸ To test whether the two conditions classified as most the associated 95% CI. For categorical variables, the
important by GPs and patients are concordant. We description will consist (at minimum) of the sample size;
will obtain a series of concordant and discordant numbers of missing data; valid data, median, upper and
patients’/GPs’ pairs; describe and compare the sub- lower quartiles; and the frequency and percentage of
groups of patients/GPs with concordant pairs versus each category.
discordant pairs; and evaluate whether the concord- Exploratory data analysis: t-Test will be used for continu-
ance between patients’ and GPs’ evaluations of the ous normally distributed variables; one-way analysis of vari-
most important chronic conditions correlates with ance will be used if we need to compare more than two
the TBQ scores. groups. For continuous variables not normally distributed,
Open Access
we will use non-parametric tests: the Mann-Whitney U test questionnaires. This leaves the potential for information
to compare two groups, and the Kruskall-Wallis test to bias. However, as both GPs and patients will have no
compare three or more groups. For categorical variables, detailed knowledge of the objectives of the study, or of
we will employ the χ2 test or Fisher’s exact test, depending the analyses planned, we anticipate that information bias
on the number of observations obtained in each category will not be significant or will only lead to non-differential
considered. All tests are two-sided unless otherwise speci- misclassification. We will use standardised tests of proven
fied, and p<0.05 will be considered statistically significant. high internal validity. However, for some tests, such as the
Correlation between variables will be assessed using the CIRS, the TBQ and the HLS-EU 6 questions, no data in
Pearson correlation coefficient for normally distributed Switzerland have been reported, as yet. For tests for
variables or the Spearman correlation otherwise. We will which no Swiss data are available, data from populations
evaluate the level of agreement between two of the same close to the Swiss population (German and French speak-
parameter using agreement tables, scatter plots and ing) are available. The TBQ test was developed and used
Cohen’s κ statistic. in a single French population. No German version has
Univariate tests will be used to select variables accord- been developed and used previously.
ing to the p value obtained ( p<0.25) to include in the
multivariate analyses. For the multivariate analyses, gen- Pilot phase
eralised linear regression models will be used: Poisson
A pilot phase is planned for this study. We will enrol five
regression for outcome variables in the form of scores, pilot patients through a convenience sample of five GPs
multinomial logistic regression for non-dichotomous cat- across Switzerland based on their willingness to partici-
egorical variables, or logistic regression for dichotomous
pate. We will ask each patient to complete the telephone
variables, as appropriate. Mixed effects multilevel interview questionnaire and each GP to complete the
models that take clustering and between-site differences paper questionnaire. The pilot phase aims to evaluate
into account will be considered. These models will
the feasibility of the study, to recognise and solve poten-
include two levels of clustering in order to take into tial issues with the use of questionnaires, and to better
account the variability caused by regions and GPs. define specific aspects of the training of research
Models will be compared and the best model will be
assistants.
selected on the basis of likelihood ratio tests.
Author affiliations
Ethical aspects 1
Institute of Family Medicine, University of Lausanne, Lausanne, Vaud,
The study protocol and study documentation, including Switzerland
2
all questionnaires and the informed consent, were Institute of Primary Care, University of Zürich, Zürich, Switzerland
3
accepted by the ethical committee of the Canton of Institute of Primary Care at the University of Berne (BIHAM), University of
Berne, Berne, Switzerland
Vaud acting as the lead ethical committee for 4
Centre for Primary Health Care, University of Basel, Basel, Switzerland
Switzerland. The protocol was then transmitted to the 5
Primary Care Unit, Faculty of Medicine, University of Geneva, Geneva,
local ethical commissions of the different regions Switzerland
6
involved in the study. Institute of Social and Preventive Medicine, Lausanne University Hospital,
We anticipate no direct benefits for the patients. Lausanne, Vaud, Switzerland
7
Department of Ambulatory Care and Community Medicine, Lausanne
Indirect benefits include contribution to understanding
University Hospital, Lausanne, Vaud, Switzerland
the mechanisms underlying the handling of patients
Contributors All the authors developed the study’s objectives and defined the
with multimorbidity, which will eventually improve the
list of variables to be collected. AD-L, AAN, BB, PB, NS, DW, LH, PF and RT
management of patients. No important risk is foreseen developed the questionnaires in French and German. AD-L, AAN and LH
as a direct result of the survey. GPs will handle the drafted the protocol and oversaw submission of the protocol to the ethics
healthcare of included patients as normal. commission. AD-L, AAN and LH developed the necessary study documents
for the ethics commission. All authors contributed to the revision of the
manuscript and the decision to submit for publication.
Potential biases and limits
We will use a convenience sample of 100 GPs, and thus Funding The Swiss University Conference granted funding to reinforce
will not follow a randomised sampling for the identifica- teaching and research in primary care in Switzerland. Within the framework of
this financial support, the five Swiss institutes for Family Medicine (Basel,
tion of GPs. As a result, participating GPs may not be rep- Bern, Geneva, Zürich and Lausanne) collaborated under the denomination:
resentative of the overall population of GPs practising in Swiss Academy for Family Medicine (SAFMED). Part of the funding is to be
Switzerland. Sociodemographic data collected, such as used for national research projects in primary care.
sex, age and location of practice, will allow for the charac- Competing interests None declared.
terisation of the participating GPs and the evaluation of
Patient consent Obtained.
external validity. Recruitment of patients will follow a
strict randomised procedure, and no selection bias is Ethics approval Research ethics committee of Canton Vaud, Switzerland
(Protocol 315/14).
foreseen. In addition, demographic data will be collected
from patients who refuse to participate in the study, as Provenance and peer review Not commissioned; externally peer reviewed.
well as their reasons for non-participation. Data will Open Access This is an Open Access article distributed in accordance with
mainly be collected through self-assessment the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,
Open Access
which permits others to distribute, remix, adapt, build upon this work non- 20. Ostbye T, Yarnall KS, Krause KM, et al. Is there time for
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Notes