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# A multimodal and multidisciplinary program to prevent loss of mobility in patients aged over 70 years: study protocol of a multicenter cluster randomized study in primary care (the PRISME-3P study)

Sofia Perrotin<fnref n="1" />*®, Thomas Gilbert², Marine Dupuis³, Laurent Villeneuve³,⁴, Sylvie Bin-Dorel³,⁵, Amna Klich⁶,⁷, Laurent Letrilliart⁸,⁹ and Marc Bonnefoy²,¹⁰

**Abstract**

**Background:** Reduced mobility is the first sign of functional decline and can lead to dependency in elderly people. Screening for the risk of mobility limitation in this population is an important public health issue to prevent further disabilities. Despite the current lack of guidelines, primary care healthcare providers may have a central role to play in this type of screening. Multi-domain physical exercise interventions in older persons have shown some efficacy/ effectiveness on frailty status, yet, to the best of our knowledge, no published study has focused on patients screened in primary care.

**Method:** The PRISME-3P study is a national, interventional, multicenter, cluster randomized trial. Patients over 70 years of age will be systematically screened by their general practitioner (GP) on the basis of clinical criteria of mobility limitation. To avoid contamination bias, the unit of randomization will be the GP practice. In the intervention group, patients will consult a geriatrician and a dietician, and will receive a physical training program from a personal trainer who will demonstrate the exercises and provide follow-up coaching. The control group will receive standard care. The primary outcome will be the change in Short Physical Performance Battery (SPPB) scores between inclusion and 6-months follow-up.

**Discussion:** We expect an improvement of the SPPB between inclusion and 6 months of follow-up.

**Trial registration:** This study is registered in [ClinicalTrials.gov (NCT02847871), 27 July 2016](https://ClinicalTrials.gov).

**Keywords:** Mobility, Exercise, Nutrition, Primary care, Prevention, Elderly patients

**Background**

Senior citizens are particularly exposed to the risk of de-
pendency or functional disabilities, which represent in in-
dustrial countries a large proportion of current healthcare
costs. It is also a major concern for the future considering
current demographics as, although life expectancy con-
tinues to increase, life expectancy without disability tends

to remain stable, and therefore the burden of disability in
older people is set to increase [1, 2].

Disease, cellular aging, musculoskeletal changes, and
undernutrition all contribute to decrease muscle mass
which leads to sarcopenia in older adults [3, 4]. Loss of
muscle mass also causes a reduced muscle strength and a
decrease of maximal oxygen uptake [5]; this ultimately
leads to a mobility limitation [6] and a vicious circle is
established as this in turn leads to loss of muscle mass [7].
Mobility limitation is common in older adults, almost 30%
in those aged over 65 years [8, 9], and the most frequently
used method in the literature to measure this has been the

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BMC

© The Author(s). 2019 **Open Access** This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

<footnote>* Correspondence: sofia.perrotin@univ-lyon1.fr</footnote>

<footnote n="1">¹University Lyon, Université Claude Bernard Lyon 1, Collège universitaire de médecine générale, Lyon, France</footnote>

<footnote>Full list of author information is available at the end of the article</footnote>
ability to rise from a chair, walking speed, or capacity to walk 400 m [10, 11]. It is predictive of dependence and the first sign of functional decline [10, 12], which increases the likelihood of depression [13], risk of falls and fractures [14], institutionalization [15] and mortality [16], and lowers quality of life. Mobility limitation is also considered as part of the definition of frailty. For example, Fried et al. have defined frailty as a clinical syndrome in which three or more of the following criteria are present: unintentional weight loss (10 lbs. in past year), self-reported exhaustion, weakness (grip strength), slow walking speed and low physical activity [7].

To preserve muscle strength, non-pharmacological interventions promoting physical exercise or improving nutrition could be important. For instance, physical exercise is reported to preserve muscle quality and strength, but also help prevent dependency [17, 18]. Furthermore, a nutritional approach with qualitative (e.g. sufficient protein intake) and quantitative (e.g. sufficient calorie intake) nutritional factors and a higher dietary intake macro and micronutrients such as antioxidants contributes to preserve physical performance and strength [19]. Several studies have found evidence of a synergy between adapted physical activities and dietary advice to prevent mobility impairment and decrease in functional status [17, 20–24].

The systematic detection of physical impairment to be able to intervene in the negative vicious circle towards dependency is an important public health goal. Screening and prevention are 2 of the core tasks of GPs, which are often the first medical contact with older patients. There is, however, no guideline or recommendation to screen the risk of mobility limitation in older adults in primary care [25]. Mobility assessment in clinical general practice should be performed using simple, easy, and quick tools. Several tools have been developed to detect loss of mobility; identifying functional complaints in patients with mobility difficulties has proven to be a valid screening tool for detecting subsequent loss of mobility [11, 26, 27].

The aim of this study is to assess the benefits of a multimodal intervention for older adults with complaints of reduced mobility, screened systematically in primary care. The main objective of this study will be to evaluate between the control and intervention groups change in mobility and muscular force at 6 and 12 months of follow-up, evaluate physical performance, nutritional status, quality of life, and autonomy.

# Methods

## Study design

PRISME-3P is a national, multicenter, and cluster randomized trial conducted in France (Fig. 1). GPs will be randomly assigned to the intervention group or to the control group. Recruitment and inclusion will be performed by GPs and the intervention will take place at the hospital and

home of the patient. The planned inclusion period is 24 months with 12 months follow-up.

In both groups, GPs will perform a consultation for inclusion at baseline and two evaluations at 6 and 12 months thereafter. In the intervention group, an initial blood test will be performed (blood cell count, CRP, pre-albuminemia, and albuminemia). Follow-up will include two visits to the allocated study hospital outpatient clinic (within 2 weeks and at 3 months from inclusion) and 3 visits to the GP (at 3, 6, and 12 months from inclusion). All data collected will be notified by the GPS on the case report form (CRF).

## Identification of areas of recruitment

First, we have searched for hospital that could participate in the study (having a geriatric unit with a dietician). We have invited 8 geriatric units to participate. Second, we have contacted the university general practice department of each hospital areas, i.e. Lyon (Lyon, Villefranche-sur-Saône, Bourg-en-Bresse, Annemasse), Nantes (Nantes), Saint-Etienne (Saint Etienne) and Nice (Menton). In each department a coordinator will be designated with responsibility to recruit GPs near the hospital.

## Recruitment and randomization of GPs

A total of 60 GPs will be recruited in 8 areas of France (6 in Nantes, 6 in Dijon, 19 in Lyon, 8 in Villefranche-sur-Saône, 5 in Bourg-en-Bresse, 5 in Annemasse, 6 in Saint-Etienne, and 5 in Menton). They will be assigned to the intervention group or to the control group using the survey select procedure of SAS* (SAS Institute Inc., Cary, NC, USA). The sampling will be stratified on the referring geriatric center (i.e. city). GPs working in the same practice will be considered as a unique sampling unit to avoid risk of contamination. Each collaborating university general practice department will organize training for the screening and assessment of patients required by the study protocol, including the provision of information on the eligibility criteria and study organization.

## Participants

All subjects aged over 70 years old will be eligible except patients with functional or locomotor disabilities, a life expectancy less than 6 months, a progressive chronic disease affecting participation in the program, or a MMSE< 20.

For each consecutive patient over 70 years of age without exclusion criteria, GPs will screen patients with medical interview to detect 2 or more inclusion criteria described in Table 1. These criteria are partly derived from the sarc-f screening tool for sarcopenia [28].

In the presence of 2 or more inclusion criteria, GPs will assess the patient using the Short Physical Performance Battery (SPPB) [29]. In the event of a SPPB score < 10 (out of 12), patients will be given 9 questionnaires grouped in a
<figure><img src="image_3.png" /><figcaption>**Fig. 1** Design of the PRISME 3P randomized controlled trial</figcaption></figure>

unique folder: Activity Scale for the Elderly (PASE) [30], weekly sedentary time inspired by Gardiner [31], Activity of daily living scale (ADL), Instrumental activities of daily living scale (IADL) [32], SF-12 scale [33], Mini-Nutritional Assessment (MNA) [34], EPICES score (Evaluation de la précarité et des inégalités de santé dans les centres de santé (in French)) [35, 36], Charlson index [37], Geriatric Depression Scale (GDS) [38] (Table 2) that measure their autonomy, nutrition and physical activity, and will be proposed another medical appointment for inclusion in the study. If a patient refuses to participate in the study, this will be noted in the CRF.

## Multimodal and multidisciplinary intervention

At the hospital, a three-step intervention are planned. First, participating geriatricians will perform a standardized geriatric assessment of each patient to rule out underlying diseases that might cause exhaustion or weight loss and hamper participation in the study. Second, a dietician from the study center will evaluate the nutritional status of patients (Mini Nutritional Assessment, weight, Body Mass Index, weight loss) and analyse the dietary intake reported on a three-day survey given to the patients to complete prior to the visit. On the day, the dietician will also perform calorimetric measurements to estimate dietary needs of each patient. A

dietary strategy will be planned and agreed with the patients. The dietician will give written advice to each patient about calorie, protein, calcium, omega-3 fatty acid, and vitamin requirements (Fig. 2). Third, the patient will meet a personal trainer, who is specialized in physical exercise in the older age. A physical training program has been developed for the purpose of the study. It is based on existing validated training programs, with sets of exercises dedicated to three specific targets: muscle reinforcement, balance/flexibility, and endurance. It will consist of daily exercises lasting approximately 30 min and performed 5 days a week. These exercises are simple and require no specific equipment. Three sessions are dedicated to muscle reinforcement (lower limbs, upper limbs, and chest), and two to balance/flexibility and endurance. Intensity will increase over time to improve muscle strength, tailored to the abilities of individual patients. This program will be supported by a dedicated personal trainer, who will evaluate the patients: the personal trainer will explain and demonstrate each exercise to the patient (and caregiver), then the patient will practice each exercise in front of the monitor and be given the opportunity to rectify, and once the monitor has checked that the exercises are fully understood, he/she will hand the patient and caregiver a written handbook with illustrated explanations of the exercises for home training. Patients will be asked to report their
<table><caption>**Table 1** Summary of eligibility, inclusion, non-inclusion and exclusion criteria</caption><thead><tr><th>Eligibility criteria</th><th>Inclusion criteria</th><th>Exclusion criteria</th></tr></thead><tbody><tr><td>Difficulty lifting packages over 4.5 Kg</td><td>Age > 70</td><td>Patient refusal to participate to the study</td></tr><tr><td>Difficulty rising from low seats without help of arms</td><td>SPPB <10</td><td>Functional or locomotor disabilities</td></tr><tr><td>Difficulty climbing less than 10 steps of stairs</td><td>≥ 2 eligibility criteria</td><td>Life expectancy less than 6 months</td></tr><tr><td>Difficulty moving or reduced walking speed</td><td></td><td>A chronic disease affecting participation to the program</td></tr><tr><td>Difficulty walking over 400 m without break</td><td></td><td>MMSE< 20</td></tr><tr><td>Walking time less than 1 hour per week</td><td></td><td></td></tr><tr><td>Feeling of exhaustion during domestic activity</td><td></td><td></td></tr><tr><td>> 2 falls during the last year</td><td></td><td></td></tr><tr><td>Involuntary weight loss (> 5% in 1 month or > 10% in 6 months)</td><td></td><td></td></tr></tbody></table>

activity and adherence to the program in the handbook. A monthly telephone follow-up will be set up, by which the monitor will be able to provide some advice and encourage- ments to the patients.

By contrast with the control group, patients in the intervention group will visit the GP at 3 months, who will perform an intermediate SPPB assessment in order to adapt the intensity of the intervention. If SPPB im- proves by one point or more, no change will be planned, if not they consult the same geriatrician and dietician, and will receive again the physical training program from the personal trainer who will demonstrate the exer- cises and propose individual (home) or group training sessions (hospital) twice a week for 10 weeks.

**Outcomes and measurements (Table 3)**

**Primary outcome**

The primary outcome will be the difference in SPPB scores between inclusion and 6-month visits. To allow comparison, the SPPB will be evaluated by the same GP as far as possible. The SPPB measure reflects the per- formance status in 3 dimensions: balance, gait, strength/ endurance are evaluated by examining ability to stand with the feet together in the side-by-side, semi-tandem

and tandem positions, time to walk 4 or 6 m, and time to rise from a chair and return to the seated position 5 times [39].

**Secondary outcomes**

The change of the secondary outcomes between the inclu- sion, 6, and 12-month follow-up will be analyzed. Second- ary outcomes are: physical performance evaluated by the PASE [30] and sedentary behavior inspired by Gardiner et al. [31], and the distance walking; autonomy evaluated by the ADL and IADL [32]; quality of life evaluated by the SF-12 scale [33]; the number of serious injuries, hospitali- zations, and institutionalizations, falls with healthcare consumption; nutritional status: weight, BMI, albumine- mia (adjusted on CRP level) and MNA [34].

Additional outcomes will estimate prevalence of pa- tients over 70 years of age with mobility limitation, ad- herence of patient and GPs to the program, and describe geriatric diagnosis after the consultation for the inter- vention group.

At baseline, GPs will collect data from the patients so- cial environment EPICES score) comorbidities (Charlson index) [37], depression symptoms (GDS) [38], and medi- cation inventory.

<table><caption>**Table 2** List of questionnaires</caption><thead><tr><th colspan="2">List of questionnaires</th></tr></thead><tbody><tr><td>Physical activity</td><td>Activity Scale for the Elderly (PASE) [30]<br/>Weekly sedentary time inspired by Gardiner [31]</td></tr><tr><td>Autonomy</td><td>Activity of Daily Living scale (ADL)<br/>Instrumental Activities of Daily Living scale (IADL) [32]</td></tr><tr><td>Quality of life</td><td>SF-12 scale [33]</td></tr><tr><td>Nutrition</td><td>Mini-Nutritional Assessment (MNA) [34]</td></tr><tr><td>Patient's social environment</td><td>EPICES score [35, 36]</td></tr><tr><td>Comorbidities</td><td>Charlson index [37]</td></tr><tr><td>Depression symptoms</td><td>Geriatric Depression Scale (GDS) [38]</td></tr></tbody></table>

**Sample size calculation**

The inclusion of 28 GPs per arm will provide a power of 80% to detect a difference of 0.8 points in SPPB score change between arms (1.2 points increase in the control group, versus 2 points in the intervention group), with 5 patients for each GP, an intra-cluster correlation coeffi- cient of 0.15, and with a standard deviation of inter-individual variability of 1.7. Accounting for loss to follow-up, it is planned to randomize 30 GPs in each group, giving a total of 60 GPs and 300 patients (5 patients for each GP). The power of the study was calculated using the method described by Donner and Klar [40] and with the package CRTsize in the R program, version 3.3.1 (R foundation, Vienna, Austria).
<figure><img src="image_4.png" /><figcaption>**Table 3 Schedule of outcome assessments**</figcaption></figure>

<table><thead><tr><th rowspan="2"></th><th rowspan="2">Baseline</th><th colspan="3">Intervention Group</th><th colspan="2">Control Group</th></tr><tr><th>M 3</th><th>M 6</th><th>M 12</th><th>M 6</th><th>M 12</th></tr></thead><tbody><tr><td>SPPB score</td><td>X</td><td>X</td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Walk test distance</td><td>X</td><td></td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>SPPB</td><td>X</td><td>X</td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Physical activity</td><td>X</td><td></td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>ADL/IADL</td><td>X</td><td></td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>SF 12</td><td>X</td><td></td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Serious falls assessments</td><td>X</td><td></td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>Hospitalization</td><td>X</td><td></td><td></td><td>X</td><td></td><td>X</td></tr><tr><td>Institutionalization</td><td></td><td></td><td></td><td>X</td><td></td><td>X</td></tr><tr><td>Weight, BMI</td><td>X</td><td>X</td><td>X</td><td>X</td><td>X</td><td>X</td></tr><tr><td>MNA</td><td>X</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Social score</td><td>X</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Charlson Index</td><td>X</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Medication inventory</td><td>X</td><td></td><td></td><td></td><td></td><td></td></tr></tbody></table>

PASE Physical Activity Scale for the Elderly, SF12 12-Item Short Form Health Survey, BMI Body Mass Index, MNA Mini Nutritional Assessment, CRP C-Reactive Protein, GDS Geriatric Depression Scale, GP General Practitioners, EPICES Evaluation de la précarité et des Inégalités de santé dans les centres de santé (in French)

## Statistical analyses

The patient characteristics at inclusion will be described according to each group (intervention and control groups). A summary table will be provided in order to ensure the homogeneity of the prognostic factor distributions according to the groups. A second summary table of clusters (GPs) will also be provided. The method and the presentation of the results will be according to the guidelines for cluster trials [41].

## Primary outcome

All analyses of the primary outcome will be performed on the intent-to-treat population. The distribution of the primary outcome (difference in SPPB scores between inclusion and 6-month visits) will be described and presented for the two groups (graphical representation, e.g. boxplot). The primary outcome will be analyzed using a multiple linear regression model. When the conditions for application of the linear model are not respected (normality of residuals, independently distributed residuals...), a transformation (logarithmic or even Box-Cox, quantile, or z-score) of the SPPB score will be considered.
The main analysis of the primary outcome will be ad-
justed on the center using a mixed effect linear model
with a random GP effect, and as fixed effects: an inter-
vention effect (the control group as reference), a period
effect (the inclusion as reference), and an interaction be-
tween treatment and period. This model will also be ad-
justed on the age at inclusion. An interaction between
the SPPB at inclusion and intervention will be added to
the model to test whether the treatment effect is differ-
ent for patients with lower vs. higher level of SPPB score
at inclusion. P-values and 95% confidence intervals of
the fixed effects will be provided. Another analysis using
the SPPB score as independent variable in a longitudinal
mixed effect linear model will also be considered.

Secondary outcomes

The analysis used for the primary outcome will be used
to evaluate the change of the secondary outcomes be-
tween the inclusion and the 6-month follow-up visit.

The analysis of the change of secondary outcomes in
the interventional group will be performed using a longi-
tudinal mixed effect linear model with a fixed period ef-
fect and as random effects: the center, the GP, and the
patient nested within the GP. This analysis will be ad-
justed on the age at inclusion.

A univariate analysis will be performed using a longitu-
dinal mixed effect linear model to identify the factors associ-
ated with the SPPB result at 6 months in the interventional
group. The model will include as random effects the center,
the GP and the patient nested within the GP, and as fixed ef-
fect the corresponding factor. This analysis will provide the
effect estimation of each factor with its 95% confidence inter-
vals. The independent factors found significant in this uni-
variate analysis will be included in a multivariate analysis.

All analysis will be performed using the statistical ana-
lysis program SAS® version 9.4 (SAS Institute Inc., Cary,
NC, USA), and the R program, version 3.3.1 (R founda-
tion, Vienna, Austria).

Ethics approval and consent to participate

The study protocol was approved by the Sud Est 4 Ethics
Committee on October 18, 2016 and cover all sites in-
volved in this study. The research carried out will be on
accordance with the Helsinki Declaration and ICH GCP
Guidelines. The study complies with the principles of
the data protection act in France. Each GP had to collect
a writer consent at the beginning of the procedure. This
consent is retained in the CRF. The patient can stop the
study at any time with an oral information at his GP.

Discussion

The majority of studies are based on non-pharmacological
interventions to prevent mobility impairment. This large-
scale randomized trial is a program for older patients

screened in primary care. To the best of our knowledge, this
will be the first study in France in which a multimodal inter-
vention with cooperation between geriatricians, general prac-
titioners, dieticians, and personal trainers will be
implemented.

Discussion of the study design

The study will be randomized and multicenter, and will
investigate the effect of a specific clinical pathway with
both the effects of the intervention and, simultaneously,
the implementation of the program in current practice
conditions, across various areas of France. Rather than
an individual randomization, a cluster design was chosen
in order to limit the risk of contamination, but also for
reasons of feasibility and ethics; it would have been diffi-
cult to justify why two different patients in the same
practice would not have access to the same manage-
ment. Likewise, we chose to stratify randomization to
ensure that GPs working in the same practice would be
randomized to the same group. The high number of
clusters (60 in total) and low number of patients within
each cluster should help reduce the risk of bias due to
intra-cluster correlation.

Despite the cluster design, the effects of the inter-
vention will be determined individually. An open-label
design is necessary given the nature of the interven-
tion. The effects of the intervention will be evaluated
using an objective outcome, the SPPB, which has
shown to be reproducible [29, 39]. An SPPB score
below 10 is predictive of all-cause mortality [42] and
reveals a weakness of lower extremity function and
higher mobility disabilities [43]. Clinically, an im-
provement of one point in the SPPB score is associ-
ated with substantial and clinically relevant changes
in physical performance [44]. SPPB is a reliable tool
to screen for patients likely to benefit from a physical
exercise program [41] and it is generally considered
as a valid predictive tool to assess physical perform-
ance and predict risk of mobility loss [11, 39, 42].
The GPs will screen systematically each consecutive
patient over 70 years of age to limit selection bias.
Furthermore, they will note each refusal to participate
in order to evaluate the acceptability of the program
from the patients’ perspective.

Standard training will be provided to the participating
GPs for the recruitment and to physical trainer to ensure
harmonized delivery of information. All GPs will be
given specific training in group sessions for the loss of
mobility screening assessment, prior to randomization.
This will ensure that the screening and inclusion proced-
ure is the same for all patients, and ensure comparability
between groups for the measurement of the primary
outcome. Moreover, GPs in the intervention group will
not be involved directly in the intervention itself.
## Feasibility

Patients with an estimated life expectancy of less than 6 months will be excluded as they would derive no benefit from intervention. In France, patients choose their GP and generally trust him/her. We believe this privileged relationship might help acceptance and adherence to the program, and also limit the rate of patients lost to follow-up. Conversely, part of the intervention will take place in a hospital setting and this might limit the acceptability of the program. This was decided for feasibility reasons, as this limited the number of personal trainers required and helped to optimize their time by avoiding multiple home visits.

The recruitment of patients from primary care will be facilitated by the collaboration and institutional support of the university general practice departments in each participating area. To facilitate GP adherence and acceptability of a screening, GP needs a valid, simple and rapidly administered tool. The FRASI-Study found that the use of SPPB is feasible in daily practice in primary care [45]; it is a simple tool that has good performance to predict incident ADL disability, worsening mobility, and death [39, 43, 46]. We have estimated the time required to deliver the SPPB to be less than 20 min, which corresponds to the mean duration of a regular GP consultation in France. To minimize the duration of the inclusion visit, GPs will screen and assess patients and give them a questionnaire during a routine visit. They will be invited to read this questionnaire and answer the questions to the best of their abilities, which will be then completed with the help from GPs during a dedicated inclusion visit.

To the best of our knowledge, this will be the first study in France in which a multimodal intervention with cooperation between geriatricians, general practitioners, dieticians, and personal trainers will be implemented. We will be able to evaluate the implementation of a collaborative program that may help setting-up effective pathways for prevention of loss of mobility in primary care.

## Abbreviations

ADL: Activity Daily Life; BMI: Body Mass Index; EPICES: Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examen de Santé (in French); GDS: Geriatric Depression Scale; GP: General Practitioner; IADL: Instrumental Activity Daily Life; MAPA: Monitor of Adapted Physical Activities; MMSE: Mini Mental State Examination; MNA: Mini Nutritional Assessment; PASE: Physical Activity Scale for the Elderly; PRISME-3P: Elderly Patient at RISK of loss of Mobility, Exercise - Primary care, Prevention, care Pathways; SPPB: Short Physical Performance Battery

## Acknowledgements

The authors acknowledge Dr. Philip Robinson (Hospices civilles de Lyon) for his contribution and help in manuscript preparation. The authors acknowledge the associated university department of general practice (Dijon, Nantes, Saint-Etienne and Lyon) and geriatric teams of Champ maillot hospital in Dijon, Bellier Hospital in Nantes, Hospitals of Villefranche sur Saône Hospital, Alpes-Léman, Fleyriat Hospital in Bourg-en-Bresse, La Palmosa Hospital in Menton, Hospital of Saint-Etienne and the Hospices Civils de Lyon, who have accepted to take part in this study.

## Funding

Study protocol was peer-reviewed as part of the PREPS "Programme de recherche sur la performance du système de soins". A panel of national experts review and select projects to be funded by the French Ministry of Social Affairs and Health.

The PRISME-3P study is supported by a grant from the French ministry of Social Affairs and Health (PREPS-15-0099). The funding body has no influence on the study design, collection, analysis, and interpretation of data and in writing the future manuscript.

## Availability of data and materials

Not applicable

## Authors' contributions

The national coordinator investigator of the PRISME-3P study, MB, as well as SBD, LV, MD, TG, AK, SP and LL, were responsible for the study concept, the trial design, the methodology and organization of the study; obtaining ethics approval and regulatory authorization; acquiring financial support and writing the paper. SBD and RE contributed to the fine-tuning of the methodology (SBD) and statistical analysis (AK). All authors contributed to draft writing and revised the manuscript. All authors approved the final version.

## Competing interest

The authors declare that they have no competing interests.

## Ethics approval and consent to participate

The study protocol was approved by the Sud Est 4 Ethics Committee on October 18, 2016 and cover all sites involved in this study. The research carried out will be on accordance with the Helsinki Declaration and ICH GCP Guidelines. The study complies with the principles of the data protection act in France. Each GP had to collect a writer consent at the beginning of the procedure. This consent is retained in the CRF. The patient can stop the study at any time with an oral information at his GP.

## Consent for publication

Not applicable

## Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

## Author details

¹University Lyon, Université Claude Bernard Lyon 1, Collège universitaire de médecine générale, Lyon, France. ²Hospices Civils de Lyon, Service de Médecine Gériatrique, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.

³Hospices Civils de Lyon, Unité de Recherche Clinique, Pôle Information Médicale Evaluation Recherche, Lyon, France. ⁴University Lyon, Université Claude Bernard Lyon 1, EMR 3738, Lyon, France. ⁵University Lyon, Université Claude Bernard Lyon 1, EAM Parcours Santé Systémique, 4128 Lyon, France.

⁶Hospices Civils de Lyon, Service de Biostatistique, Lyon, France. ⁷CNRS UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France. ⁸University Lyon, Université Claude Bernard Lyon 1, Université Saint-Etienne, Collège universitaire de médecine générale, Lyon, France. ⁹University Lyon, Université Claude Bernard Lyon 1, Université Saint-Etienne, HESPER EA, 7425 Lyon, Saint-Etienne, France.

¹⁰Laboratoire CarMeN (cardiovasculaire, métabolisme, diabétologie et nutrition), University Lyon, Université Claude Bernard Lyon 1, INSERM U1060, Pierre-Bénite, France.

Received: 18 June 2018 Accepted: 11 February 2019

Published online: 19 February 2019

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