Standardised brief geriatric evaluation versus routine care for preventing functional decline in general practice: a pragmatic cluster-randomised trial, AGE3
Switzerland, 2016 - 2020
Mueller, Yolanda, Schwarz, Joëlle, Monod, Stéphanie, Locatelli, Isabella, Senn, Nicolas
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November 04, 2020
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August 05, 2021
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Identification
Survey ID Number
10.16909-DATASET-23
Title
Standardised brief geriatric evaluation versus routine care for preventing functional decline in general practice: a pragmatic cluster-randomised trial, AGE3
Subtitle
AGE3
Translated Title
Une évaluation gériatrique brève conduite en médecine de famille versus soins habituels pour prévenir le déclin fonctionnel des patients âgés : un essai randomisé en grappes
Country
| Name | Country code |
|---|---|
| Switzerland | CHE |
Abstract
Objective. To determine whether a systematic geriatric evaluation performed by general practitioners (GPs) that includes a brief assessment of geriatric syndromes and a management plan can prevent functional decline in older patients.
Design. Controlled, open-label, pragmatic cluster-randomised trial, randomising at the GP level.
Setting. 42 GP practices, western Switzerland.
Participants. Participating GPs had to work at least 20 hours per week as GPs in French-speaking Switzerland, and were expected to enroll ten community-dwelling adults at least 75-years-old, able to understand French, and having visited their GP at least twice in the prior year.
Intervention. Yearly assessment by the GP of eight geriatric syndromes associated with ad hoc management plans.
Main outcome measures. The primary outcome was, at individual participant level, the proportion of patients losing at least one instrumental activity of daily living (IADL) over two years, compared by a generalised 2-level mixed model with a logit regression. Secondary outcomes were losses in basic ADLs and quality-of-life (WHOQOL-OLD) scores. After complete case analysis, predefined sensitivity analyses were performed with last observation carried forward and considering patients who died or were institutionalized as having lost an IADL.
Randomization and masking. The randomisation unit was the GP, with GPs assigned on a 1:1 ratio to the intervention or usual care arm, based on a computer-based randomisation list, using uneven block sizes. GPs were allocated to their respective arm after patient enrolment. The study staff performing the main outcome measures (telephone interviews), study coordinator and study statistician were blinded to the allocation.
Results: 42 GPs recruited 429 participants of mean age 82·5 years (SD 4·8) at inclusion, 63% women, with 217 participants allocated to the intervention and 212 to the control arm. The proportion of patients losing at least one IADL during the course of the study was 43·6% and 47·6% in the intervention and control arms, respectively (p=0·476). Mean reduction in quality-of-life score was -0·12 and 0·74 (p=0·331). There was no difference between arms in any of the outcomes considered. Concerning adhesion to the intervention, 85·7% (186/217) of patients in the intervention arm had at least one assessment and GPs adhered to 43·4% of the recommendations in the management plans.
Conclusion. A yearly geriatric evaluation associated with a management plan conducted systematically among community-dwelling, ≥75-year-old patients in GP practices does not lessen functional decline.
Trial registration. The trial was registered in ClinicalTrials.gov with identifier NCT02618291.
Design. Controlled, open-label, pragmatic cluster-randomised trial, randomising at the GP level.
Setting. 42 GP practices, western Switzerland.
Participants. Participating GPs had to work at least 20 hours per week as GPs in French-speaking Switzerland, and were expected to enroll ten community-dwelling adults at least 75-years-old, able to understand French, and having visited their GP at least twice in the prior year.
Intervention. Yearly assessment by the GP of eight geriatric syndromes associated with ad hoc management plans.
Main outcome measures. The primary outcome was, at individual participant level, the proportion of patients losing at least one instrumental activity of daily living (IADL) over two years, compared by a generalised 2-level mixed model with a logit regression. Secondary outcomes were losses in basic ADLs and quality-of-life (WHOQOL-OLD) scores. After complete case analysis, predefined sensitivity analyses were performed with last observation carried forward and considering patients who died or were institutionalized as having lost an IADL.
Randomization and masking. The randomisation unit was the GP, with GPs assigned on a 1:1 ratio to the intervention or usual care arm, based on a computer-based randomisation list, using uneven block sizes. GPs were allocated to their respective arm after patient enrolment. The study staff performing the main outcome measures (telephone interviews), study coordinator and study statistician were blinded to the allocation.
Results: 42 GPs recruited 429 participants of mean age 82·5 years (SD 4·8) at inclusion, 63% women, with 217 participants allocated to the intervention and 212 to the control arm. The proportion of patients losing at least one IADL during the course of the study was 43·6% and 47·6% in the intervention and control arms, respectively (p=0·476). Mean reduction in quality-of-life score was -0·12 and 0·74 (p=0·331). There was no difference between arms in any of the outcomes considered. Concerning adhesion to the intervention, 85·7% (186/217) of patients in the intervention arm had at least one assessment and GPs adhered to 43·4% of the recommendations in the management plans.
Conclusion. A yearly geriatric evaluation associated with a management plan conducted systematically among community-dwelling, ≥75-year-old patients in GP practices does not lessen functional decline.
Trial registration. The trial was registered in ClinicalTrials.gov with identifier NCT02618291.
Unit of Analysis
429 individuals from 42 clusters
Version
Version Description
Version 1.0
Version Date
2020-04-20
Scope
Keywords
| Keyword |
|---|
| Functional decline |
| geriatric assessment |
| geriatric syndrome |
| activities of daily living |
| primary care |
| general practice |
Coverage
Geographic Coverage
Western Switzerland (cantons of Vaud, Neuchâtel, Fribourg)
Universe
family medicine patients aged 75 years and older
Producers and sponsors
Primary investigators
| Name | Affiliation |
|---|---|
| Mueller, Yolanda | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland |
| Schwarz, Joëlle | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland |
| Monod, Stéphanie | Faculty of Biology and Medicine, University of Lausanne, Switzerland |
| Locatelli, Isabella | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland |
| Senn, Nicolas | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland |
Funding Agency/Sponsor
| Name | Abbreviation |
|---|---|
| Swiss National Science Foundation | SNF |
Other Identifications/Acknowledgments
| Name | Affiliation | Role |
|---|---|---|
| Viret, Ophélie | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland | Data acquisition |
| Cornuz, Jacques | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland | input into the study conception |
| Büla, Christophe | CHUV | input into the study conception |
| Price, Mélanie | English editing |
Sampling
Sampling Procedure
Consecutive enrolment or random sampling at family physician level
Data Collection
Dates of Data Collection
| Start | End |
|---|---|
| 2016-08-12 | 2020-01-31 |
Data Collection Mode
phone interview, data extraction from medical file
Questionnaires
Questionnaires
eCRF (secuTrial)
Data Processing
Data Editing
Electronic and central data validation
AGE3 data are collected via secuTrial.
Predefined checks incorporated in secuTrial concern mainly:
- Respect of the time intervals between annual study visits.
- Height (>= 120 and <220 cm)
Secutrial software has an inbuilt data management tool allowing investigators to produce queries. Each form is revised by a member of the study staff. After solving of the pending queries, each form is locked, preventing further modification.
Completion status of each section was predefined during database development. The secuTrial system includes visual aid to inform of data entry completion.
Monthly exports of the data as .csv files were performed by the data manager and stored in her personal folder. Data were then transformed to respect anonymisation (excluding Contact information) and blinding of study coordinator (_4_egb and _10_plansoins forms unlinked to study ID), and stored in .dta format for further management within Stata.
The study coordinator performed monthly data monitoring, to identify missing items or discrepancies, in which case an electronic query was made in secuTrial to the person responsible of data entry for this section.
Source data validation (when applicable) was performed by the study assistant during his/her annual visits to each practice (“review A”). These visits were also an opportunity to solve all remaining queries.
A final data validation took place when data entry was considered complete. The database was locked after all study data had been validated and monitoring review had been completed.
AGE3 data are collected via secuTrial.
Predefined checks incorporated in secuTrial concern mainly:
- Respect of the time intervals between annual study visits.
- Height (>= 120 and <220 cm)
Secutrial software has an inbuilt data management tool allowing investigators to produce queries. Each form is revised by a member of the study staff. After solving of the pending queries, each form is locked, preventing further modification.
Completion status of each section was predefined during database development. The secuTrial system includes visual aid to inform of data entry completion.
Monthly exports of the data as .csv files were performed by the data manager and stored in her personal folder. Data were then transformed to respect anonymisation (excluding Contact information) and blinding of study coordinator (_4_egb and _10_plansoins forms unlinked to study ID), and stored in .dta format for further management within Stata.
The study coordinator performed monthly data monitoring, to identify missing items or discrepancies, in which case an electronic query was made in secuTrial to the person responsible of data entry for this section.
Source data validation (when applicable) was performed by the study assistant during his/her annual visits to each practice (“review A”). These visits were also an opportunity to solve all remaining queries.
A final data validation took place when data entry was considered complete. The database was locked after all study data had been validated and monitoring review had been completed.
Access policy
Access authority
| Name | Affiliation | |
|---|---|---|
| Müller, Yolanda | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland | yolanda.mueller@unisante.ch |
| Senn, Nicolas | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland | nicolas.senn@unisante.ch |
| Racine, Céline (Repository manager) | Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland | dfri.data@unisante.ch |
Confidentiality
Access conditions
Licensed datasets, accessible under conditions
To request access to licensed datasets, please register to the website to continue (https://data.unisante.ch/index.php/auth/register). Once your registration will be approved you must login and go to the "GET MICRODATA" tab and fill in the application form for access to the licensed dataset.
This form includes our Data access agreement and must be filled and submitted by the Lead Researcher. Lead Researcher refers to the person who serves as the main point of contact for all communications involving this agreement. The Lead Researcher assumes all responsibility for compliance with all terms of this Data Access Agreement by employees of the receiving organization.
This request will be reviewed by the Primary Investigator, who may decide to approve the request, to deny access to the data, or to request additional information from the Lead Researcher. A signed copy of this request form may also be requested.
If special conditions apply to the transfer of the requested data (e.g. transfer under a contract between Unisanté and a third party), the references of the contract concerned or the document in which the conditions are specified must be referenced in the request form. The person who makes the request will still need to check the box confirming the acceptance of the terms of use, it being understood that the conditions written in the above mentioned contract will apply.
To request access to licensed datasets, please register to the website to continue (https://data.unisante.ch/index.php/auth/register). Once your registration will be approved you must login and go to the "GET MICRODATA" tab and fill in the application form for access to the licensed dataset.
This form includes our Data access agreement and must be filled and submitted by the Lead Researcher. Lead Researcher refers to the person who serves as the main point of contact for all communications involving this agreement. The Lead Researcher assumes all responsibility for compliance with all terms of this Data Access Agreement by employees of the receiving organization.
This request will be reviewed by the Primary Investigator, who may decide to approve the request, to deny access to the data, or to request additional information from the Lead Researcher. A signed copy of this request form may also be requested.
If special conditions apply to the transfer of the requested data (e.g. transfer under a contract between Unisanté and a third party), the references of the contract concerned or the document in which the conditions are specified must be referenced in the request form. The person who makes the request will still need to check the box confirming the acceptance of the terms of use, it being understood that the conditions written in the above mentioned contract will apply.
Citation requirements
Mueller Y., Schwarz J, Monod S. , Locatelli I., and Senn N. Standardised brief geriatric evaluation versus routine care for preventing functional decline in primary care: a pragmatic cluster-randomised trial. Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland. Version 1.0 of the licensed dataset (December 2020), provided by the Unisanté Research Data Repository. DOI:10.16909/DATASET/23
Disclaimer and copyrights
Disclaimer
The user of the data acknowledges that the original collector of the data, the authorized distributor of the data, and the relevant funding agency bear no responsibility for use of the data or for interpretations or inferences based upon such uses.
Copyright
(c) 2020, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland
Metadata production
DDI Document ID
10.16909-DATASET-23
Producers
| Name | Abbreviation | Role |
|---|---|---|
| Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland | Unisanté | Data publisher |
DDI Document version
Version 1.0 (November 2020)