Advance planning for health care and research among older adults

ISRCTN ISRCTN89993391
DOI https://doi.org/10.1186/ISRCTN89993391
Secondary identifying numbers MCT-94830
Submission date
10/08/2009
Registration date
20/08/2009
Last edited
29/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gina Bravo
Scientific

Research Centre on Aging
1036 South Belvedere Street
Sherbrooke
J1H 4C4
Canada

Study information

Study designSingle centre single-blind stratified randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAdvance planning for health care and research among older adults: a single centre, single-blind randomised controlled trial
Study objectivesBy comparison with a non-exposed control group, does a multimodal professionally-led advance planning intervention stimulating discussion between an older adult and a self-selected proxy about end-of-life care and research participation, and including an educational component on advance directives (ADs) improve the accuracy of substitute decision-making and increase the frequency of written ADs for health care and research?
Ethics approval(s)Local medical ethics committee (comité d'éthique de la recherche sur le vieillissement du Centre de santé et de services sociaux - Institut universitaire de gériatrie de Sherbrooke [CSSS-IUGS]) approved on the 7th July 2009 (ref: 2009-12)
Health condition(s) or problem(s) studiedAdvance directives for health care and research
InterventionExperimental group:
One- to two-hour meetings once monthly over three months. First and third meetings will be with trained social workers, at the home of the older adult or proxy. Second meeting will be a group information session on ADs at the research centre, conducted by three co-investigators with expertise in health law, decisional incapacity and end-of-life care. At the first home visit, there will be discussion of vignettes highlighting importance of communicating one's wishes about future medical care and research participation. At third and last meeting, understanding of the information delivered at second meeting will be checked.

Control group:
One- to two-hour group educational seminars held once a month over three months, about preventive health practices.
Intervention typeOther
Primary outcome measurePrediction accuracy of substitute decision-making. Concordance assessments will be measured at 3 months and 12 months after the end of the intervention, using the same procedure as at baseline.
Secondary outcome measuresRates of written ADs. Three months and 12 months post-intervention, participants will be asked whether they have indicated their healthcare and/or research preferences in writing.
Overall study start date01/10/2009
Completion date01/02/2011

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants240 dyads
Total final enrolment470
Key inclusion criteria1. Community-dwelling French-speaking individuals
2. Aged 70 years and over, either sex
3. Living in the Sherbrooke area in the province of Quebec
4. No cognitive deficits
5. Agree to designate a potential French-speaking proxy living in the same area
Key exclusion criteria1. Mental disorders (International Classification of Diseases, 9th Edition [ICD-9], section 5)
2. Some diseases of the nervous system and sense organs (ICD-9, section 6)
3. Deafness
4. Blindness
5. Alcoholism
Date of first enrolment01/10/2009
Date of final enrolment01/02/2011

Locations

Countries of recruitment

  • Canada

Study participating centre

Research Centre on Aging
Sherbrooke
J1H 4C4
Canada

Sponsor information

Research Centre on Aging (Canada)
Research organisation

Sherbrooke University Institute of Geriatrics
1036 South Belvedere Street
Sherbrooke QC
J1H 4C4
Canada

Website http://www.csss-iugs.ca/cdrv
ROR logo "ROR" https://ror.org/05jsjqy14

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-94830)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 05/01/2012 29/12/2020 Yes No
Results article results 01/07/2017 29/12/2020 Yes No
Results article results 01/07/2018 29/12/2020 Yes No

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.