Advance planning for health care and research among older adults
| ISRCTN | ISRCTN89993391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89993391 |
| Protocol serial number | MCT-94830 |
| Sponsor | Research Centre on Aging (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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
Scientific
Research Centre on Aging
1036 South Belvedere Street
Sherbrooke
J1H 4C4
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre single-blind stratified randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Advance planning for health care and research among older adults: a single centre, single-blind randomised controlled trial |
| Study objectives | By 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) studied | Advance directives for health care and research |
| Intervention | Experimental 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 type | Other |
| Primary outcome measure(s) | Prediction 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. |
| Key secondary outcome measure(s) | Rates 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. |
| Completion date | 01/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 480 |
| Total final enrolment | 470 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/10/2009 |
| Date of final enrolment | 01/02/2011 |
Locations
Countries of recruitment
- Canada
Study participating centre
Research Centre on Aging
Sherbrooke
J1H 4C4
Canada
J1H 4C4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2017 | 29/12/2020 | Yes | No |
| Results article | results | 01/07/2018 | 29/12/2020 | Yes | No |
| Protocol article | protocol | 05/01/2012 | 29/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
