AgingNCT04327830
What Older Adults and Their Caregivers Need for Making Better Decisions at Home
An observational study of Aging, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Most Canadians wish to stay at home in their old age. As older adults stay at home with the support of home and community services, they are often faced with difficult decisions, such as "Who will look after me when I can't look after myself any more, or if I have dementia?" or "Should I move to a nursing home, or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Decisional needs assessment
- How many people
- 5,000 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2019to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults who have received or are receive home care services (and their caregivers)
Who may be able to join
- older adults who have received, or are receiving home care services
- caregivers of older adults who have received, or are receiving home care services
- interdisciplinary health and social care providers who provide home care services for older adults
Who cannot join
- no experience receiving or providing home care services
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decision-making Needs of Older Adults Receiving Home Care From the Perspective of Older Adults, Their Caregivers and Inter-disciplinary Health and Social Care Providers: Participatory Mixed Methods Study
Most Canadians wish to stay at home in their old age. As older adults stay at home with the support of home and community services, they are often faced with difficult decisions, such as "Who will look after me when I can't look after myself any more, or if I have dementia?" or "Should I move to a nursing home, or stay here?" Care providers in the home and community can support older adults and their families make these difficult decisions by providing them with information they need and asking them about their values and preferences. By helping older adults and their families know more about their choices and choose options that reflect what is important to them, care providers can work with their clients to help them make informed health decisions together. In this fellowship, the investigators will study what supports are needed for older adults to make informed health decisions from the perspective of older adults, caregivers and front-line care providers in the home and community setting across Canada. This can help improve the home and community services provided to older adults (and their caregivers) so that older adults (and their caregivers) can make better decisions together with their health care team.
Read the detailed description
Introduction Shared decision making is an interpersonal process whereby healthcare providers collaborate with and support patients in decision-making. Older adults receiving home care need support with decision-making (e.g., information on risks and benefits of options). This study will explore what older adults and their caregivers need for making better health-related decisions at home, and what health and social care providers need for supporting their home care clients with decision-making.
Methods and analysis This two-phase sequential exploratory mixed methods study will be conducted in a pan-Canadian healthcare organization, St Elizabeth Health Care. First, the investigators will create a participant advisory group (one older adult, one caregiver and two care providers) to advise us throughout the research process. In Phase 1 (qualitative), the investigators will recruit a convenient sample of older adults and caregivers receiving home care to participate in open-ended semi-structured interviews to discuss what health-related decisions they face at home and what they need for making better decisions (e.g. types of knowledge, sources of support). In Phase 2 (quantitative), interdisciplinary health and social care providers (e.g., nurses, personal support workers, occupational therapists, physiotherapists) will be invited to answer an online survey to share their views on the decision-making needs of older adults and their caregivers. The survey will include close-ended questions informed by findings from the qualitative interviews in Phase 1. Finally, qualitative and quantitative results will be triangulated from the perspective of older adults, caregivers and health and social care providers. Results will be reported using EQUATOR guidelines.
- Conditions
- Aging
- Being tested
- Decisional needs assessment
- Keywords
- Shared decision making, Home care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decisional needs assessmentOther
Assessment of decision-making needs
| Study group | Role | What they receive |
|---|---|---|
| Older adults and their caregivers | Older adults who have received or are receiving home care services and their caregivers Receives: Other: Decisional needs assessment | |
| Interdisciplinary health and social care providers | Interdisciplinary health and social care providers who provide home care services to older adults Receives: Other: Decisional needs assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision making needs of older adults who receive home care services and their caregivers.
Interview of older adults and their caregivers. Open-ended questions guide by the Ottawa Decision Support Framework (ODSF).
Measured: About 60 minutes
What health and social care providers need to support older adults and their caregivers with making decisions.
Survey of interdisciplinary health and social care providers, based on the Ottawa Decision Support Framework (ODSF) factors contributing to difficulty.
Measured: 5 to 10 minutes
Secondary outcomes (1)
-Health and social care providers opinion how often older adults faced difficult decisions. -Shared decision-making. -Others participants involved in the decision making.
- Opinion frequency; 5-point Likert scale always to never.
- Shared decision-making generic approach in 5 questions; 5-point Likert scale always to never.
Measured: 5 to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start15 Aug 2019
- Primary completion4 May 2020
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- St Elizabeth Healthcare
- Responsible party
- Sponsor
- Investigators
- France Legare, Study chair, Laval University /SE Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327830
- Sponsor's protocol ID
- MCD315
- Status last verified
- Feb 2021
- First submitted
- 27 Mar 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Statistics Canada. Home health care and related services [Report on the Internet]. Ottawa: Statitics Canada, 2017 (cited July 31, 2019). Accessed on Feb 10, 2020 from: https://www150.statcan.gc.ca/n1/daily-quotidien/190731/dq190731c-eng.htm
2. Canadian Institute for Health Information. Home care expenditures in the NHEX Database [Technical note on the Internet] Ottawa: The Institute; 2017 (cited November 2017). Accessed on Feb 20, 2020 from: https://www.cihi.ca/sites/default/files/document/technical_notes_on_home_care-nhex2017-en.pdf.
Lai C, Holyoke P, Plourde KV, Decary S, Legare F. What older adults and their caregivers need for making better health-related decisions at home: a participatory mixed methods protocol. BMJ Open. 2020 Nov 9;10(11):e039102. doi: 10.1136/bmjopen-2020-039102.
PubMed 33168556
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision-making Needs of Older Adults Receiving Home Care From the Perspective of Older Adults, Their Caregivers and Inter-disciplinary Health and Social Care Providers: Participatory Mixed Methods Study
- ClinicalTrials.gov ID
- NCT04327830
- Acronym / sponsor ID
- MCD315
- Conditions
- Aging
- Keywords
- Shared decision making, Home care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- St Elizabeth Healthcare
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most Canadians wish to stay at home in their old age. As older adults stay at home with the support of home and community services, they are often faced with difficult decisions, such as "Who will look after me when I can't look after myself any more, or if I have dementia?" or "Should I move to a nursing home, or stay here?" Care providers in the home and community can support older adults and their families make these difficult decisions by providing them with information they need and asking them about their values and preferences. By helping older adults and their families know more about their choices and choose options that reflect what is important to them, care providers can work with their clients to help them make informed health decisions together. In this fellowship, the investigators will study what supports are needed for older adults to make informed health decisions from the perspective of older adults, caregivers and front-line care providers in the home and community setting across Canada. This can help improve the home and community services provided to older adults (and their caregivers) so that older adults (and their caregivers) can make better decisions together with their health care team.
Detailed description
Introduction Shared decision making is an interpersonal process whereby healthcare providers collaborate with and support patients in decision-making. Older adults receiving home care need support with decision-making (e.g., information on risks and benefits of options). This study will explore what older adults and their caregivers need for making better health-related decisions at home, and what health and social care providers need for supporting their home care clients with decision-making.
Methods and analysis This two-phase sequential exploratory mixed methods study will be conducted in a pan-Canadian healthcare organization, St Elizabeth Health Care. First, the investigators will create a participant advisory group (one older adult, one caregiver and two care providers) to advise us throughout the research process. In Phase 1 (qualitative), the investigators will recruit a convenient sample of older adults and caregivers receiving home care to participate in open-ended semi-structured interviews to discuss what health-related decisions they face at home and what they need for making better decisions (e.g. types of knowledge, sources of support). In Phase 2 (quantitative), interdisciplinary health and social care providers (e.g., nurses, personal support workers, occupational therapists, physiotherapists) will be invited to answer an online survey to share their views on the decision-making needs of older adults and their caregivers. The survey will include close-ended questions informed by findings from the qualitative interviews in Phase 1. Finally, qualitative and quantitative results will be triangulated from the perspective of older adults, caregivers and health and social care providers. Results will be reported using EQUATOR guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older adults and their caregivers | – | Other: Decisional needs assessmentOlder adults who have received or are receiving home care services and their caregivers |
| Interdisciplinary health and social care providers | – | Other: Decisional needs assessmentInterdisciplinary health and social care providers who provide home care services to older adults |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults who have received or are receive home care services (and their caregivers)
Key inclusion criteria (3 listed)
- older adults who have received, or are receiving home care services
- caregivers of older adults who have received, or are receiving home care services
- interdisciplinary health and social care providers who provide home care services for older adults
Key exclusion criteria (1 listed)
- no experience receiving or providing home care services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decisional needs assessmentAssessment of decision-making needs | Other | Interdisciplinary health and social care providers, Older adults and their caregivers |
Primary outcome
Decision making needs of older adults who receive home care services and their caregivers.
Time frame: About 60 minutes
Interview of older adults and their caregivers. Open-ended questions guide by the Ottawa Decision Support Framework (ODSF).
What health and social care providers need to support older adults and their caregivers with making decisions.
Time frame: 5 to 10 minutes
Survey of interdisciplinary health and social care providers, based on the Ottawa Decision Support Framework (ODSF) factors contributing to difficulty.
1 secondary outcome
-Health and social care providers opinion how often older adults faced difficult decisions. -Shared decision-making. -Others participants involved in the decision making.
Time frame: 5 to 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background1. Statistics Canada. Home health care and related services [Report on the Internet]. Ottawa: Statitics Canada, 2017 (cited July 31, 2019). Accessed on Feb 10, 2020 from: https://www150.statcan.gc.ca/n1/daily-quotidien/190731/dq190731c-eng.htm
- Background2. Canadian Institute for Health Information. Home care expenditures in the NHEX Database [Technical note on the Internet] Ottawa: The Institute; 2017 (cited November 2017). Accessed on Feb 20, 2020 from: https://www.cihi.ca/sites/default/files/document/technical_notes_on_home_care-nhex2017-en.pdf.
- Derived from this study: PubMed 33168556Lai C, Holyoke P, Plourde KV, Decary S, Legare F. What older adults and their caregivers need for making better health-related decisions at home: a participatory mixed methods protocol. BMJ Open. 2020 Nov 9;10(11):e039102. doi: 10.1136/bmjopen-2020-039102.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
France Legare study chair
Laval University /SE Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision making needs of older adults who receive home care services and their caregivers. (time frame: About 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327830, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.