- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02592525
Implementing Shared Decision Making in Interprofessional Home Care Teams (IPSDM-SW)
Implementing Shared Decision Making in Interprofessional Home Care Teams : a Stepped Wedge Cluster Randomized Trial
This study will train health providers in home care teams across Quebec in shared decision making about the decision to stay at home or move to another location. This decision is one of the toughest for older Canadians. Decisions that are informed, shared and supported produce better results. An interprofessional approach to shared decision making is when older persons and their caregivers are supported by not just one but by all the professionals involved in their care.The impact of the training program in interprofessional shared decision making (IPSDM) above that of the passive dissemination of a decision guide will be assessed by measuring to what extent older persons caregivers say they took active part in the decision-making process.
Other outcome measures will be:
i) what option they chose, whether they feel conflict or regret about their decision, and the burden of care they feel; ii) the quality of life of clients;
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Quebec
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Québec, Quebec, Canada, G1J 0A4
- Centre de recherche sur les soins et les services de première ligne de l'Université Laval (CERSSPL-UL)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Clients or caregivers of clients :
- Aged ≥65 years;
- Receiving care from the IP home care team of the enrolled CISSS/CIUSSS
- Have made a decision about whether to stay at home or move to another location during the recruitment periods
- Are able to read, understand and write French or English
- Can give informed consent
In the case clients are not able to provide informed consent, their caregiver will be eligible.
Exclusion Criteria:
- Clients who are not able to provide informed consent and who don't have a caregiver
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cluster A
IP-SDM training for health professionals (intervention at 4 months)
|
Multifaceted SDM training program for providers: i) 1.5-hour online tutorial, ii) 3.5-hour skills building workshop; iii) video-clip demonstrating SDM in the context of an IP home care team with an aging adult making a decision about location of care (to be used with clients and providers as well); and iv) performance feedback to providers (role play during the workshop).
|
|
Experimental: Cluster B
IP-SDM training for health professionals (intervention at 11 months)
|
Multifaceted SDM training program for providers: i) 1.5-hour online tutorial, ii) 3.5-hour skills building workshop; iii) video-clip demonstrating SDM in the context of an IP home care team with an aging adult making a decision about location of care (to be used with clients and providers as well); and iv) performance feedback to providers (role play during the workshop).
|
|
Experimental: Cluster C
IP-SDM training for health professionals (intervention at 18 months)
|
Multifaceted SDM training program for providers: i) 1.5-hour online tutorial, ii) 3.5-hour skills building workshop; iii) video-clip demonstrating SDM in the context of an IP home care team with an aging adult making a decision about location of care (to be used with clients and providers as well); and iv) performance feedback to providers (role play during the workshop).
|
|
Experimental: Cluster D
IP-SDM training for health professionals (intervention at 25 months)
|
Multifaceted SDM training program for providers: i) 1.5-hour online tutorial, ii) 3.5-hour skills building workshop; iii) video-clip demonstrating SDM in the context of an IP home care team with an aging adult making a decision about location of care (to be used with clients and providers as well); and iv) performance feedback to providers (role play during the workshop).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assumed Role in decision making
Time Frame: 7 months
|
To assess the proportion of caregivers reporting an active role, a modified version of the Control Preferences Scale designed to assess the role assumed in the decision making process will be used.
The scale consists of a single question and is the one most frequently used in studies assessing the implementation of SDM in clinical practice.
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7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient involvement in decision making
Time Frame: 7 months
|
Assessed with the Dyadic-OPTION scale, a 12-item self-administered instrument that assesses 12 specific SDM behaviours during the decision-making process
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7 months
|
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Decisional Regret
Time Frame: 7 months
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Assessed with the Decisional Regret Scale
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7 months
|
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Decisional Conflict
Time Frame: 7 months
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Assessed with the Decisional Conflict Scale
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7 months
|
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Health-related quality of life
Time Frame: 7 months
|
Assessed with two subscales (Social isolation and Emotional reactions) of the HR-QoL questionnaire from the Nottingham Health Profile, clients only
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7 months
|
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Burden of care
Time Frame: 7 months
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Assessed with the Zarit Burden Inventory Scale (ZBI), caregivers only
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7 months
|
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Preferred and chosen option (remain at home or move to another location)
Time Frame: 7 months
|
Questionnaire assessing the prefered and chosen option
|
7 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: France Légaré, Ph. D., Laval University
Publications and helpful links
General Publications
- Adisso EL, Taljaard M, Stacey D, Briere N, Zomahoun HTV, Durand PJ, Rivest LP, Legare F. Shared Decision-Making Training for Home Care Teams to Engage Frail Older Adults and Caregivers in Housing Decisions: Stepped-Wedge Cluster Randomized Trial. JMIR Aging. 2022 Sep 20;5(3):e39386. doi: 10.2196/39386.
- Legare F, Briere N, Stacey D, Lacroix G, Desroches S, Dumont S, Fraser KD, Rivest LP, Durand PJ, Turcotte S, Taljaard M, Bourassa H, Roy L, Painchaud Guerard G. Implementing shared decision-making in interprofessional home care teams (the IPSDM-SW study): protocol for a stepped wedge cluster randomised trial. BMJ Open. 2016 Nov 24;6(11):e014023. doi: 10.1136/bmjopen-2016-014023.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015-2016 01-01-E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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