AgingIPSDM-SWNCT02592525
Implementing Shared Decision Making in Interprofessional Home Care Teams
A study testing IP-SDM training for health professionals in people with Aging, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- IP-SDM training for health professionals
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 653 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Dec 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clients who are not able to provide informed consent and who don't have a caregiver
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche sur les soins et les services de première ligne de l'Université Laval (CERSSPL-UL)
Québec, Quebec, G1J 0A4
About this study
Official title: 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:
- 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;
- Conditions
- Aging
- Being tested
- IP-SDM training for health professionals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP-SDM training for health professionalsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Cluster A | Experimental | IP-SDM training for health professionals (intervention at 4 months) Receives: Behavioral: IP-SDM training for health professionals |
| Cluster B | Experimental | IP-SDM training for health professionals (intervention at 11 months) Receives: Behavioral: IP-SDM training for health professionals |
| Cluster C | Experimental | IP-SDM training for health professionals (intervention at 18 months) Receives: Behavioral: IP-SDM training for health professionals |
| Cluster D | Experimental | IP-SDM training for health professionals (intervention at 25 months) Receives: Behavioral: IP-SDM training for health professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assumed Role in decision making
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.
Measured: 7 months
Secondary outcomes (6)
Patient involvement in decision making
Assessed with the Dyadic-OPTION scale, a 12-item self-administered instrument that assesses 12 specific SDM behaviours during the decision-making process
Measured: 7 months
Decisional Regret
Assessed with the Decisional Regret Scale
Measured: 7 months
Decisional Conflict
Assessed with the Decisional Conflict Scale
Measured: 7 months
Health-related quality of life
Assessed with two subscales (Social isolation and Emotional reactions) of the HR-QoL questionnaire from the Nottingham Health Profile, clients only
Measured: 7 months
Burden of care
Assessed with the Zarit Burden Inventory Scale (ZBI), caregivers only
Measured: 7 months
Preferred and chosen option (remain at home or move to another location)
Questionnaire assessing the prefered and chosen option
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, France Legare, CHU de Quebec-Universite Laval
- Investigators
- France Légaré, Ph. D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592525
- Sponsor's protocol ID
- 2015-2016 01-01-E
- Acronym
- IPSDM-SW
- Status last verified
- Dec 2019
- First submitted
- 28 Oct 2015
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 35759791Legare 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.
PubMed 27884857
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Shared Decision Making in Interprofessional Home Care Teams : a Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02592525
- Acronym / sponsor ID
- IPSDM-SW / 2015-2016 01-01-E
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Oct 2015 (estimated)
- 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.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cluster A | Experimental | Behavioral: IP-SDM training for health professionalsIP-SDM training for health professionals (intervention at 4 months) |
| Cluster B | Experimental | Behavioral: IP-SDM training for health professionalsIP-SDM training for health professionals (intervention at 11 months) |
| Cluster C | Experimental | Behavioral: IP-SDM training for health professionalsIP-SDM training for health professionals (intervention at 18 months) |
| Cluster D | Experimental | Behavioral: IP-SDM training for health professionalsIP-SDM training for health professionals (intervention at 25 months) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Clients who are not able to provide informed consent and who don't have a caregiver
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 |
|---|---|---|
| IP-SDM training for health professionalsMultifaceted 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). | Behavioural | Cluster A, Cluster B, Cluster C, Cluster D |
Primary outcome
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.
6 secondary outcomes
Patient involvement in decision making
Time frame: 7 months
Decisional Regret
Time frame: 7 months
Decisional Conflict
Time frame: 7 months
Health-related quality of life
Time frame: 7 months
Burden of care
Time frame: 7 months
Preferred and chosen option (remain at home or move to another location)
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Derived from this study: PubMed 35759791Adisso 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.
- Derived from this study: PubMed 27884857Legare 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.
- Related InfoLink provided by the sponsor.
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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 Légaré, Ph. D. principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IP-SDM training for health professionals in people with 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 7 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: finished, as of the sponsor's last update on 20 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assumed Role in decision making (time frame: 7 months). 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 NCT02592525, which also lists 2 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 20 Dec 2019.