- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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;
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Quebec
-
Québec, Quebec, Kanada, G1J 0A4
- Centre de recherche sur les soins et les services de première ligne de l'Université Laval (CERSSPL-UL)
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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).
|
|
Experimentální: 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).
|
|
Experimentální: 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).
|
|
Experimentální: 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).
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Assumed Role in decision making
Časové okno: 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.
|
7 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient involvement in decision making
Časové okno: 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
|
7 months
|
|
Decisional Regret
Časové okno: 7 months
|
Assessed with the Decisional Regret Scale
|
7 months
|
|
Decisional Conflict
Časové okno: 7 months
|
Assessed with the Decisional Conflict Scale
|
7 months
|
|
Health-related quality of life
Časové okno: 7 months
|
Assessed with two subscales (Social isolation and Emotional reactions) of the HR-QoL questionnaire from the Nottingham Health Profile, clients only
|
7 months
|
|
Burden of care
Časové okno: 7 months
|
Assessed with the Zarit Burden Inventory Scale (ZBI), caregivers only
|
7 months
|
|
Preferred and chosen option (remain at home or move to another location)
Časové okno: 7 months
|
Questionnaire assessing the prefered and chosen option
|
7 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: France Légaré, Ph. D., Laval University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2015-2016 01-01-E
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .