- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03935997
Zavedení, vyhodnocení a rozšíření programu Posílení paliativního přístupu v dlouhodobé péči (SPA-LTC)
This study will evaluate the implementation of the Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) program using a cross-jurisdictional, effectiveness-implementation type II hybrid design (dual testing of clinical and implementation interventions) to assess the implementation (feasibility, fidelity, reach, sustainability) and effectiveness (family satisfaction, staff knowledge and confidence implementing a palliative approach to care, hospital use).
Přehled studie
Postavení
Podmínky
Detailní popis
The SPA-LTC program has been developed and refined through prior participatory action based studies.
Evidence-based components of the program include:
Palliative Champion Teams; Palliative Care Education, including illness-trajectory pamphlets for staff and family members; Comfort Care Rounds with staff; Prognostic Tools to trigger end-of-life discussions; Palliative Care Conferences; Bereavement Pamphlets for families; and Post-Bereavement Follow-Up for families, and staff
The goal is to implement and assess this program across three provinces in Canada (Ontario, Saskatchewan, Manitoba). The investigators will use the findings to revise the program and inform the scaling up of the program across diverse settings and provinces.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Manitoba
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Winnipeg, Manitoba, Kanada
- University of Manitoba
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Ontario
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Hamilton, Ontario, Kanada
- McMaster University
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Saskatchewan
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Regina, Saskatchewan, Kanada
- University of Regina
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Saskatoon, Saskatchewan, Kanada
- University of Saskatchewan
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- English-speaking LTC residents with a score of 50% or less on the Palliative Performance Scale.
Exclusion Criteria:
- Non-English speaking LTC residents
- residents with a score of more than 50% on the Palliative Performance Scale.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Intervention
Within the intervention arm 9 long-term care homes will receive the SPA-LTC program:3 in Ontario; 3 in Saskatchewan and 3 in Manitoba. |
Our team will work with long-term care homes in the study to implement the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) which consists of the following core, evidence-informed components: Palliative Champion Teams (to provide leadership and support implementation); Palliative Care Education (including illness trajectory pamphlets); Comfort Care Rounds with staff (for capacity building and reflection); Prognostic Tools to trigger end-of-life discussions; Palliative Care Conferences with families and residents; Bereavement Pamphlets; and Post-Bereavement Follow-Up for families, and staff. |
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Žádný zásah: Control
Within the control arm 9 long-term care homes will receive the standard of care: 3 in Ontario; 3 in Saskatchewan and 3 in Manitoba. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Počet návštěv pohotovosti v posledním roce života rezidenta
Časové okno: Všichni obyvatelé domova, kteří zemřeli jeden rok před implementací a jeden rok před datem úmrtí, pro všechny obyvatele domova, kteří zemřeli během období intervence studie.
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Všichni obyvatelé domova, kteří zemřeli jeden rok před implementací a jeden rok před datem úmrtí, pro všechny obyvatele domova, kteří zemřeli během období intervence studie.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Family Perceptions of End of Life Care
Časové okno: Survey completed at enrolment into the study; survey completed 2 months after the Family Care Conference or 1 month after the end of the intervention period if no Family Care Conference occurred.
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Survey |
Survey completed at enrolment into the study; survey completed 2 months after the Family Care Conference or 1 month after the end of the intervention period if no Family Care Conference occurred.
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Family Experiences with End of Life Care
Časové okno: Interview completed at enrolment into the study; survey completed 2 months after the Family Care Conference or 1 month after the end of the intervention period if no Family Care Conference occurred.
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Interview |
Interview completed at enrolment into the study; survey completed 2 months after the Family Care Conference or 1 month after the end of the intervention period if no Family Care Conference occurred.
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Staff Knowledge about a Palliative Approach to Care
Časové okno: All staff in all participating long-term care homes will complete a staff survey at 2 points in the study: at the beginning and the end of the intervention
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Survey |
All staff in all participating long-term care homes will complete a staff survey at 2 points in the study: at the beginning and the end of the intervention
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Number of Hospital Transfers per Resident
Časové okno: Chart audit at start of the trial to capture data on residents who died in the year prior to the trial. Chart audits also during the transition phase prior to Steps 2 and 3; and one month after the intervention period for the trial ends.
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Chart data at each study site will be audited to capture data on the number of hospital transfers in the last year of life for residents who died 1 year before the trial or who die during the trial. |
Chart audit at start of the trial to capture data on residents who died in the year prior to the trial. Chart audits also during the transition phase prior to Steps 2 and 3; and one month after the intervention period for the trial ends.
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Number of Hospital Deaths during the trial
Časové okno: Chart audit at start of the trial to capture data on residents who died in the year prior to the trial. Chart audits also during the transition phase prior to Steps 2 and 3; and one month after the intervention period for the trial ends.
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Chart data at each study site will be audited to capture data on the number of hospital deaths in the year prior to the trial and during the trial. Chart data at each study site will be audited to capture data on the number of hospital transfers in the residents last year of life. |
Chart audit at start of the trial to capture data on residents who died in the year prior to the trial. Chart audits also during the transition phase prior to Steps 2 and 3; and one month after the intervention period for the trial ends.
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Bereaved Family Satisfaction with End of Life Care
Časové okno: 6 weeks to 2 months after the resident's death
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Qualitative interview with family members whose loved one died during the trial. |
6 weeks to 2 months after the resident's death
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Resident Satisfaction with End of Life Care
Časové okno: At the time of enrolment and 2 months after the Family Care Conference or 1 month after the intervention period if no Family Care Conference occurred.
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Qualitative interview with residents who are enrolled in the trial |
At the time of enrolment and 2 months after the Family Care Conference or 1 month after the intervention period if no Family Care Conference occurred.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fidelity of the Intervention
Časové okno: Checklist completed weekly during the intervention period for up to 160 weeks.
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Checklist |
Checklist completed weekly during the intervention period for up to 160 weeks.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Sharon Kaasalainen, PhD, McMaster University, School of Nursing
Publikace a užitečné odkazy
Obecné publikace
- Sussman T, Kaasalainen S, Lee E, Akhtar-Danesh N, Strachan PH, Brazil K, Bonifas R, Bourgeois-Guerin V, Durivage P, Papaioannou A, Young L. Condition-Specific Pamphlets to Improve End-of-life Communication in Long-term Care: Staff Perceptions on Usability and Use. J Am Med Dir Assoc. 2019 Mar;20(3):262-267. doi: 10.1016/j.jamda.2018.11.009. Epub 2018 Dec 21.
- Thompson G, Shindruk C, Wickson-Griffiths A, Sussman T, Hunter P, McClement S, Chochinov H, McCleary L, Kaasalainen S, Venturato L. "Who would want to die like that?" Perspectives on dying alone in a long-term care setting. Death Stud. 2019;43(8):509-520. doi: 10.1080/07481187.2018.1491484. Epub 2018 Sep 12.
- Sussman T, Kaasalainen S, Bui M, Akhtar-Danesh N, Mintzberg S, Strachan P. "Now I Don't Have to Guess": Using Pamphlets to Encourage Residents and Families/Friends to Engage in Advance Care Planning in Long-Term Care. Gerontol Geriatr Med. 2017 Dec 20;3:2333721417747323. doi: 10.1177/2333721417747323. eCollection 2017 Jan-Dec.
- Durepos P, Kaasalainen S, Sussman T, Parker D, Brazil K, Mintzberg S, Te A. Family care conferences in long-term care: Exploring content and processes in end-of-life communication. Palliat Support Care. 2018 Oct;16(5):590-601. doi: 10.1017/S1478951517000773. Epub 2017 Dec 29.
- Kaasalainen S, Sussman T, Durepos P, McCleary L, Ploeg J, Thompson G; SPA-LTC Team. What Are Staff Perceptions About Their Current Use of Emergency Departments for Long-Term Care Residents at End of Life? Clin Nurs Res. 2019 Jul;28(6):692-707. doi: 10.1177/1054773817749125. Epub 2017 Dec 22.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SPA-LTC408466
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
There is no plan to make individual participant data (IPD) available to other researchers.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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