- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03935997
Implementación, evaluación y ampliación del programa Fortalecimiento de un enfoque paliativo en cuidados a largo plazo (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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Manitoba
-
Winnipeg, Manitoba, Canadá
- University of Manitoba
-
-
Ontario
-
Hamilton, Ontario, Canadá
- McMaster University
-
-
Saskatchewan
-
Regina, Saskatchewan, Canadá
- University of Regina
-
Saskatoon, Saskatchewan, Canadá
- University of Saskatchewan
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Número de visitas al servicio de urgencias en el último año de vida del residente
Periodo de tiempo: Todos los residentes del hogar que fallecieron un año antes de la implementación y un año antes de la fecha de fallecimiento para todos los residentes del hogar que fallecieron durante el período de intervención del estudio.
|
Todos los residentes del hogar que fallecieron un año antes de la implementación y un año antes de la fecha de fallecimiento para todos los residentes del hogar que fallecieron durante el período de intervención del estudio.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Family Perceptions of End of Life Care
Periodo de tiempo: 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.
|
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.
|
|
Family Experiences with End of Life Care
Periodo de tiempo: 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.
|
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.
|
|
Staff Knowledge about a Palliative Approach to Care
Periodo de tiempo: 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
|
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
|
|
Number of Hospital Transfers per Resident
Periodo de tiempo: 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.
|
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.
|
|
Number of Hospital Deaths during the trial
Periodo de tiempo: 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.
|
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.
|
|
Bereaved Family Satisfaction with End of Life Care
Periodo de tiempo: 6 weeks to 2 months after the resident's death
|
Qualitative interview with family members whose loved one died during the trial. |
6 weeks to 2 months after the resident's death
|
|
Resident Satisfaction with End of Life Care
Periodo de tiempo: 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.
|
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.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fidelity of the Intervention
Periodo de tiempo: Checklist completed weekly during the intervention period for up to 160 weeks.
|
Checklist |
Checklist completed weekly during the intervention period for up to 160 weeks.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sharon Kaasalainen, PhD, McMaster University, School of Nursing
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SPA-LTC408466
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
There is no plan to make individual participant data (IPD) available to other researchers.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .