- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03935997
Mise en œuvre, évaluation et intensification du programme de renforcement d'une approche palliative dans les soins de longue durée (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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Manitoba
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Winnipeg, Manitoba, Canada
- University of Manitoba
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Ontario
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Hamilton, Ontario, Canada
- McMaster University
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Saskatchewan
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Regina, Saskatchewan, Canada
- University of Regina
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Saskatoon, Saskatchewan, Canada
- University of Saskatchewan
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Nombre de visites aux urgences au cours de la dernière année de vie du résident
Délai: Tous les résidents du foyer décédés un an avant la mise en œuvre et un an avant la date du décès pour tous les résidents du foyer décédés pendant la période d'intervention de l'étude.
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Tous les résidents du foyer décédés un an avant la mise en œuvre et un an avant la date du décès pour tous les résidents du foyer décédés pendant la période d'intervention de l'étude.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Family Perceptions of End of Life Care
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
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Bereaved Family Satisfaction with End of Life Care
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fidelity of the Intervention
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sharon Kaasalainen, PhD, McMaster University, School of Nursing
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SPA-LTC408466
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
There is no plan to make individual participant data (IPD) available to other researchers.
Informations sur les médicaments et les dispositifs, documents d'étude
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