NCT03935997

Brief Summary

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
594

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

September 25, 2025

Status Verified

November 1, 2024

Enrollment Period

2.7 years

First QC Date

April 26, 2019

Last Update Submit

September 24, 2025

Conditions

Keywords

Palliative careEnd of life careLong-term careNursing home

Outcome Measures

Primary Outcomes (1)

  • Number of Emergency Department Visits in the Resident's Last Year of Life

    All residents in the home who died one year prior to the implementation and one year prior to the date of death for all residents in the home who die during the study intervention period.

Secondary Outcomes (7)

  • Family Perceptions of End of Life Care

    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

    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

    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

    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

    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.

  • +2 more secondary outcomes

Other Outcomes (1)

  • Fidelity of the Intervention

    Checklist completed weekly during the intervention period for up to 160 weeks.

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) Program

Control

NO INTERVENTION

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.

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking LTC residents with a score of 50% or less on the Palliative Performance Scale.

You may not qualify if:

  • Non-English speaking LTC residents
  • residents with a score of more than 50% on the Palliative Performance Scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Manitoba

Winnipeg, Manitoba, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

University of Regina

Regina, Saskatchewan, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Location

Related Publications (5)

  • 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.

    PMID: 30583908BACKGROUND
  • 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.

    PMID: 30207512BACKGROUND
  • 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.

    PMID: 29308424BACKGROUND
  • 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.

    PMID: 29284551BACKGROUND
  • 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.

    PMID: 29271241BACKGROUND

Related Links

MeSH Terms

Interventions

Long-Term Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sharon Kaasalainen, PhD

    McMaster University, School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There is no need to mask participants, clinicians or research staff.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Within each of the three provinces, six LTC homes will be randomly selected, and then randomly allocated using a 1:1 ratio, stratified according to province, to either the intervention or control group using a computer-generated list. For each province, three LTC homes will receive the intervention and three will receive usual care. A biostatistician not involved in recruitment will generate group assignments.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 2, 2019

Study Start

June 1, 2022

Primary Completion

January 31, 2025

Study Completion

January 31, 2026

Last Updated

September 25, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers.

Locations