Clinical trial NCT03935997: Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Official title: Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: Palliative care
End of life care
Long-term care
Nursing home
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: Hospice Palliative Care Ontario
name: Canadian Hospice Palliative Care Association
name: Canadian Virtual Hospice
name: Saskatchewan Health Authority - Regina Area
name: Interlake-Eastern Regional Health Authority
First posted: 2019-05-02
Enrollment: 594
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Emergency Department Visits in the Resident's Last Year of Life
timeFrame: 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:
measure: Family Perceptions of End of Life Care
timeFrame: 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.
measure: Family Experiences with End of Life Care
timeFrame: 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.
measure: Staff Knowledge about a Palliative Approach to Care
timeFrame: 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
measure: Number of Hospital Transfers per Resident
timeFrame: 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.
measure: Number of Hospital Deaths during the trial
timeFrame: 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.
measure: Bereaved Family Satisfaction with End of Life Care
timeFrame: 6 weeks to 2 months after the resident's death
measure: Resident Satisfaction with End of Life Care
timeFrame: 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.
Other outcomes:
measure: Fidelity of the Intervention
timeFrame: Checklist completed weekly during the intervention period for up to 160 weeks.
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: McMaster University, School of Nursing
name: Sharon Kaasalainen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.