Frail Elderly SyndromeNCT03935997
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
A study testing Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) Program in people with Frail Elderly Syndrome, run by McMaster University at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Jun 2022to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- English-speaking LTC residents with a score of 50% or less on the Palliative Performance Scale.
Who cannot join
- Non-English speaking LTC residents
- residents with a score of more than 50% on the Palliative Performance Scale.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
McMaster University
Hamilton, Ontario
University of Regina
Regina, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan
University of Manitoba
Winnipeg, Manitoba
About this study
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).
Read the 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.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) Program
- Keywords
- Palliative care, End of life care, Long-term care, Nursing home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department Visits in the Resident's Last Year of Life
Measured: 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
Measured: 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
Measured: 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
Survey
Measured: 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 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.
Measured: 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 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.
Measured: 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
Qualitative interview with family members whose loved one died during the trial.
Measured: 6 weeks to 2 months after the resident's death
Resident Satisfaction with End of Life Care
Qualitative interview with residents who are enrolled in the trial
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Jun 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, Hospice Palliative Care Ontario, Canadian Hospice Palliative Care Association, Canadian Virtual Hospice, Saskatchewan Health Authority - Regina Area, Interlake-Eastern Regional Health Authority
- Responsible party
- Sponsor
- Investigators
- Sharon Kaasalainen, PhD, Principal investigator, McMaster University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935997
- Sponsor's protocol ID
- SPA-LTC408466
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2019
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 30583908Thompson 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.
PubMed 30207512Sussman 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.
PubMed 29308424Durepos 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.
PubMed 29284551Kaasalainen 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.
PubMed 29271241
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
- ClinicalTrials.gov ID
- NCT03935997
- Acronym / sponsor ID
- SPA-LTC408466
- Conditions
- Frail Elderly Syndrome
- Keywords
- Palliative care, End of life care, Long-term care, Nursing home
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Alberta Health services, Hospice Palliative Care Ontario, Canadian Hospice Palliative Care Association, Canadian Virtual Hospice, Saskatchewan Health Authority - Regina Area, Interlake-Eastern Regional Health Authority
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) ProgramWithin the intervention arm 9 long-term care homes will receive the SPA-LTC program:3 in Ontario; 3 in Saskatchewan and 3 in Manitoba. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking LTC residents with a score of 50% or less on the Palliative Performance Scale.
Key exclusion criteria (2 listed)
- Non-English speaking LTC residents
- residents with a score of more than 50% on the Palliative Performance Scale.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) ProgramOur 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. | Other | Intervention |
Primary outcome
Number of Emergency Department Visits in the Resident's Last Year of Life
Time frame: 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.
7 secondary outcomes
Family Perceptions of End of Life Care
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 weeks to 2 months after the resident's death
Resident Satisfaction with End of Life Care
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 30583908Sussman 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.
- Background: PubMed 30207512Thompson 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.
- Background: PubMed 29308424Sussman 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.
- Background: PubMed 29284551Durepos 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.
- Background: PubMed 29271241Kaasalainen 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.
- SPA-LTC webpage (housed on the Canadian Hospice Palliative Care Association website)Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Kaasalainen, PhD principal investigator
McMaster University, School of Nursing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) Program in people with Frail Elderly Syndrome, run by McMaster University at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Emergency Department Visits in the Resident's Last Year of Life (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935997, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.