Palliative CareCAPACITINCT05120154
Building CAPACITI for Community-Based Palliative Care
A study testing Online educational materials and Facilitated online webinars in people with Palliative Care, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this cluster randomized controlled trial is to assess the efficacy of a quality improvement intervention called CAPACITI intended to increase competency among primary care teams to deliver early palliative care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- Online educational materials and Facilitated online webinars
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each team must be comprised of primary care providers, defined as having a minimum of at least 1 of the following: family physician, nurse practitioner, or nurse and practice coordinator (including manager or administrator) that provides primary care. Teams can be a single provider. Teams can also have other team members (e.g. social worker, pharmacist, etc.).
- Each team must be community-based and willing to provide palliative care, defined as managing symptoms, addressing psychosocial needs, educating patients and families, and coordinating care.
Who cannot join
- Not community-based
- Not willing to provide palliative care
- Outside of Canada
Trial locations and contacts
1 site in 1 country.
Canada1 site
Juravinski Cancer Centre - Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
About this study
Official title: Improving Palliative Care in the Home and Community: Building CAPACITI (Community Access to Palliative Care Via Interprofessional Primary Care Teams Improvement) Cluster Randomized Controlled Trial
The purpose of this cluster randomized controlled trial is to assess the efficacy of a quality improvement intervention called CAPACITI intended to increase competency among primary care teams to deliver early palliative care. CAPACITI is palliative care training and coaching program for primary care teams, comprised of three, two-month (4 session) modules, each addressing a critical component of implementing a palliative care approach into primary care practice.
Read the detailed description
Improving access to home-based palliative care can improve patient and system outcomes; however, there is a lack of programs to build capacity among primary care teams to deliver this care. To address this gap, the investigators are offering a quality improvement intervention called CAPACITI. CAPACITI is palliative care training and coaching program for primary care teams, comprised of three, two-month (4 session) modules. Each module addresses a critical component of implementing a PC approach into primary care practice: (1) Identify and Assess; (2) Enhance Communication Skills; (3) Enhance Skills for Ongoing Care (including involvement of family and specialists). Over bi-monthly (one hour) sessions, each CAPACITI module uniquely integrates 3 components: clinical education in the form of expert advice and tips; evidence-based tools; and high-facilitation and expert coaching for adaptation to local context. The study will offer the CAPACITI modules to primary care teams across Canada. Teams that register for a module will be randomized to one of two arms: 1) facilitated learning where the module materials are covered in live webinars, and 2) non-facilitated learning where teams have access to all module materials to use a self-directed approach. The online materials for both study arms will be provided on a learning management system. The investigators will examine the difference between the facilitated and nonfacilitated approaches in teams' abilities to provide a palliative care approach in relation to the content of the module. Ultimately this research program will strengthen the primary care system and increase access to home-based palliative care for patients across Canada.
- Conditions
- Palliative Care
- Being tested
- Online educational materials, Facilitated online webinars
- Keywords
- Palliative care, CAPACITI, End of life, Primary care, Early identification
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online educational materialsOther
The CAPACITI program is comprised of three independent modules, taken separately (each constituting an intervention): (1) Identify and Assess; (2) Enhance Communication Skills; (3) Enhance Skills for Ongoing Care (including involvement of family and specialists). Each module addresses a critical component of implementing a palliative care approach into primary care practice. The CAPACITI program emphasizes practice supports in each module, integrating two components: 1) clinical education in the form of expert advice and tips, and 2) evidence-based tools with action steps.
Facilitated online webinarsBehavioural
Intervention participants will be invited to participate in facilitated online discussions. These discussions review the online materials and share strategies for problem-solving.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to all the CAPACITI module materials, provided on a learning management system. The intervention group will also receive the CAPACITI program with module facilitation, namely high-facilitation and expert coaching in the coverage of module materials in four live webinars (bimonthly for the 2 month duration of the module = 4 webinars). Receives: Other: Online educational materials; Behavioral: Facilitated online webinars |
| Control | Active comparator | Access to all the CAPACITI module materials, provided on a learning management system. The control group will not receive module facilitation (i.e., will entail self-directed learning). Receives: Other: Online educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of case load identified as requiring a palliative care approach
Measured based on self-reported i) Number of patients in caseload and number (calculated %) reported as identified as requiring a palliative care approach, ii) Typical timing of when to initiate a palliative care approach for cancer and non-cancer patients respectively.
Measured: Up to one month post module
End-of-Life Professional Caregiver Survey (EPCS)
The EPCS is a 28-item scale developed to assess palliative care-specific educational needs within an interprofessional team related to three main subdomains: Effective Care Delivery (ECD 8-items); Patient and Family-Centered Communication (PFCC 12-items); and Cultural and Ethical Values (CEV 8-items) (Lazenby, 2012). Each item is scored on a 5-point Likert scale ranging from 1 (lowest level of skill) to 5 (greatest level of skill). Items represent care-provider comfort with a variety of situations related to palliative and EOL care. The EPCS covers all eight domains of the national palliative care guidelines and core lessons of physician-specific and nurse-specific end of life education curricula in the USA. The EPCS exhibits strong internal consistency (alpha = 0.96). For the purposes of this study we will exclude the CEV sub-domain items from the EPCS.
Measured: Up to one month post module
Assignment Completion & Change Survey
This survey is a two-part, study created questionnaire based on the CAPACITI module activities. Part A is unique to each module, asking participants to indicate the extent to which they were able to complete each of the session assignments for the module. Response options are: Have not started (1), Started but not completed (2), Completed (3). Part B contains four items assessing changes in thinking, behaviour, processes, and patient/family experience, respectively. Each item is scored on a 5-point Likert scale, rating the strength of agreement with each element of change, from 1 (strongly disagree) to 5 (strongly agree).
Measured: Up to one month post module
Secondary outcomes (3)
CAPACITI Competencies Survey
The CAPACITI Competencies Survey is a study created questionnaire based on the CanMEDS framework for improving patient care by enhancing physician training and the topics covered in the CAPACITI program. CanMEDS, developed by the Royal College of Physicians, delineates critical competencies to effectively meeting the health care needs of patients, including communication, expertise, collaboration, advocacy, and commitment (cite https://www.royalcollege.ca/rcsite/canmeds/canmeds-framework-e). Each item is scored on a 7-point Likert scale ranging from 1 (lowest level of confidence) to 7 (greatest level of confidence). The Competencies Survey was developed and tested in the CAPACITI pilot study. The CAPACITI Competencies Survey exhibits strong internal consistency (alpha = 0.96).
Measured: Up to one month post module
Assessment of Interprofessional Team Collaboration Scale II (AITCS II)
The AITCS is an instrument designed to measure interprofessional collaboration among team members. The AITCS consists of 23 items considered characteristic of interprofessional collaboration (how team works and acts). Scale items represent three elements considered to be key to collaborative practice. These subscales are: Partnership (8 items), Cooperation (8 items), and Coordination (7 items). Each item is scored on a 5-point Likert scale indicating the extent to which the team exhibits each, ranging from 1 (Never) to 5 (Always). Internal consistency estimates for reliability of each subscale range from 0.80 to 0.97, with an overall reliability of 0.98.
Measured: Up to one month post module
Module Session Evaluation
Participants will be asked to complete an evaluation poll at the end of each module session, consisting of 4 items: 3 items scored on a 5-point Likert scale ranging from 1 (Not at all/ Poor/ Not successful) to 5 (Very likely/ Excellent / Extremely successful) and 1 dichotomous item assessing perceived bias (Yes/No).
Measured: Up to one month post module
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start15 Nov 2021
- Primary completion1 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsien Seow, PhD, Principal investigator, Department of Oncology, McMaster University and Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120154
- Sponsor's protocol ID
- 13867
- Acronym
- CAPACITI
- Status last verified
- May 2024
- First submitted
- 15 Oct 2021
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
Matthew M, Bainbridge D, Myers J, Levine O, Steinberg L, Incardona N, Winemaker S, Kortes-Miller K, Stajduhar K, Kilbertus F, Pereira J, Seow H. Facilitated Versus Self-Directed Educational Modalities in Palliative Care Training: A Randomized Controlled Trial of the CAPACITI Intervention. Palliat Med Rep. 2025 Jun 17;6(1):365-373. doi: 10.1089/pmr.2025.0010. eCollection 2025.
PubMed 40919547Seow H, Bainbridge D, Winemaker S, Stajduhar K, Pond G, Kortes-Miller K, Marshall D, Kilbertus F, Myers J, Steinberg L, Incardona N, Levine O, Pereira J. Increasing palliative care capacity in primary care: study protocol of a cluster randomized controlled trial of the CAPACITI training program. BMC Palliat Care. 2023 Jan 5;22(1):2. doi: 10.1186/s12904-022-01124-x.
PubMed 36604714
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Palliative Care in the Home and Community: Building CAPACITI (Community Access to Palliative Care Via Interprofessional Primary Care Teams Improvement) Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05120154
- Acronym / sponsor ID
- CAPACITI / 13867
- Conditions
- Palliative Care
- Keywords
- Palliative care, CAPACITI, End of life, Primary care, Early identification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 15 Nov 2021 (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.
The purpose of this cluster randomized controlled trial is to assess the efficacy of a quality improvement intervention called CAPACITI intended to increase competency among primary care teams to deliver early palliative care. CAPACITI is palliative care training and coaching program for primary care teams, comprised of three, two-month (4 session) modules, each addressing a critical component of implementing a palliative care approach into primary care practice.
Detailed description
Improving access to home-based palliative care can improve patient and system outcomes; however, there is a lack of programs to build capacity among primary care teams to deliver this care. To address this gap, the investigators are offering a quality improvement intervention called CAPACITI. CAPACITI is palliative care training and coaching program for primary care teams, comprised of three, two-month (4 session) modules. Each module addresses a critical component of implementing a PC approach into primary care practice: (1) Identify and Assess; (2) Enhance Communication Skills; (3) Enhance Skills for Ongoing Care (including involvement of family and specialists). Over bi-monthly (one hour) sessions, each CAPACITI module uniquely integrates 3 components: clinical education in the form of expert advice and tips; evidence-based tools; and high-facilitation and expert coaching for adaptation to local context. The study will offer the CAPACITI modules to primary care teams across Canada. Teams that register for a module will be randomized to one of two arms: 1) facilitated learning where the module materials are covered in live webinars, and 2) non-facilitated learning where teams have access to all module materials to use a self-directed approach. The online materials for both study arms will be provided on a learning management system. The investigators will examine the difference between the facilitated and nonfacilitated approaches in teams' abilities to provide a palliative care approach in relation to the content of the module. Ultimately this research program will strengthen the primary care system and increase access to home-based palliative care for patients across Canada.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Online educational materials, Behavioral: Facilitated online webinarsAccess to all the CAPACITI module materials, provided on a learning management system. The intervention group will also receive the CAPACITI program with module facilitation, namely high-facilitation and expert coaching in the coverage of module materials in four live webinars (bimonthly for the 2 month duration of the module = 4 webinars). |
| Control | Active comparator | Other: Online educational materialsAccess to all the CAPACITI module materials, provided on a learning management system. The control group will not receive module facilitation (i.e., will entail self-directed learning). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Each team must be comprised of primary care providers, defined as having a minimum of at least 1 of the following: family physician, nurse practitioner, or nurse and practice coordinator (including manager or administrator) that provides primary care. Teams can be a single provider. Teams can also have other team members (e.g. social worker, pharmacist, etc.).
- Each team must be community-based and willing to provide palliative care, defined as managing symptoms, addressing psychosocial needs, educating patients and families, and coordinating care.
Key exclusion criteria (3 listed)
- Not community-based
- Not willing to provide palliative care
- Outside of Canada
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 |
|---|---|---|
| Online educational materialsThe CAPACITI program is comprised of three independent modules, taken separately (each constituting an intervention): (1) Identify and Assess; (2) Enhance Communication Skills; (3) Enhance Skills for Ongoing Care (including involvement of family and specialists). Each module addresses a critical component of implementing a palliative care approach into primary care practice. The CAPACITI program emphasizes practice supports in each module, integrating two components: 1) clinical education in the form of expert advice and tips, and 2) evidence-based tools with action steps. | Other | Control, Intervention |
| Facilitated online webinarsIntervention participants will be invited to participate in facilitated online discussions. These discussions review the online materials and share strategies for problem-solving. | Behavioural | Intervention |
Primary outcome
Proportion of case load identified as requiring a palliative care approach
Time frame: Up to one month post module
Measured based on self-reported i) Number of patients in caseload and number (calculated %) reported as identified as requiring a palliative care approach, ii) Typical timing of when to initiate a palliative care approach for cancer and non-cancer patients respectively.
End-of-Life Professional Caregiver Survey (EPCS)
Time frame: Up to one month post module
The EPCS is a 28-item scale developed to assess palliative care-specific educational needs within an interprofessional team related to three main subdomains: Effective Care Delivery (ECD 8-items); Patient and Family-Centered Communication (PFCC 12-items); and Cultural and Ethical Values (CEV 8-items) (Lazenby, 2012). Each item is scored on a 5-point Likert scale ranging from 1 (lowest level of skill) to 5 (greatest level of skill). Items represent care-provider comfort with a variety of situations related to palliative and EOL care. The EPCS covers all eight domains of the national palliative care guidelines and core lessons of physician-specific and nurse-specific end of life education curricula in the USA. The EPCS exhibits strong internal consistency (alpha = 0.96). For the purposes of this study we will exclude the CEV sub-domain items from the EPCS.
Assignment Completion & Change Survey
Time frame: Up to one month post module
This survey is a two-part, study created questionnaire based on the CAPACITI module activities. Part A is unique to each module, asking participants to indicate the extent to which they were able to complete each of the session assignments for the module. Response options are: Have not started (1), Started but not completed (2), Completed (3). Part B contains four items assessing changes in thinking, behaviour, processes, and patient/family experience, respectively. Each item is scored on a 5-point Likert scale, rating the strength of agreement with each element of change, from 1 (strongly disagree) to 5 (strongly agree).
3 secondary outcomes
CAPACITI Competencies Survey
Time frame: Up to one month post module
Assessment of Interprofessional Team Collaboration Scale II (AITCS II)
Time frame: Up to one month post module
Module Session Evaluation
Time frame: Up to one month post module
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 40919547Matthew M, Bainbridge D, Myers J, Levine O, Steinberg L, Incardona N, Winemaker S, Kortes-Miller K, Stajduhar K, Kilbertus F, Pereira J, Seow H. Facilitated Versus Self-Directed Educational Modalities in Palliative Care Training: A Randomized Controlled Trial of the CAPACITI Intervention. Palliat Med Rep. 2025 Jun 17;6(1):365-373. doi: 10.1089/pmr.2025.0010. eCollection 2025.
- Derived from this study: PubMed 36604714Seow H, Bainbridge D, Winemaker S, Stajduhar K, Pond G, Kortes-Miller K, Marshall D, Kilbertus F, Myers J, Steinberg L, Incardona N, Levine O, Pereira J. Increasing palliative care capacity in primary care: study protocol of a cluster randomized controlled trial of the CAPACITI training program. BMC Palliat Care. 2023 Jan 5;22(1):2. doi: 10.1186/s12904-022-01124-x.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Hsien Seow, PhD principal investigator
Department of Oncology, McMaster University and Juravinski Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online educational materials and Facilitated online webinars in people with Palliative Care, run by McMaster University at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of case load identified as requiring a palliative care approach (time frame: Up to one month post module). The study lists 3 primary outcomes in all. 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 NCT05120154, which also lists 2 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 3 May 2024.