- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05120154
Building CAPACITI for Community-Based Palliative Care (CAPACITI)
May 2, 2024 updated by: McMaster University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
566
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre - Hamilton Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Not community-based
- Not willing to provide palliative care
- Outside of Canada
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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).
|
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.
Intervention participants will be invited to participate in facilitated online discussions.
These discussions review the online materials and share strategies for problem-solving.
|
|
Active Comparator: Control
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Up to one month post module
|
|
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.
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Up to one month post module
|
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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).
|
Up to one month post module
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CAPACITI Competencies Survey
Time Frame: Up to one month post module
|
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).
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Up to one month post module
|
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Assessment of Interprofessional Team Collaboration Scale II (AITCS II)
Time Frame: Up to one month post module
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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.
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Up to one month post module
|
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Module Session Evaluation
Time Frame: Up to one month post module
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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).
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Up to one month post module
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hsien Seow, PhD, Department of Oncology, McMaster University and Juravinski Cancer Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2021
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
March 1, 2024
Study Registration Dates
First Submitted
October 15, 2021
First Submitted That Met QC Criteria
November 2, 2021
First Posted (Actual)
November 15, 2021
Study Record Updates
Last Update Posted (Actual)
May 3, 2024
Last Update Submitted That Met QC Criteria
May 2, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 13867
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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