ClinicalTrials.gg
CompletedNCT05120154CAPACITIUpdated May 3, 2024

Building CAPACITI for Community-Based Palliative Care

An interventional study of Online educational materials and Facilitated online webinars in Palliative Care, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by McMaster University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
566
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Palliative Care

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Keywords

  • Palliative care
  • CAPACITI
  • End of life
  • Primary care
  • Early identification
03

In context

Death

583 studies on the registry are indexed under Death; 109 are open to participants now.

This study's enrollment of 566 is above the median of 131 across 267 interventional studies indexed under Death.

Browse Death studies →

Lead sponsor

McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Not community-based
  • Not willing to provide palliative care
  • Outside of Canada
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
566 participants (actual)

Study arms

  • 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).

    Other: Online educational materials · Behavioral: Facilitated online webinars

  • 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).

    Other: Online educational materials

Interventions

  • OtherOnline educational materials

    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.

  • BehavioralFacilitated online webinars

    Intervention participants will be invited to participate in facilitated online discussions. These discussions review the online materials and share strategies for problem-solving.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to one month post module

  2. 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.

    Time frame: Up to one month post module

  3. 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).

    Time frame: Up to one month post module

Secondary outcomes

  1. 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).

    Time frame: Up to one month post module

  2. 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.

    Time frame: Up to one month post module

  3. 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).

    Time frame: Up to one month post module

07

Study locations

1 site
  • Juravinski Cancer Centre - Hamilton Health Sciences
    Hamilton, Ontario L8V 5C2, Canada
08

References and documents

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 40919547 ↗
  • Seow 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 documents

  • Protocol and statistical analysis plan · Jul 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — No plan to share IPD

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Dec 2023, 24 months.

Of 133 non-industry interventional studies with no phase under Death, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 24 months is close to that.

Counting every sponsor, half of 138 studies reached it within 25 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2021
First posted
Nov 15, 2021
StartActual
Nov 15, 2021
Primary completionActual
Dec 1, 2023
CompletionActual
Mar 1, 2024
Last update
May 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05120154
Responsible party
Sponsor
First posted
Nov 15, 2021
Start date
Nov 15, 2021
Primary completion
Dec 1, 2023
Completion
Mar 1, 2024
Last update
May 3, 2024

Study contacts

Hsien Seow, PhD
principal investigator · Department of Oncology, McMaster University and Juravinski Cancer Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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