NCT05120154

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

October 15, 2021

Last Update Submit

May 2, 2024

Conditions

Keywords

Palliative careCAPACITIEnd of lifePrimary careEarly identification

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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).

    Up to one month post module

Secondary Outcomes (3)

  • CAPACITI Competencies Survey

    Up to one month post module

  • Assessment of Interprofessional Team Collaboration Scale II (AITCS II)

    Up to one month post module

  • Module Session Evaluation

    Up to one month post module

Study Arms (2)

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).

Other: Online educational materialsBehavioral: 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).

Other: Online educational materials

Interventions

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.

ControlIntervention

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juravinski Cancer Centre - Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hsien Seow, PhD

    Department of Oncology, McMaster University and Juravinski Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2021

First Posted

November 15, 2021

Study Start

November 15, 2021

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations