NCT06606470

Brief Summary

High quality, person-centered communication for those living with serious illness benefits patients, families and clinicians. Evidence shows that clinicians rarely engage patients in these, sometimes challenging, discussions. Current education programs to build health care provider competency in serious illness communication are often inconsistent in defined purpose and use of terms. This education also tends to be oriented to treatments, not a person or do not cover the full range of difficult conversations between diagnosis and delivery of end-of-life care. The ABCs program is an education intervention for health care providers that features a blended format of online modules and interactive virtual workshops, relevant to clinicians at all levels of training and practice. This study will examine the effectiveness of this training (over no training) for impacting provider competency and behavior change in serious illness communication. All participants in this study will receive the full ABCs training, but at different times. The overall intended impact of this program is to improve clinician confidence and satisfaction in having conversations with patients and families about serious illness. The ultimate goal of the ABCs program is to increase access to early palliative care by empowering more providers to initiate this care.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress79%
Sep 2024Jan 2027

First Submitted

Initial submission to the registry

September 11, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

September 23, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

September 11, 2024

Last Update Submit

January 14, 2026

Conditions

Keywords

Palliative CareEducationseriously ill communicationObserved Structured Clinical Examination (OSCE)Provider TrainingVirtual learning

Outcome Measures

Primary Outcomes (1)

  • Assessment of Clinical Encounter-Communications Tool (ACE-CT)

    The Assessment of Clinical Encounter-Communications Tool (ACE-CT) is completed by external raters of the recorded simulated practices, on a 5-point scale (1 to 5), with higher scores representing a better outcome. The ACE-CT is comprised of 14 items that were developed by the research team through a rigorous mixed methods Bayesian and Delphi process. This scale was derived from an extensive review of existing validated tools to measure quality of communication, including Communication in Oncology Questionnaire \[Com-On\], Family Meeting Communication Assessment Tool \[FaMCAT\] Comskil Coding System (CCS), Serious Illness Conversation Evaluation Exercise \[SIC-Ex\], and Gap-Kalamazoo Communication Skills Assessment Form. Item selection was based on the evidence of elements of HCP communication that are of high importance to patients and families and in which there are gaps in current experiences and practices.

    All groups: 1) From enrollment to start of Intervention Group ABCs education, 2) Post ABCs education for Intervention Group, at 4 months, 3) Post ABCs education for Control Group, at 8 months. Sample: 6 months post ABCs (14 months).

Secondary Outcomes (6)

  • Self-Efficacy Questionnaire (SE-12)

    All groups: 1) From enrollment to start of Intervention Group ABCs education, 2) Post ABCs education for Intervention Group, at 4 months, 3) Post ABCs education for Control Group, at 8 months. Sample: 6 months post ABCs (14 months).

  • End-of-life Professional Caregiver Survey (EPCS)

    All groups: 1) From enrollment to start of Intervention Group ABCs education, 2) Post ABCs education for Intervention Group, at 4 months, 3) Post ABCs education for Control Group, at 8 months. Sample: 6 months post ABCs (14 months).

  • Blended Learning Usability Evaluation - Questionnaire (BLUE-Q)

    Post ABCs education, at 4 months for Intervention Group, at 8 months for Control Group

  • Qualitative Interviews

    Post ABCs education, at 4 months for Intervention Group, at 8 months for Control Group

  • Questionnaire on Quality of Physician-Patient Interaction (QQPPI)

    All groups: 1) From enrollment to start of Intervention Group ABCs education, 2) Post ABCs education for Intervention Group, at 4 months, 3) Post ABCs education for Control Group, at 8 months. Sample: 6 months post ABCs (14 months).

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Full ABCs education program

Behavioral: All providers Better Communication Skills program' (ABCs) interprofessional provider education

Control

NO INTERVENTION

No ABCs education program

Interventions

The 'All providers: Better Communication Skills program' (ABCs) is a virtual, person-centred education curriculum for interprofessional health care providers. The ABCs program adopts a blended format (i.e., participants engage in both asynchronous online modules \[five\] and synchronous interactive workshops \[three\]) that has relevance to learners and clinicians at all levels of training and practice. The ABCs program focuses on four essential elements of being a skillful communicator: principles of effective communication, conversation structure, communication skills, and reflective practice. The program consists of virtual modules that provide any clinician with practical tools, tips, and strategies to implement when communicating with seriously ill patients and their families. Terminology is clarified and consistent, the complexities of conversations are simplified and the fundamental approach and structure can be applied to different contexts.

Intervention

Eligibility Criteria

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

You may qualify if:

  • All individuals that work in a health care provision capacity including health care professionals, care coordinators and administrators are eligible to enroll and participate in the ABCs study.

You may not qualify if:

  • Individuals, including patients, that do not work in a health care provision capacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

McMaster University

Hamilton, Ontario, Canada

RECRUITING

Related Publications (1)

  • Seow H, Arora AK, Bainbridge D, Jia Z, Steinberg L, Incardona N, Levine O, Sanders JJ, Simon J, des Ordons AR, Zhang K, Myers J. All providers Better Communication Skills (ABCs) program: protocol for a randomized controlled trial assessing communication training effectiveness with interprofessional clinicians. BMC Palliat Care. 2025 Nov 29;25(1):4. doi: 10.1186/s12904-025-01954-5.

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Hsien Seow, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsien Seow, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The study design is a prospective stepped wedge group - randomized controlled trial (SWGRT) of interprofessional health care providers (HCPs) who enroll in the ABCs program. In this trial design, half of the participants begin the study in the control condition as randomly assigned, and cross-over to the intervention condition at a pre-determined time points, so that both the intervention and control groups eventually receive the intervention. The primary comparison will be between the trial arms upon completion of a program by the initial intervention group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 23, 2024

Study Start

September 23, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Information deemed confidential.

Locations