NCT03464110

Brief Summary

The purpose of this study is to determine the effect of a clinician communication coaching intervention versus control on an objective measure of the quality of communication (primary outcome) and patients' perceptions of the quality of patient-centered care (secondary outcome), both overall and within Black and White patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

March 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 2, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

May 28, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

3.1 years

First QC Date

March 5, 2018

Results QC Date

November 9, 2022

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cardiologist Behavior as Measured by WISER (Writing, Immersive Experiences, Speaking, Ethical Communication, and Research) Assessment.

    WISER is based on established codebooks (i.e., Motivational Interviewing Treatment Integrity manual, and Suchman's codebook for patient emotion and physician empathic responses). Communication coaches taught five skills: 1) sitting down and making eye contact with all in the room, 2) open-ended questions, 3) reflective statements, 4) empathic statements, and 5) "What questions do you have?". Reported here is the number of Reflective Statements made.

    One encounter, up to approximately 1 hour

  • Cardiologist Behavior as Measured by WISER (Writing, Immersive Experiences, Speaking, Ethical Communication, and Research) Assessment.

    WISER is based on established codebooks (i.e., Motivational Interviewing Treatment Integrity manual, and Suchman's codebook for patient emotion and physician empathic responses). Communication coaches taught five skills: 1) sitting down and making eye contact with all in the room, 2) open-ended questions, 3) reflective statements, 4) empathic statements, and 5) "What questions do you have?". Reported here is the number of Open-ended Questions asked.

    One encounter, up to approximately 1 hour

  • Ratio of Empathic Responses to Empathic Opportunities

    Communication coaches taught five skills: 1) sitting down and making eye contact with all in the room, 2) open-ended questions, 3) reflective statements, 4) empathic statements, and 5) "What questions do you have?". Reported here is the ratio of empathic responses to empathic opportunities.

    One encounter, up to approximately 1 hour

Secondary Outcomes (1)

  • Global Ratings of Communication as Measured by WISER (Writing, Immersive Experiences, Speaking, Ethical Communication, and Research) Assessment

    One encounter, up to approximately 1 hour

Study Arms (2)

Standard of Care

NO INTERVENTION

Investigator will compare patients randomized into the intervention group to those who receive standard of care.

Communication Intervention

EXPERIMENTAL

The intervention will contain elements of Motivational Interviewing coaching but also will teach providers how to address patient emotion and increase the efficiency of their visits. Clinicians randomized to the intervention will receive a tailored communication coaching intervention that includes didactic elements, audio recording encounters and providing feedback, and role-playing.

Behavioral: Communication Intervention

Interventions

. The intervention will contain elements of Motivational Interviewing coaching but also will teach providers how to address patient emotion and increase the efficiency of their visits. Clinicians randomized to the intervention will receive a tailored communication coaching intervention that includes didactic elements, audio recording encounters and providing feedback, and role-playing.

Communication Intervention

Eligibility Criteria

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

You may qualify if:

  • Patients must be 18 years or older
  • Must be able to read
  • Must speak English
  • Capable of providing informed consent
  • Must be receiving continuity care from and enrolled clinician

You may not qualify if:

  • Currently hospitalized
  • Awaiting heart transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Duke University Medical Center - Cancer Prevention, Detection and Control

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Pollak KI, Olsen MK, Yang H, Prose N, Jackson LR 2nd, Pinheiro SO, Dunbar TK, Johnson KS. Effect of a Coaching Intervention to Improve Cardiologist Communication: A Randomized Clinical Trial. JAMA Intern Med. 2023 Jun 1;183(6):544-553. doi: 10.1001/jamainternmed.2023.0629.

Results Point of Contact

Title
Dr. Kathryn Pollak
Organization
Duke University

Study Officials

  • Kathryn Pollak, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Interventional: To determine the effect of a clinician communication coaching intervention versus control on an objective measure of the quality of communication (primary outcome) and patients' perceptions of the quality of patient-centered care (secondary outcome), both overall and within Black and White patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 13, 2018

Study Start

October 2, 2018

Primary Completion

November 12, 2021

Study Completion

November 15, 2021

Last Updated

May 28, 2024

Results First Posted

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations