- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03464110
Communication Coaching to Improve Patient and Clinician Satisfaction in Cardiology Encounters
May 3, 2024 updated by: Duke University
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The investigators propose a two-arm cluster randomized controlled design, in which the unit of randomization is the clinician.
Up to fifty cardiology clinicians will be randomly assigned to either the coaching intervention or to a control condition.
The investigators will recruit up to 50 clinicians to ensure that we have at least 40 clinicians with complete pre- and post-intervention measures.
Although the unit of randomization is the clinician, the unit of evaluation is the patient: 10 patients per clinician who get cardiology care from the enrolled clinicians will consent to audio-recording of their encounters and to completing the surveys.
Clinicians randomized to the intervention will obtain verbal consent from additional patients to audio-record the encounter for coaching.
The intervention will be delivered in the clinic or via video-conference (Skype or Facetime), providing individual coaching and professional feedback on the communication behaviors encounters.
The investigators will also measure Press Ganey scores by clinician pre- and post-intervention.
Study Type
Interventional
Enrollment (Actual)
280
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
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Durham, North Carolina, United States, 27710
- Duke University Medical Center - Cancer Prevention, Detection and Control
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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:
- 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
Exclusion Criteria:
- Currently hospitalized
- Awaiting heart transplant
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of Care
Investigator will compare patients randomized into the intervention group to those who receive standard of care.
|
|
|
Experimental: Communication Intervention
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.
|
. 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiologist Behavior as Measured by WISER (Writing, Immersive Experiences, Speaking, Ethical Communication, and Research) Assessment.
Time Frame: One encounter, up to approximately 1 hour
|
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.
Time Frame: One encounter, up to approximately 1 hour
|
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
Time Frame: One encounter, up to approximately 1 hour
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Ratings of Communication as Measured by WISER (Writing, Immersive Experiences, Speaking, Ethical Communication, and Research) Assessment
Time Frame: One encounter, up to approximately 1 hour
|
Global ratings represent areas of effective communication that address many domains of patient-centered communication or areas that facilitate patient satisfaction with communication.
WISER is based on established codebooks (i.e., Motivational Interviewing Treatment Integrity manual, and Suchman's codebook for patient emotion and physician empathic responses.
Scores of 1-5 with 3 being average, 1 being below average, 5 being above average.
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One encounter, up to approximately 1 hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathryn Pollak, PhD, Duke University
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)
October 2, 2018
Primary Completion (Actual)
November 12, 2021
Study Completion (Actual)
November 15, 2021
Study Registration Dates
First Submitted
March 5, 2018
First Submitted That Met QC Criteria
March 12, 2018
First Posted (Actual)
March 13, 2018
Study Record Updates
Last Update Posted (Actual)
May 28, 2024
Last Update Submitted That Met QC Criteria
May 3, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Pro00091691
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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