An interventional study of Communication Intervention in Improved Communication Between Clinician and Patient, sponsored by Duke University. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Duke University · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
Investigator will compare patients randomized into the intervention group to those who receive standard of care.
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
. 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: One encounter, up to approximately 1 hour
Global Ratings of Communication as Measured by WISER (Writing, Immersive Experiences, Speaking, Ethical Communication, and Research) Assessment
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.
Time frame: One encounter, up to approximately 1 hour
| Milestone | Standard of Care - Physicians | Communication Intervention - Physicians | Standard of Care - Patients | Communication Intervention - Patients |
|---|---|---|---|---|
| Started | 20 | 20 | 120 | 120 |
| Completed | 20 | 20 | 120 | 120 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Number of Reflective Statements | Standard of Care - Patients | Communication Intervention - Patients |
|---|---|---|
| Cardiologist Behavior as Measured by WISER (Writing, Immersive Experiences, Speaking, Ethical Communication, and Research) Assessment. | 11.95 ± 8.81 | 13.15 ± 9.96 |
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.
| questions asked | Standard of Care - Patients | Communication Intervention - Patients |
|---|---|---|
| Cardiologist Behavior as Measured by WISER (Writing, Immersive Experiences, Speaking, Ethical Communication, and Research) Assessment. | 3.41 ± 2.84 | 3.28 ± 2.89 |
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.
| ratio of responses to opportunities | Standard of Care - Patients | Communication Intervention - Patients |
|---|---|---|
| Ratio of Empathic Responses to Empathic Opportunities | 0.20 ± 0.36 | 0.50 ± 0.47 |
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.
| score on a scale | Standard of Care - Patients | Communication Intervention - Patients |
|---|---|---|
| Attentiveness | 3.8 ± 0.9 | 3.8 ± 0.9 |
| Flow | 2.9 ± 1.1 | 3.3 ± 1.0 |
| Concern | 4.0 ± 0.8 | 4.2 ± 0.7 |
| Respect | 3.8 ± 1.0 | 4.0 ± 0.9 |
| Warmth | 3.5 ± 0.9 | 3.6 ± 0.8 |
Collected over One encounter, up to approximately 1 hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care (Provider) | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Communication Intervention (Provider) | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Standard of Care (Patient) | 0/120 (0%) | 0/120 (0%) | 0/120 (0%) |
| Communication Intervention (Patient) | 0/120 (0%) | 0/120 (0%) | 0/120 (0%) |
| Age, Continuous(years) | Standard of Care (Provider) | Communication Intervention (Provider) | Standard of Care (Patient) | Communication Intervention (Patient) | Total |
|---|---|---|---|---|---|
| Mean | 48 ± 9 | 46 ± 9 | 60 ± 14 | 56 ± 15 | 56.4 ± 12.4 |
| Sex: Female, Male(Participants) | Standard of Care (Provider) | Communication Intervention (Provider) | Standard of Care (Patient) | Communication Intervention (Patient) | Total |
|---|---|---|---|---|---|
| Female | 4 | 3 | 65 | 61 | 133 |
| Male | 16 | 17 | 55 | 59 | 147 |
| Ethnicity (NIH/OMB)(Participants) | Standard of Care (Provider) | Communication Intervention (Provider) | Standard of Care (Patient) | Communication Intervention (Patient) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 1 | 1 | 5 |
| Not Hispanic or Latino | 18 | 19 | 119 | 119 | 275 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Standard of Care (Provider) | Communication Intervention (Provider) | Standard of Care (Patient) | Communication Intervention (Patient) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 6 | 4 | 0 | 0 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 60 | 58 | 120 |
| White | 9 | 16 | 60 | 62 | 147 |
| More than one race | 3 | 0 | 0 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Average Number of Direct Patient Care Hours per Week(hours per week) | Standard of Care (Provider) | Communication Intervention (Provider) | Standard of Care (Patient) | Communication Intervention (Patient) | Total |
|---|---|---|---|---|---|
| Mean | 32 ± 14 | 29 ± 15 | — | — | 30 ± 15 |
| Type of visit(Participants) | Standard of Care (Provider) | Communication Intervention (Provider) | Standard of Care (Patient) | Communication Intervention (Patient) | Total |
|---|---|---|---|---|---|
| Procedural | 7 | 8 | — | — | 15 |
| Non-procedural | 13 | 12 | — | — | 25 |
| No prior communication training(Participants) | Standard of Care (Provider) | Communication Intervention (Provider) | Standard of Care (Patient) | Communication Intervention (Patient) | Total |
|---|---|---|---|---|---|
| Count of participants | 13 | 14 | — | — | 27 |
| Practice Specialty(Participants) | Standard of Care (Provider) | Communication Intervention (Provider) | Standard of Care (Patient) | Communication Intervention (Patient) | Total |
|---|---|---|---|---|---|
| General | 8 | 6 | — | — | 14 |
| Electrophysiology | 3 | 4 | — | — | 7 |
| Interventional | 4 | 3 | — | — | 7 |
| Advanced Heart Failure | 3 | 5 | — | — | 8 |
| Cardiac Imaging | 2 | 1 | — | — | 3 |
| Congenital disease | 0 | 1 | — | — | 1 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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