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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication Intervention | Behavioral | . 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Pollak, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States | ||
| Duke University Medical Center - Cancer Prevention, Detection and Control |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37036721 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care - Physicians | Investigator will compare patients randomized into the intervention group to those who receive standard of care. |
| FG001 | Communication Intervention - Physicians | 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: . 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. |
| FG002 | Standard of Care - Patients | Investigator will compare patients randomized into the intervention group to those who receive standard of care. |
| FG003 | Communication Intervention - Patients | 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: . 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (Provider) | Control cardiology providers. Receiving no intervention. |
| BG001 | Communication Intervention (Provider) | 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: . 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only applies to Patient groups. Data not collected on 10 participants. | Posted | Mean | Standard Deviation | Number of Reflective Statements | One encounter, up to approximately 1 hour |
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One encounter, up to approximately 1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care (Provider) | Investigator will compare patients randomized into the intervention group to those who receive standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathryn Pollak | Duke University | 919-681-4757 | kathryn.pollak@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2018 | Oct 13, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2018 | Oct 13, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2021 | Oct 19, 2022 | ICF_002.pdf |
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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.
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|
| One encounter, up to approximately 1 hour |
| Durham |
| North Carolina |
| 27710 |
| United States |
| BG002 | Standard of Care (Patient) | Patients seen by standard of care (control) cardiology providers. |
| BG003 | Communication Intervention (Patient) | Patients seen by cardiologists who received the communication coaching intervention. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Average Number of Direct Patient Care Hours per Week | Only applicable to Providers. This data was not collected for patients - not applicable. | Mean | Standard Deviation | hours per week |
|
| Type of visit | Procedural versus non-procedural | Only applicable to Providers. This data was not collected for patients - not applicable. | Count of Participants | Participants |
|
| No prior communication training | Only applicable to Providers. This data was not collected for patients - not applicable. | Count of Participants | Participants |
|
| Practice Specialty | Only applicable to Providers. This data was not collected for patients - not applicable. | Count of Participants | Participants |
|
| Years in Practice | Only applicable to Providers. This data was not collected for patients - not applicable. | Count of Participants | Participants |
|
| Patient Education | Only applicable to Patients. This data was not collected for providers - not applicable. | Count of Participants | Participants |
|
| Patient Marital Status | Married or live with partner. | Only applicable to Patients. This data was not collected for providers - not applicable. | Count of Participants | Participants |
|
| Patient Employment | Working full or part time. | Only applicable to Patients. This data was not collected for providers - not applicable. | Count of Participants | Participants |
|
| Patient Insurance | Only applicable to Patients. This data was not collected for providers - not applicable. | Count of Participants | Participants |
|
| Patient Income | Only applicable to Patients. This data was not collected for providers - not applicable. | Count of Participants | Participants |
|
| OG001 | Communication Intervention - Patients | 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. |
|
|
| Primary | 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. | Only applies to Patient groups. Data not collected on 10 participants. | Posted | Mean | Standard Deviation | questions asked | One encounter, up to approximately 1 hour |
|
|
|
| Primary | 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. | Participants with encounters in which the clinician had at least one empathic response. Only applies to Patient groups. | Posted | Mean | Standard Deviation | ratio of responses to opportunities | One encounter, up to approximately 1 hour |
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| Secondary | 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. | Only applies to Patient groups. Data not collected on 10 participants. | Posted | Mean | Standard Deviation | score on a scale | One encounter, up to approximately 1 hour |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Communication Intervention (Provider) | 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: . 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Standard of Care (Patient) | Patients seen by Standard of Care cardiologists | 0 | 120 | 0 | 120 | 0 | 120 |
| EG003 | Communication Intervention (Patient) | Patients seen by Communication Intervention cardiologists | 0 | 120 | 0 | 120 | 0 | 120 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Interventional |
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| Advanced Heart Failure |
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| Cardiac Imaging |
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| Congenital disease |
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| 6-10 Years |
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| 11-15 Years |
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| More than 15 Years |
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| Prefer not to answer |
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| You have money to pay the bills, but only because you have cut back on things |
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| You are having difficulty paying the bills, no matter what you do |
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| Prefer not to answer |
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| Missing |
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| Concern |
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| Respect |
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| Warmth |
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