Improved Communication Between Clinician and PatientNCT03464110
Communication Coaching to Improve Patient and Clinician Satisfaction in Cardiology Encounters
A study testing Communication Intervention in people with Improved Communication Between Clinician and Patient, run by Duke University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Improved Communication Between Clinician and Patient
- What is being tested?
- Communication Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Oct 2018to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently hospitalized
- Awaiting heart transplant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27705
Duke University Medical Center - Cancer Prevention, Detection and Control
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Being tested
- Communication Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionBehavioural
. 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Communication Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: One encounter, up to approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start2 Oct 2018
- Primary completion12 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Improved Communication Between Clinician and PatientStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Pollak, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464110
- Sponsor's protocol ID
- Pro00091691
- Status last verified
- May 2024
- First submitted
- 5 Mar 2018
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37036721
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Coaching to Improve Patient and Clinician Satisfaction in Cardiology Encounters
- ClinicalTrials.gov ID
- NCT03464110
- Acronym / sponsor ID
- Pro00091691
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Posted 28 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Investigator will compare patients randomized into the intervention group to those who receive standard of care. |
| Communication Intervention | Experimental | Behavioral: Communication InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Currently hospitalized
- Awaiting heart transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Communication Intervention |
Primary outcome
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.
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.
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37036721Pollak 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Pollak, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Intervention in people with Improved Communication Between Clinician and Patient, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiologist Behavior as Measured by WISER (Writing, Immersive Experiences, Speaking, Ethical Communication, and Research) Assessment. (time frame: One encounter, up to approximately 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03464110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.