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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL174728 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Brief Summary:
The study has three main goals: The first goal is to make a skills training program that improves how doctors talk with, listen to, and work with patients. The second goal is to make sure the process of collecting data and completing the program can be done. The third goal is to make sure the skills training program is feasible and acceptable for doctors.
Study Activities:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinicians | Experimental | Doctors will complete the program over 5-6 weeks, requiring a total of 3 hours. |
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| Patients | No Intervention | Enrolled patients will be asked to audio-record their clinical encounter with their enrolled primary care provider and complete two surveys. No intervention will be administered to the enrolled patients. | |
| EHR (Electronic Health Record) Cohort | No Intervention | EHR data will be collected on all patients of enrolled doctors. These patients will not consent, and no Intervention will be administered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH - Hypertension | Other | The intervention is a skills training program for doctors that includes 3 self-paced on-line learning modules and 3 coaching sessions (one in-person and 2 virtual). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention as measured by Clinician enrollment | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention | |
| Feasibility of the intervention as measured by Patient enrollment | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention | |
| Feasibility of the intervention as measured by number of participants with completion of analyzable audio-recorded encounters | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention | |
| Feasibility of the intervention as measured by the number of participants with intervention completion | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention | |
| Feasibility of the intervention as measured by the number of participants with survey completion | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention | |
| Feasibility of the intervention as measured by the number of participants with usable electronic health record (EHR) data | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention | |
| Change in patient-centeredness as measured by Roter interaction analysis system (RIAS) | Primary outcome for audio-recorded clinical encounters, the primary outcome is change in patient-centeredness, which includes behaviors like exploring the patient's perspective, showing empathy, and involving the patient in decision-making. This measure will be assessed using the Roter interaction analysis system (RIAS), a method for coding medical dialogue. The system codes each utterance (the smallest meaningful unit of speech) into one of approximately 40 categories related to task-focused or socioemotional communication. The scores derived are typically percentages or frequencies of specific communication behaviors within a given interaction (e.g., percentage of doctor talk, patient questions, or empathetic statements). A higher score is generally associated with more patient-centered communication. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in diastolic blood pressure | A lower (mean) diastolic blood pressure may suggest the intervention was effective. | Baseline - [spanning 6 months pre-intervention for all patients of the enrolled clinicians] to end point - [spanning 6 months post-intervention for all patients of the enrolled clinicians] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Investigator, PhD | Duke University | Principal Investigator |
| Investigator, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Primary Care South Durham | Durham | North Carolina | 27713 | United States |
Individual Particpant Data (IPD) will not be shared
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Patient | Mar 14, 2025 | Aug 13, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Clinician | Apr 23, 2025 | Aug 13, 2025 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: 3rd party | Mar 14, 2025 | Aug 13, 2025 | ICF_002.pdf |
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| Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention |
| Change in systolic blood pressure | A lower (mean) systolic blood pressure may suggest the intervention was effective. | Baseline - [spanning 6 months pre-intervention for all patients of the enrolled clinicians] to end point - [spanning 6 months post-intervention for all patients of the enrolled clinicians] |
| Change in hypertension control as defined by Healthcare Effectiveness Data and Information Set (HEDIS) criteria |
Secondary Outcomes for EHR data is hypertension control defined by Healthcare Effectiveness Data and Information Set (HEDIS) criteria. HEDIS criteria are grouped into six domains: Effectiveness of Care, Access/Availability of Care, Experience of Care, Utilization and Risk Adjusted Utilization, Health Plan Descriptive Information, and Measures Reported Using Electronic Clinical Data Systems. HEDIS measures are used to evaluate performance on important dimensions of care and service, and are crucial for quality improvement and value-based care initiatives. A high score may suggest the intervention was effective. |
| Baseline - [spanning 6 months pre-intervention for all patients of the enrolled clinicians] to end point - [spanning 6 months post-intervention for all patients of the enrolled clinicians]. |
| Change in treatment intensification | Secondary Outcome for EHR data is treatment intensification (a measure of therapeutic inertia). These scores are calculated by comparing observed medication changes with expected changes, often based on clinical guidelines or individual patient needs. These scores range from -1 to +1. A score of 0 indicates perfect responsiveness to treatment goals, while -1 represents complete neglect, and +1 suggests excessive aggression in treatment adjustments. | Baseline - [spanning 6 months pre-intervention for all patients of the enrolled clinicians] to end point - [spanning 6 months post-intervention for all patients of the enrolled clinicians] |
| Change in verbal dominance as measured by Roter interaction analysis system (RIAS) | Secondary outcome for audio-recorded encounters is verbal dominance. This measure will be assessed using the Roter interaction analysis system (RIAS), a method for coding medical dialogue. The scores derived are typically percentages or frequencies of specific communication behaviors within a given interaction. The RIAS defines verbal dominance as a reflection of the patient's overall participation in the consultation, measured by their total speech time in relation to the physician's speech time. Greater change scores may suggest the intervention was effective. | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention |
| Change in story questions as measured by Roter interaction analysis system (RIAS) | Secondary outcome for audio-recorded encounters is story questions (lifestyle and psychosocial topics queried by the clinician). This measure will be assessed using the Roter interaction analysis system (RIAS), a method for coding medical dialogue. The scores derived are typically percentages or frequencies of specific communication behaviors within a given interaction. Greater change scores may suggest the intervention was effective. | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention |
| Change in partnering behaviors as measured by Roter interaction analysis system (RIAS) | Secondary outcome for audio-recorded encounters is partnering behaviors such as fostering active participation and collaboration with patients. This measure will be assessed using the Roter interaction analysis system (RIAS), a method for coding medical dialogue. The scores derived are typically percentages or frequencies of specific communication behaviors within a given interaction. Greater change scores may suggest the intervention was effective. | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention |
| Change in emotional statements as measured by Roter interaction analysis system (RIAS) | Secondary outcome for audio-recorded encounters is emotional statements. These measure will be assessed using the Roter interaction analysis system (RIAS), a method for coding medical dialogue. The scores derived are typically percentages or frequencies of specific communication behaviors within a given interaction. Greater change scores may suggest the intervention was effective. | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention |
| Change in encounter duration as measured by Roter interaction analysis system (RIAS) | Secondary outcome for audio-recorded encounters is encounter duration. This measure will be assessed by the length of the recorded dialogue of the Roter interaction analysis system (RIAS), a method for coding medical dialogue. Longer recorded encounters may suggest the interventon was effective. | Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention |