Provider Skill Building for Engagement and Communication in Healthcare - Hypertension Management

NCT07147075 | Enrolling By Invitation

• 2 other identifiers: Pro00115680R34HL174728
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Doctors will first complete a questionnaire and have their patients' appointments audio-recorded.
• Then they will go through the training program.
• After finishing the program, doctors will have more patient appointments audio-recorded.
• Then the doctors will complete questionnaires again and have an interview with the study team.

Conditions

Patient-centered Care

Keywords

Clinician Training; Patient-Centered Care; Health Equity; Hypertension Management; Pilot Trial

Outcome Measures

Primary Outcomes (8)

• 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.

  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]

Secondary Outcomes (8)

• Change in diastolic blood pressure

  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

  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

  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)

  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)

  Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention

Study Arms (3)

Clinicians

EXPERIMENTAL

Doctors will complete the program over 5-6 weeks, requiring a total of 3 hours.

Other: REACH - Hypertension

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

Interventions

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).

Clinicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Doctor Cohort: Independently practicing physicians (MD, DO, PA, or NP)
• Doctor Cohort: Responsible for a panel of primary care adult patients in the Duke Primary Care clinic
• Patient Cohort: Receiving primary care from an enrolled DPC clinician at the enrolled DPC clinic
• Patient Cohort: Age at least 18 years
• Patient Cohort: Diagnosis of hypertension based on EHR ICD coding
• Patient Cohort: Able to complete a primary care encounter without an interpreter
• Patient Cohort: Able to use the study tablet for consent, data collection, and audio-recording a clinical encounter
• Patient Cohort, post-intervention: Not previously enrolled at any other timepoint
• EHR Cohort: Non-urgent patient encounters for enrolled clinicians 6 months pre intervention to 6 months post intervention completion

You may not qualify if:

• Doctor Cohort: Not an independently practicing physician (MD, DO, PA, or NP) at the enrolled Duke Primary Care clinic
• Patient Cohort: Previously enrolled at any other timepoint
• EHR Cohort: Urgent patient encounters

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke Primary Care South Durham

Durham, North Carolina, 27713, United States

Location

Study Officials

• Investigator, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Investigator, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: September 2, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)