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Enrolling by invitation NCT07147075

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

No phase Interventional Patient-centered Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REACH - Hypertension.
Who it may be relevant to
Registry conditions: Patient-centered Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other REACH - Hypertension
    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).

Primary outcome measures

  • Feasibility of the intervention as measured by Clinician enrollment [Time frame: Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention]
  • Feasibility of the intervention as measured by Patient enrollment [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention]
  • Change in systolic blood pressure [Time frame: 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 outcome measures (8)
  • Change in diastolic blood pressure [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Duke Primary Care South Durham — Durham

Identifiers

NCT: NCT07147075 · Pro00115680 · R34HL174728

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗