跳至主要内容
临床试验/NCT07147075
NCT07147075Enrolling By Invitation不适用

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

Duke University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年9月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
180
试验地点
1
主要终点
Feasibility of the intervention as measured by Clinician enrollment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Clinicians

Experimental

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

干预措施: REACH - Hypertension (Other)

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

结局指标

主要结局

Feasibility of the intervention as measured by Clinician enrollment

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

Feasibility of the intervention as measured by Patient enrollment

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

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

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.

Change in systolic blood pressure

时间窗: 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]

A lower (mean) systolic blood pressure may suggest the intervention was effective.

次要结局

  • 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)
  • Change in partnering behaviors as measured by Roter interaction analysis system (RIAS)(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)(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)(Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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