Patient-centered CareREACH - HTNNCT07147075
Provider Skill Building for Engagement and Communication in Healthcare - Hypertension Management
A study testing REACH - Hypertension in people with Patient-centered Care, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient-centered Care
- What is being tested?
- REACH - Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke Primary Care South Durham
Durham, North Carolina, 27713
About this study
Official title: Provider Skill Building for Engagement and Communication in Healthcare - Hypertension Management (REACH - Hypertension)
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.
Read more
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
- Being tested
- REACH - Hypertension
- Keywords
- Clinician Training, Patient-Centered Care, Health Equity, Hypertension Management, Pilot Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACH - HypertensionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Clinicians | Experimental | Doctors will complete the program over 5-6 weeks, requiring a total of 3 hours. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention as measured by Clinician enrollment
Measured: Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention
Feasibility of the intervention as measured by Patient enrollment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
A lower (mean) diastolic blood pressure may suggest the intervention was effective.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention), within 6 weeks post-intervention, and 12-16 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start2 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient-centered CareStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Investigator, PhD, Principal investigator, Duke UniversityInvestigator, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147075
- Sponsor's protocol ID
- Pro00115680
- Other IDs
- R34HL174728
- Acronym
- REACH - HTN
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Particpant Data (IPD) will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider Skill Building for Engagement and Communication in Healthcare - Hypertension Management (REACH - Hypertension)
- ClinicalTrials.gov ID
- NCT07147075
- Acronym / sponsor ID
- REACH - HTN / Pro00115680
- Conditions
- Patient-centered Care
- Keywords
- Clinician Training, Patient-Centered Care, Health Equity, Hypertension Management, Pilot Trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinicians | Experimental | Other: REACH - HypertensionDoctors will complete the program over 5-6 weeks, requiring a total of 3 hours. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| REACH - HypertensionThe 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). | Other | Clinicians |
Primary outcome
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
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
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]
A lower (mean) systolic blood pressure may suggest the intervention was effective.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. Individual Particpant Data (IPD) will not be shared
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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.
Investigator, PhD principal investigator
Duke University
Investigator, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACH - Hypertension in people with Patient-centered Care, run by Duke University at 1 site 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 9 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026.