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Active, Not Recruiting

NCT Number: NCT05488795

Team-Based Home Blood Pressure Monitoring

The overall goal of this study is to identify and rigorously evaluate strategies for implementing and sustaining team-based home blood pressure monitoring (TB-HBPM) within primary care.

The TB-HBPM intervention is a multifaceted program involving patient transmission of blood readings to EHR and clinical decision support. Implementation strategies include group-based education on hypertension measurement, target blood pressure goals, drug and lifestyle management, referral to community resources, and team training designed to optimize the coordination of hypertension care, and monthly audit and feedback reports to teams and clinicians.

Hypertension control rates are suboptimal in many primary care practices with persistent racial disparities in control. Team-based home blood pressure monitoring (TB-HPBM) involving patient transmission of their home blood pressure readings in real-time to their clinical team has been shown to improve blood pressure control. There is an urgent need to implement TB-HBPM into practice. The overall objective of this research is to assess implementation strategies that mitigate barriers and leverage facilitators to TB-HBHM on hypertension control and disparities between Black and White patients. The study team and investigators will use mixed methods to assess the process and generate knowledge to facilitate broader uptake of TB-HBPM.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Highland Family Medicine

Rochester, New York, 14620, United States

About this study

Aim 2: Deploy theorized implementation strategies using a type-2 hybrid stepped-wedge randomized cluster trial The department of family medicine will roll out the clinical intervention (TBHBPM).

To improve rigor in evaluation, the study biostatistician will use computer-generated numbers to randomly assign each of the eight suites to when they will begin the intervention during one of three wedges (Figure 1). The study team and investigators will randomize two suites in the first wedge and three each to the second and third wedge.

Aim 3: Assess the impact of implementation strategies using specific metrics based on RE-AIM

Aim 4: Test theoretical assumptions underlying the implementation strategies

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

ELIGIBILITY CRITERIA

Clinicians and Staff Eligibility Criteria Practice employees (practice leaders, administrators, clinicians, or staff) that work with hypertensive patients during the study period (scheduling appointments, coordinating care, measuring blood pressure, responding to questions, and/or treating their blood pressure)

Patient Inclusion Criteria

  • Current HFM patient 18-85 years of age with hypertension diagnosis
  • Diagnosis of hypertension based on ICD-10 codes of I10-I14
  • at least one HFM health visit and hypertension diagnosis beginning no later than 7/1/2021.

Patient Exclusion Criteria

  • Not current patient in the participating practices
  • Diagnosis of dementia, end-stage renal disease, and/or in hospice
  • Currently pregnant

Treatment and study plan

Team-Based Home Blood Pressure Monitoring

Behavioral

Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention

Primary outcomes

  1. Blood pressure control

    Time frame: Up to 48 months participation

    Change in percent of participants whose BP is controlled (defined as <140/90 mm Hg) among all eligible patients diagnosed with hypertension based on the last BP reading during the control period and the last BP reading during the follow-up period.

Secondary outcomes

  1. Blood pressure control by race and ethnicity

    Time frame: Up to 48 months participation

    Change in percent of participants with blood pressure controlled defined as <140/90 mm Hg by race/ethnicity: among eligible Non-Hispanic White patients, non-Hispanic Black patients, and Hispanic patients.

  2. Blood pressure control by insurance

    Time frame: Up to 48 months participation

    Change in percent of participants with blood pressure controlled defined as <140/90 mm Hg by insurance (Commercial, Medicaid, Medicare, Other and None)

  3. Participation in Home Blood Pressure Monitoring (HBPM)

    Time frame: Beginning of the intervention for the relevant wedge up to 48 months participation

    Percentage of participants eligible for home blood pressure monitoring (HBPM) who agree to participate in HBPM based on EHR documentation

  4. Transmission of home blood pressure readings

    Time frame: First three months following each participant's enrollment in HBPM

    Percentage of participants who participate in HPBM who transmit a least 10 BP readings per month

  5. Chronic disease self-management capacity (QICA)

    Time frame: Pre-intervention and six months post-intervention

    Change in Quality Improvement Capacity Assessment QICA scores, scale range 20-200 with higher indicating better outcomes.

  6. Sustained blood pressure control

    Time frame: Beginning with the 6-month intervention period and up to 48 months participation

    Change in percent of participants with blood pressure in control (<140/90 mm Hg) post-intervention

  7. Cost Analysis

    Time frame: Up to 48 months participation

    Marginal changes in net revenue (marginal billing and bonus revenue) and marginal changes in costs related to time for training, staffing costs, and BP monitor

Other outcomes

  1. Clinician mean blood pressure (BP) goal (mm Hg) for patients

    Time frame: Up to 48 months participation

    We will calculate the mean BP goal for each clinician based on the specified BP goal listed in EHR smartphrase for each of the clinician's patients. The mean goal is calculated by the sum of all systolic (SBP) and diastolic BP (DBP) goals divided by the number of patients with goals for each participating clinician. A reasonable range of mean BP goals are: SBP: 120-150 mm Hg and DBP: 80-100 mm Hg for different clinicians

  2. Anti-hypertensive medication intensification

    Time frame: Up to 48 months participation

    Frequency of anti-hypertensive medication intensification (e.g., the number of additions/deletions of anti-hypertensive medication and/or number of changes in dose of anti-hypertensive medication)

  3. The percentage of participants who are managed by a clinical pharmacist

    Time frame: Up to 48 months participation

    The percentage of HBPM participants who are managed by a clinical pharmacist based on EHR data

  4. Team function

    Time frame: Up to 48 months participation

    Change in team function score based on the score on the TEAMS Tool scale at pre-intervention and post-intervention periods for that wedge. Scale range 14-70 with higher scores indicating better outcomes.

  5. Exploratory outcomes- LDL control levels

    Time frame: Up to 48 months participation

    Change in LDL-cholesterol level (mg/dl) based on lipid blood testing in the EHR over 48 months.

  6. Exploratory outcomes- Smoking status

    Time frame: Up to 48 months participation

    Change in percent of current smokers among eligible participants based on EHR documentation over 48 months.

  7. Exploratory outcomes- Hypertension-related Emergency department visits

    Time frame: Up to 48 months participation

    Change in emergency department visits (number) involving a primary diagnosis of hypertension diagnosis among eligible patients recorded on the emergency department discharge summary from the EHR over 48 months.

  8. Exploratory outcomes- Hypertension-related Hospitalizations

    Time frame: Up to 48 months participation

    Change in hospitalization (number) involving a primary diagnosis of hypertension diagnosis among eligible patients recorded on the hospital discharge summary from the EHR over 48 months.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Identifying Successful Strategies for Implementing Team-Based Home Blood Pressure Monitoring in Primary Care

Acronym: TB-HBPM

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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