Team-Based Home Blood Pressure Monitoring

Hypertension Clinical Trial

— TB-HBPM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488795
• Other study ID #: RSRB 6036
• Secondary ID: R33HL157643
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 2026

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: Kevin Fiscella
• Phone: 585-324-4563
• Email: Kevin_Fiscella[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5760
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Behavioral:
• Team-Based Home Blood Pressure Monitoring
Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention

Locations

Country	Name	City	State
United States	Highland Family Medicine	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinician mean blood pressure (BP) goal (mm Hg) for patients	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	Up to 48 months participation
Other	Anti-hypertensive medication intensification	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)	Up to 48 months participation
Other	The percentage of participants who are managed by a clinical pharmacist	The percentage of HBPM participants who are managed by a clinical pharmacist based on EHR data	Up to 48 months participation
Other	Team function	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.	Up to 48 months participation
Other	Exploratory outcomes- LDL control levels	Change in LDL-cholesterol level (mg/dl) based on lipid blood testing in the EHR over 48 months.	Up to 48 months participation
Other	Exploratory outcomes- Smoking status	Change in percent of current smokers among eligible participants based on EHR documentation over 48 months.	Up to 48 months participation
Other	Exploratory outcomes- Hypertension-related Emergency department visits	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.	Up to 48 months participation
Other	Exploratory outcomes- Hypertension-related Hospitalizations	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.	Up to 48 months participation
Primary	Blood pressure control	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.	Up to 48 months participation
Secondary	Blood pressure control by race and ethnicity	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.	Up to 48 months participation
Secondary	Blood pressure control by insurance	Change in percent of participants with blood pressure controlled defined as <140/90 mm Hg by insurance (Commercial, Medicaid, Medicare, Other and None)	Up to 48 months participation
Secondary	Participation in Home Blood Pressure Monitoring (HBPM)	Percentage of participants eligible for home blood pressure monitoring (HBPM) who agree to participate in HBPM based on EHR documentation	Beginning of the intervention for the relevant wedge up to 48 months participation
Secondary	Transmission of home blood pressure readings	Percentage of participants who participate in HPBM who transmit a least 10 BP readings per month	First three months following each participant's enrollment in HBPM
Secondary	Chronic disease self-management capacity (QICA)	Change in Quality Improvement Capacity Assessment QICA scores, scale range 20-200 with higher indicating better outcomes.	Pre-intervention and six months post-intervention
Secondary	Sustained blood pressure control	Change in percent of participants with blood pressure in control (<140/90 mm Hg) post-intervention	Beginning with the 6-month intervention period and up to 48 months participation
Secondary	Cost Analysis	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	Up to 48 months participation