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Team-Based Home Blood Pressure Monitoring (TB-HBPM)

Primary Purpose

High Blood Pressure, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Team-Based Home Blood Pressure Monitoring
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for High Blood Pressure focused on measuring Home blood pressure monitoring, Hypertension control, Primary Care Teams, Implementation Research, Health Equity, Clinical Trial

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HFM employee (practice leaders, administrators, clinicians, or staff) that works with hypertensive patients during the study period (scheduling appointments, coordinating care, measuring blood pressure, responding to questions, and/or treating their blood pressure)
  • 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.

Exclusion Criteria:

  • <18 years of age
  • >85 years of age
  • Not current HFM patient
  • No hypertension diagnosis
  • HFM patients with co-morbidities
  • HFM patients with dementia, end-stage renal disease, and/or in hospice
  • Pregnant patients

Sites / Locations

  • Highland Family MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Suite TB-HBPM pre intervention

Suite TB-HBPM throughout intervention implementation

Suite TB-HBPM post intervention implementation

Arm Description

Each suite/cluster throughout the institution will begin in the baseline usual care phase in the first year.

Each suite will be randomized to implement the TB-HBPM program during one of three wedges separated by six months between each, 1.5 years later.

Post implementation phase of the suites 2 years after introduction of intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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
Transmission of home blood pressure readings
Percentage of participants who participate in HPBM who transmit a least 10 BP readings per month
Chronic disease self-management capacity (QICA)
Change in Quality Improvement Capacity Assessment QICA scores, scale range 20-200 with higher indicating better outcomes.
Sustained blood pressure control
Change in percent of participants with blood pressure in control (<140/90 mm Hg) post-intervention
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

Full Information

First Posted
July 6, 2022
Last Updated
July 20, 2023
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05488795
Brief Title
Team-Based Home Blood Pressure Monitoring
Acronym
TB-HBPM
Official Title
Identifying Successful Strategies for Implementing Team-Based Home Blood Pressure Monitoring in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure, Hypertension
Keywords
Home blood pressure monitoring, Hypertension control, Primary Care Teams, Implementation Research, Health Equity, Clinical Trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped Wedge Cluster Randomized Design. Each practice suite represents a cluster. All eight suites begin in the control group and then cross over (one-way) to the intervention group at one of three randomly assigned time periods, ensuring that all suites eventually receive implementation of TB-HBPM.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suite TB-HBPM pre intervention
Arm Type
Other
Arm Description
Each suite/cluster throughout the institution will begin in the baseline usual care phase in the first year.
Arm Title
Suite TB-HBPM throughout intervention implementation
Arm Type
Other
Arm Description
Each suite will be randomized to implement the TB-HBPM program during one of three wedges separated by six months between each, 1.5 years later.
Arm Title
Suite TB-HBPM post intervention implementation
Arm Type
Other
Arm Description
Post implementation phase of the suites 2 years after introduction of intervention.
Intervention Type
Behavioral
Intervention Name(s)
Team-Based Home Blood Pressure Monitoring
Intervention Description
Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention
Primary Outcome Measure Information:
Title
Blood pressure control
Description
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.
Time Frame
Up to 48 months participation
Secondary Outcome Measure Information:
Title
Blood pressure control by race and ethnicity
Description
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.
Time Frame
Up to 48 months participation
Title
Blood pressure control by insurance
Description
Change in percent of participants with blood pressure controlled defined as <140/90 mm Hg by insurance (Commercial, Medicaid, Medicare, Other and None)
Time Frame
Up to 48 months participation
Title
Participation in Home Blood Pressure Monitoring (HBPM)
Description
Percentage of participants eligible for home blood pressure monitoring (HBPM) who agree to participate in HBPM based on EHR documentation
Time Frame
Beginning of the intervention for the relevant wedge up to 48 months participation
Title
Transmission of home blood pressure readings
Description
Percentage of participants who participate in HPBM who transmit a least 10 BP readings per month
Time Frame
First three months following each participant's enrollment in HBPM
Title
Chronic disease self-management capacity (QICA)
Description
Change in Quality Improvement Capacity Assessment QICA scores, scale range 20-200 with higher indicating better outcomes.
Time Frame
Pre-intervention and six months post-intervention
Title
Sustained blood pressure control
Description
Change in percent of participants with blood pressure in control (<140/90 mm Hg) post-intervention
Time Frame
Beginning with the 6-month intervention period and up to 48 months participation
Title
Cost Analysis
Description
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
Time Frame
Up to 48 months participation
Other Pre-specified Outcome Measures:
Title
Clinician mean blood pressure (BP) goal (mm Hg) for patients
Description
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
Time Frame
Up to 48 months participation
Title
Anti-hypertensive medication intensification
Description
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)
Time Frame
Up to 48 months participation
Title
The percentage of participants who are managed by a clinical pharmacist
Description
The percentage of HBPM participants who are managed by a clinical pharmacist based on EHR data
Time Frame
Up to 48 months participation
Title
Team function
Description
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.
Time Frame
Up to 48 months participation
Title
Exploratory outcomes- LDL control levels
Description
Change in LDL-cholesterol level (mg/dl) based on lipid blood testing in the EHR over 48 months.
Time Frame
Up to 48 months participation
Title
Exploratory outcomes- Smoking status
Description
Change in percent of current smokers among eligible participants based on EHR documentation over 48 months.
Time Frame
Up to 48 months participation
Title
Exploratory outcomes- Hypertension-related Emergency department visits
Description
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.
Time Frame
Up to 48 months participation
Title
Exploratory outcomes- Hypertension-related Hospitalizations
Description
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.
Time Frame
Up to 48 months participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Fiscella
Phone
585-324-4563
Email
Kevin_Fiscella@urmc.rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Strujo
Phone
585-324-4553
Email
Emma_Strujo@urmc.rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Fiscella, MD, MPH
Organizational Affiliation
URMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Highland Family Medicine
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Maguire, MD
Phone
585-279-4800
Email
jennifer_maguire@urmc.rochester.eduU

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data Quality and Management a. Description of Plan for Data Quality and Management - The PI will review all data collection forms on an ongoing basis for data completeness and accuracy as well as protocol compliance. A statement reflecting the results of the review will be sent to the NIH in the annual report. The EHR is the primary data source. EHR data quality will be assessed using extreme outlier data, missing data for outcome variables (i.e. office or transmitted blood pressure readings, dates of visits, participant ID), and loss to follow-up (no data for the participant appears in EHR, e.g. due to relocation, left practice etc). Note: clinical staff will conduct outreach to all participants as part of sound clinical practice. Regular data checks and data cleaning will be deployed to optimize data quality. Multiple imputation methods will be used as necessary to address missing data as described in the statistical analysis.
IPD Sharing Time Frame
No personally identifiable information will be transcribed. The de-identified data will be stored in a password-protected file on a secure URMC shared drive housed in the Department of Family Medicine. Only the research team will have access to the de-identified data. 7 years after the completion of the study, the audio recordings will destroyed.
IPD Sharing URL
https://www.rochester.edu/orpa/

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Team-Based Home Blood Pressure Monitoring

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