Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-03 @ 10:06 PM
Study NCT ID:
NCT05488795
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Team-Based Home Blood Pressure Monitoring
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Identifying Successful Strategies for Implementing Team-Based Home Blood Pressure Monitoring in Primary Care
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TB-HBPM
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R33HL157643 | NIH | None | https://reporter.nih.gov/quic… | View |