Identifying Successful Strategies for Implementing Team-Based Home Blood Pressure Monitoring in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,760
- 试验地点
- 1
- 主要终点
- Blood pressure control
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/
排除标准
- •Not current patient in the participating practices
- •Diagnosis of dementia, end-stage renal disease, and/or in hospice
- •Currently pregnant
结局指标
主要结局
Blood pressure control
时间窗: 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.
次要结局
- Participation in Home Blood Pressure Monitoring (HBPM)(Beginning of the intervention for the relevant wedge up to 48 months participation)
- Blood pressure control by race and ethnicity(Up to 48 months participation)
- Blood pressure control by insurance(Up to 48 months participation)
- Chronic disease self-management capacity (QICA)(Pre-intervention and six months post-intervention)
- Sustained blood pressure control(Beginning with the 6-month intervention period and up to 48 months participation)
- Transmission of home blood pressure readings(First three months following each participant's enrollment in HBPM)
- Cost Analysis(Up to 48 months participation)
研究者
Kevin Fiscella
Professor, Family Medicine
University of Rochester