Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16,895
- 试验地点
- 14
- 主要终点
- Systolic blood pressure (SBP) improvement
研究概览
简要总结
High blood pressure (BP) or hypertension (HTN) affects over 100 million individuals in the US, increasing the risk of adverse outcomes, including stroke, myocardial infarction (MI), and chronic kidney disease (CKD). Effective therapies include non-pharmacologic approaches and multiple medication classes. Successful HTN management requires ongoing patient engagement for BP monitoring and treatment intensification. Reaching this goal is challenging, and many patients with HTN do not have controlled BP.
Using a collaborative partnership between patients, clinicians, health system and public health stakeholders, and the research team the investigators plan to overcome barriers to widespread implementation of evidence-based health system strategies to improve BP control in a large, urban, primary care-based safety-net setting for diverse populations experiencing disparities in HTN-related outcomes.
详细描述
A hybrid type 1 effectiveness-implementation study will be implemented to evaluate the comparative impact of each intervention on clinical outcomes while also assessing implementation at each site. The multi-site cluster randomized stepped-wedge design allows for feasible resource allocation and sequential roll out of the interventions for comparison, ensuring each site has the opportunity to benefit from both approaches. Data will be collected for multiple patient reported outcomes (PROs) to understand the range of impacts of the interventions from the patient perspective.
The specific aims are to:
- Assess comparative effectiveness of remote BP monitoring (RBPM) versus RBPM + multilevel intensification intervention (MII) on HTN control and quality of care. Prior research has demonstrated the effectiveness of each of these interventions yet the optimal approach to achieve equity in HTN control in safety net practices remains unknown.
- Use mixed methods, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, to assess implementation of the two comparators as measured by reach, adoption, implementation (fidelity) and maintenance. Using a convergent parallel design, the investigators will use concurrent quantitative and qualitative data to obtain perspectives across multiple levels to understand the reasons for success or failure of implementation of each comparator. By merging these data, integration can be achieved by using qualitative themes related to implementation to support or refute quantitative findings of reach and fidelity.
- Evaluate the comparative impacts of each intervention on PROs assessed with validated measures of patient activation, medication adherence, and trust in medical settings. The study intervention approaches were informed by direct feedback from the targeted diverse patients and clinical providers to address patient-reported barriers to HTN control: lack of activation, adherence to medications, and trust in their care providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age>18) patients receiving primary care at one of the 9 participating sites, with primary care provider (PCP) visit in the preceding year
- •Presence of HTN defined by one or more of: 1) diagnosis included on active problem list, 2) active HTN medications in prior year, 3) 3 separate elevated BP measurements
- •Uncontrolled HTN defined as systolic blood pressure (SBP)>140
排除标准
- •Not meeting the inclusion criteria
结局指标
主要结局
Systolic blood pressure (SBP) improvement
时间窗: Baseline, every 3 months up to 54 months
Change in BP abstracted from the electronic health record (EHR).
Interventions received
时间窗: Baseline, 54 months
The number and proportion of individuals who receive each intervention.
Patient activation
时间窗: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
Patient activation will be assessed with the Consumer Health Activation index (CHAI), a 10 item validated instrument that generates a score of 0-100, with ≥80 indicating moderate/high activation.
次要结局
- Blood pressure control(Baseline, 18 months, 30 months, 36 months, 42 months, 54 months)
- Medication intensification(Baseline, 18 months, 30 months, 36 months, 42 months, 54 months)
- BP monitoring(Baseline, 18 months, 30 months, 36 months, 42 months, 54 months)
- Fidelity of interventions(Baseline, 18 months, 30 months, 36 months, 42 months, 54 months)
- Medication adherence(Baseline, 18 months, 30 months, 36 months, 42 months, 54 months)
- Trust in primary care(Baseline, 18 months, 30 months, 36 months, 42 months, 54 months)