Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of Nurses who adopt the PACE intervention
研究概览
简要总结
To use practice facilitation (PF) + community health worker (CHW) facilitation as a practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions [nurse case management (NCM), remote blood pressure monitoring (RBPM), and social determinants of health (SDOH) support] delivered as an integrated community-clinic linkage model [Practice support And Community Engagement (PACE) to address patient-, physician-, health system-, and community-level barriers to hypertension (HTN) control in Blacks across 25 primary practices within NYU Langone Health in New York City (NYC) and, in partnership with an established Community-Clinic-Academic Advisory Board and HealthFirst (NYC's largest Medicaid payer).
The goal for the UH3 Implementation Phase (Years 4-7, Intervention) is to evaluate a stepped-wedge cluster RCT of 25 primary care practices in Black patients with uncontrolled hypertension (HTN)
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
- Single (Outcomes Assessor)
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
- •UH3 IMPLEMENTATION PHASE (Years 4 - 7): INTERVENTION
- •Inclusion Criteria:
- •Patients are eligible if he/she:
- •identifies as Black (through EHR code or self-report)
- •is 18+ years of age
- •has a diagnosis of HTN (identified by ICD-10 codes for HTN)
- •prescribed an antihypertensive medication(s)
- •has a clinic BP > 130/80 mmHg
排除标准
- •Patients will be ineligible for the study if they:
- •are deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
- •participate in other hypertension-related clinical trials
- •have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
- •plan to discontinue care at the site within the next 12 months; or
- •are pregnant or planning to become pregnant in the next 12 months
- •IMPLEMENTATION EVALUATION
- •NYULH Primary care provider (MD/DO, NP), Clinical Director, Site Administrator, Medical Assistant, or administrative staff employed at the participating practices and interacts with at least five patients with a diagnosis of hypertension; or
- •NYULH Nurse case manager within centralized service; or
- •Staff and leadership of community- and faith-based organizations serving the Black community; or
- •NYULH Organizational leadership; or
- •NYULH Project Staff: Community Health Workers/CHW Supervisor/Practice Facilitators; and
- •Able and willing to provide consent
- •Exclusion Criteria:
- •1. Refusal to participate
研究组 & 干预措施
Usual care (UC) Group
The study design is a randomized stepped wedge cluster trial whereby all clusters (practice sites) begin as part of the Usual Care (UC) control condition.
Clusters are then randomly assigned to cross over at different times with all clusters eventually receiving PACE. The study will involve each site starting with the UC, followed by a period of 3 months during which practice facilitators will train NCMs and CHWs, and finally followed by the PACE intervention for 12 months with a 6-month follow-up for outcome assessment. During the UC Period, patients at the sites will receive standard HTN care and standard printed HTN treatment guidelines. Immediately following this period, prior to implementation of PACE, we will conduct a practice capacity assessment at each site for 3 months. This period is then followed by the implementation of PACE.
Intervention Group
Thus, each cluster will belong successively to the control group and the intervention group. During the control period (UC) patients at the sites will receive standard HTN care delivered by their primary care providers and standard printed HTN treatment guidelines. This period is then followed by the implementation of PACE. Clusters are randomly assigned to cross over at different times with all clusters eventually receiving PACE. During the PACE implementation period, which will last 12 months, practice facilitators will work with each site to implement the components of PACE.
干预措施: Practice support And Community Engagement (PACE) (Other)
结局指标
主要结局
Number of Nurses who adopt the PACE intervention
时间窗: Month 12
Defined at the Nurse-level who adopt both electronic health record (EHR) remote BP monitoring (RBPM) and social determinants of health (SDOH) Smartsets
次要结局
未报告次要终点