Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Change in clinic systolic BP
研究概览
简要总结
This clinical trial aims to assess the impact of patient-focused and clinical-focused implementation strategies on blood pressure control. The investigators will assess the costs of these strategies and how effective they were at safely and equitably increasing home blood pressure monitoring.
详细描述
This study will focus on assessing implementation strategies to increase adoption of self-monitored blood pressure (SMBP) monitoring among low-income, culturally and linguistically diverse patients with hypertension in an urban safety net. The investigators propose a hybrid type 1 effectiveness-implementation trial of implementation strategies to increase use of SMBP monitoring with clinical support in an urban safety net system. 330 patients will be randomized to a low-intensity vs high-intensity implementation strategy for SMBP monitoring. The low-intensity strategy will replicate frequently used implementation efforts (provision of BP monitor with training on using a monitor) while the high-intensity strategy will address additional factors identified in prior work (e.g., digital literacy, social support). In six adult primary clinics, the investigators will concurrently provide a stepped-wedge clinic-level implementation strategy (clinical champions, electronic health record [EHR] tools) to increase provision of clinical support for SMBP data. To guide dissemination in other under-resourced settings, an economic evaluation will also be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •18 years old/order
- •Any sex or gender
- •Any race or ethnicity
- •Must be receiving primary care at any of the six enrolled clinics
- •Have uncontrolled hypertension (two clinic BP readings ≥140/90 mmHg within the previous 18 months)
- •Can read and write English, Spanish, or Cantonese
- •Be able to provide consent
- •Must own a cell phone that receives SMS or text messages
排除标准
- •Those with conditions that might complicate remote BP monitoring:
- •Pregnancy (and 12 months postpartum)
- •Acute myocardial infarction or stroke in the last 12 months
- •End-stage renal disease on dialysis
- •Stage D heart failure
- •Active treatment for cancer (except for nonmelanoma skin cancers)
- •Pacemaker use
- •Those with dementia, in hospice care, or with serious behavioral health conditions impeding participation
研究组 & 干预措施
Low-Intensity (Usual Care)
Patient level: training on how to use a blood pressure (BP) monitor and online patient portal (ex. MyChart), receive reminders to take their BP at home, receive educational messages, and access to language-concordant educational materials.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: BP monitor use training and app training (Behavioral)
Low-Intensity (Usual Care)
Patient level: training on how to use a blood pressure (BP) monitor and online patient portal (ex. MyChart), receive reminders to take their BP at home, receive educational messages, and access to language-concordant educational materials.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: Online patient portal enrollment and training (Behavioral)
Low-Intensity (Usual Care)
Patient level: training on how to use a blood pressure (BP) monitor and online patient portal (ex. MyChart), receive reminders to take their BP at home, receive educational messages, and access to language-concordant educational materials.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: SMS reminders to take blood pressure (Behavioral)
Low-Intensity (Usual Care)
Patient level: training on how to use a blood pressure (BP) monitor and online patient portal (ex. MyChart), receive reminders to take their BP at home, receive educational messages, and access to language-concordant educational materials.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: Education about self-management of hypertension (Behavioral)
High-Intensity
Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: BP monitor use training and app training (Behavioral)
High-Intensity
Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: Online patient portal enrollment and training (Behavioral)
High-Intensity
Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: SMS reminders to take blood pressure (Behavioral)
High-Intensity
Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: Education about self-management of hypertension (Behavioral)
High-Intensity
Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: Educational text messages that encourage seeking support from a support person (Behavioral)
High-Intensity
Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: Involvement of caregiver or support person (Behavioral)
High-Intensity
Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person.
Clinic level: training on standardized workflows and EHR tools, audit and feedback
干预措施: Group classes (Behavioral)
结局指标
主要结局
Change in clinic systolic BP
时间窗: Baseline, 12 months, 18 months
BP Control
时间窗: Monthly (-6 to 18 months)
Clinic patients with EHR recorded BP \< 140/90
次要结局
- BP Control(Baseline, 12 months, 18 months)
- Home Systolic BP (SBP)(Baseline, 12 months, 18 months)
- Patient Adoption(12 months)
- Clinic adoption(Monthly (-6 to 18 months))
- Reach(12 months)
- Costs(During trial; 12 months)
- Patient Activation(Baseline, 12 months)