Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- Rate of Blood Pressure Receipt
研究概览
简要总结
The goal of this study is to identify what cuff delivery and BP log return modality most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?
详细描述
The study team developed a clinical integration package as a multicomponent primary care-based approach to increase SMBP adoption through structured workflows, patient training, blood pressure logs, reminders/support, and clinical follow-up. Pilot work demonstrated that SMBP uptake can be significantly improved in underserved primary care settings. However, the pilot relied on research funds to purchase cuffs, which is not sustainable for health-system scale. A scalable model must identify practical pathways for patients to obtain standard validated blood pressure cuffs through routine care mechanisms, including vendor-supported, insurance-billed, consignment, or mail-order pathways, without depending on research-purchased devices.
In addition to cuff access, effective SMBP implementation also requires feasible approaches to patient training. Many patients do not receive standardized instruction on how to correctly measure and record home blood pressure readings, and intensive in-person training models may be difficult to sustain in routine primary care workflows. Health systems therefore need practical training strategies that balance effectiveness with scalability, ranging from brief hands-on education delivered during clinic visits to lower-touch written or self-guided educational materials.
Patients will be randomized to one of four arms:
- Mail-order cuff delivery with enhanced return conversation
- Mail-order cuff delivery with written instructions
- In-clinic cuff distribution with enhanced return conversation
- In-clinic cuff distribution with written instructions
All other intervention components will be standardized across study arms, including receipt of a blood pressure log, written instructions on when and how to obtain home blood pressure readings, and routine clinic processes for documenting or reviewing SMBP readings returned by patients. The design is intended to evaluate implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself. This design is intended to evaluate operational implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age 18 years or older.
- •Diagnosed hypertension documented prior to the index clinic visit.
- •Scheduled for and attends an in-person visit with a participating clinician at a study clinic.
- •Elevated BP (blood pressure) documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP >=140 mmHg or diastolic BP >=90 mmHg.
排除标准
- •Visit is canceled, rescheduled, or the patient does not attend the visit.
- •Patient already has a usable home BP cuff provide through insurance within the past 5 years.
- •Patient declines assistance obtaining a BP cuff.
- •Patient declines submitting cuff order to insurance.
- •Patient unable to participate for operational reasons.
研究组 & 干预措施
In-clinic cuff distribution - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team.
干预措施: In-Clinic Cuff Delivery - Written Instructions (Behavioral)
Mail-order cuff delivery - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team.
干预措施: Mail Order Cuff Delivery - Written Instructions (Behavioral)
Mail-order cuff delivery - Enhanced Return Conversation
Patients will receive a blood pressure cuff in the mail and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team.
干预措施: Mail Order Cuff Delivery - Enhanced Return Conversation (Behavioral)
In-clinic cuff distribution - Enhanced Return Conversation
Patients will receive a blood pressure cuff in the clinic and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team.
干预措施: In-Clinic Cuff Delivery - Enhanced Return Conversation (Behavioral)
结局指标
主要结局
Rate of Blood Pressure Receipt
时间窗: up to day 14
Number of participants that have received their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available
Rate of Training Completion
时间窗: up to day 14
Number of participants that completed the assigned training modality as documented on the envelope checklist.
Rate of Cuff Order Completion
时间窗: up to day 14
Number of participants that have ordered their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available.
Rate of Return Modality Completion
时间窗: up to day 14
Number of participants that completed the assigned return modality as documented on the envelope checklist.
次要结局
- Time to Complete Intervention(up to day 14)
- Number of Participants Documenting at Least One Blood Pressure Reading(up to day 21)
- Time Between Cuff Receipt and First Documented Reading(up to day 21)
- Rate of Workflow Barriers(up to day 14)
- Rate of Fidelity(up to day 14)
- Rate of Differential Implementation Success(up to day 14)