HSII PCORI/OSF Hypertension (HTN) Care Management (PHCM) With Remote Patient Monitoring Support
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure Change
研究概览
简要总结
The goal of this observational pragmatic study is to learn about how evidence-based interventions and best practices for management of uncontrolled hypertension can be integrated across a large healthcare system through the use of virtual and clinic-based care approaches.
The primary outcome for this work is the sustained change over time in patients' reported blood pressure readings relative to guidelines-based thresholds for treatment. Measures in all domains of the RE-AIM (reach, effectiveness, adoption, Implementation and Maintenance) implementation science framework will be used.
详细描述
The overall purpose of this project is to study the implementation of the organization's PCORI Hypertension Care Management (PHCM) program and evaluate its impact on patients' health and experiences with care. Patients will be offered two different clinical pathways to manage their uncontrolled hypertension (hybrid [telehealth + in-person clinic visits], or telehealth only). Both of these approaches are evidence-based. Their effectiveness in relation to health outcomes will be examined.
Data will be analyzed to provide context to the quantitative RE-AIM findings and to capture information on outcomes that cannot be collected by other means.
This protocol includes both program evaluation activities conducted by the health system and research activities conducted by the study team to generate generalizable knowledge about patient experiences and outcomes.
Part 1: Program Evaluation Aims:
1. Conduct an evaluation of the reach, effectiveness, adoption, implementation, and maintenance of the telehealth care and clinic-based care interventions using a mixed-methods, real-world approach supported by the RE-AIM framework.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Has a hypertension diagnosis code; 2 or more blood pressure readings greater than or equal to 130 mmHg systolic or diastolic greater than or equal to 80 mmHg.
排除标准
- •Enrolled in the OSF Saint Francis Medical Center Hypertension Center.
- •Under the care of a palliative or hospice care team
- •pregnant patients
- •patients residing in nursing homes
- •patients with end-stage renal disease
研究组 & 干预措施
OSF Patients in Waves 1-5
OSF patients identified via a hypertension registry as uncontrolled
Non-OSF Patients in Waves 1-5
Non-OSF Patients with uncontrolled HTN who visit an OSF prompt or urgent care clinic
Self-Referral patients across all markets (Wave 6)
Patients who self-refer/enroll, and those who are outreached to by OSF virtual care staff
结局指标
主要结局
Systolic Blood Pressure Change
时间窗: Trajectory over 12 months and 24 months
Average change in systolic blood pressure between baseline, 12 Months and 24 months (mm Hg)
次要结局
- Diastolic Blood Pressure Change(Trajectory over 12 months and 24 months)
- Symptom Reporting (Side effects of Antihypertensive Medication)(Baseline to 6 months)
- Patient Care Experience(baseline to 6 months)
- Self-monitoring/Confidence in Self-Care(baseline to 6 months)
- Qualitive Interviews with Patients(baseline to 6 months, 12, months, 18 months, and 24 months)
- Provider and Staff Interviews(baseline, 6 months, 12 months, 18 months, and 24 months.)
- Unplanned Care Visits(baseline to 6 months)
研究者
Colleen J Klein
Principal Investigator, Education & Research Scientist
OSF Healthcare System