NCT07450222

Implementation of Effective Hypertension Management Approaches: OSF HealthCare

HSII PCORI/OSF Hypertension (HTN) Care Management (PHCM) With Remote Patient Monitoring Support

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Colleen J Klein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Part 2: Qualitative Component of Study (Anticipated enrollment numbers on this site reflect this portion of the study) Research Aims: 1. Identify how patients describe changes in their self-management behaviors, confidence, health beliefs, and relationships with care teams as they engage in the care approaches. 2. Examine how patients and healthcare staff describe their experiences with the implementation strategies used to deliver the PCHM program across diverse settings.

Conditions

• Uncontrolled Hypertension

Timeline

• Start date: 2026-03-06
• Primary completion: 2029-09-01
• Completion: 2029-12-31
• First posted: 2026-03-04
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States