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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07450222
Enrollment
130
Registered
2026-03-04
Start date
2026-03-06
Completion date
2029-12-31
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncontrolled Hypertension

Keywords

Best Practice Clinic-Based Care;, telehealth care, uncontrolled hypertension

Brief 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.

Interventions

None listed

Sponsors

Colleen J Klein
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Systolic Blood Pressure ChangeTrajectory over 12 months and 24 monthsAverage change in systolic blood pressure between baseline, 12 Months and 24 months (mm Hg)

Secondary

MeasureTime frameDescription
Diastolic Blood Pressure ChangeTrajectory over 12 months and 24 monthschange in patient diastolic blood pressure change from baseline
Symptom Reporting (Side effects of Antihypertensive Medication)Baseline to 6 months• Number of Participants Reporting Dizziness, Hypotension or fainting as a Side Effect of Antihypertensive Medication at Six Months
Patient Care Experiencebaseline to 6 monthsNumber of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.
Self-monitoring/Confidence in Self-Carebaseline to 6 monthsNumber of patients reporting confidence in managing hypertension (Blood Pressure Care Survey) at Six Months
Qualitive Interviews with Patientsbaseline to 6 months, 12, months, 18 months, and 24 monthsPatients' experiences over time in program (longitudinal interviews) - purposive sample
Provider and Staff Interviewsbaseline, 6 months, 12 months, 18 months, and 24 months.Qualitative interviews will provide descriptions of experiences pre-, mid- and later phase implementation to provide insights into staff and organizational factors influencing uptake and success of PHCM interventions.
Unplanned Care Visitsbaseline to 6 monthsUnplanned care visits due to high blood pressure, change in blood pressure, blood pressure control rate

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORColleen Klein, PhD, APRN, FNP-BC

OSF HealthCare

PRINCIPAL_INVESTIGATORMelinda Cooling, DNP, APRN, FAANP

OSF HealthCare

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026