Implementation of Effective Hypertension Management Approaches: OSF HealthCare

March 13, 2026 updated by: Colleen J Klein

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 61602
        • OSF Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The PHCM program will be offered to all eligible patients who receive care at the following OSF sites across the health care system: primary care, urgent care or prompt care clinics and OSF OnCall. The intervention will be rolled out in six waves over 18 months at OSF HealthCare locations noted above in two states: Illinois and Michigan.

The first waves will consist of 2-3 markets each and focused on OSF affiliated patients. Once the implementation has started in a market area, patients who visit a clinic locally can also be referred to the program by a provider. In Wave 6, those patients (non-responders to text messages and those without a primary care provider [non-OSF affiliated]) will be outreached and encouraged to self-enroll using a self-enrollment portal and PHCM enrollment specialists and will be referred primarily to the remote (virtual) monitoring program.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure Change
Time Frame: Trajectory over 12 months and 24 months
Average change in systolic blood pressure between baseline, 12 Months and 24 months (mm Hg)
Trajectory over 12 months and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic Blood Pressure Change
Time Frame: Trajectory over 12 months and 24 months
change in patient diastolic blood pressure change from baseline
Trajectory over 12 months and 24 months
Symptom Reporting (Side effects of Antihypertensive Medication)
Time Frame: Baseline to 6 months
• Number of Participants Reporting Dizziness, Hypotension or fainting as a Side Effect of Antihypertensive Medication at Six Months
Baseline to 6 months
Patient Care Experience
Time Frame: baseline to 6 months
Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.
baseline to 6 months
Self-monitoring/Confidence in Self-Care
Time Frame: baseline to 6 months
Number of patients reporting confidence in managing hypertension (Blood Pressure Care Survey) at Six Months
baseline to 6 months
Qualitive Interviews with Patients
Time Frame: baseline to 6 months, 12, months, 18 months, and 24 months
Patients' experiences over time in program (longitudinal interviews) - purposive sample
baseline to 6 months, 12, months, 18 months, and 24 months
Provider and Staff Interviews
Time Frame: baseline, 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.
baseline, 6 months, 12 months, 18 months, and 24 months.
Unplanned Care Visits
Time Frame: baseline to 6 months
Unplanned care visits due to high blood pressure, change in blood pressure, blood pressure control rate
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colleen J Klein

Investigators

  • Principal Investigator: Colleen Klein, PhD, APRN, FNP-BC, OSF Healthcare
  • Principal Investigator: Melinda Cooling, DNP, APRN, FAANP, OSF Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2394654

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Restrictions for data sharing are described within the IRB protocol. In any published works, no individual participant data as specified will be reported by practice sites. Aggregated data reports will be provided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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