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Enrolling by Invitation

NCT Number: NCT07450222

Implementation of Effective Hypertension Management Approaches: OSF HealthCare

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.

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Key information

Conditions

Uncontrolled Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OSF HealthCare System

Peoria, Illinois, 61602, United States

About this study

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:

  • 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:

  • 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.
  • Examine how patients and healthcare staff describe their experiences with the implementation strategies used to deliver the PCHM program across diverse settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Diastolic Blood Pressure Change

    Time frame: Trajectory over 12 months and 24 months

    change in patient diastolic blood pressure change from baseline

  2. 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

  3. Patient Care Experience

    Time frame: baseline to 6 months

    Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.

  4. 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

  5. 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

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Colleen J Klein

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 4, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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