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Uncontrolled HypertensionNCT07450222

Implementation of Effective Hypertension Management Approaches: OSF HealthCare

An observational study of Uncontrolled Hypertension, run by Colleen J Klein at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Uncontrolled Hypertension
How many people
130 participants
Where
1 siteUnited States
Study dates
6 Mar 2026to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • OSF HealthCare System

    Peoria, Illinois, 61602

Other trials in United States

About this study

Official title: 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.

Read the 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.
Keywords
Best Practice Clinic-Based Care;, telehealth care, uncontrolled hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07450222
Study groupRoleWhat they receive
OSF Patients in Waves 1-5OSF patients identified via a hypertension registry as uncontrolled
Non-OSF Patients in Waves 1-5Non-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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic Blood Pressure Change

    Average change in systolic blood pressure between baseline, 12 Months and 24 months (mm Hg)

    Measured: Trajectory over 12 months and 24 months

Secondary outcomes (7)

  1. Diastolic Blood Pressure Change

    change in patient diastolic blood pressure change from baseline

    Measured: Trajectory over 12 months and 24 months

  2. Symptom Reporting (Side effects of Antihypertensive Medication)

    • Number of Participants Reporting Dizziness, Hypotension or fainting as a Side Effect of Antihypertensive Medication at Six Months

    Measured: Baseline to 6 months

  3. Patient Care Experience

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

    Measured: baseline to 6 months

  4. Self-monitoring/Confidence in Self-Care

    Number of patients reporting confidence in managing hypertension (Blood Pressure Care Survey) at Six Months

    Measured: baseline to 6 months

  5. Qualitive Interviews with Patients

    Patients' experiences over time in program (longitudinal interviews) - purposive sample

    Measured: baseline to 6 months, 12, months, 18 months, and 24 months

  6. Provider and Staff Interviews

    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.

    Measured: baseline, 6 months, 12 months, 18 months, and 24 months.

  7. Unplanned Care Visits

    Unplanned care visits due to high blood pressure, change in blood pressure, blood pressure control rate

    Measured: baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2026
  2. Study start6 Mar 2026
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07450222
Sponsor's protocol ID
2394654
Status last verified
Feb 2026
First submitted
27 Feb 2026
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857.

    PubMed 18577730

  • Solberg LI, Crain AL, Green BB, Ziegenfuss JY, Beran MS, Sperl-Hillen JM, Norton CK, Margolis KL. Experiences and Perceptions of Patients with Uncontrolled Hypertension Who are Dissatisfied with Their Hypertension Care. J Am Board Fam Med. 2021 Nov-Dec;34(6):1115-1122. doi: 10.3122/jabfm.2021.06.210240.

    PubMed 34772767

  • Glasgow RE, Estabrooks PE. Pragmatic Applications of RE-AIM for Health Care Initiatives in Community and Clinical Settings. Prev Chronic Dis. 2018 Jan 4;15:E02. doi: 10.5888/pcd15.170271.

    PubMed 29300695

  • Margolis KL, Crain AL, Bergdall AR, Beran M, Anderson JP, Solberg LI, O'Connor PJ, Sperl-Hillen JM, Pawloski PA, Ziegenfuss JY, Rehrauer D, Norton C, Haugen P, Green BB, McKinney Z, Kodet A, Appana D, Sharma R, Trower NK, Williams R, Crabtree BF. Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure. Contemp Clin Trials. 2020 May;92:105939. doi: 10.1016/j.cct.2020.105939. Epub 2020 Jan 22.

    PubMed 31981712

  • Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Green BB, O'Connor PJ. Comparing Telehealth and Clinic-Based Care for Lowering Uncontrolled High Blood Pressure [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2023 Mar. Available from http://www.ncbi.nlm.nih.gov/books/NBK616711/

    PubMed 40763225

Questions about this trial

What is this clinical trial studying?

An observational study of Uncontrolled Hypertension, run by Colleen J Klein at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure Change (time frame: Trajectory over 12 months and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07450222, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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