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.
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
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.
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:
- 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.
- Conditions
- Uncontrolled Hypertension
- 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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Diastolic Blood Pressure Change
change in patient diastolic blood pressure change from baseline
Measured: Trajectory over 12 months and 24 months
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
Patient Care Experience
Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.
Measured: baseline to 6 months
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
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
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.
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.
- First posted4 Mar 2026
- Study start6 Mar 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Colleen J Klein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Colleen J Klein, OSF Healthcare System
- Investigators
- Colleen Klein, PhD, APRN, FNP-BC, Principal investigator, OSF HealthCareMelinda Cooling, DNP, APRN, FAANP, Principal investigator, OSF HealthCare
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 18577730Solberg 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 34772767Glasgow 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 29300695Margolis 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 31981712Margolis 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