Implementation of Effective Hypertension Management Approaches: OSF HealthCare

NCT07450222 | Enrolling By Invitation

• 1 other identifier: 2394654
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncontrolled Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure Change

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

  Trajectory over 12 months and 24 months

Secondary Outcomes (7)

• Diastolic Blood Pressure Change

  Trajectory over 12 months and 24 months

• Symptom Reporting (Side effects of Antihypertensive Medication)

  Baseline to 6 months

• Patient Care Experience

  baseline to 6 months

• Self-monitoring/Confidence in Self-Care

  baseline to 6 months

• Qualitive Interviews with Patients

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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Colleen J Klein: lead

Study Sites (1)

OSF HealthCare System

Peoria, Illinois, 61602, United States

Location

Related Publications (5)

• 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.

  PMID: 18577730 BACKGROUND

• 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.

  PMID: 34772767 BACKGROUND

• 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.

  PMID: 29300695 BACKGROUND

• 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.

  PMID: 31981712 BACKGROUND

• Margolis KL, Bergdall AR, Crain AL, et al. Comparing telehealth and clinic-based care for lowering uncontrolled high blood pressure. Patient-Centered Outcomes Research Institute (PCORI). (2022). Accessed September 4, 2024. https://www.pcori.org/research-results/2016/comparing-telehealth-and-clinic-based-care-lowering-uncontrolled-high-blood-pressure

  BACKGROUND

Related Links

• Patient Centered Outcomes Research Institute (PCORI) HSII Addressing Hypertension in Adults
• OSF HealthCare PCORI HSII Public Summary

Study Officials

• Colleen Klein, PhD, APRN, FNP-BC

  OSF HealthCare

  PRINCIPAL INVESTIGATOR

• Melinda Cooling, DNP, APRN, FAANP

  OSF HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Education & Research Scientist

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)