Implementation of Effective Hypertension Management Approaches: OSF HealthCare

Official title

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

Overview

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.

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.

Primary outcome measures

• Systolic Blood Pressure Change [Time frame: Trajectory over 12 months and 24 months]

Secondary outcome measures (7)

• Diastolic Blood Pressure Change [Time frame: Trajectory over 12 months and 24 months]
• Symptom Reporting (Side effects of Antihypertensive Medication) [Time frame: Baseline to 6 months]
• Patient Care Experience [Time frame: baseline to 6 months]
• Self-monitoring/Confidence in Self-Care [Time frame: baseline to 6 months]
• Qualitive Interviews with Patients [Time frame: 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.]
• Unplanned Care Visits [Time frame: baseline to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

United States · 1 center

• OSF HealthCare System — Peoria

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. PMID 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. PMID 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. PMID 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. Contem PMID 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/ PMID 40763225

Identifiers

NCT: NCT07450222 · 2394654

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗