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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure Change | change in patient diastolic blood pressure change from baseline | Trajectory over 12 months and 24 months |
| Symptom Reporting (Side effects of Antihypertensive Medication) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Colleen Klein, PhD, APRN, FNP-BC | OSF HealthCare | Principal Investigator |
| Melinda Cooling, DNP, APRN, FAANP | OSF HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OSF HealthCare System | Peoria | Illinois | 61602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18577730 | Background | 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. | |
| 34772767 | Background |
| Label | URL |
|---|---|
| Patient Centered Outcomes Research Institute (PCORI) HSII Addressing Hypertension in Adults | View source |
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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.
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• Number of Participants Reporting Dizziness, Hypotension or fainting as a Side Effect of Antihypertensive Medication at Six Months
| Baseline to 6 months |
| Patient Care Experience | Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months. | 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 | baseline to 6 months |
| Qualitive Interviews with Patients | Patients' experiences over time in program (longitudinal interviews) - purposive sample | 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. | 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 | baseline to 6 months |
| 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. |
| 29300695 | 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. |
| 31981712 | 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. |
| 40763225 | Background | 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/ |
| OSF HealthCare PCORI HSII Public Summary | View source |