Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic

NCT07232017 | Recruiting

• 1 other identifier: 25-792
• Study Type: observational
• Target: 1,520
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the Implementation of Effective Hypertension Management Approaches: Cleveland Clinic program is to improve blood pressure control for patients diagnosed with hypertension (HTN) and uncontrolled blood pressure, specifically defined as a blood pressure greater than 150/95, across all Cleveland Clinic Northeast Ohio primary care practices. The project will scale up the availability of resources for treating hypertension in 56 primary care practices within the Cleveland Clinic Health System in Northern Ohio, reaching up to approximately 3800 patients. This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.

Conditions

Hypertension (HTN)

Keywords

hypertension; uncontrolled blood pressure; home blood pressure; pharmacist; advanced practice provider

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure Change

  The main effectiveness finding the investigators expect to report at the end of the proposed implementation project is the change in patient systolic blood pressure from baseline to 12 months post-implementation. The expected change in systolic blood pressure based upon Margolis et al.(1) is -18mmHg. The period of evaluation will be from the time of program enrollment, with home BP measurements assessed every 2-3 weeks until the blood pressure is less than 135/85 and at 12 months. The blood pressure will continue to be measured every 6 months through the full the 24-month implementation/intervention period (allowing all sites to roll out the intervention) and a 9-month maintenance period.

  Patients will be followed for up to 33 months: 24-month implementation/intervention period and 9-month maintenance period.

Secondary Outcomes (23)

• Diastolic Blood Pressure Change

  The patient's blood pressure will be measured for up to 33 months (24-month implementation/intervention period and 9-month maintenance period). Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance.

• Reach (Actual): Patients Offered, Initiated, Completed

  Measured every 3 months for up to 33 months.

• Effectiveness: Equity in Outcomes (Race)

  Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.

• Effectiveness: Equity in Outcomes (Ethnicity)

  Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.

• Effectiveness: Equity in Outcomes (Gender)

  Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.

Study Arms (1)

IN-HOME BP: titrating BP medications based on patient-recorded home blood pressure readings

This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.

Other: IN-HOME BP

Interventions

IN-HOME BP OTHER

A team-based approach with a primary care provider (PCP) collaborating with pharmacists and advanced practice providers (APP) and will use a mechanism (frequent follow-up- phone or virtual appointments) that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.

IN-HOME BP: titrating BP medications based on patient-recorded home blood pressure readings

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Per inclusion criteria and that the patient has at least 2 encounters with a HTN diagnosis within the past 24 months; had an encounter within the past 12 months at their PCPs assigned location; had a documented systolic blood pressure of \>150 or diastolic blood pressure of \>95 at the most recent encounter at the primary care location, and a previous encounter within the health system within the past 24-month qualifying time frame with a documented systolic blood pressure of \>150 or diastolic blood pressure of \>95.

You may qualify if:

• Hypertension diagnosis, aged 18-85 years old
• Uncontrolled blood pressure, defined as a blood pressure reading of \> 150/95

You may not qualify if:

• pregnant, stage 5 chronic kidney disease, End Stage Renal Disease, enrolled in hospice care

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute: collaborator
• The Cleveland Clinic: collaborator
• Anita Misra-Hebert: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (3)

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.

  PMID: 19543809 BACKGROUND

• Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Sperl-Hillen J, Beran M, Green BB, Haugen P, Norton CK, Kodet AJ, Sharma R, Appana D, Trower NK, Pawloski PA, Rehrauer DJ, Simmons ML, McKinney ZJ, Kottke TE, Ziegenfuss JY, Williams RA, O'Connor PJ. Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Hypertension. 2022 Dec;79(12):2708-2720. doi: 10.1161/HYPERTENSIONAHA.122.19816. Epub 2022 Oct 25.

  PMID: 36281763 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Anita Misra-Hebert, MD, MPH, FACP

CONTACT

216-445-8542; MISRAA@ccf.org

Christopher Babuich, MD

CONTACT

440 204-7400; babiucc@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Staff, Department of Internal Medicine, Director, Healthcare Delivery and Implementation Science Center

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)