Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic

NCT ID: NCT07232017

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1520 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-07-31

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.

Detailed Description

Primary care providers will offer the program to patients in Northeast Ohio with a hypertension diagnosis and aged 18-85, except those who are pregnant, have stage 5 chronic kidney disease or end stage renal disease, or enrolled in hospice care. The project time frame is 48 months. Quantitative and qualitative methods will be used to evaluate implementation and effectiveness outcomes associated with the program. Electronic medical records and surveys will be the key data sources for the quantitative evaluation. Qualitative data collection methods will include semi-structured interviews, field observations, and periodic reflections.

Specific Aims Aim 1. To prepare for implementation of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Pre-Implementation) Pre-Implementation Phase (12 months)

• Quantitative assessment of practice variation in HTN control.
• Qualitative assessment of practice barriers and facilitators to HTN management.
• Creation of a clinical decision support tool for program referral.
• Creation of project-specific patient and employee Advisory Panel.
• Pharmacist and advanced practice provider (APP) training for delivery of the program.
• Practice facilitation training with the Cleveland Clinic continuous improvement team.
• Community Health Worker/Primary Care Navigator Training for Patient Outreach.
• Creation of presentations for primary care staff meetings. Aim 2. To implement the intensive HTN management program across all Northeast Ohio Primary Care Practices (Rollout and Active Implementation) Implementation Phase (24 months)
• Stepped wedge rollout of intensive HTN management program.
• Implementation of the clinical decision support tool at implementation sites.
• Community Health Worker/Primary Care Navigator outreach to patients.
• Delivery of Presentations at primary care staff meetings.
• Practice Facilitation at Implementation Sites.
• Qualitative data collection regarding patient and provider implementation outcomes of acceptability and feasibility.
• Quantitative data collection of implementation outcomes of adoption, fidelity, effectiveness, implementation cost; provider surveys re: acceptability, appropriateness, feasibility.
• Patient and employee advisory panel input into implementation evaluation. Aim 3. To monitor and evaluate the maintenance of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Maintenance) Maintenance Phase (9 months)
• Quantitative data collection of implementation outcomes-reach, adoption, fidelity, effectiveness, cost-compared to the active implementation phase.
• Capture practice-level adaptations with comparison to the active implementation phase.
• Complete final data collection and analyses.

Conditions

Hypertension (HTN)

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

IN-HOME BP

Intervention Type: 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.

Interventions

IN-HOME BP

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Anita Misra-Hebert

OTHER

Sponsor Role: lead

Responsible Party

Anita Misra-Hebert

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

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Central Contacts

Anita Misra-Hebert, MD, MPH, FACP

Role: CONTACT

Phone: 216-445-8542

Email: MISRAA@ccf.org

Christopher Babuich, MD

Role: CONTACT

Phone: 440 204-7400

Email: babiucc@ccf.org

References

Cuttaree P, Edlund G, Eriksson M, Granberg P, Lager O, Lonberg E, Sjoberg P, Widell K. [Should sick children be kept in bed?]. Lakartidningen. 1971 Mar 24;68(13):1485-8. No abstract available. Swedish.

Reference Type: BACKGROUND

PMID: 5576104 (View on PubMed)

Murakami K, Minoshima S, Uno K, Arimizu N, Kobayashi M, Fujita M, Okamoto S, Ikehira H, Fukuda H, Tateno Y. [Imaging of malignant melanoma with In-111-labeled monoclonal antibody (ZME-018) and Ga-67 scintigraphy]. Kaku Igaku. 1989 Jan;26(1):113-9. No abstract available. Japanese.

Reference Type: BACKGROUND

PMID: 2724630 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36281763 (View on PubMed)

Other Identifiers

25-792

Identifier Type: -

Identifier Source: org_study_id