Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure

NCT02996565 | Completed Results DMC

• 1 other identifier: HealthPartners Institute
• Study Type: interventional
• Target: 3,071
• Locations: 1 country
• Sites: 1

Brief Summary

This pragmatic trial will compare two team-based care models for managing hypertension, Best Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care system in Minnesota. Clinics in the study are randomized to offer one of the two treatment models to participants with uncontrolled hypertension. The investigators aim to determine a) whether one model is more effective than the other for lowering patient's blood pressure and b) which model patients prefer.

Conditions

Hypertension

Keywords

Clinic care; Team-based care; Medication Therapy Management (MTM); Telehealth; Cluster-randomized; Home blood pressure monitoring; Pharmacist

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)

  Change in systolic BP, collected from medical records

  Trajectory over 12 months

Secondary Outcomes (29)

• Change in Diastolic BP Between Baseline and 12 Months (mm Hg)

  Trajectory over 12 months

• Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up

  Baseline to 6 months

• Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.

  Baseline to 6 months

• Number of Participants Who Are Current Smokers at Twelve Months

  Baseline to 12 months

• Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months

  Baseline to 6 months

Study Arms (2)

Best Practice Clinic-Based Care

ACTIVE COMPARATOR

Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention.

Other: Best Practice Clinic-Based Care

Telehealth Care

ACTIVE COMPARATOR

Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention.

Other: Telehealth Care

Interventions

Best Practice Clinic-Based Care OTHER

Relies primarily on the physician-medical assistant dyad and face-to-face visits to promote: 1. Improved recognition of uncontrolled BP at primary care encounters, 2. Therapeutic action to address uncontrolled BP at primary care encounters, 3. Reliable follow-up visits to re-assess uncontrolled BP every 2-4 weeks.

Best Practice Clinic-Based Care

Telehealth Care OTHER

All elements of Clinic-Based Care are performed, plus a telemonitoring and pharmacist case management program is offered, specifically: 1. Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device 2. Systematic home BP telemonitoring with data transmitted into patient medical record 3. Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email

Telehealth Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension diagnosis code in medical record, twice in last 24 months
• Attends study clinic for primary care visit within study period with uncontrolled blood pressure
• Systolic blood pressure \>=150 mm Hg or Diastolic blood pressure \>=95 mm Hg at current visit
• Systolic blood pressure \>=150 mm Hg or Diastolic blood pressure \>=95 mm Hg at most recent previous visit

You may not qualify if:

• Pregnancy
• End Stage Kidney Disease
• Patients in hospice care and patients who permanently reside in a nursing home

Sponsors & Collaborators

• HealthPartners Institute: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

HealthPartners Institute

Bloomington, Minnesota, 55425, United States

Location

Related Publications (6)

• Margolis KL, Crain AL, Pawloski PA, Ziegenfuss JY, Trower NK, Bergdall AR, Beran M, Norton CK, Haugen PK, Rehrauer DJ, Green BB, Solberg LI, Sperl-Hillen JM. Blood Pressure Medication Side Effect Symptoms and Patient Treatment Satisfaction and Adherence. J Am Board Fam Med. 2025 Mar-Apr;38(2):312-329. doi: 10.3122/jabfm.2024.240288R1.

  PMID: 40578923 DERIVED

• 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 DERIVED

• JaKa M, Bergdall A, Beran MS, Solberg L, Green BB, Andersen J, Kodet A, Norman S, Haugen P, Crain L, Trower N, Sharma R, Rehrauer D, Maeztu C, Margolis K. Reach in a pragmatic hypertension trial: A critical RE-AIM component. Contemp Clin Trials. 2022 Oct;121:106896. doi: 10.1016/j.cct.2022.106896. Epub 2022 Aug 24.

  PMID: 36029952 DERIVED

• Margolis KL, Crain AL, Green BB, O'Connor PJ, Solberg LI, Beran M, Bergdall AR, Pawloski PA, Ziegenfuss JY, JaKa MM, Appana D, Sharma R, Kodet AJ, Trower NK, Rehrauer DJ, McKinney Z, Norton CK, Haugen P, Anderson JP, Crabtree BF, Norman SK, Sperl-Hillen JM. Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence. Trials. 2022 Aug 17;23(1):673. doi: 10.1186/s13063-022-06611-3.

  PMID: 35978336 DERIVED

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Karen Margolis, MD MPH
• Organization: HealthPartners Institute

Karen.L.Margolis@HealthPartners.com

952-967-7301

Study Officials

• Karen Margolis, MD

  HealthPartners Institution

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 19, 2016
• Study Start: November 15, 2017
• Primary Completion: April 17, 2020
• Study Completion: June 30, 2021
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)