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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Best Practice Clinic-Based Care; Other: Telehealth Care

Detailed Description

The objectives of the study are:

Aim 1: Compare the effects of two evidence-based strategies on lowering blood pressure and other outcomes important to patients: best-practice clinic-based care and home-based telehealth care.

• Hypothesis 1.1: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will have a 5 mm Hg greater change in systolic blood pressure over 12 months of follow-up.
• Hypothesis 1.2: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will report: a) fewer treatment side effects; b) better ratings of patient experience of hypertension care; and c) higher self-monitoring rates and confidence in self-care.

Aim 2: Conduct an evaluation of the reach, adoption, implementation, and maintenance of the telehealth care and clinic-based care interventions using a mixed-methods approach supported by the RE-AIM framework and the Consolidated Framework for Implementation Research (CFIR).

• Study Type: Interventional
• Enrollment (Actual): 3071
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • HealthPartners Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Best Practice Clinic-Based Care; 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; Relies primarily on the physician-medical assistant dyad and face-to-face visits to promote: Improved recognition of uncontrolled BP at primary care encounters,; Therapeutic action to address uncontrolled BP at primary care encounters,; Reliable follow-up visits to re-assess uncontrolled BP every 2-4 weeks.
Active Comparator: Telehealth Care; Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention.	Other: Telehealth Care; All elements of Clinic-Based Care are performed, plus a telemonitoring and pharmacist case management program is offered, specifically: Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device; Systematic home BP telemonitoring with data transmitted into patient medical record; Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diastolic BP Between Baseline and 12 Months (mm Hg)	change in diastolic BP, collected from medical records	Trajectory over 12 months
Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up	Patient report of monitoring BP at least 2 times per week	Baseline to 6 months
Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.	Patient rating of 9-10 vs. 0-8 on a scale of 0 (low satisfaction) to 10 (high satisfaction). Developed from a scale used by Green, et al (2008). Citation: 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;299:2857-2867. doi:10.1001/jama.299.24.2857	Baseline to 6 months
Number of Participants Who Are Current Smokers at Twelve Months	Current smoker at 12 months	Baseline to 12 months
Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months	Patient report that side effect is a problem	Baseline to 6 months
Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months	Patient report that side effect is a problem	Baseline to 6 months
Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months	Patient report that side effect is a problem	Baseline to 6 months
Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months	Patient report that side effect is a problem	Baseline to 6 months
Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months	Patient report that side effect is a problem	Baseline to 6 months
Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months	Patient report that side effect is a problem	Baseline to 6 months
Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months	Patient report that activity is helpful for BP self-management	Baseline to 6 months
Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months	Patient report that activity is helpful for BP self-management	Baseline to 6 months
Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months	Patient report that activity is helpful for BP self management	Baseline to 6 months
Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months	Patient report that activity is helpful for BP self management	Baseline to 6 months
Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months	Patient report that activity is helpful for BP self management	Baseline to 6 months
Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months	Patient report that burden is a problem	Baseline to 6 months
Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months	Patient report that burden is a problem	Baseline to 6 months
Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months	Patient report that burden is a problem	Baseline to 6 months
Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months	Patient report that burden is a problem	Baseline to 6 months
Number of Participants Reporting Measuring BP as BP Care Burden at Six Months	Patient report that burden is a problem	Baseline to 6 months
Number of Participants Reporting Phone Visits as BP Care Burden at Six Months	Patient report that burden is a problem	Baseline to 6 months
Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months	Patient report that burden is a problem	Baseline to 6 months
Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months	Patient report that burden is a problem	Baseline to 6 months
Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team	Patient reported "very" or "extremely" confident in this aspect of BP management.	Baseline to 6 months
Number of Participants Reporting High Confidence in Keeping BP Below Target at Six Months	Patient reported "very" or "extremely" confident in this aspect of BP management.	Baseline to 6 months
Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months	Patient reported "very" or "extremely" confident in this aspect of BP management	Baseline to 6 months
Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months	Patient reported "very" or "extremely" confident in this aspect of BP management	Baseline to 6 months
Number of Participants Reporting High Confidence in Taking BP Medications at Six Months	Patient reported "very" or "extremely" confident in this aspect of BP management	Baseline to 6 months
Number of Participants With Statin Addition at 12 Months	New statin medication current at 12 months	Baseline to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure	change in diastolic BP, collected from medical records	Trajectory, 6,12 and 24 months
Lipid Levels	element of cardiovascular risk models, collected from medical records	Trajectory, 12 and 24 months
Statin Use (yes/no)	element of cardiovascular risk models, collected from medical records	Baseline and 24 months
Smoking status (yes/no)	element of cardiovascular risk models, collected from medical records	Baseline, 6, 12, and 24 months
10 year cardiovascular event risk (for patients ages 40-85)	Predictive risk model using individual elements of cardiovascular risk collected from medical records	Trajectory over 12 and 24 months
30 year cardiovascular event risk (for patients ages 18-39)	Predictive risk model using individual elements of cardiovascular risk collected from medical records	Trajectory over 12 and 24 months
Lab abnormalities related to hypertension and anti-hypertensive drug treatment	Collected from medical records	Trajectory over 12 and 24 months
Hypotension or fainting diagnosis codes	Diagnosis codes collected from medical records	Any occurrence between baseline and 24 months

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Karen Margolis, MD, HealthPartners Institution

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): April 17, 2020
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimated): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Telehealth; Pharmacist; Home blood pressure monitoring; Team-based care; Clinic care; Medication Therapy Management (MTM); Cluster-randomized
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HealthPartners Institute

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will provide a de-identified, individual-level dataset to PCORI if requested at the end of the study. The dataset will be made publicly available and will contain no identifying information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No