Clinical trial NCT02996565: Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
Official title: Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Clinic care
Team-based care
Medication Therapy Management (MTM)
Telehealth
Cluster-randomized
Home blood pressure monitoring
Pharmacist
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-12-19
Enrollment: 3071
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)
timeFrame: Trajectory over 12 months
Secondary outcomes:
measure: Change in Diastolic BP Between Baseline and 12 Months (mm Hg)
timeFrame: Trajectory over 12 months
measure: Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up
timeFrame: Baseline to 6 months
measure: Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.
timeFrame: Baseline to 6 months
measure: Number of Participants Who Are Current Smokers at Twelve Months
timeFrame: Baseline to 12 months
measure: Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Measuring BP as BP Care Burden at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Phone Visits as BP Care Burden at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting High Confidence in Keeping BP Below Target at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants Reporting High Confidence in Taking BP Medications at Six Months
timeFrame: Baseline to 6 months
measure: Number of Participants With Statin Addition at 12 Months
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: HealthPartners Institute
state: Minnesota
Study officials:
affiliation: HealthPartners Institution
name: Karen Margolis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.