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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996565
• Other study ID #: HealthPartners Institute
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2020
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3072
• Est. completion date: June 30, 2021
• Est. primary completion date: April 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

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.
• 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

Locations

Country	Name	City	State
United States	HealthPartners Institute	Bloomington	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diastolic Blood Pressure	change in diastolic BP, collected from medical records	Trajectory, 6,12 and 24 months
Other	Lipid Levels	element of cardiovascular risk models, collected from medical records	Trajectory, 12 and 24 months
Other	Statin Use (yes/no)	element of cardiovascular risk models, collected from medical records	Baseline and 24 months
Other	Smoking status (yes/no)	element of cardiovascular risk models, collected from medical records	Baseline, 6, 12, and 24 months
Other	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
Other	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
Other	Lab abnormalities related to hypertension and anti-hypertensive drug treatment	Collected from medical records	Trajectory over 12 and 24 months
Other	Hypotension or fainting diagnosis codes	Diagnosis codes collected from medical records	Any occurrence between baseline and 24 months
Primary	Systolic Blood Pressure	Change in systolic BP, collected from medical records	Trajectory over 12 months
Secondary	Self-reported side-effects of antihypertensive medications	Questionnaire measure	Change between baseline and 6 months
Secondary	Self-reported patient experience/satisfaction with care	Questionnaire measure	Change between baseline and 6 months
Secondary	Self-reported confidence in self-management of blood pressure	Questionnaire measure	Change between baseline and 6 months