Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Northwestern University
- Enrollment
- 1,304
- Locations
- 1
- Primary Endpoint
- Systolic blood pressure at 12 months
Study Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of automatically-generated medical advice to patients about to their home blood pressure monitoring results sent through patient portal messages compared to no automated advice and the effectiveness of automated transmission of remotely-obtained blood pressure values compared to self-reported values on systolic blood pressure at 1-year follow up in patients with uncontrolled hypertension whose physicians or advance practice providers provide primary care at Northwestern Medicine. Persistence of effects through 18 months will also be assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-84 years at enrollment date
- •Receives hypertension care primarily from a participating clinician
- •Blood pressure on the two most recent days when ambulatory clinic blood pressure was obtained prior to patient identification to was ≥140 mm Hg systolic and/or ≥90 diastolic or last ambulatory clinic blood pressure was ≥150 mm Hg systolic and/or ≥95 diastolic
- •Currently has or is willing to obtain a patient portal account from NM.
Exclusion Criteria
- •Dementia,
- •Nursing home resident,
- •Stage 5 chronic kidney disease or renal replacement therapy,
- •Pregnancy,
- •Receiving hospice,
- •Not planning to continue to receive hypertension care from NM clinician for the next year,
- •Planning to move from the region in the next year,
- •Planning to change clinician treating their hypertension in the next year,
- •Medical or psychological reason they cannot perform home blood pressure monitoring.
- •Known to have average home blood pressure or most recent home blood pressure value of <130/80 mm Hg.
- •CLINICIAN PARTICIPANT INCLUSION Physician, advanced practice nurse or physician assistant working at a Northwestern Medicine ambulatory primary care site that cares for adults with hypertension (family medicine, internal medicine, medicine/pediatrics, and ambulatory geriatrics sites).
- •CLINICIAN PARTICIPANT EXCLUSION
- •Primary care physicians and clinicians not willing for their patients to participate in study
- •Planning to depart NM within the next year
- •Not willing to receive patients' out-of-office blood pressure data
Arms & Interventions
Automated Transmission of Remotely Monitored Blood Pressure
Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record.
Intervention: Automated Transmission of Remotely Measured Blood Pressure (Other)
Enhanced Usual Care
Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal.
Intervention: Self report of home measured blood pressure via patient EHR portal (Other)
Automated Patient Feedback on Self Blood Pressure Monitoring
Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal. Participants receive messages through the EHR patient portal about their home blood pressure results.
Intervention: Self report of home measured blood pressure via patient EHR portal (Other)
Automated Patient Feedback on Self Blood Pressure Monitoring
Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal. Participants receive messages through the EHR patient portal about their home blood pressure results.
Intervention: Automated feedback about home blood pressure results (Other)
Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback
Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record. Participants receive messages through the EHR patient portal about their home blood pressure results.
Intervention: Automated feedback about home blood pressure results (Other)
Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback
Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record. Participants receive messages through the EHR patient portal about their home blood pressure results.
Intervention: Automated Transmission of Remotely Measured Blood Pressure (Other)
Outcomes
Primary Outcomes
Systolic blood pressure at 12 months
Time Frame: 12 months
Secondary Outcomes
- Systolic blood pressure at 18 months(18 months)
- Antihypertensive medication changes from baseline(From baseline to 12 months and 18 months)
- Antihypertensive medication classes prescribed, standardized count(12 months and 18 months)
- Medication adherence (patient report, Domains of Subjective Extent of Nonadhernece)(12 months and 18 months)
- Diastolic blood pressure(12 months and 18 months)
- Blood pressure <130/80 mm Hg(12 months and 18 months)
- Blood pressure <140/90 mm Hg(12 months and and 18 months)
Investigators
Stephen Persell, MD, MPH
Professor of Medicine
Northwestern University