A Pilot Study of Hypertension Management Using Remote Patient Monitoring

NCT04604925 | Completed

• 1 other identifier: STU00213093
• Study Type: observational
• Target: 7,068
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a pragmatic pilot test of a remote patient monitoring system (RPM) for blood pressure measurement for Medicare patients with hypertension. The primary objective is to better understand how patients' remote monitoring of blood pressure and the direct transmission of this data to a healthcare system's EHR can be used by the patient and the care team to support optimal hypertension care. This pilot study which we will conduct in two Northwestern Medical Group (NMG) primary care practices will: evaluate the integration of Omron's remote monitoring system into Northwestern Medicine's electronic health record (so that clinical data can flow directly from the patient's monitor to the EHR), evaluate the use of billing work flows for covered Medicare services, build and deploy clinical decision support to aid with patient identification and ordering of the remote patient monitoring system, and evaluate the uptake and clinical effects of this system in the pilot practices compared to matched patients selected from non-pilot control practices. The investigators will conduct a pragmatic non-blinded, non-randomized pilot study with contemporaneous controls among NMG outpatient clinics that provide adult primary care. They will make comparisons of data obtained through the course of routine care delivery from pilot and non-pilot practices.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Performance measure Controlling High Blood Pressure (NQF 0018)

  Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period \<140/90 mm Hg

  6 months

• Systolic blood pressure at the most recent office visit

  Systolic blood pressure at the most recent office visit (mm Hg)

  6 months

Secondary Outcomes (6)

• Antihypertensive medication intensification

  6 months

• Antihypertensive medication intensification

  3 months

• Performance measure Controlling High Blood Pressure (NQF 0018)

  3 month

• Performance measure Controlling High Blood Pressure (NQF 0018)

  1 month

• Systolic blood pressure at the most recent office visit

  3 months

Study Arms (2)

Remote patient monitoring for hypertension

RPM Integration: All intervention practices will receive communication by email explaining RPM procedures, ordering, use, and financial implications. We will also present this information at practice meetings. Primary care clinicians at these sites will receive clinical decision support (Epic Best Practice Alert) for patients meeting primary or secondary eligibility criteria. It will be at the discretion of the primary care clinicians when to offer or refer patients to RPM.

Behavioral: Remote patient monitoring for hypertension

Usual care

Matching patients from control practices will be selected from remaining Northwestern Medical Group primary care sites and be chosen to provide as sufficiently large number of eligible patients for comparison. These groups will contribute EHR data through the NM EDW but will not have any new procedures put in place

Interventions

Remote patient monitoring for hypertension BEHAVIORAL

Intervention involves practices making available remote physiologic monitoring treatment management services allowable under Medicare for blood pressure (and weight if desired) to Medicare patients in the practice when ordered by the patient's clinician.

Remote patient monitoring for hypertension

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will take place in several Northwestern Medicine Group outpatient primary care clinic settings. Patients at these practices will be eligible for inclusion in the primary study population if they have diagnosed hypertension, are 65 to 85 years old, have Medicare insurance, and have their last two prior office blood pressures ≥140 mm Hg systolic or ≥90 mm Hg diastolic. Patients at these practices will be eligible for inclusion in the secondary study population if either they meet the inclusion criteria for the primary population or they are 65 to 85 years old, have Medicare insurance and either have diagnosed hypertension but do not have their last two office blood pressures prior ≥140 mm Hg systolic or ≥90 mm Hg diastolic, or they do not have hypertension diagnosed and have their most recent prior office blood pressure ≥140 mm Hg systolic or ≥90 mm Hg diastolic.

You may qualify if:

• Adults aged 65 to 85 years at the time of the study start date
• Receive their primary care from an eligible Northwestern Medicine clinic site
• One or more office or telehealth visits in the year preceding the study start date
• Last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic
• Diagnosis of hypertension in the year preceding the study start date (problem list or encounter diagnosis)
• Meet criteria for primary population OR
• Diagnosed hypertension but did not have the last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic OR
• No diagnosis of hypertension in the past year but did have the last office blood pressure ≥140 mm Hg systolic or ≥90 mmHg diastolic

You may not qualify if:

• Stage IV or more severe kidney disease, defined as estimated glomerular filtration rate \<30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)
• Diagnosis of dementia as indicated in the electronic health record

Sponsors & Collaborators

• Northwestern University: lead
• Omron Healthcare Co., Ltd.: collaborator

Study Sites (1)

Northwestern University, Division of General Internal Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Petito LC, Anthony L, Peprah YA, Lee JY, Li J, Sato H, Persell SD. Remote physiologic monitoring for hypertension in primary care: a prospective pragmatic pilot study in electronic health records using propensity score matching. JAMIA Open. 2023 Jan 31;6(1):ooac111. doi: 10.1093/jamiaopen/ooac111. eCollection 2023 Apr.

  PMID: 36743315 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Stephen D Persell, MD/MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division of General Internal Medicine & Geriatrics

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 27, 2020
• Study Start: November 19, 2020
• Primary Completion: August 14, 2021
• Study Completion: January 31, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

US (1)