Hypertension Management Using Remote Patient Monitoring

A Pilot Study of Hypertension Management Using Remote Patient Monitoring- Extended Follow Up Using Matched Cohort Design

A longer-term follow-up of patients with remote patient monitoring ordered from the initial six pilot primary care clinics (from the prior study periods: Study 1 and Study 2) will be performed and compared to a cohort of patients without RPM orders, matched on clinical and demographic characteristics, from the same six pilot primary care clinics, to serve as contemporary controls.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Cases-remote patient monitoring prescribed; Behavioral: Controls-ususal care

• Study Type: Observational
• Enrollment (Actual): 1440

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 106 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Case population includes patients with RPM for blood pressure ordered from the six pilot primary care clinics between November 18, 2018 and August 14, 2021, are 65 to 85 years old, and have Medicare insurance.

Control population are patients selected from the same practices using propensity score matching who were not prescribed RPM for blood pressure.

Description

Inclusion Criteria Cases Patients from any of 6 primary care sites that participated in remote monitoring pilots who had remote patient monitoring (RPM) ordered by a primary care clinician between November 18, 2018 and August 14, 2021

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Exclusion Criteria:

• Patients whose RPM ordered by non-primary care clinics

Matching cohort Inclusion

• Patients from the six pilot clinics AND
• Meet the matching criteria Exclusion
• Patients with any RPM order between between November 18, 2018 and August 14, 2021

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	Behavioral: Controls-ususal care; Controls: patients who did not receive remote patient monitoring for blood pressure prescribed during routine care delivery, with multivariable matching to cases
Case	Behavioral: Cases-remote patient monitoring prescribed; Cases: patients prescribed remote patient monitoring for blood pressure during routing care delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Controlling High Blood Pressure (NQF 0018)	Proportion of patients who satisfy the performance measure Controlling High Blood Pressure (NQF 0018), last BP done within 1 year and is less than 140/90 mm Hg	18 months
Controlling High Blood Pressure (NQF 0018)	Proportion of patients who satisfy the performance measure Controlling High Blood Pressure (NQF 0018), last BP done within 1 year and is less than 140/90 mm Hg	15 months
Controlling High Blood Pressure (NQF 0018)	Proportion of patients who satisfy the performance measure Controlling High Blood Pressure (NQF 0018), last BP done within 1 year and is less than 140/90 mm Hg	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antihypertensive medication intensification	Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued	18 months
Antihypertensive medication intensification	Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued	15 months
Antihypertensive medication intensification	Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean SBP at most recent office visit	Mean SBP at most recent office visit	18 months
Mean SBP at most recent office visit	Mean SBP at most recent office visit	15 months
Mean SBP at most recent office visit	Mean SBP at most recent office visit	12 months
Mean SBP on most recent measurement date (office or out of office)	Mean SBP on most recent measurement date (office or out of office)	18 months
Mean SBP on most recent measurement date (office or out of office)	Mean SBP on most recent measurement date (office or out of office)	15 months
Mean SBP on most recent measurement date (office or out of office)	Mean SBP on most recent measurement date (office or out of office)	12 months
Ambulatory care utilization--office visits	Count of primary care office visits during time frame	18 months
Ambulatory care utilization--telephone calls	Count of primary care telephone encounters during time frame	18 months
Ambulatory care utilization--patient portal messages	Count of primary care patient portal encounters during time frame	18 months
Proportion of patients with an increase in serum creatinine of ≥30%	Proportion of patients with an increase in serum creatinine of ≥30%	18 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Omron Healthcare Co., Ltd.
• Investigators: Principal Investigator: Stephen D Persell, MD/MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2018
• Primary Completion (Actual): August 14, 2022
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: STU00213093-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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