Virtual Hypertension Management Pilot

Virtual Hypertension Management Pilot: Randomized Evaluation of Electronic Health Record-connected Blood Pressure Cuffs in a Clinical Pharmacist Panel.

Investigators are examining the quality improvement impact of providing patients with a an electronic health record-connected blood pressure cuff. Investigators will give half of patients already eligible for hypertension management within a clinical pharmacist panel, the ability to upload their blood pressure data into Stanford's electronic health record.

Study Overview

• Status: Completed
• Conditions: Hypertension; Electronic Health Record; Digital Health
• Intervention / Treatment: Other: Usual care; Other: Connected-device

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Portola Valley, California, United States, 94028
      • Stanford Primary Care
    • Santa Clara, California, United States, 95054
      • Stanford Primary Care Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hypertension as defined by clinical pharmacist usual care panel (2 or more readings of blood pressure >140/90)

Exclusion Criteria:

• Pregnancy
• Chronic kidney disease III or IV
• Systolic heart failure with ejection fraction <35%
• Current use of 3 or more anti-hypertension drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; This arm will consist of the usual care of management of hypertension by a clinical pharmacist.	Other: Usual care; This intervention will consist of usual clinical care as determined by the clinical pharmacist.
Active Comparator: Intervention; This arm will consistent of usual care plus the addition of a blood pressure cuff that will allow patients to upload data to the electronic health record via a secure portal.	Other: Connected-device; This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure over time in control group vs. the intervention group	Difference in the change in blood pressure between the control group and intervention group.	From enrollment to 6 months later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient visits	Measurement of the number of in-person visits	From enrollment to 6 months later
Patient remote interactions	Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist	From enrollment to 6 months later
Medication changes	Number of changes in medication or medication dose	From enrollment to 6 months later
Blood pressure control	Time to reach target blood pressure control (Adults 18-59 years of age <140/90 mm Hg, Adults 60-85 years of age, without a diagnosis of diabetes, <150/90 mm Hg, Adults 60-85 years of age, with a diagnosis of diabetes, <140/90 mm Hg)	From enrollment to 6 months later

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2017
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 12397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided, this is a quality improvement project.

Drug and device information, study documents

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