Back to resultsVirtual Hypertension Management Pilot
Primary Purpose
Hypertension, Electronic Health Record, Digital Health
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Connected-device
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility Criteria
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
Sites / Locations
- Stanford Primary Care
- Stanford Primary Care Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Intervention
Arm Description
This arm will consist of the usual care of management of hypertension by a clinical pharmacist.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient visits
Measurement of the number of in-person visits
Patient remote interactions
Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist
Medication changes
Number of changes in medication or medication dose
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03291535
Brief Title
Virtual Hypertension Management Pilot
Official Title
Virtual Hypertension Management Pilot: Randomized Evaluation of Electronic Health Record-connected Blood Pressure Cuffs in a Clinical Pharmacist Panel.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Electronic Health Record, Digital Health
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This arm will consist of the usual care of management of hypertension by a clinical pharmacist.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Connected-device
Intervention Description
This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
This intervention will consist of usual clinical care as determined by the clinical pharmacist.
Primary Outcome Measure Information:
Title
Change in blood pressure over time in control group vs. the intervention group
Description
Difference in the change in blood pressure between the control group and intervention group.
Time Frame
From enrollment to 6 months later
Secondary Outcome Measure Information:
Title
Patient visits
Description
Measurement of the number of in-person visits
Time Frame
From enrollment to 6 months later
Title
Patient remote interactions
Description
Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist
Time Frame
From enrollment to 6 months later
Title
Medication changes
Description
Number of changes in medication or medication dose
Time Frame
From enrollment to 6 months later
Title
Blood pressure control
Description
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)
Time Frame
From enrollment to 6 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford Primary Care
City
Portola Valley
State/Province
California
ZIP/Postal Code
94028
Country
United States
Facility Name
Stanford Primary Care Clinic
City
Santa Clara
State/Province
California
ZIP/Postal Code
95054
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided, this is a quality improvement project.
Learn more about this trial
Virtual Hypertension Management Pilot
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