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Virtual Hypertension Management Pilot

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ClinicalTrials.gov Identifier: NCT03291535
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
N. Lance Downing, MD, Stanford University

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.

Condition or disease Intervention/treatment Phase
Hypertension Electronic Health Record Digital Health Other: Connected-device Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Virtual Hypertension Management Pilot: Randomized Evaluation of Electronic Health Record-connected Blood Pressure Cuffs in a Clinical Pharmacist Panel.
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in blood pressure over time in control group vs. the intervention group [ Time Frame: From enrollment to 6 months later ]
    Difference in the change in blood pressure between the control group and intervention group.


Secondary Outcome Measures :
  1. Patient visits [ Time Frame: From enrollment to 6 months later ]
    Measurement of the number of in-person visits

  2. Patient remote interactions [ Time Frame: From enrollment to 6 months later ]
    Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist

  3. Medication changes [ Time Frame: From enrollment to 6 months later ]
    Number of changes in medication or medication dose

  4. Blood pressure control [ Time Frame: From enrollment to 6 months later ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291535


Contacts
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Contact: Norman Downing, MD 650-723-6000 ldowning@stanford.edu

Locations
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United States, California
Stanford Primary Care Recruiting
Portola Valley, California, United States, 94028
Contact: Vanessa Guzman, PharmD    650-498-9000    uzman@stanfordhealthcare.org   
Stanford Primary Care Clinic Recruiting
Santa Clara, California, United States, 95054
Contact: Marcie Levine, MD    408-688-9721    mlevine@stanford.edu   
Sponsors and Collaborators
Stanford University

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Responsible Party: N. Lance Downing, MD, Clinical Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03291535     History of Changes
Other Study ID Numbers: 12397
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided, this is a quality improvement project.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases