NCT03291535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

4.6 years

First QC Date

August 17, 2017

Last Update Submit

August 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient visits

    From enrollment to 6 months later

  • Patient remote interactions

    From enrollment to 6 months later

  • Medication changes

    From enrollment to 6 months later

  • Blood pressure control

    From enrollment to 6 months later

Study Arms (2)

Control

PLACEBO COMPARATOR

This arm will consist of the usual care of management of hypertension by a clinical pharmacist.

Other: Usual care

Intervention

ACTIVE COMPARATOR

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

Interventions

This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.

Intervention

This intervention will consist of usual clinical care as determined by the clinical pharmacist.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford Primary Care

Portola Valley, California, 94028, United States

Location

Stanford Primary Care Clinic

Santa Clara, California, 95054, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Medicine

Study Record Dates

First Submitted

August 17, 2017

First Posted

September 25, 2017

Study Start

July 26, 2017

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

August 19, 2022

Record last verified: 2022-08

Locations