UCSF BP Activate Letter Study

Hypertension Clinical Trial

Official title:

UCSF BP Activate Letter Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06152094
• Other study ID #: 22-37619
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The BP Activate Study aims to assess the effectiveness of the BP Report letter with personalized BP medication recommendations, compared with Control letters and no intervention, at shortening time to appointment, time to visit, time to medication change, and time to achievement of BP goal.

Description:

The BP Activate Study is a randomized quality improvement trial. We will deliver one of two versions of a letter to established English-speaking primary care patients at Mt Zion with uncontrolled hypertension, defined by SBP>140 or DBP>90 in the past two years (identified via EHR). The letter will prompt patients to schedule a visit with their provider or team nurse practitioner to discuss their BP recommendations with their clinician. We will test 2 versions of the letter and a usual care control:

1. The "BP Activate Report Letter" group will get a letter that presents recommendations for medication changes from a computerized algorithm using the patient's medical records and recommends discussing these specific recommendations with their clinician; or

2. The "Control Letter" group will get a letter that suggests they talk to their clinician about their BP without providing any specific medication recommendations.

3. The "Usual Care" group will not receive any intervention.

This primary goal of the study is to assess the effectiveness of the BP Activate Report Letter compared with the Control Letter, and see if it shortens time to appointment, time to visit, time to medication change (primary outcome), and time to achievement of BP goal. Clinicians, with patient input, will still have full control of how BP is clinically managed. A small number of patients will be contacted by a research coordinator to hear what they thought when they received the letter, and why they did or did not act upon the information.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 484
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is a primary care patient of a clinician in a general internal medicine clinic who has agreed to have their patients participate in the study

• Lowest SBP>140 or lowest DBP>90 at last visit in general internal medicine clinic

• Last visit in general internal medicine clinic was < 2 years ago

• EngageRx algorithm determines that a medication intensification step is indicated

Exclusion Criteria:

• Primary language is not English

• Patient's provider indicates (through an active opt-out process) that they do not want the patient to receive a BP Activate letter

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• BP Activate Letter
Participants in the BP Activate Letter arm will receive a BP Activate Report that includes personalized details about recent measurements, current medications, and "computer-generated medication recommendations that might improve your blood pressure", along with a log for tracking additional SMBP measurements. They will also receive a cover letter that includes an assessment that BP appears to be uncontrolled, and suggesting a visit with their provider to discuss.
• Control Letter
Participants in the Control Letter arm will receive a cover letter that includes an assessment that BP appears to be uncontrolled, and suggesting a visit with their provider to discuss.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to medication change or demonstrated BP control at 6 months	Time is measured as number of days between randomization date and the day that a participant is prescribed a new anti-HTN medication or an increase in dose of a prior anti-HTN medication, or they have a documented BP measurement <140 mmHg systolic and <90 mmHg diastolic.	6 months
Secondary	Time to medication change or demonstrated BP control at 3 months	Time is measured as number of days between randomization date and the day that a participant is prescribed a new anti-HTN medication or an increase in dose of a prior anti-HTN medication, or they have a documented BP measurement <140 mmHg systolic and <90 mmHg diastolic.	3 months
Secondary	Time to completed visit at 3 months	Time to medication change is defined as number of days between randomization and the day the participant completes a visit in the Division of General Internal Medicine.	3 months
Secondary	Time to BP goal at 3 months	Time is defined as number of days from randomization until first documentation of a BP measurement <140 mmHg systolic and <90 mmHg diastolic.	3 months
Secondary	Time to medication change at 3 months	Time is measured as number of days between randomization date and the day that a participant is prescribed a new anti-HTN medication or an increase in dose of a prior anti-HTN medication.	3 months
Secondary	Time to completed visit at 6 months	Time to medication change is defined as number of days between randomization and the day the participant completes a visit in the Division of General Internal Medicine.	6 months
Secondary	Time to BP goal at 6 months	Time is defined as number of days from randomization until first documentation of a BP measurement <140 mmHg systolic and <90 mmHg diastolic.	6 months
Secondary	Time to medication change at 6 months	Time is measured as number of days between randomization date and the day that a participant is prescribed a new anti-HTN medication or an increase in dose of a prior anti-HTN medication.	6 months