UCSF BP Activate Letter Study

NCT ID: NCT06152094

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BP Activate Letter

Participants in the BP Activate Letter arm will receive a BP Report letter that includes computerized algorithm recommendations for medication changes they should discuss with their clinician.

Group Type EXPERIMENTAL

BP Activate Letter

Intervention Type OTHER

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 Control letter suggesting they talk to their clinician about their blood pressure (without BP history or specific medication recommendations).

Group Type ACTIVE_COMPARATOR

Control Letter

Intervention Type OTHER

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.

Usual Care

Participants in the Usual Care arm will not receive any letter or any other intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Pletcher, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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22-37619

Identifier Type: -

Identifier Source: org_study_id

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