Clinical trial NCT06152094: UCSF BP Activate Letter Study
Official title: UCSF BP Activate Letter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to medication change or demonstrated BP control at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Time to medication change or demonstrated BP control at 3 months
timeFrame: 3 months
measure: Time to completed visit at 3 months
timeFrame: 3 months
measure: Time to BP goal at 3 months
timeFrame: 3 months
measure: Time to medication change at 3 months
timeFrame: 3 months
measure: Time to completed visit at 6 months
timeFrame: 6 months
measure: Time to BP goal at 6 months
timeFrame: 6 months
measure: Time to medication change at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mark Pletcher, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: