Testing the Impact of Pre-visit Priming for Medications

NCT ID: NCT07281131

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-02
• Study Completion Date: 2026-09-30

Brief Summary

We will use EHR data to identify eligible patients at BWH primary care clinics. Patients will be eligible if they have an upcoming primary care provider (PCP) appointment at an included BWH clinic, are ≥65 years, and are eligible for a medication target; exclusion criteria will include relevant EHR-documented allergies. After sharing patients with PCPs for potential opt-out, patients will be randomized 1:1 in REDCap® to intervention or usual care (no prompt). The intervention will include a pre-visit patient-facing prompt with information about the evidence-based medication target. If patients are eligible for multiple targets, one will be randomly selected. The primary clinical outcome will be measured on the day of the PCP visit using EHR data, depending on target: a) discontinuation or tapering order, or b) prescribing. Secondary outcomes will include a) these same measures in a 60-day follow-up period after the visit to capture any follow-up actions. We will use an intention-to-treat approach including patients regardless of whether the visit occurred. We plan to conduct the trial until 1700 patients are reached. We will also conduct exploratory mediation analyses of mechanisms through brief patient surveys with behavioral scales and PCP survey.

Conditions

Deprescribing; Statin Prescribing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Pre-visit patient prompts

The intervention itself is a pre-visit prompt delivered prior to upcoming visits that includes a brief recommendation to the patient to discuss the medication use target with the PCP at the visit and a handout about the medication.

Group Type: EXPERIMENTAL

Pre-visit prompts

Intervention Type: BEHAVIORAL

The intervention itself is a pre-visit prompt delivered prior to upcoming visits that includes a brief recommendation to the patient to discuss the medication use target with the PCP at the visit and a handout about the medication. The medication targets include potentially-inappropriate medications and statin prescribing.

Usual Care

No intervention delivery outside of regular clinical practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pre-visit prompts

The intervention itself is a pre-visit prompt delivered prior to upcoming visits that includes a brief recommendation to the patient to discuss the medication use target with the PCP at the visit and a handout about the medication. The medication targets include potentially-inappropriate medications and statin prescribing.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥65 years of age
• Have an upcoming clinic appointment with a BWH PCP at one of the included clinics

In addition, they must meet the following eligibility criteria for at least one medication target behavior (based on EHR data):

1. Statin use for primary prevention (65-75 years of age): Having a EHR diagnosis or problem list documentation of: diabetes, hypertension, smoking, or high cholesterol and estimated eligible cardiovascular risk and no current outpatient prescription for a statin

2. High-risk medication use (≥65 years of age): Have an active outpatient prescription for ≥1 medication on the American Geriatrics Society Beers Criteria® List for Avoid Medications based on EHR records

Exclusion Criteria

• Documented allergy to one of the components (statin).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julie Lauffenburger

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Julie C Lauffenburger, PharmD, PhD

Role: CONTACT

jlauffenburger@bwh.harvard.edu

617-525-8865

Other Identifiers

5P30AG024968

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P003030

Identifier Type: -

Identifier Source: org_study_id