Testing the Impact of Pre-visit Priming for Medications

NCT07281131 | Not Yet Recruiting

• 2 other identifiers: 2025P0030305P30AG024968
• Study Type: interventional
• Target: 1,700
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Completion of medication prescribing/deprescribing target on day of PCP visit

  The primary clinical outcome will be measured on the day of the primary care provider (PCP) visit through EHR data, depending on medication target: a) discontinuation or taper, or b) statin prescribing.

  1 day

Secondary Outcomes (1)

• Completion of medication prescribing/deprescribing target within 60 days

  60 days

Study Arms (2)

Pre-visit patient prompts

EXPERIMENTAL

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.

Behavioral: Pre-visit prompts

Usual Care

NO INTERVENTION

No intervention delivery outside of regular clinical practice.

Interventions

Pre-visit prompts 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.

Pre-visit patient prompts

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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):
• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator
• University of Southern California: collaborator

Central Study Contacts

Julie C Lauffenburger, PharmD, PhD

CONTACT

617-525-8865; jlauffenburger@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 15, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: These data will be available upon request. To the extent the context of data collection can be revealed without compromising privacy and identity of research participants, it will be included. Algorithms and other programming code used to identify patients for the study and evaluate study outcomes will be available upon request. We will also provide the underlying logic to build the tools to other health systems upon request.
• Access Criteria: Data will be controlled access with the General Research Use Data Use Limitation, as allowed by the informed consent and the institutional certification, anticipated through the Aging Research Biobank.