Testing the Impact of Pre-visit Priming for Medications

Testing the Impact of Pre-visit Priming as a Mechanism Across Multiple Medication Use Behavioral Targets in Primary Care Practice

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Deprescribing; Statin Prescribing
• Intervention / Treatment: Behavioral: Pre-visit prompts

• Study Type: Interventional
• Enrollment (Estimated): 1700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie C Lauffenburger, PharmD, PhD; Phone Number: 617-525-8865; Email: jlauffenburger@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Usual Care; No intervention delivery outside of regular clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of medication prescribing/deprescribing target within 60 days	The secondary clinical outcome will be measured within the 60-day follow-up on or after the primary care provider (PCP) visit through EHR data, depending on medication target: a) discontinuation or taper, or b) statin prescribing.	60 days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute on Aging (NIA); University of Southern California

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 14, 2026

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025P003030; 5P30AG024968 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The project will result in a Limited Data Set and a de-identified data set of the outcomes, intervention arms, and sociodemographic and clinical characteristics.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No