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Testing the Impact of Pre-visit Priming for Medications

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Mass General Brigham

Status

Begins enrollment this month

Conditions

Deprescribing
Statin Prescribing

Treatments

Behavioral: Pre-visit prompts

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07281131
2025P003030
5P30AG024968 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

1,700 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,700 participants in 2 patient groups

Pre-visit patient prompts
Experimental group
Description:
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.
Treatment:
Behavioral: Pre-visit prompts
Usual Care
No Intervention group
Description:
No intervention delivery outside of regular clinical practice.

Trial contacts and locations

0

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Central trial contact

Julie C Lauffenburger, PharmD, PhD

Data sourced from clinicaltrials.gov

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