Testing the Impact of Pre-visit Priming for Medications

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Completion of medication prescribing/deprescribing target on day of PCP visit [Time frame: 1 day]

Secondary outcome measures (1)

• Completion of medication prescribing/deprescribing target within 60 days [Time frame: 60 days]

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):

• 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
• 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)
• Current or recent prescription for a statin or PCSK9-inhibitor or bempedoic acid
• Primary language recorded other than English or Spanish

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

United States · 1 center

• Mass General Brigham — Boston

Identifiers

NCT: NCT07281131 · 2025P003030 · 5P30AG024968

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗