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临床试验/NCT07281131
NCT07281131尚未招募不适用

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

Brigham and Women's Hospital0 个研究点目标入组 1,700 人开始时间: 2026年3月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,700
主要终点
Completion of medication prescribing/deprescribing target on day of PCP visit

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥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

排除标准

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

研究组 & 干预措施

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.

干预措施: Pre-visit prompts (Behavioral)

Usual Care

No Intervention

No intervention delivery outside of regular clinical practice.

结局指标

主要结局

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

时间窗: 1 day

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.

次要结局

  • Completion of medication prescribing/deprescribing target within 60 days(60 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Lauffenburger

Associate Professor

Brigham and Women's Hospital

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