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临床试验/NCT05299528
NCT05299528已完成不适用

A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
2
主要终点
Percentage of Surgeons Approached Who Agree to Participate

研究概览

简要总结

This is a pilot single site randomized controlled trial to assess the feasibility and acceptability of a nudging intervention providing surgeons with procedure-specific feedback regarding patients' postoperative opioid prescription-to-consumption ratio in individuals 18 years of age and older.

详细描述

The trial will randomize surgeons to either intervention (direct feedback) or control (no direct feedback) arms. Surgeons who frequently performing specific elective general, gynecologic, orthopedic, and neurologic surgeries at Vanderbilt University Medical Center will be identified during a 30-day study lead-in period. Then, patients aged at least 18 years undergoing these surgeries at VUMC during study days 1-60 will be contacted by telephone 14 days postoperatively (study days 15-74) and asked to perform an opioid pill count; they will also be asked about opioid refills, satisfaction with analgesia, emergency room visits or hospitalizations for pain, and opioid misuse. The electronic medical record will be also queried for the size of the initial postoperative opioid prescription as well as evidence of any refills for each enrolled subject. Following the first block of surgeries and associated patient follow-up (study days 1-74), data will be analyzed and then surgeons will be randomized in a 1:1 ratio to the intervention or control arms. Randomization will be stratified by both surgical specialty and by mean opioid prescription size during the initial block of surgeries. After study day 97, surgeons in the intervention arm will be provided procedure-specific direct feedback on opioid prescribing and consumption for their patients who had surgery during days 1-60.

After this intervention, the trial will assess pre-post change in opioid prescription size (measured in oral morphine equivalents) from baseline between the two groups for surgeries performed during days 108-167.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Direct Feedback

Experimental

On approximately study day 97, surgeon participants will receive procedure-specific direct feedback through electronic and written communication, on patients' opioid consumption-to-prescription ratio. Surgeon participants who perform more than 1 of the specified procedures will receive nudging communications for each individual procedure.

干预措施: Direct Feedback (Behavioral)

No Direct Feedback

No Intervention

Surgeon participants randomized to No Direct Feedback will not be contacted directly at any time in the study and will not receive feedback about patients' opioid consumption-to-prescription ratio.

结局指标

主要结局

Percentage of Surgeons Approached Who Agree to Participate

时间窗: At consent (study days -30 to 0)

Feasibility outcome: Percentage of surgeons approached who agree to participate in study

Percentage of Patients Contacted Who Agree to Participate in Study

时间窗: At consent (single time during study days 15-74 (group 1) or 122-181 (group 2))

Feasibility outcome: Percentage of patients contacted who agree to participate in study

Surgeon-reported Acceptability of Intervention

时间窗: Post intervention (once on study day 181)

Acceptability outcome: Surgeon-reported acceptability of intervention as measured by a "yes" response to the question "Would you find receiving such feedback on your patients' opioid consumption acceptable?"

次要结局

未报告次要终点

研究者

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

Daniel Larach

Asst Professor of Anesthesiology

Vanderbilt University Medical Center

研究点 (2)

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