跳至主要内容
临床试验/NCT06640023
NCT06640023进行中(未招募)不适用

The Study in Outpatient Medicine Using Nudges to Improve Sleep: The SOMNUS Trial

University of Southern California2 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2024年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
444
试验地点
2
主要终点
Z-drug pill count

研究概览

简要总结

The goal of this clinical trial is to learn if electronic health record (EHR) nudges (changes to the EHR that do not restrict freedom of choice or alter incentives) can reduce Z-drug prescribing in primary care clinics for patients with insomnia. The main questions it aims to answer are:

  1. Can Z-drug prescribing be reduced by setting the dispense quantity default of new Z-drug orders in the EHR to 10 pills with 0 refills?
  2. Can Z-drug prescribing be reduced by an EHR alert that suggests clinicians remove a Z-drug and/or add an evidence-based behavioral treatment for insomnia, followed by a request to justify their reasoning if the suggestion is not followed?
  3. Does combining these two nudges reduce Z-drug prescribing?

Researchers will compare each nudge individually and in combination to an guideline education control group to see if each nudge (separately and in combination) can reduce Z-drug prescribing.

Clinician-participants will:

  1. Complete an introductory educational module about treating insomnia and relevant EHR changes.
  2. Complete their routine patient visits.
  3. Either experience EHR changes when prescribing Z-drugs, including a Z-drug dispense quantity default of 10 pills for new orders, a prompt to remove or justify Z-drug orders, both, or neither.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

盲法说明

The investigator is masked during data and safety monitoring only.

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

  • Outpatient primary care clinician at Northwestern Medicine

排除标准

  • Clinician participated in pilot study
  • Clinician-investigator for this trial
  • Visit involves patient with ICD-10 F31.X diagnosis code (bipolar disorder) present in the last year or on active problem list

研究组 & 干预措施

Control

No Intervention

Clinicians randomized to this arm receive guideline education prior to the trial.

Combined

Experimental

Clinicians randomized to this arm receive guideline education + 10 pill quantity defaults + alerts requiring justification of orders discordant with guidelines. Justifications are entered in the patient's medical record, and can be viewed by other clinicians

干预措施: Z-drug Default Quantity (Behavioral)

Redirection + Accountable Justification

Experimental

Clinicians randomized to this arm receive guideline education + alerts requiring justification of orders discordant with guidelines. Justifications are entered in the patient's medical record, and can be viewed by other clinicians.

干预措施: Redirection + Accountable Justification (Behavioral)

Combined

Experimental

Clinicians randomized to this arm receive guideline education + 10 pill quantity defaults + alerts requiring justification of orders discordant with guidelines. Justifications are entered in the patient's medical record, and can be viewed by other clinicians

干预措施: Redirection + Accountable Justification (Behavioral)

Z-drug Default Quantity

Experimental

Clinicians randomized to this arm receive guideline education + 10 pill quantity defaults.

干预措施: Z-drug Default Quantity (Behavioral)

结局指标

主要结局

Z-drug pill count

时间窗: 36 months

Dose-equivalent Z-drug pill count prescribed at eligible encounters by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.

次要结局

  • Z-drug pill count among short-term users(36 months)
  • Z-drug pill count among long-term users(36 months)
  • CBT-I referrals(18 months)
  • CBT-I referrals among short-term users(18 months)
  • CBT-I referrals among long-term users(18 months)
  • Monthly Z-drug pill count(36 months)
  • Benzodiazepine pill count(36 months)
  • Z-drug guideline discordant duration(36 months)

研究者

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

Jason Doctor

Professor

University of Southern California

研究点 (2)

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