Studies

Interventional Active not recruiting

NCT06640023 on ClinicalTrials.gov

The Study in Outpatient Medicine Using Nudges to Improve Sleep

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

  • Sponsor: University of Southern California
  • Collaborators: Northwestern Medicine, National Heart, Lung, and Blood Institute (NHLBI)
  • Enrollment: 444 (Actual)
  • Study start: 2024-12-20 (Actual)
  • Primary completion: 2027-06-01 (Estimated)
  • Study completion: 2027-06-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Factorial
  • InterventionModelDescription: 2x 2
  • Masking: None
  • PrimaryPurpose: Health Services Research

Brief Summary

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.

Conditions

  • Inappropriate Prescribing

Intervention / Treatment

  • Behavioral: Z-drug Default Quantity
  • Behavioral: Redirection + Accountable Justification

Primary Outcome Measures

  • Z-drug pill count (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.

Countries

United States

Locations and Investigators

  • Northwestern Medicine, Chicago, United States

Study Officials

  • Jason Doctor, PhD (Principal Investigator) — University of Southern California