The Study in Outpatient Medicine Using Nudges to Improve Sleep: The SOMNUS Trial
Overview
- Phase
- Not Applicable
- Intervention
- Control
- Conditions
- Inappropriate Prescribing
- Sponsor
- University of Southern California
- Enrollment
- 444
- Locations
- 2
- Primary Endpoint
- Z-drug pill count
- Status
- Enrolling By Invitation
- Last Updated
- 5 days ago
Overview
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:
- 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?
- 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?
- 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:
- Complete an introductory educational module about treating insomnia and relevant EHR changes.
- Complete their routine patient visits.
- 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.
Investigators
Jason Doctor
Professor
University of Southern California
Eligibility Criteria
Inclusion Criteria
- •Outpatient primary care clinician at Northwestern Medicine
Exclusion Criteria
- •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
Arms & Interventions
Control
Clinicians randomized to this arm receive guideline education prior to the trial.
Z-drug Default Quantity
Clinicians randomized to this arm receive guideline education + 10 pill quantity defaults.
Intervention: Z-drug Default Quantity
Redirection + Accountable Justification
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.
Intervention: Redirection + Accountable Justification
Combined
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
Intervention: Z-drug Default Quantity
Combined
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
Intervention: Redirection + Accountable Justification
Outcomes
Primary Outcomes
Z-drug pill count
Time Frame: 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.
Secondary Outcomes
- 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)