The Study in Outpatient Medicine Using Nudges to Improve Sleep

NCT06640023 | Enrolling By Invitation DMC

• 2 other identifiers: UP-23-003171R01HL167023-01
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Does combining these two nudges reduce Z-drug prescribing?
4. 4.Complete an introductory educational module about treating insomnia and relevant EHR changes.
5. 5.Complete their routine patient visits.
6. 6.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

Keywords

Sleep Aids, Pharmaceutical; Zolpidem; zaleplon; Eszopiclone; Cognitive Behavioral Therapy; Insomnia; Clinical Decision-Making; Decision Support Systems, Clinical; Economics, Behavioral

Outcome Measures

Primary Outcomes (1)

• Z-drug pill count

  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.

  36 months

Secondary Outcomes (8)

• 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

Other Outcomes (9)

• Z-drug pill count at follow-up

  48 months

• Z-drug pill count at follow-up among short-term users

  48 months

• Z-drug pill count at follow-up among long-term users

  48 months

Study Arms (4)

Control

NO INTERVENTION

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

Z-drug Default Quantity

EXPERIMENTAL

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

Behavioral: Z-drug Default Quantity

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.

Behavioral: Redirection + Accountable Justification

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

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

Interventions

Z-drug Default Quantity BEHAVIORAL

For new orders of oral Z-drugs tablets (zolpidem, zolpidem CR, zaleplon, and eszopiclone), the EHR dispense quantity default will be changed to 10 pills with 0 refills for all dosage levels. Dispense quantities for Z-drug reorders and renewals will not be changed.

Combined; Z-drug Default Quantity

Redirection + Accountable Justification BEHAVIORAL

For qualifying Z-drug orders, an EHR alert will suggest removing the Z-drug, adding a CBT-I referral, or both. If the alert recommendation is not followed, clinicians will be asked to provide a justification for their decision when the order is signed. The justification will display in the Encounter Report. The alert suggestion depends on the recent history of Z-drug prescriptions for a given patient. When a Z-drug is being ordered for patients with 180 days supply of Z-drugs or fewer in the last 365 days, the alert will prompt removal of the Z-drug and addition of a CBT-I referral to the order. When a Z-drug is being ordered for patients with 181 days supply of Z-drugs or more in the last 365 days, the alert will only prompt addition of a CBT-I referral to the order. If a CBT-I referral is already in the current order or has been ordered for a patient in the past 180 days, the alert to add a CBT-I referral to the order will not display.

Combined; Redirection + Accountable Justification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient primary care clinician at Northwestern Medicine

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Northwestern Medicine: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Cloughesy JN, Linder JA, Knight TK, Persell SD, Sullivan MD, Meeker D, Brown T, Lee JY, Stewart EP, Fox CR, Goldstein NJ, Sumitro RG, Vitiello MV, Mack WJ, Doctor JN. The Study in Outpatient Medicine using Nudges to Improve Sleep (SOMNUS): study protocol for an 18-month factorial, cluster-randomized trial to increase guideline-concordant treatment of insomnia in primary care. Trials. 2025 Dec 23;27(1):85. doi: 10.1186/s13063-025-09385-6.

  PMID: 41430294 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Behavior

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jason Doctor, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The investigator is masked during data and safety monitoring only.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2x2

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 15, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available for one year following study completion date.

Locations

US (1)