Clinical trial NCT06640023: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Inappropriate Prescribing
Keywords: Sleep Aids, Pharmaceutical
Zolpidem
zaleplon
Eszopiclone
Cognitive Behavioral Therapy
Insomnia
Clinical Decision-Making
Decision Support Systems, Clinical
Economics, Behavioral
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Northwestern Medicine
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-10-15
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2
Primary purpose: 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.


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

Primary outcomes:
measure: Z-drug pill count
timeFrame: 36 months
Secondary outcomes:
measure: Z-drug pill count among short-term users
timeFrame: 36 months
measure: Z-drug pill count among long-term users
timeFrame: 36 months
measure: CBT-I referrals
timeFrame: 18 months
measure: CBT-I referrals among short-term users
timeFrame: 18 months
measure: CBT-I referrals among long-term users
timeFrame: 18 months
measure: Monthly Z-drug pill count
timeFrame: 36 months
measure: Benzodiazepine pill count
timeFrame: 36 months
measure: Z-drug guideline discordant duration
timeFrame: 36 months
Other outcomes:
measure: Z-drug pill count at follow-up
timeFrame: 48 months
measure: Z-drug pill count at follow-up among short-term users
timeFrame: 48 months
measure: Z-drug pill count at follow-up among long-term users
timeFrame: 48 months
measure: CBT-I referrals at follow-up
timeFrame: 30 months
measure: CBT-I referrals at follow-up among short-term users
timeFrame: 30 months
measure: CBT-I referrals at follow-up among long-term users
timeFrame: 30 months
measure: Monthly Z-drug pill count at follow-up
timeFrame: 48 months
measure: Benzodiazepine pill count at follow-up
timeFrame: 48 months
measure: Z-drug guideline discordant duration at follow-up
timeFrame: 48 months
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: University of Southern California
name: Jason Doctor, PhD
role: PRINCIPAL_INVESTIGATOR
References: