The Study in Outpatient Medicine Using Nudges to Improve Sleep (SOMNUS)

University of Southern California

Status: Invitation-only

Conditions: Inappropriate Prescribing

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06640023

UP-23-00317

1R01HL167023-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 443 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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443 participants in 4 patient groups

Control

No Intervention group

Description:

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

Z-drug Default Quantity

Experimental group

Description:

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

Treatment:

Behavioral: Z-drug Default Quantity

Redirection + Accountable Justification

Experimental group

Description:

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.

Treatment:

Behavioral: Redirection + Accountable Justification

Combined

Experimental group

Description:

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

Treatment:

Behavioral: Z-drug Default Quantity

Behavioral: Redirection + Accountable Justification