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Active, Not Recruiting

NCT Number: NCT06640023

The Study in Outpatient Medicine Using Nudges to Improve Sleep

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inappropriate Prescribing Behavior Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Z-drug pill count among short-term users

    Time frame: 36 months

    Dose-equivalent Z-drug pill count prescribed at eligible encounters with short-term Z-drug use patients (less than or equal to 180 days of Z-drugs prescribed in last 365 days) by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.

  2. Z-drug pill count among long-term users

    Time frame: 36 months

    Dose-equivalent Z-drug pill count prescribed at eligible encounters of long-term Z-drug use patients (greater than 180 days of Z-drugs prescribed in last 365 days) by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.

  3. CBT-I referrals

    Time frame: 18 months

    Number of patients who are referred to CBT-I from intervention start to 18 months after the intervention start.

  4. CBT-I referrals among short-term users

    Time frame: 18 months

    Number of short-term Z-drug use patients (less than or equal to 180 days of Z-drugs prescribed in last 365 days) who are referred to CBT-I from intervention start to 18 months after the intervention start.

  5. CBT-I referrals among long-term users

    Time frame: 18 months

    Number of long-term Z-drug use patients (greater than 180 days of Z-drugs prescribed in last 365 days) who are referred to CBT-I from intervention start to 18 months after the intervention start.

  6. Monthly Z-drug pill count

    Time frame: 36 months

    Total monthly dose-equivalent Z-drug pill count prescribed by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.

  7. Benzodiazepine pill count

    Time frame: 36 months

    Dose-equivalent benzodiazepine pill count prescribed at eligible encounters by clinicians from 18 months prior to the intervention start to 18 months after the intervention start.

  8. Z-drug guideline discordant duration

    Time frame: 36 months

    Proportion of eligible encounters when patients were prescribed more than 35 Z-drug pills for use within a 5 week period from 18 months prior to the intervention start to 18 months after the intervention start.

Other outcomes

  1. Z-drug pill count at follow-up

    Time frame: 48 months

    Dose-equivalent Z-drug pill count prescribed at eligible encounters by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.

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

    Time frame: 48 months

    Dose-equivalent Z-drug pill count prescribed at eligible encounters of short-term Z-drug use patients (less than or equal to 180 days of Z-drugs prescribed in the last 365 days) by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.

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

    Time frame: 48 months

    Dose-equivalent Z-drug pill count prescribed at eligible encounters of long-term Z-drug use patients (greater than 180 days of Z-drugs prescribed in the last 365 days) by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.

  4. CBT-I referrals at follow-up

    Time frame: 30 months

    Number of patients who are referred to CBT-I from intervention start to 30 months after the intervention start.

  5. CBT-I referrals at follow-up among short-term users

    Time frame: 30 months

    Number of short-term Z-drug use patients (less than or equal to 180 days of Z-drugs prescribed in last 365 days) who are referred to CBT-I from intervention start to 30 months after the intervention start.

  6. CBT-I referrals at follow-up among long-term users

    Time frame: 30 months

    Number of long-term Z-drug use patients (greater than 180 days of Z-drugs prescribed in last 365 days) who are referred to CBT-I from intervention start to 30 months after the intervention start.

  7. Monthly Z-drug pill count at follow-up

    Time frame: 48 months

    Total monthly dose-equivalent Z-drug pill count prescribed by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.

  8. Benzodiazepine pill count at follow-up

    Time frame: 48 months

    Dose-equivalent benzodiazepine pill count prescribed at eligible encounters by clinicians from 18 months prior to the intervention start to 30 months after the intervention start.

  9. Z-drug guideline discordant duration at follow-up

    Time frame: 48 months

    Proportion of eligible encounters when patients were prescribed more than 35 Z-drug pills for at least 5 consecutive weeks from 18 months prior to the intervention start to 30 months after the intervention start.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Northwestern Medicine

Registry information

Official study title

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

Acronym: SOMNUS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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