The Study in Outpatient Medicine Using Nudges to Improve Sleep
- Conditions
- Inappropriate Prescribing
- Registration Number
- NCT06640023
- Lead Sponsor
- University of Southern California
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 443
- Outpatient primary care clinician at Northwestern Medicine
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Z-drug pill count 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 Outcome Measures
Name Time Method Z-drug pill count among short-term users 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.
Z-drug pill count among long-term users 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.
CBT-I referrals 18 months Number of patients who are referred to CBT-I from intervention start to 18 months after the intervention start.
CBT-I referrals among short-term users 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.
CBT-I referrals among long-term users 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.
Monthly Z-drug pill count 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.
Benzodiazepine pill count 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.
Z-drug guideline discordant duration 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.
Trial Locations
- Locations (1)
Northwestern Medicine
🇺🇸Chicago, Illinois, United States