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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL167023-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northwestern Medicine | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Z-drug pill count among short-term users | 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. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Z-drug pill count at follow-up | 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. | 48 months |
| Z-drug pill count at follow-up among short-term users |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Doctor, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41430294 | Derived | 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. |
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Individual participant data as part of a HIPAA compliant limited data set may be shared with researchers under a signed Data Use Agreement.
Data will be available for one year following study completion date.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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2x2
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The investigator is masked during data and safety monitoring only.
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| 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. |
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| Z-drug pill count among long-term users |
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. |
| 36 months |
| CBT-I referrals | Number of patients who are referred to CBT-I from intervention start to 18 months after the intervention start. | 18 months |
| CBT-I referrals among short-term users | 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. | 18 months |
| CBT-I referrals among long-term users | 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. | 18 months |
| Monthly Z-drug pill count | 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. | 36 months |
| Benzodiazepine pill count | 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. | 36 months |
| Z-drug guideline discordant duration | 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. | 36 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. |
| 48 months |
| Z-drug pill count at follow-up among long-term users | 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. | 48 months |
| CBT-I referrals at follow-up | Number of patients who are referred to CBT-I from intervention start to 30 months after the intervention start. | 30 months |
| CBT-I referrals at follow-up among short-term users | 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. | 30 months |
| CBT-I referrals at follow-up among long-term users | 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. | 30 months |
| Monthly Z-drug pill count at follow-up | 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. | 48 months |
| Benzodiazepine pill count at follow-up | 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. | 48 months |
| Z-drug guideline discordant duration at follow-up | 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. | 48 months |
| D001523 |
| Mental Disorders |