Inappropriate Prescribing
Conditions
Keywords
Sleep Aids, Pharmaceutical, Zolpidem, zaleplon, Eszopiclone, Cognitive Behavioral Therapy, Insomnia, Clinical Decision-Making, Decision Support Systems, Clinical, Economics, Behavioral
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.
Interventions
BEHAVIORALZ-drug Default Quantity
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.
BEHAVIORALRedirection + Accountable Justification
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.
Sponsors
University of Southern California
Northwestern Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
The investigator is masked during data and safety monitoring only.
Intervention model description
2x2
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason Doctor, PhD
University of Southern California
Outcome results
None listed