The Study in Outpatient Medicine Using Nudges to Improve Sleep

Conditions

• Inappropriate Prescribing

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Dec 20, 2024

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

444 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• No Intervention: Control
  Clinicians randomized to this arm receive guideline education prior to the trial.
• Experimental: Z-drug Default Quantity
  Clinicians randomized to this arm receive guideline education + 10 pill quantity defaults.
• Experimental: Redirection + Accountable Justification
  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.
• Experimental: Combined
  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

Primary Outcome Measure

Z-drug pill count [ Time Frame: 36 months ]

Locations (1)

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