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E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs

Last registered on July 11, 2024
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Pre-Trial

Trial Information

General Information

Title
E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs
RCT ID
AEARCTR-0013549
Initial registration date
May 09, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 13, 2024, 12:39 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
July 11, 2024, 1:22 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
United States of America
Region
Minnesota

Primary Investigator

Name
Adam Sacarny
Affiliation
Columbia University
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Other Primary Investigator(s)

PI Name
Mireille Jacobson
PI Affiliation
University of Southern California
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PI Name
Tatyana Avilova
PI Affiliation
Bowdoin College
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Additional Trial Information

Status
In development
Start date
2024-07-17
End date
2025-12-31
Keywords
Health
Additional Keywords
Opioids, prescribing, overprescribing, prescription drug monitoring programs, controlled substances
JEL code(s)
I18, H75
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Drug overdose deaths have skyrocketed in recent years, and many overdoses continue to involve prescribed medications like opioids and stimulants. At the same time, state prescription drug monitoring programs (PDMPs), which help clinicians prescribe these medications safely, remain underused. In Minnesota, 32% of opioid prescriptions are written by clinicians who do not use the PDMP. In many states, including Minnesota, policymakers have limited tools to raise PDMP use even though it is often required under state law. To address this policy dilemma, we will test e-mails designed to facilitate PDMP use and evaluate their effects on PDMP use and controlled substance prescribing. Our work will include a projected 7,126 physician and physician assistant prescribers of opioids and other controlled substances who lack active PDMP accounts, never query the PDMP, or query the PDMP infrequently relative to their prescribing volume. To generate evidence on clinician motivation for responding to encouragement, we will randomly vary messaging to focus on legal requirements to use the PDMP vs. clinical benefits of the PDMP.
External Link(s)

Registration Citation

Citation
Avilova, Tatyana , Mireille Jacobson and Adam Sacarny. 2024. "E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs." AEA RCT Registry. July 11. https://doi.org/10.1257/rct.13549-1.3
Sponsors & Partners

Sponsors

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Experimental Details

Interventions

Intervention(s)
Prescribers will be assigned at random to one of three arms:
1. PDMP Legal Mandate E-mails: Clinicians are sent e-mails highlighting the state’s legal requirements to use the PDMP.
2. PDMP Clinical Benefit Emails: Clinicians are sent emails highlighting the clinical benefits of having access to the PDMP and checking the PDMP before prescribing opioids.
3. Control: These clinicians are not sent any emails through this trial.

Each arm will receive one initial email and one follow-up email one month later.
Intervention (Hidden)
Intervention Start Date
2024-07-17
Intervention End Date
2024-08-17

Primary Outcomes

Primary Outcomes (end points)
1) PDMP engagement and 2) potentially guideline-discordant opioid prescribing
Primary Outcomes (explanation)
1) PDMP Engagement: An indicator for increased PDMP engagement during the 2-month period after the first e-mails were sent. It will indicate whether the level of engagement rose from the baseline level that resulted in the clinician’s enrollment into the study. For clinicians who lacked an account, the outcome will indicate whether they created one; for clinicians with an inactive account, the outcome will indicate whether they reactivated it. For those who never searched, it will indicate any search, and for those who rarely searched, it will indicate whether their search rate rose.

2) Potentially Guideline-Discordant Opioid Prescribing: A composite of several measures of potentially guideline-discordant opioid prescribing. These will include:
1. Opioid co-prescriptions with other opioids
2. Opioid co-prescriptions with benzodiazepines
3. Opioid co-prescriptions with gabapentinoids
4. High daily opioid doses
5. Long-duration opioid prescriptions to opioid-naïve individuals

Secondary Outcomes

Secondary Outcomes (end points)
Secondary outcomes include search query volume, creation of delegate users, characteristics of average patient searched by clinicians, e-mail engagement (open, click-through, and bounce), and volume measures of prescribing (e.g. days supplied of controlled substances, days supplied of opioids, and total opioid morphine milligram equivalents). The full set of secondary outcomes will be specified in the pre-analysis plan.
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
This study will enroll Minnesota physicians and physician assistants who are not following the state’s requirements to maintain a PDMP account or search the PDMP. Specifically, clinicians who prescribe controlled substances but lack an account or have allowed their account to become inactive, as well as clinicians who prescribe opioids but do not search the PDMP or search infrequently relative to their prescribing, will be enrolled. Clinicians will be randomized at 1:1:1 ratio to two treatment arms and a control group.
Experimental Design Details
Randomization Method
Randomization with optimal stratification to maximize statistical power on primary prescribing endpoint
Randomization Unit
Clinicians
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
7,126 clinicians
Sample size: planned number of observations
7,126 clinicians
Sample size (or number of clusters) by treatment arms
2,375 clinicians per arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Columbia University Human Research Protection Office
IRB Approval Date
2024-04-30
IRB Approval Number
IRB-AAAV1928
Analysis Plan

Analysis Plan Documents

Pre-Analysis Plan

MD5: 1a78077fa0a1c7f826d8e83474b2272f

SHA1: 106ab595ffb9293c851b130afac0cf40f808be44

Uploaded At: July 11, 2024

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials