Back to History Current Version

Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms

Last registered on February 08, 2021

Pre-Trial

Trial Information

General Information

Title
Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms
RCT ID
AEARCTR-0006602
Initial registration date
October 20, 2020

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
October 21, 2020, 8:36 AM EDT

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

Last updated
February 08, 2021, 9:54 AM EST

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

Locations

Primary Investigator

Affiliation
Columbia University

Other Primary Investigator(s)

PI Affiliation
RAND
PI Affiliation
University of Southern California

Additional Trial Information

Status
In development
Start date
2020-12-15
End date
2022-01-15
Secondary IDs
Abstract
Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits when health care professionals are required to use them. Even with PMP mandates in place, providers may be unaware of the dangers of co-prescribing opioids with benzodiazepines or gabapentinoids, which include increased risk of overdose and death. Working with the Minnesota state government, we will mail letters to guideline-discordant opioid prescribers that either highlight an upcoming legally mandated requirement to check the PMP before prescribing an opioid, inform and educate providers about their patients filling concurrent prescriptions and the dangers of such co-prescribing, or both. Study participants will be randomized to receive no intervention or one of the three treatment letters. Using administrative data, we will track effects of the letters on not only prescribing but also PMP usage and queries. Findings form the multiplicity of treatment messages and outcomes will shed light on the mechanisms driving overprescribing. Results will inform future work by state and local policymakers to make opioid prescribing safer.
External Link(s)

Registration Citation

Citation
Jacobson, Mireille, David Powell and Adam Sacarny. 2021. "Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms." AEA RCT Registry. February 08. https://doi.org/10.1257/rct.6602-1.2000000000000002
Experimental Details

Interventions

Intervention(s)
Prescribers will be assigned at random to one of four arms:
1. PMP Use Mandate Letter: Prescribers are sent letters with reminders about the mandate to check the PMP when prescribing opioids.
2. Prescribing Information Letter: Prescribers are sent letters with information about their patients who received co-prescriptions. The letters will provide clinical background on the harms of co-prescribing and encourage prescribers to avoid co-prescribing in the future.
3. Prescribing Information + PMP Use Mandate Letter: Prescribers are sent letters combining the content in arms 1 and 2, reminding them about the PMP use mandate and providing information about their patients who received co-prescriptions.
4. Control (As Usual / No Letter): These prescribers are not sent letters, the as-usual case.
Intervention Start Date
2020-12-15
Intervention End Date
2021-01-15

Primary Outcomes

Primary Outcomes (end points)
1. Number of patients with co-prescriptions during the 60 days after letters were sent
2. Indicator for checking the PMP during the 60 days after letters were sent
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
At the start of the study, we will conduct a review of PMP records to identify prescribers who wrote opioid-benzodiazepine and opioid-gabapentinoid co-prescriptions. Prescribers will be randomized at 1:1:1:1 ratio to one of three treatment arms or a control arm. Then prescribers in the treatment arms will be sent two letters, one month apart.
Experimental Design Details
Randomization Method
Stratified randomization done using random numbers generated in Stata
Randomization Unit
Prescriber
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
12,000 prescribers
Sample size: planned number of observations
12,000 prescribers
Sample size (or number of clusters) by treatment arms
3,000 prescribers per arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Primary outcome 1 (number of patients with co-prescriptions) - MDE, arm-to-arm comparison: 0.19 patients (5.1% of mean) - MDE, all interventional arms vs. control: 0.15 patients (4.2% of mean) Primary outcome 2 (indicator for checking the PMP) - MDE, arm-to-arm comparison: 2.2 percentage points (4.5% of mean) - MDE, all interventional arms vs. control: 1.8 percentage points (3.7% of mean)
IRB

Institutional Review Boards (IRBs)

IRB Name
National Bureau of Economic Research
IRB Approval Date
2020-09-04
IRB Approval Number
20_216
IRB Name
Columbia University Human Research Protection Office
IRB Approval Date
2020-10-16
IRB Approval Number
AAAT2489

Post-Trial

Post Trial Information

Study Withdrawal

There is information in this trial unavailable to the public. Use the button below to request access.

Request Information

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