The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances

Last registered on April 10, 2018

Pre-Trial

Trial Information

General Information

Title
The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances
RCT ID
AEARCTR-0000525
Initial registration date
October 06, 2014
Last updated
April 10, 2018, 6:05 PM EDT

Locations

Region

Primary Investigator

Affiliation
MIT

Other Primary Investigator(s)

PI Affiliation
General Services Administration
PI Affiliation
Harvard University

Additional Trial Information

Status
Completed
Start date
2014-08-01
End date
2016-10-01
Secondary IDs
Abstract
Fraud and waste is estimated to cost the American health care system nearly $200 billion each year, and the public Medicare and Medicaid programs about $60 billion each year. This study will evaluate a new method for fighting fraud: mailing informative letters to outlier providers to notify them of their aberrant behavior. These letters are targeted at high prescribers of schedule II controlled substances in Medicare Part D. We will look at the effects of these letters on the behavior of providers and their patients. These effects are of substantial policy interest as they suggest how to best design anti-fraud policies. They are also of academic interest, shedding light on the behavior of physicians and their patients.
External Link(s)

Registration Citation

Citation
Finkelstein, Amy, Adam Sacarny and David Yokum. 2018. "The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances." AEA RCT Registry. April 10. https://doi.org/10.1257/rct.525-7.0
Former Citation
Finkelstein, Amy et al. 2018. "The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances." AEA RCT Registry. April 10. https://www.socialscienceregistry.org/trials/525/history/27956
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
A letter to outlier prescribers of schedule II controlled substances explaining that their prescribing behavior is highly unlike their peers.
Intervention Start Date
2014-09-11
Intervention End Date
2015-09-11

Primary Outcomes

Primary Outcomes (end points)
The primary outcome of the study is the effect of the letters on the prescribing of schedule II controlled substances over the 3 months following the initial sending of the letters. Prescribing is defined as the total “days supply” of schedule II controlled substances attributed to the prescriber, expressed in “30-day equivalents” i.e. divided by 30.

We consider additional outcomes as well. Through these additional analyses, we hope to understand the totality of the effects of the letters. The secondary analysis for prescribers includes explorations of effect heterogeneity, quantile treatment effects, substitution toward other substances, and peer effects. We also conduct analyses looking at a cohort of patients who were treated by the prescribers prior to the sending of the letters. We will assign these patients to treatment and control groups based on whether their attributed prescriber was a treatment or control prescriber and study the total receipt of controlled substances by patients, heterogeneity in treatment effects, substitution toward other substances, and health outcomes.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
An analysis was conducted to identify outlier prescribers of Schedule II controlled substances in the Medicare Part D. This analysis identified a group of prescribers, and they were then randomly allocated to a treatment or a control group.
Experimental Design Details
Randomization Method
Randomization done by computer (in Stata)
Randomization Unit
The prescriber (e.g. physician, nurse, physician assistant, etc.)
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
Approximately 1500 prescribers
Sample size: planned number of observations
Approximately 1500 prescribers
Sample size (or number of clusters) by treatment arms
Approximately 750 providers in the control arm and 750 providers in the treatment arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
We constructed a sample of outlier prescribers that replicated the method used in the study but was built from a more limited dataset. Using these prescribers we estimated that at a significance level of 5% and a power of 80%, we could detect a change in the number of schedule II prescription drug events of 136.9 (baseline mean level: 1,556.7; standard deviation: 1,231.2; effect as a share of baseline mean: 8.8%) and a change in the dollar value of schedule II prescriptions of $34,069 (baseline mean level: $217,204; standard deviation: $239,759; effect as a share of baseline mean: 15.7%). Since we will have access to richer data with better control variables, we believe that these estimates are conservative.
IRB

Institutional Review Boards (IRBs)

IRB Name
Harvard Committee on the Use of Human Subjects in Research
IRB Approval Date
2014-09-19
IRB Approval Number
IRB14-3112
IRB Name
MIT Committee on the Use of Human as Experimental Subjects
IRB Approval Date
2014-10-06
IRB Approval Number
1409006595
Analysis Plan

Analysis Plan Documents

Prespecification of Analyses for Schedule II Controlled Substances Letter Campaign

MD5: ee633ba75ac91f0f867c554569d247ae

SHA1: b5f0460655f0fb2a328131327037e592baf59102

Uploaded At: January 20, 2015

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
March 11, 2015, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
August 14, 2015, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
1518 prescribers
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
1518 prescribers
Final Sample Size (or Number of Clusters) by Treatment Arms
760 prescribers treatment 758 prescribers control
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Abstract
Inappropriate prescribing is a rising threat to the health of Medicare beneficiaries and a drain on Medicare’s finances. In this study we used a randomized controlled trial approach to evaluate a low-cost, light-touch intervention aimed at reducing the inappropriate provision of Schedule II controlled substances in the Medicare Part D program. Potential overprescribers were sent a letter explaining that their practice patterns were highly unlike those of their peers. Using rich administrative data, we were unable to detect an effect of these letters on prescribing. We describe ongoing efforts to build on this null result with alternative interventions. Learning about the potential of light-touch interventions, both effective and ineffective, will help produce a better toolkit for policy makers to improve the value and safety of health care.
Citation
Sacarny, Adam, David Yokum, Amy Finkelstein, and Shantanu Agrawal. "Medicare Letters To Curb Overprescribing Of Controlled Substances Had No Detectable Effect On Providers." Health Affairs. 2016; 35(3); 471-479. doi:10.1377/hlthaff.2015.1025

Reports & Other Materials