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

October 11, 2021 updated by: Abdul Latif Jameel Poverty Action Lab
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. The investigators 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1525

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outlier with respect to the count of schedule II prescription drug events relative to peer group of prescribers in two of the three years 2011, 2012, and 2013
  • Outlier with respect to the 30-day equivalent prescriptions of schedule II substances relative to peer group of prescribers in two of the three years 2011, 2012, and 2013

Exclusion Criteria:

- Deceased

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No informative letter
This is the control arm and it involves no contact with the prescriber
Experimental: Informative letter
This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)
Other: Informative letter
The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.
Other Names:
  • Comparative billing report
  • Peer activity report

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time Frame: 1 month
1 month
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time Frame: 6 months
6 months
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time Frame: 9 months
9 months
30-day Equivalent Prescribing of Schedule II Controlled Substances
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abdul Latif Jameel Poverty Action Lab

Collaborators

Centers for Medicare and Medicaid Services
General Services Administration (GSA)

Investigators

  • Principal Investigator: Amy Finkelstein, PhD, Massachusetts Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • JPAL-LETTERS-SII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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