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

• ClinicalTrials.gov Identifier: NCT02345434
• Recruitment Status: Completed
• First Posted: January 26, 2015
• Results First Posted: November 8, 2021
• Last Update Posted: November 8, 2021
• Sponsor: Abdul Latif Jameel Poverty Action Lab
• Collaborators: Centers for Medicare and Medicaid Services; General Services Administration (GSA)
• Information provided by (Responsible Party): Abdul Latif Jameel Poverty Action Lab

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Economics; Fraud; Delivery of Health Care; Health Expenditures; Centers for Medicare and Medicaid Services (U.S.)	Other: Informative letter	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1525 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances
• Study Start Date: August 2014
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 30-day Equivalent Prescribing of Schedule II Controlled Substances [ Time Frame: 1 month ]
2. 30-day Equivalent Prescribing of Schedule II Controlled Substances [ Time Frame: 6 months ]
3. 30-day Equivalent Prescribing of Schedule II Controlled Substances [ Time Frame: 9 months ]
4. 30-day Equivalent Prescribing of Schedule II Controlled Substances [ Time Frame: 1 year ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Abdul Latif Jameel Poverty Action Lab

Centers for Medicare and Medicaid Services

General Services Administration (GSA)

Investigators

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

More Information

Additional Information:

American Economic Association Randomized Controlled Trials Registry Entry 

• Responsible Party: Abdul Latif Jameel Poverty Action Lab
• ClinicalTrials.gov Identifier: NCT02345434
• Other Study ID Numbers: JPAL-LETTERS-SII
• First Posted: January 26, 2015
• Results First Posted: November 8, 2021
• Last Update Posted: November 8, 2021
• Last Verified: October 2021