The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances
1 other identifier
interventional
1,525
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
November 8, 2021
CompletedNovember 8, 2021
October 1, 2021
1 year
October 6, 2014
August 5, 2021
October 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
30-day Equivalent Prescribing of Schedule II Controlled Substances
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 Outcomes (4)
30-day Equivalent Prescribing of Schedule II Controlled Substances
1 month
30-day Equivalent Prescribing of Schedule II Controlled Substances
6 months
30-day Equivalent Prescribing of Schedule II Controlled Substances
9 months
30-day Equivalent Prescribing of Schedule II Controlled Substances
1 year
Study Arms (2)
No informative letter
NO INTERVENTIONThis is the control arm and it involves no contact with the prescriber
Informative letter
EXPERIMENTALThis is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Deceased
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
Results Point of Contact
- Title
- Adam Sacarny
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Finkelstein, PhD
Massachusetts Institute of Technology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2014
First Posted
January 26, 2015
Study Start
August 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
November 8, 2021
Results First Posted
November 8, 2021
Record last verified: 2021-10