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

Study Overview
=================
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.

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

Conditions
-----------------
Economics, Fraud, Delivery of Health Care, Health Expenditures, Centers for Medicare and Medicaid Services (U.S.)

Intervention / Treatment
-----------------
* Other: Informative letter


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No informative letter<br>This is the control arm and it involves no contact with the prescriber | |
| Experimental: Informative letter<br>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<br>* 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.<br>* Other names: 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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |