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

This study has been completed.
Sponsor:
Collaborators:
Centers for Medicare and Medicaid Services
General Services Administration (GSA)
Information provided by (Responsible Party):
Abdul Latif Jameel Poverty Action Lab
ClinicalTrials.gov Identifier:
NCT02345434
First received: October 6, 2014
Last updated: September 28, 2015
Last verified: September 2015
  Purpose
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 Intervention
Economics
Fraud
Delivery of Health Care
Health Expenditures
Centers for Medicare and Medicaid Services (U.S.)
Other: Informative letter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances

Further study details as provided by Abdul Latif Jameel Poverty Action Lab:

Primary Outcome Measures:
  • 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:
  • 30-day equivalent prescribing of schedule II controlled substances [ Time Frame: 1 month ]
  • 30-day equivalent prescribing of schedule II controlled substances [ Time Frame: 6 months ]
  • 30-day equivalent prescribing of schedule II controlled substances [ Time Frame: 9 months ]
  • 30-day equivalent prescribing of schedule II controlled substances [ Time Frame: 1 year ]

Enrollment: 1525
Study Start Date: August 2014
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02345434

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:
Responsible Party: Abdul Latif Jameel Poverty Action Lab
ClinicalTrials.gov Identifier: NCT02345434     History of Changes
Other Study ID Numbers: JPAL-LETTERS-SII
Study First Received: October 6, 2014
Last Updated: September 28, 2015

ClinicalTrials.gov processed this record on May 25, 2017