NCT02345434

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,525

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

November 8, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

October 6, 2014

Results QC Date

August 5, 2021

Last Update Submit

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 INTERVENTION

This is the control arm and it involves no contact with the prescriber

Informative letter

EXPERIMENTAL

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

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.

Also known as: Comparative billing report, Peer activity report
Informative letter

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

  • Amy Finkelstein, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

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