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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02345434
Enrollment
1525
Registered
2015-01-26
Start date
2014-08-31
Completion date
2015-08-31
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERInformative 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.

Sponsors

Centers for Medicare and Medicaid Services
CollaboratorFED
General Services Administration (GSA)
CollaboratorFED
Abdul Latif Jameel Poverty Action Lab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
30-day Equivalent Prescribing of Schedule II Controlled Substances3 monthsThe 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

MeasureTime frame
30-day Equivalent Prescribing of Schedule II Controlled Substances1 month

Participant flow

Recruitment details

There was no recruitment in the traditional sense. High prescribers of Schedule II controlled substances were identified in Medicare administrative data using a Tukey outlier method.

Pre-assignment details

Seven of the identified outliers had died by the time of the study and were excluded from the intervention and later analysis.

Participants by arm

ArmCount
No Informative Letter
This is the control arm and it involves no contact with the prescriber
0
Informative Letter
This is the treatment arm; prescribers in this arm receive an informative letter (called a comparative billing report or peer activity report) 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.
0
Total0

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeceased (excluded from intervention and analysis)52

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 7580 / 760
serious
Total, serious adverse events
0 / 7580 / 760

Outcome results

Primary

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.

Time frame: 3 months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
No Informative Letter30-day Equivalent Prescribing of Schedule II Controlled Substances461.1 30-day equivalent prescription fillsStandard Deviation 443.9
Informative Letter30-day Equivalent Prescribing of Schedule II Controlled Substances450.0 30-day equivalent prescription fillsStandard Deviation 450.9
95% CI: [-6.35, 13.4]
Secondary

30-day Equivalent Prescribing of Schedule II Controlled Substances

Time frame: 6 months

Population: Outcome measure not collected for study

Secondary

30-day Equivalent Prescribing of Schedule II Controlled Substances

Time frame: 9 months

Population: Outcome measure not collected for study

Secondary

30-day Equivalent Prescribing of Schedule II Controlled Substances

Time frame: 1 month

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
No Informative Letter30-day Equivalent Prescribing of Schedule II Controlled Substances155.5 30-day equivalent prescription fillsStandard Deviation 148.8
Informative Letter30-day Equivalent Prescribing of Schedule II Controlled Substances151.1 30-day equivalent prescription fillsStandard Deviation 150.4
95% CI: [-3.68, 2.1]
Secondary

30-day Equivalent Prescribing of Schedule II Controlled Substances

Time frame: 1 year

Population: Outcome measure not collected for study

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026