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

• Sponsor: Abdul Latif Jameel Poverty Action Lab (Other)
• Overall Status: Completed
• CT.gov ID: NCT02345434
• Collaborator: Centers for Medicare and Medicaid Services (U.S. Fed), General Services Administration (GSA) (U.S. Fed)
• Enrollment: 1,525
• Arms: 2
• Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Economics; Fraud; Delivery of Health Care; Health Expenditures; Centers for Medicare and Medicaid Services (U.S.)	Other: Informative letter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1525 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 30-day Equivalent Prescribing of Schedule II Controlled Substances [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

1. 30-day Equivalent Prescribing of Schedule II Controlled Substances [1 month]

2. 30-day Equivalent Prescribing of Schedule II Controlled Substances [6 months]

3. 30-day Equivalent Prescribing of Schedule II Controlled Substances [9 months]

4. 30-day Equivalent Prescribing of Schedule II Controlled Substances [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• American Economic Association Randomized Controlled Trials Registry Entry

Publications

None provided.

• Responsible Party: Abdul Latif Jameel Poverty Action Lab
• ClinicalTrials.gov Identifier: NCT02345434
• Other Study ID Numbers: JPAL-LETTERS-SII
• First Posted: Jan 26, 2015
• Last Update Posted: Nov 8, 2021
• Last Verified: Oct 1, 2021

Study Results

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

Arm/Group Title	No Informative Letter	Informative Letter
Arm/Group Description	This is the control arm and it involves no contact with the prescriber	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.
Period Title: Overall Study
STARTED	763	762
COMPLETED	758	760
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	No Informative Letter	Informative Letter	Total
Arm/Group Description	This is the control arm and it involves no contact with the prescriber	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.	Total of all reporting groups
Overall Participants	0	0	0
Age (years) []
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []

Outcome Measures

1. Primary Outcome

Title	30-day Equivalent Prescribing of Schedule II Controlled Substances
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Informative Letter	Informative Letter
Arm/Group Description	This is the control arm and it involves no contact with the prescriber	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.
Measure Participants	758	760
Least Squares Mean (Standard Deviation) [30-day equivalent prescription fills]	461.1 (443.9)	450.0 (450.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Informative Letter, Informative Letter
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.53
	Confidence Interval	(2-Sided) 95%; -6.35 to 13.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	30-day Equivalent Prescribing of Schedule II Controlled Substances
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Informative Letter	Informative Letter
Arm/Group Description	This is the control arm and it involves no contact with the prescriber	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.
Measure Participants	758	760
Least Squares Mean (Standard Deviation) [30-day equivalent prescription fills]	155.5 (148.8)	151.1 (150.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Informative Letter, Informative Letter
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 95%; -3.68 to 2.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	30-day Equivalent Prescribing of Schedule II Controlled Substances
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Outcome measure not collected for study

Arm/Group Title	No Informative Letter	Informative Letter
Arm/Group Description	This is the control arm and it involves no contact with the prescriber	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.
Measure Participants	0	0

4. Secondary Outcome

Title	30-day Equivalent Prescribing of Schedule II Controlled Substances
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Outcome measure not collected for study

Arm/Group Title	No Informative Letter	Informative Letter
Arm/Group Description	This is the control arm and it involves no contact with the prescriber	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.
Measure Participants	0	0

5. Secondary Outcome

Title	30-day Equivalent Prescribing of Schedule II Controlled Substances
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Outcome measure not collected for study

Arm/Group Title	No Informative Letter	Informative Letter
Arm/Group Description	This is the control arm and it involves no contact with the prescriber	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.
Measure Participants	0	0

Adverse Events

Arm/Group Title	No Informative Letter		Informative Letter
Arm/Group Description	This is the control arm and it involves no contact with the prescriber		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.
All Cause Mortality
	No Informative Letter		Informative Letter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	No Informative Letter		Informative Letter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/758 (0%)		0/760 (0%)
Other (Not Including Serious) Adverse Events
	No Informative Letter		Informative Letter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/758 (0%)		0/760 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.