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The Effect of Informative Letters on the Prescription and Receipt of Seroquel

Last registered on September 24, 2015

Pre-Trial

Trial Information

General Information

Title
The Effect of Informative Letters on the Prescription and Receipt of Seroquel
RCT ID
AEARCTR-0000729
Initial registration date
June 08, 2015

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
June 08, 2015, 11:53 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
September 24, 2015, 6:00 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
Columbia University

Other Primary Investigator(s)

PI Affiliation
General Services Administration

Additional Trial Information

Status
On going
Start date
2015-04-20
End date
2017-07-01
Secondary IDs
Abstract
Abusive prescribing exposes patients to unnecessary health risks and results in wasteful public expenditures. This study will evaluate an innovative approach to fighting abusive prescription: sending letters to suspected inappropriate prescribers warning them that they are outliers compared to their peers and have been flagged for review. The study will target high prescribers of Seroquel (Quetiapine), an atypical antipsychotic. Using claims data, we will assess the effect of the letters on prescribing of Seroquel, receipt of Seroquel by patients, substitution behavior by prescribers and patients, and health outcomes of patients.
External Link(s)

Registration Citation

Citation
Sacarny, Adam and David Yokum. 2015. "The Effect of Informative Letters on the Prescription and Receipt of Seroquel." AEA RCT Registry. September 24. https://doi.org/10.1257/rct.729-2.0
Former Citation
Sacarny, Adam and David Yokum. 2015. "The Effect of Informative Letters on the Prescription and Receipt of Seroquel." AEA RCT Registry. September 24. https://www.socialscienceregistry.org/trials/729/history/5391
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
Placebo Arm: The placebo arm receives a letter unrelated to Seroquel. The placebo letter describes a new rule in Medicare that requires prescribers to enroll in Medicare
Interventional Arm: The interventional arm prescribers receive an initial informative letter (called a comparative billing report or peer activity report) followed by 3 followup informative letters at 3 month intervals. The intervention is a letter that describes the Seroquel 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.
Intervention Start Date
2015-04-20
Intervention End Date
2016-01-20

Primary Outcomes

Primary Outcomes (end points)
The primary outcome of the study is the 30-day equivalent prescribing of Seroquel treatments over the 1 year following the initial sending of the letters. Prescribing is defined as the total "days supply" of Seroquel attributed to the prescriber, expressed in "30-day equivalents" i.e. divided by 30. This outcome and the secondary outcomes are described in greater detail in the study prespecification document.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
An analysis was conducted to identify outlier prescribers of Seroquel in the Medicare Part D events file. This analysis identified a group of prescribers, and they were then randomly allocated to a treatment or a control group. The approach is explained in more detail in the study protocol document.
Experimental Design Details
Randomization Method
Randomization done by computer (in Stata)
Randomization Unit
The prescriber
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
5,055
Sample size: planned number of observations
5,055
Sample size (or number of clusters) by treatment arms
2,527 allocated to treatment arm
2,528 allocated to control (placebo) arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Modeling Seroquel prescribing according to the distribution of Schedule II controlled substance prescribing, we estimated a minimum detectable effect of 1.5-1.7% of the baseline mean at a sample size of N=5,000 for 1-month and 3-month prescription drug treatments and 30-day equivalents. Because we will have access to control variables like prior prescribing that will improve our statistical power, we believe these estimates are conservative.
IRB

Institutional Review Boards (IRBs)

IRB Name
MIT Committee on the Use of Human as Experimental Subjects
IRB Approval Date
2015-03-23
IRB Approval Number
1409006595
IRB Name
Harvard Committee on the Use of Human Subjects in Research
IRB Approval Date
2015-03-30
IRB Approval Number
MOD14-3112-01
Analysis Plan

Analysis Plan Documents

Protocol Attachments - September 24, 2015

MD5: ab1786fad1ec0653312b82071231692e

SHA1: 96932c19e42b508209c068c6d5d55efe1ef4636d

Uploaded At: September 24, 2015

Study Protocol - September 24, 2015

MD5: 4259518688152081eb295128fbf6560d

SHA1: 9df4c7ea4e9807179603ae5cef09c91024f01b5a

Uploaded At: September 24, 2015

Prespecification Document - September 24, 2015

MD5: 31e71e3746663a9bdfb29b61ca5efe9a

SHA1: a4d319ff142234eca016a52f81b0df62438fdf48

Uploaded At: September 24, 2015

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials