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

Last registered on September 25, 2016

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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

Last updated

September 25, 2016 10:22 PM EDT

Location(s)

Country

United States of America

Region

Primary Investigator

Name

Adam Sacarny

Affiliation

Columbia University

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Other Primary Investigator(s)

PI Name

David Yokum

PI Affiliation

General Services Administration

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Additional Trial Information

Status

On going

Start date

2015-04-20

End date

2017-07-01

Keywords

Health

Additional Keywords

JEL code(s)

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. 2016. "The Effect of Informative Letters on the Prescription and Receipt of Seroquel." AEA RCT Registry. September 25. https://doi.org/10.1257/rct.729-5.0

Former Citation

Sacarny, Adam and David Yokum. 2016. "The Effect of Informative Letters on the Prescription and Receipt of Seroquel." AEA RCT Registry. September 25. https://www.socialscienceregistry.org/trials/729/history/10764

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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 2 followup informative letters at approximately 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 9 months 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

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?

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.

Supporting Documents and Materials

IRB

INSTITUTIONAL REVIEW BOARDS (IRBs)

IRB Name

Harvard Committee on the Use of Human Subjects in Research

IRB Approval Date

2015-03-30

IRB Approval Number

MOD14-3112-01

IRB Name

MIT Committee on the Use of Human as Experimental Subjects

IRB Approval Date