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Field
Last Published
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Before
June 08, 2015 11:53 AM
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After
September 24, 2015 06:00 PM
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Field
Intervention (Public)
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Before
An initial letter to outlier prescribers of Seroquel explaining that their prescribing behavior is highly unlike their peers and has been flagged for review, then a series of followup letters in the same format updating them on their recent prescribing.
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After
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.
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Field
Intervention End Date
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Before
April 20, 2016
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After
January 20, 2016
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Field
Primary Outcomes (End Points)
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Before
The primary outcome of the study is the effect of the letters on the prescribing of Seroquel. We will consider additional outcomes as well.
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After
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.
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Field
Experimental Design (Public)
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Before
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.
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After
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.
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Field
Planned Number of Clusters
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Before
Approximately 5,000
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After
5,055
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Field
Planned Number of Observations
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Before
Approximately 5,000
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After
5,055
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Field
Sample size (or number of clusters) by treatment arms
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Before
Approximately 2,500 allocated to treatment arm
Approximately 2,500 allocated to control (placebo) arm
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After
2,527 allocated to treatment arm
2,528 allocated to control (placebo) arm
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