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

Study Overview
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Brief Summary
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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, the investigators 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.

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

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

Intervention / Treatment
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* Other: Placebo letter
* Other: Initial Informative letter
* Other: Followup Informative Letter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General care practitioner Outlier with respect to the count of Seroquel prescription drug treatments relative to peer group of prescribers in 2013 and 2014 Outlier with respect to the count of Seroquel 30-day equivalent prescription drug treatments relative to peer group of prescribers in 2013 and 2014 Exclusion Criteria: Deceased
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The placebo arm receives a placebo letter unrelated to Seroquel | Other: Placebo letter<br>* The placebo letter describes a new rule in Medicare that requires prescribers to enroll in Medicare<br>|
| Experimental: Informative Letter<br>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. | Other: Initial Informative letter<br>* 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.<br>Other: Followup Informative Letter<br>* The followup informative letter is identical to the initial informative letter except it provides an update on more recent prescribing rather than a description of earlier prescribing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day equivalent prescribing of Seroquel treatments | The prescribing of Seroquel 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. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day equivalent prescribing of Seroquel treatments |  | 3 months | 
| 30-day equivalent prescribing of Seroquel treatments |  | 6 months | 
| 30-day equivalent prescribing of Seroquel treatments |  | 1 year |