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

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.

Study Overview

• Status: Completed
• Conditions: Delivery of Health Care; Economics; Fraud; Health Expenditures; Centers for Medicare and Medicaid Services (U.S.)
• Intervention / Treatment: Other: Placebo letter; Other: Initial Informative letter; Other: Followup Informative Letter

• Study Type: Interventional
• Enrollment (Actual): 5055
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; The placebo arm receives a placebo letter unrelated to Seroquel	Other: Placebo letter; The placebo letter describes a new rule in Medicare that requires prescribers to enroll in Medicare
Experimental: Informative Letter; 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; 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.; Other: Followup Informative Letter; 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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Abdul Latif Jameel Poverty Action Lab
• Collaborators: Centers for Medicare and Medicaid Services; General Services Administration (GSA)
• Investigators: Principal Investigator: Adam Sacarny, PhD, Columbia University

Publications and helpful links

General Publications

• Sacarny A, Barnett ML, Le J, Tetkoski F, Yokum D, Agrawal S. Effect of Peer Comparison Letters for High-Volume Primary Care Prescribers of Quetiapine in Older and Disabled Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):1003-1011. doi: 10.1001/jamapsychiatry.2018.1867.

Helpful Links

• American Economic Association Randomized Controlled Trials Registry Entry

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: JPAL-LETTERS-SEROQUEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. Study Protocol
   Information identifier: 449
   Information comments: Study protocol archived on American Economic Association Social Science Registry page.
2. Statistical Analysis Plan
   Information identifier: 448
   Information comments:

   Pre-specified analysis plan archived on American Economic Association Social Science Registry page.

   Final version prior to unblinding: Version 2.0 (March 5, 2016)