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

Sponsor

Abdul Latif Jameel Poverty Action Lab (Other)

Overall Status

Completed

CT.gov ID

NCT02467933

Collaborator

Centers for Medicare and Medicaid Services (U.S. Fed), General Services Administration (GSA) (U.S. Fed)

5,055

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Economics Fraud Delivery of Health Care Health Expenditures Centers for Medicare and Medicaid Services (U.S.)	Other: Placebo letter Other: Initial Informative letter Other: Followup Informative Letter	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5055 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

30-day equivalent prescribing of Seroquel treatments [9 months]
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.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Abdul Latif Jameel Poverty Action Lab
Centers for Medicare and Medicaid Services
General Services Administration (GSA)

Investigators

Principal Investigator: Adam Sacarny, PhD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

American Economic Association Randomized Controlled Trials Registry Entry

Publications

None provided.

Responsible Party:

Abdul Latif Jameel Poverty Action Lab

ClinicalTrials.gov Identifier:

NCT02467933

Other Study ID Numbers:

JPAL-LETTERS-SEROQUEL

First Posted:

Jun 10, 2015

Last Update Posted:

Aug 9, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Study Results

No Results Posted as of Aug 9, 2021