NCT02467933

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,055

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

June 8, 2015

Last Update Submit

August 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo arm receives a placebo letter unrelated to Seroquel

Other: Placebo letter

Informative Letter

EXPERIMENTAL

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 letterOther: Followup Informative Letter

Interventions

The placebo letter describes a new rule in Medicare that requires prescribers to enroll in Medicare

Placebo

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.

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.

Informative Letter

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Deceased

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Adam Sacarny, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 10, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2016

Study Completion

April 1, 2017

Last Updated

August 9, 2021

Record last verified: 2021-08