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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02467933
First Posted: June 10, 2015
Last Update Posted: March 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centers for Medicare and Medicaid Services
General Services Administration (GSA)
Information provided by (Responsible Party):
Abdul Latif Jameel Poverty Action Lab
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abdul Latif Jameel Poverty Action Lab:

Primary Outcome Measures:
  • 30-day equivalent prescribing of Seroquel treatments [ Time Frame: 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 [ Time Frame: 3 months ]
  • 30-day equivalent prescribing of Seroquel treatments [ Time Frame: 6 months ]
  • 30-day equivalent prescribing of Seroquel treatments [ Time Frame: 1 year ]

Enrollment: 5055
Study Start Date: April 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467933


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
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 449
Study protocol archived on American Economic Association Social Science Registry page.
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 448

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

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



Responsible Party: Abdul Latif Jameel Poverty Action Lab
ClinicalTrials.gov Identifier: NCT02467933     History of Changes
Other Study ID Numbers: JPAL-LETTERS-SEROQUEL
First Submitted: June 8, 2015
First Posted: June 10, 2015
Last Update Posted: March 8, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs