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

NCT03202745 | Withdrawn DMC

• 1 other identifier: JPAL-LETTERS-OPIOIDS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inappropriate prescribing exposes patients to health risks and results in wasteful public expenditures. This study will evaluate an approach to fighting abusive prescription: sending letters to suspected potentially 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 opioids in the Schedule II controlled substances class. Two types of letters will be tested: one focusing on the health consequences of inappropriate prescribing for patients, and the other focusing on the consequences for prescribers including e.g. potential administrative actions. Using claims data, the investigators will assess the effect of the letters on prescribing of opioids, receipt of opioids by patients, substitution behavior by prescribers and patients, and health outcomes of patients.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Morphine Milligrams Equivalent (MME)

  9 months

Study Arms (3)

Control

NO INTERVENTION

The control arm will not receive any communications as a result of this study.

Patient Consequences

EXPERIMENTAL

The patient consequences arm prescribers receive an initial patient consequences letter followed by 2 followup letters at approximately 3 month intervals. The letters focus on the consequences of inappropriate prescribing for patients.

Other: Patient Consequences Letter

Prescriber Consequences

EXPERIMENTAL

The prescriber consequences arm prescribers receive an initial prescriber consequences letter followed by 2 followup letters at approximately 3 month intervals. The letters focus on the consequences of inappropriate prescribing for prescribers.

Other: Prescriber Consequences Letter

Interventions

Patient Consequences Letter OTHER

This letter focuses on the consequences of inappropriate prescribing for patients. It also includes a peer comparison.

Patient Consequences

Prescriber Consequences Letter OTHER

This letter focuses on the consequences of inappropriate prescribing for prescribers. It also includes a peer comparison.

Prescriber Consequences

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in prescription drug events (PDE), in 2014Q3-2015Q2 and 2015Q3-2016Q2
• Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in 30-day equivalents, in 2014Q3-2015Q2 and 2015Q3-2016Q2

You may not qualify if:

• Deceased
• Fewer than 75 Schedule II Opioid PDE in 2015Q3-2016Q2
• Specialty listed as "Student in an Organized Health Care Education/Training Program"

Sponsors & Collaborators

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

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 27, 2017
• First Posted: June 29, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: August 12, 2021

Record last verified: 2021-08