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

NCT ID: NCT03202745

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-01-31

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.)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Patient Consequences

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.

Group Type: EXPERIMENTAL

Patient Consequences Letter

Intervention Type: OTHER

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

Prescriber Consequences

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.

Group Type: EXPERIMENTAL

Prescriber Consequences Letter

Intervention Type: OTHER

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

Interventions

Patient Consequences Letter

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

Intervention Type: OTHER

Prescriber Consequences Letter

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Medicare and Medicaid Services

FED

Sponsor Role: collaborator

General Services Administration (GSA)

FED

Sponsor Role: collaborator

Abdul Latif Jameel Poverty Action Lab

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Sacarny, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Other Identifiers

JPAL-LETTERS-OPIOIDS

Identifier Type: -

Identifier Source: org_study_id