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

Sponsor

Abdul Latif Jameel Poverty Action Lab (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03202745

Collaborator

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

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Economics Fraud Delivery of Health Care Health Expenditures Prescribing Centers for Medicare and Medicaid Services (U.S.)	Other: Patient Consequences Letter Other: Prescriber Consequences Letter	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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 Opioids

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control The control arm will not receive any communications as a result of this study.
Experimental: 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.	Other: Patient Consequences Letter This letter focuses on the consequences of inappropriate prescribing for patients. It also includes a peer comparison.
Experimental: 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.	Other: Prescriber Consequences Letter This letter focuses on the consequences of inappropriate prescribing for prescribers. It also includes a peer comparison.

Arm

Intervention/Treatment

No Intervention: Control

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

Experimental: 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.

Other: Patient Consequences Letter

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

Experimental: 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.

Other: Prescriber Consequences Letter

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

Outcome Measures

Primary Outcome Measures

Morphine Milligrams Equivalent (MME) [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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"

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

Publications

None provided.

Responsible Party:

Abdul Latif Jameel Poverty Action Lab

ClinicalTrials.gov Identifier:

NCT03202745

Other Study ID Numbers:

JPAL-LETTERS-OPIOIDS

First Posted:

Jun 29, 2017

Last Update Posted:

Aug 12, 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 12, 2021