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

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.

Study Overview

• Status: Withdrawn
• Conditions: Delivery of Health Care; Economics; Fraud; Health Expenditures; Centers for Medicare and Medicaid Services (U.S.); Prescribing
• Intervention / Treatment: Other: Patient Consequences Letter; Other: Prescriber Consequences Letter

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morphine Milligrams Equivalent (MME)	9 months

Collaborators and Investigators

• Sponsor: Abdul Latif Jameel Poverty Action Lab
• Collaborators: Centers for Medicare and Medicaid Services; General Services Administration (GSA)
• Investigators: Principal Investigator: Adam Sacarny, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: JPAL-LETTERS-OPIOIDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED