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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Patient Consequences Letter
* Other: Prescriber Consequences Letter


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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