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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03202745

Enrollment

Registered

2017-06-29

Start date

2017-01-31

Completion date

2019-01-31

Last updated

2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERPatient Consequences Letter

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

OTHERPrescriber Consequences Letter

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Morphine Milligrams Equivalent (MME)	9 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026