Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients

NCT ID: NCT03377855

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 948 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-12-31

Brief Summary

Risk of long-term opioid dependence increases with initial opioid dose/duration, but despite recent Centers for Disease Control and Prevention (CDC)-endorsed minimum doses for initial opioid prescription, primary care providers are likely to overprescribe. In this quality improvement project, primary care departments at Weill Cornell and the Institute for Family Health (federally qualified health center in New York City) will implement an unobtrusive "nudge" in their electronic prescribing software to promote the CDC-endorsed low doses for all opioids. In the evaluation, we will employ a quasi-experimental design with rigorous interrupted time series analysis methods to assess the effect of the "nudge" on prescribing rates. The analysis will be performed at the provider level, with deidentified physician data and a limited data set (fully deidentified except for date of prescription) of patient-level data.

Detailed Description

The two participating institutions, WCMC (Weill Cornell Medical College) and IFH (Institute for Family Health), intend to redesign the e-prescribing interface to create a minor "nudge" to encourage prescribers to prescribe the minimum dose set by the 2016 CDC guideline for opioid-naive patients in 2018. The change to the e-prescribing system is that after a prescriber chooses the drug they wish to prescribe, the minimum recommended dosage from the CDC guidelines will be displayed. The prescriber can choose to change the dosage by overwriting in the field box. The changes to the prescriber system will be implemented at two Weill Cornell clinical organizations: Weill Cornell Internal Medicine Associates (WCIMA) and Weill Cornell Medical Associates (CMA), and at all locations at our collaborating institution IFH (Institute for Family Health). Weill Cornell and IFH will provide data for the analysis, which will be conducted by the co-investigators on this protocol. The project will assess data pre- and post- implementation to study prescribing patterns.

Conditions

Opioid Use; Opioid-Related Disorders; Opioid Abuse; Prescription Drug Abuse and Dependency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Default Prescribing Change

In the e-prescribing system, the default opioid dosage/duration is changed to the minimum recommended dosage from the CDC guidelines for short acting opioids.

Group Type: EXPERIMENTAL

Default Prescribing Change

Intervention Type: OTHER

In the e-prescribing system, the default opioid dosage/duration is changed to the minimum recommended dosage from the CDC guidelines for short acting opioids.

Interventions

Default Prescribing Change

In the e-prescribing system, the default opioid dosage/duration is changed to the minimum recommended dosage from the CDC guidelines for short acting opioids.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Prescriber - practices internal medicine at WCMC OR family practice at IFH and has prescribed opioids since 11/1/2015

Exclusion Criteria

• Prescriber - has not written any opioid prescriptions during the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York State Health Foundation

UNKNOWN

Sponsor Role: collaborator

The Institute for Family Health

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica S Ancker, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

The Institute for Family Health

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

Countries

United States

References

Malhotra S, Cheriff AD, Gossey JT, Cole CL, Kaushal R, Ancker JS. Effects of an e-Prescribing interface redesign on rates of generic drug prescribing: exploiting default options. J Am Med Inform Assoc. 2016 Sep;23(5):891-8. doi: 10.1093/jamia/ocv192. Epub 2016 Feb 17.

Reference Type: BACKGROUND

PMID: 26911828 (View on PubMed)

Other Identifiers

17-05047

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1710018646

Identifier Type: -

Identifier Source: org_study_id