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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377855
• Other study ID #: 1710018646
• Secondary ID: 17-05047
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 948
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Abuse
• Opioid Use
• Opioid-Related Disorders
• Prescription Drug Abuse and Dependency
• Substance-Related Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	The Institute for Family Health	New York	New York
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	New York State Health Foundation, The Institute for Family Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention	Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention	Two years prior to and six months after implementation
Secondary	Change in the average days of supply of opioids for opioid naive patients	Change in the average days of supply of opioids for opioid naive patients	Two years prior to and six months after implementation