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

NCT03377855 | Completed

• 2 other identifiers: 171001864617-05047
• Study Type: interventional
• Target: 948
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in the average days of supply of opioids for opioid naive patients

  Two years prior to and six months after implementation

Study Arms (1)

Default Prescribing Change

EXPERIMENTAL

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.

Other: Default Prescribing Change

Interventions

Default Prescribing Change 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.

Default Prescribing Change

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• New York State Health Foundation: collaborator
• The Institute for Family Health: collaborator

Study Sites (2)

The Institute for Family Health

New York, New York, 10035, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Related 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.

  PMID: 26911828 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jessica S Ancker, PhD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a interrupted time series study model with one study group.

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Study Start: February 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)