Clinical trial NCT03377855: Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients
Official title: Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Opioid-Related Disorders
Opioid Abuse
Prescription Drug Abuse and Dependency
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York State Health Foundation
name: The Institute for Family Health
First posted: 2017-12-19
Enrollment: 948
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a interrupted time series study model with one study group.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention
timeFrame: Two years prior to and six months after implementation
Secondary outcomes:
measure: Change in the average days of supply of opioids for opioid naive patients
timeFrame: Two years prior to and six months after implementation
Other outcomes:
Locations:
city: New York
country: United States
facility: The Institute for Family Health
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jessica S Ancker, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.