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

February 20, 2020 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

948

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10035
        • The Institute for Family Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention
Time Frame: Two years prior to and six months after implementation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the average days of supply of opioids for opioid naive patients
Time Frame: Two years prior to and six months after implementation
Change in the average days of supply of opioids for opioid naive patients
Two years prior to and six months after implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

The Institute for Family Health
New York State Health Foundation

Investigators

  • Principal Investigator: Jessica S Ancker, PhD, MPH, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1710018646
  • 17-05047 (Other Grant/Funding Number: NYS Health Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This data is protected by HIPAA and IRB/human subjects protections. In addition, the data is scheduled to be destroyed after publication of results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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