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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377855
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : February 24, 2020
Sponsor:
Collaborators:
New York State Health Foundation
The Institute for Family Health
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Opioid Use Opioid-Related Disorders Opioid Abuse Prescription Drug Abuse and Dependency Other: Default Prescribing Change Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 948 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a interrupted time series study model with one study group.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377855


Locations
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United States, New York
The Institute for Family Health
New York, New York, United States, 10035
Weill Medical College of Cornell University
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
New York State Health Foundation
The Institute for Family Health
Investigators
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Principal Investigator: Jessica S Ancker, PhD, MPH Weill Medical College of Cornell University
Publications:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03377855    
Other Study ID Numbers: 1710018646
17-05047 ( Other Grant/Funding Number: NYS Health Foundation )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders