Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients
Primary Purpose
Opioid Use, Opioid-Related Disorders, Opioid Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Default Prescribing Change
Sponsored by
About this trial
This is an interventional other trial for Opioid Use
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
Sites / Locations
- The Institute for Family Health
- Weill Medical College of Cornell University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Default Prescribing Change
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03377855
First Posted
December 13, 2017
Last Updated
February 20, 2020
Sponsor
Weill Medical College of Cornell University
Collaborators
New York State Health Foundation, The Institute for Family Health
1. Study Identification
Unique Protocol Identification Number
NCT03377855
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
New York State Health Foundation, The Institute for Family Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid-Related Disorders, Opioid Abuse, Prescription Drug Abuse and Dependency
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a interrupted time series study model with one study group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
948 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Default Prescribing Change
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Default Prescribing Change
Intervention Description
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 Measure Information:
Title
Change in the proportion of opioid prescriptions for opioid-naïve patients that comply with CDC recommendations before and after the intervention
Description
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
Secondary Outcome Measure Information:
Title
Change in the average days of supply of opioids for opioid naive patients
Description
Change in the average days of supply of opioids for opioid naive patients
Time Frame
Two years prior to and six months after implementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica S Ancker, PhD, MPH
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Institute for Family Health
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
26911828
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.
Results Reference
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Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients
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