Opioid Reduction Toolkit Reduces Opioids Prescribed and Consumed
Primary Purpose
Opioid Abuse, Opioid Misuse, Pain
Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Sponsored by
About this trial
This is an interventional prevention trial for Opioid Abuse
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- Being scheduled for an outpatient elective pancreatectomy
Exclusion Criteria:
- Urgent/emergent status
- Concomitant procedure being performed at time of pancreatectomy
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Normal Standard Practices of Prescribing
Providers prescribed a base of 15 narcotic pills
Outcomes
Primary Outcome Measures
Number of opioid pills reported being taken by the patient
Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
Number of opioid pills being prescribed
Discharge paperwork and prescription information will be searched to determine the number of opioid pills were provided to the patient at discharge
Secondary Outcome Measures
Full Information
NCT ID
NCT05363436
First Posted
May 2, 2022
Last Updated
February 2, 2023
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT05363436
Brief Title
Opioid Reduction Toolkit Reduces Opioids Prescribed and Consumed
Official Title
Successful Implementation of an Opioid Reduction Toolkit in Pancreatectomy Patients Significantly Decreases Number of Opioids Prescribed and Consumed
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Recruitment Reorganzing
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigators studied a baseline population of patients receiving pancreatectomies at their institution and determined how many opioid pills each patient was prescribed and how many they took. Based on this data they created a toolkit to provide to prescribers to give patients a modified number of pills. The amount prescribed and consumed was measured after intervention.
Detailed Description
A single academic surgical department reviewed opioid treatment patterns for patients undergoing common procedures, including open pancreatectomy, and an opioid reduction toolkit using the data collected was created. Providers were educated on the use of the toolkit and it was implemented as a standard of practice. Data were collected on pancreatectomy patients via telephone interview (performed at 2 weeks post-op) and by reviewing the state prescription drug monitoring program. Outcome variables included morphine milliequivalents (MME) of pills prescribed, MME of pills consumed, number of patients aware of proper unused pill disposal, number of patients requesting refills, and pain scores. Categorical and continuous outcomes were compared within and between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Abuse, Opioid Misuse, Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Control group, measurement, intervention group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Normal Standard Practices of Prescribing
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Providers prescribed a base of 15 narcotic pills
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Providers had to prescribe 15 oxycodone pills to each patient discharge
Primary Outcome Measure Information:
Title
Number of opioid pills reported being taken by the patient
Description
Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
Time Frame
14 days
Title
Number of opioid pills being prescribed
Description
Discharge paperwork and prescription information will be searched to determine the number of opioid pills were provided to the patient at discharge
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18
Being scheduled for an outpatient elective pancreatectomy
Exclusion Criteria:
Urgent/emergent status
Concomitant procedure being performed at time of pancreatectomy
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Opioid Reduction Toolkit Reduces Opioids Prescribed and Consumed
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