Opioid Reduction Toolkit Reduces Opioids Prescribed and Consumed

Phase 4

Suspended

• Conditions: Pain; Opioid Abuse; Opioid Misuse
• Interventions: Drug: Oxycodone

• Registration Number: NCT05363436
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Age > 18
• Being scheduled for an outpatient elective pancreatectomy

Exclusion Criteria

• Urgent/emergent status
• Concomitant procedure being performed at time of pancreatectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Oxycodone	Providers prescribed a base of 15 narcotic pills

Primary Outcome Measures

Name	Time	Method
Number of opioid pills being prescribed	14 days	Discharge paperwork and prescription information will be searched to determine the number of opioid pills were provided to the patient at discharge
Number of opioid pills reported being taken by the patient	14 days	Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States