Opioid Reduction Toolkit Reduces Opioids Prescribed and Consumed

NCT05363436 | Suspended Phase 4 DMC FDA Drug

• 1 other identifier: 19D.688Panc
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Abuse; Opioid Misuse; Pain

Outcome Measures

Primary Outcomes (2)

• 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

  14 days

• 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

  14 days

Study Arms (2)

Control

NO INTERVENTION

Normal Standard Practices of Prescribing

Intervention

EXPERIMENTAL

Providers prescribed a base of 15 narcotic pills

Drug: Oxycodone

Interventions

Oxycodone DRUG

Providers had to prescribe 15 oxycodone pills to each patient discharge

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group, measurement, intervention group

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)