Opioid Reduction Toolkit Reduces Opioids Prescribed and Consumed

Sponsor

Thomas Jefferson University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05363436

Collaborator

(none)

159

Enrollment

Location

Arms

53.9

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Abuse Opioid Misuse Pain	Drug: Oxycodone	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

159 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Control group, measurement, intervention groupControl group, measurement, intervention group

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Successful Implementation of an Opioid Reduction Toolkit in Pancreatectomy Patients Significantly Decreases Number of Opioids Prescribed and Consumed

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Normal Standard Practices of Prescribing
Experimental: Intervention Providers prescribed a base of 15 narcotic pills	Drug: Oxycodone Providers had to prescribe 15 oxycodone pills to each patient discharge

Arm

Intervention/Treatment

No Intervention: Control

Normal Standard Practices of Prescribing

Experimental: Intervention

Providers prescribed a base of 15 narcotic pills

Drug: Oxycodone

Providers had to prescribe 15 oxycodone pills to each patient discharge

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18
Being scheduled for an outpatient elective pancreatectomy

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT05363436

Other Study ID Numbers:

19D.688Panc

First Posted:

May 5, 2022

Last Update Posted:

May 5, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Opioid-Related Disorders

Oxycodone

Study Results

No Results Posted as of May 5, 2022