The Excess Opioid Disposal Study

Not Applicable

Completed

• Conditions: Surgical Procedures, Operative
• Interventions: Behavioral: phone contact

• Registration Number: NCT03694899
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

This study is designed to test the hypothesis that providing information to patients about excess opioid disposal, calling patients prior to their outpatient post-operative surgical appointment and providing a convenient drop box for opioid disposal will increase rates of FDA compliant disposal.

Detailed Description

It is hypothesized that:

1. By providing pre-operative patient education, a drop-box in a convenient location (the hospital pharmacy near the surgical outpatient clinic) and a reminder phone call prior to the post-operative clinic appointment, an increase in FDA-compliant unused opioid disposal rates to at least 40% will be seen.

2. The investigator's guideline for opioid prescribing after operations that require an inpatient admission which the investigator established for general surgical procedures will satisfy the opioid requirements of at least 85% of patients undergoing a variety of operations from differing specialties.

3. The utilization of guideline opioid prescribing and FDA-compliant unused opioid disposal will decrease the percentage of patients who are taking opioids at 6 months and 1 year after their surgery to less than 1%.

The primary objective is to determine the effect of pre-operative patient education, a drop-box in the hospital pharmacy and a reminder phone call on the proportion of patients who dispose of unused opioids using a FDA-compliant method.

Secondary objectives include:

1. Determine in a prospective study whether our guideline for opioid prescribing after surgery which requires inpatient admission fulfills the opioid requirements of at least 85% of patients undergoing a variety of operations.

2. Determining the effect of guideline opioid prescribing and FDA-compliant unused opioid disposal on the proportion of patients who are on opioids 6 months and 1 year after their surgery.

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Study Start: 2018-10-03
• Study First Posted: 2018-10-03
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Having surgery with expected duration of admission of 2 days or more

Exclusion Criteria

• Allergies to opioids
• Allergy or contra-indication to short term acetaminophen or ibuprofen
• Chronic opioid use
• History of opioid abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one	phone contact	acetaminophen 650 mg three times/day ibuprofen 600 mg three times/day opioid dose based on use in hospital day prior to discharge

Primary Outcome Measures

Name	Time	Method
opioid disposal rate	1 year	% of patients that dispose of excess opioids in an FDA compliant manner

Secondary Outcome Measures

Name	Time	Method
Does guideline predict opioid needs	6 months	1.Determine in a prospective study whether our guideline for opioid prescribing after surgery which requires inpatient admission fulfills the opioid requirements of at least 85% of patients undergoing a variety of operations.
effect on long term opioid usage	1 year	Determining the effect of guideline opioid prescribing and FDA-compliant unused opioid disposal on the proportion of patients who are on opioids 6 months and 1 year after their surgery.

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States