Lebanon, New Hampshire 03756


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

D19001


NCT ID:

NCT03694899


Secondary ID:


Study Acronym:


Brief Title:

The Excess Opioid Disposal Study


Official Title:

The Excess Opioid Disposal Study


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dartmouth-Hitchcock Medical Center


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Richard J Barth, MD
(603) 650-9479
Richard.J.Barth.Jr@hitchcock.org

Study Dates

Start Date:October 3, 2018
Completion Date:September 1, 2021
Completion Type:Anticipated
Primary Completion Date:July 1, 2020
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 21, 2019
First Received Date:October 2, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:opioid disposal rate
Time Frame:1 year
Safety Issues:False
Description:% of patients that dispose of excess opioids in an FDA compliant manner

Study Interventions

Intervention Type:Behavioral
Name:phone contact
Description:patients will be called prior to their outpatient appointment
Arm Name:one

Study Arms

Study Arm Type:Experimental
Arm Name:one
Description:acetaminophen 650 mg three times/day ibuprofen 600 mg three times/day opioid dose based on use in hospital day prior to discharge

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dartmouth-Hitchcock Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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