The Excess Opioid Disposal Study

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Richard J. Barth,Jr.，Dartmouth-Hitchcock Medical Center

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

July 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

opioid disposal rate[ Time Frame: 1 year ]

% of patients that dispose of excess opioids in an FDA compliant manner

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

The Excess Opioid Disposal Study

Official Title ^ICMJE

The Excess Opioid Disposal Study

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: phone contact
patients will be called prior to their outpatient appointment

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

300

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 1, 2021

Estimated Primary Completion Date

July 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Richard J. Barth,Jr.，Dartmouth-Hitchcock Medical Center

Study Sponsor ^ICMJE

Dartmouth-Hitchcock Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Dartmouth-Hitchcock Medical Center

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名