Clinical trial NCT03694899: The Excess Opioid Disposal Study
Official title: The Excess Opioid Disposal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedures, Operative
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: opioid disposal rate
timeFrame: 1 year
Secondary outcomes:
measure: Does guideline predict opioid needs
timeFrame: 6 months
measure: effect on long term opioid usage
timeFrame: 1 year
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
citation: Porter ED, Bessen SY, Molloy IB, Kelly JL, Ramkumar N, Phillips JD, Loehrer AP, Wilson MZ, Hasson RM, Ivatury SJ, Henkin JR, Barth RJ Jr. Guidelines for Patient-CenteredOpioid Prescribing and Optimal FDA-Compliant Disposal of Excess Pills after Inpatient Operation: Prospective Clinical Trial. J Am Coll Surg. 2021 Jun;232(6):823-835.e2. doi: 10.1016/j.jamcollsurg.2020.12.057. Epub 2021 Feb 25.