NCT03694899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 3, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

October 2, 2018

Last Update Submit

May 21, 2021

Conditions

Surgical Procedures, Operative

Outcome Measures

Primary Outcomes (1)

  • opioid disposal rate

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

    1 year

Secondary Outcomes (2)

  • Does guideline predict opioid needs

    6 months

  • effect on long term opioid usage

    1 year

Study Arms (1)

one

EXPERIMENTAL

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

Behavioral: phone contact

Interventions

phone contactBEHAVIORAL

patients will be called prior to their outpatient appointment

one

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • 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.

    PMID: 33640521DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Section of General Surgery

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 3, 2018

Study Start

October 3, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)