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Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

Primary Purpose

Opioid Use Disorders, Tooth Extraction Status Nos

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Financial
Educational
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Non-institutionalized

Exclusion Criteria:

  • pregnancy
  • a history of opioid analgesic misuse/abuse
  • ongoing participation in other clinical research
  • or daily use of opioid analgesics in the week prior to surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    Financial intervention only

    Educational intervention only

    Both interventions

    Arm Description

    Patient receives neither educational nor financial interventions

    Patient receives financial (pharmacy offer) intervention only

    Patient receives educational (narrative) intervention only

    Patient receives both educational and financial interventions

    Outcomes

    Primary Outcome Measures

    Unused opioids
    Number of opioids reported unused by the patient after postoperative day 21

    Secondary Outcome Measures

    Intent to dispose of opioids
    Patient reports intent to dispose of leftover opioids during follow-up interview or by calling study hotline

    Full Information

    First Posted
    June 16, 2016
    Last Updated
    June 22, 2016
    Sponsor
    University of Pennsylvania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02814305
    Brief Title
    Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
    Official Title
    Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania

    4. Oversight

    5. Study Description

    Brief Summary
    Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. There is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. Even less is known about patients' willingness to dispose of these leftover pills. Aims: 1) Measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused after outpatient dental surgery. Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. The primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. Secondary outcomes include patient use of prescribed opioids and their number of unused pills. These outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Use Disorders, Tooth Extraction Status Nos

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    79 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patient receives neither educational nor financial interventions
    Arm Title
    Financial intervention only
    Arm Type
    Experimental
    Arm Description
    Patient receives financial (pharmacy offer) intervention only
    Arm Title
    Educational intervention only
    Arm Type
    Experimental
    Arm Description
    Patient receives educational (narrative) intervention only
    Arm Title
    Both interventions
    Arm Type
    Experimental
    Arm Description
    Patient receives both educational and financial interventions
    Intervention Type
    Behavioral
    Intervention Name(s)
    Financial
    Intervention Description
    Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational
    Intervention Description
    Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively
    Primary Outcome Measure Information:
    Title
    Unused opioids
    Description
    Number of opioids reported unused by the patient after postoperative day 21
    Time Frame
    21 days after surgery
    Secondary Outcome Measure Information:
    Title
    Intent to dispose of opioids
    Description
    Patient reports intent to dispose of leftover opioids during follow-up interview or by calling study hotline
    Time Frame
    Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-institutionalized Exclusion Criteria: pregnancy a history of opioid analgesic misuse/abuse ongoing participation in other clinical research or daily use of opioid analgesics in the week prior to surgery

    12. IPD Sharing Statement

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    Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

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