ACE Pilot 3: Decision Aid 2 Options vs 3 Options
Post-Operative Analgesic Selection in Patients Planned for Third Molar Extraction After Undergoing Shared Decision Making Using 2- Versus 3-Option Decision-Aids
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dentists often prescribe opioids to their patients to manage acute post-surgical pain, with hydrocodone/acetaminophen being the most commonly prescribed opioid combination. With an estimated 56 million tablets of hydrocodone prescribed to 3.5 million high school and young adults each year after third molar extractions, it is vitally important to develop the best evidence for acute pain management following dental procedures.
Dentists are among the leading prescribers of opioid analgesics, writing up to 12% of all opioid prescriptions and 31% of opioid prescriptions for young patients. Shared decision making is an integral component of patient-centered clinical care. Decision aids have been shown to be effective in improving patient satisfaction, and one study suggests shared decisions have the potential to decrease the number of opioids tablets prescribed. Shared decision making studies on analgesics selection for out-patient surgery, however, are limited and no studies have investigated the "just in case" phenomenon which send a message that the opioid options are better than the non-opioid options.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Newark, New Jersey, United States, 07103
- Rutgers School of Dental Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be able to understand the informed consent.
- Provide signed and dated informed consent form
- Be able to understand all directions for data gathering instruments in English
- Be willing and able to comply with all study procedures
- Planning to undergo extraction of one or more 3rd molars
- Be 18 years or older
Exclusion Criteria:
While the actual analgesic prescribed to the patient may be different then the analgesic selected by the participant (their actual analgesic is NOT part of the research protocol) participants who self-report inability to take ibuprofen, acetaminophen or an opioid are not eligible since the decision aid is designed to help a patient select between a combination of ibuprofen/acetaminophen and an opioid containing analgesic.
Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:
- Prior participation in this study
- Inability or refusal to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Decision-Aid with 2-options
Participants in this arm will undergo a shared decision making process using a decision aid that offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone).
Subsequently, their choice for post-operative analgesic will be recorded.
|
This decision aid offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone).
|
|
Active Comparator: Decision-Aid with 3-options
Participants in this arm will undergo a shared decision making process using a decision aid that offers 3 options for post-operative analgesic: [1] a non-opioid combination (ibuprofen/acetaminophen), [2] an opioid (hydrocodone), or [3] a non-opioid combination plus an opioid prescription for "just-in-case" pain management.
Subsequently, their choice for post-operative analgesic will be recorded.
|
This decision aid offers 3 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen), an opioid (hydrocodone), or a non-opioid combination with a "just-in-case" opioid prescription.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
% participants selecting opioid analgesics versus non-opioid analgesics
Time Frame: Day 1
|
•To determine difference in proportion of patients who choose an opioid option for analgesics after participation in a shared decision making process using a decision aid
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2025000930
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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