Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
355

Summary

Conditions
  • Knowledge, Attitudes, Practice
  • Medication Adherence
  • Opioid Use
  • Pain Postoperative
  • Risk Reduction Behavior
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: randomized, controlled, factorial designMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Group assignment will be coded for subjects and data collectors. Subjects will be blinded to whether the information they receive is the Intervention vs. Control. Group assignment will coded on data entry and unblinded after analyses.Primary Purpose: Prevention

Participation Requirements

Age
Between 15 years and 24 years
Gender
Both males and females

Description

The goal of this research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition, informed decision-making including misuse among 15-24 year olds who are prescribed these agents for home use. This is a randomized, controlled study design. The investigators will enro...

The goal of this research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition, informed decision-making including misuse among 15-24 year olds who are prescribed these agents for home use. This is a randomized, controlled study design. The investigators will enroll emerging adults (aged 15-24 yrs) who are scheduled to undergo a surgical procedure and will be prescribed an opioid as part of their routine postoperative care. Comprehensive informed consent will be obtained. No medical treatments will be altered for the purposes of this educational study. All participants will complete baseline surveys to assess their pain medicine familiarity, their opioid risk knowledge and perceptions, and their analgesic self-efficacy and their pain relief/ risk avoidance preferences. Participants will also be presented (via the survey platform) with several hypothetical (mock) scenarios and will be asked to make hypothetical decisions about how they would treat pain for each. The Intervention group will receive tailored feedback and guidance after each scenario (i.e., the Scenario Tailored Opioid Messages) and the Control group will receive only routine analgesic risk and benefit information. Participants will complete the post-scenario/feedback surveys to re-assess opioid risk perceptions and self-efficacy and will complete brief health literacy surveys. On days 7, 14 and at 1 and 3 months, participants will be resurveyed (via emailed qualtrics survey link or paper -whichever is preferred) about their opioid risk knowledge, perceptions, scenario decision making, analgesic self-efficacy and pain relief/risk avoidance preferences. All surveys and datasheets will contain unique identifiers only. Identifiers will be maintained separately from survey data (linked only by unique identifier) to maintain privacy. Participants will receive up to $50 for participation.

Tracking Information

NCT #
NCT03863353
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Terri Voepel-Lewis, PhD University of Michigan