Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents
Condition: Pain, Postoperative; Medication Adherence; Opioid Use; Knowledge, Attitudes, Practice; Risk Reduction Behavior
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Millions of children and adolescents are prescribed opioid pain relievers each year, placing
      them at risk for serious adverse events and misuse in the home setting. Parents who manage
      these medicines, therefore, need to recognize opioid-related risks and make decisions that
      will both reduce these risks yet ensure effective pain relief for their children. The
      proposed research will evaluate new strategies to help parents learn about opioid risks, make
      safe and effective analgesic decisions, and develop and demonstrate safe drug management
      behaviors. 840 parents and their children who are undergoing an elective surgical procedure
      will be recruited. Parents will be randomized to receive the new educational and practical
      behavioral strategy or routine information. Parents' knowledge and perceptions will be
      evaluated at baseline and at critical times after surgery. Parents' opioid handling and
      administration will also be assessed.
    

Detailed description: 
      The overarching goal of this research is to improve opioid analgesic safety and efficacy by
      optimizing opioid risk recognition, informed analgesic decision-making, and drug
      storage/disposal behaviors among parents of youth who are prescribed these agents for home
      use. The study aims are to determine whether the Scenario-Tailored Opioid Messaging Program
      (STOMP) will: 1) Improve parents' opioid risk understanding and their analgesic
      decision-making; 2) Enhance parents' analgesic self-efficacy, analgesic use, storage
      behaviors and their children's pain outcomes, and 3) To demonstrate that the STOMP plus
      provision of a simple method to get rid of left-over opioids will effectively nudge parents
      to safely dispose of left-over opioid analgesics. Parents whose children are prescribed
      opioids for acute, short-lived pain after surgery will be randomly assigned to receive our
      interventions or a routine provider informational interaction at the time of opioid
      prescribing. Parents will be surveyed about their opioid familiarity, knowledge, risk
      perceptions and common analgesic decision-making at baseline and after hospital discharge.
      Parents will also record their child's pain medication use and symptoms after discharge. Data
      will be analyzed to determine whether the STOMP educational intervention with or without the
      behavioral nudge intervention will enhance parents' risk perceptions, their decision-making
      skills and their opioid handling behaviors.
    

Intervention name(s): Educational Intervention; Nudge
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.; Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids
Other intervention name(s): STOMP Intervention
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Four-armed, randomized, control, factorial design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention