Scenario-tailored Opioid Messaging Program (STOMP): An Interactive Intervention to Prevent Opioid-related Adverse Drug Events in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 1
- 主要终点
- Opioid-related Risk Knowledge
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Group assignment will be coded for parents and data collectors. Parents 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.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent (>=21yr) and child (5-17 yr) (dyad) who lives in the home and is prescribed an opioid for postoperative pain management
- •English speaking
排除标准
- •Child is undergoing a non-elective procedure
- •Child cannot self-report pain levels (i.e., is cognitively impaired)
- •Child has a hematologic/oncologic condition
- •Child has a kidney or liver conditions that precludes the usual analgesic prescription pattern (opioid plus a non-opioid)
- •Child has been taking opioids for prolonged pain pre-operatively (>2 weeks)
研究组 & 干预措施
Education Intervention + Nudge
This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention
干预措施: Educational Intervention (Behavioral)
Education Intervention + Nudge
This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention
干预措施: Nudge (Behavioral)
Standard of Care + Nudge
This group will receive routine, standard of care information AND the behavioral Nudge intervention
干预措施: Nudge (Behavioral)
Educational Intervention no Nudge
This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.
干预措施: Educational Intervention (Behavioral)
Standard of Care no Nudge
This group will receive only standard of care information and NO behavioral nudge intervention.
结局指标
主要结局
Opioid-related Risk Knowledge
时间窗: Day 3 follow-up assessment
Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)
Opioid Risk Perception
时间窗: Mean difference in score from baseline to follow-up assessments (Days 3 & 14)
Change in parent's perceived risk of keeping/sharing opioids (misuse) (Risk perceptions measured on scale from -4 to +4 where higher number reflects higher perception of riskiness; the outcome is measured as change in risk perception - positive change indicates that risk perception became greater)
次要结局
- Pain Interference (PROMIS)(Day 14)
- Analgesic Self-Efficacy(Efficacy scores Day 14)
- Opioid Disposal Behavior(Day 14 (or after course completion))
- Analgesic Use / Adherence(Day 14)
- Analgesic Decision Competency(Day 3)
研究者
Terri Voepel-Lewis
Associate Research Scientist
University of Michigan