Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 2
- 主要终点
- Opioid Risk Perception
研究概览
简要总结
Legitimate prescription opioid use during adolescence has been associated with later prescription opioid misuse and substance use disorder symptoms during adulthood. Thus, primary prevention interventions for older adolescents and young adults (15-24 yrs) at the time of prescribing are imperative.
The goal of our research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition and informed decision-making among 15-24 year olds who are prescribed these agents for home use. Young adults and older adolescents who manage their own prescription pain medicines need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief. The proposed research will evaluate new strategies to help subjects learn about opioid risks and make safe and effective analgesic decisions. 355 subjects who are undergoing an elective surgical procedure will be recruited. Subjects will be randomized to receive the new educational routine information. Subjects' knowledge and perceptions will be evaluated at baseline and at critical times after surgery.
详细描述
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.
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 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.
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing an elective surgical procedure for which it is expected they will receive a prescription pain medicine for management of pain during recovery at home.
排除标准
- •Undergoing non-elective procedure
- •Cognitive impairment precluding self-reporting of pain
- •Hematologic/oncologic condition
- •Liver of kidney conditions precluding usual analgesic prescription patters (opioid plus a non-opioid)
- •Use of opioids for prolonged pain pre-operatively (<2 weeks)
研究组 & 干预措施
Education Intervention
This group will receive the scenario-tailored STOMP educational feedback
干预措施: Educational Intervention (Behavioral)
Control
This group will receive only standard of care information.
结局指标
主要结局
Opioid Risk Perception
时间窗: Baseline, day 14, 3 months post intervention
Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception)
次要结局
- Opioid Misuse Intention Decisions(3 months post intervention)
研究者
Terri Voepel-Lewis
Prinicipal Investigator
University of Michigan