Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults

Not Applicable

Completed

• Conditions: Knowledge, Attitudes, Practice; Medication Adherence; Opioid Use; Risk Reduction Behavior; Pain, Postoperative
• Interventions: Behavioral: Educational Intervention

• Registration Number: NCT03863353
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed 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 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.

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Study Start: 2019-11-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Results First Submitted: 2021-12-22
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-13
• Last Update Submitted: 2022-03-13
• Results First Posted: 2022-04-06
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Education Intervention	Educational Intervention	This group will receive the scenario-tailored STOMP educational feedback

Primary Outcome Measures

Name	Time	Method
Opioid Risk Perception	Baseline, day 14, 3 months post intervention	Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception)

Secondary Outcome Measures

Name	Time	Method
Opioid Misuse Intention Decisions	3 months post intervention	Number of participants with opioid misuse intentions and behaviors

Trial Locations

Locations (2)

University of Michigan, C.S. Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States