Clinical trial NCT03863353: Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults
Official title: Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Medication Adherence
Opioid Use
Knowledge, Attitudes, Practice
Risk Reduction Behavior
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-03-05
Enrollment: 503
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: randomized, controlled, factorial design
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

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)

Primary outcomes:
measure: Opioid Risk Perception
timeFrame: Baseline, day 14, 3 months post intervention
Secondary outcomes:
measure: Opioid Misuse Intention Decisions
timeFrame: 3 months post intervention
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, C.S. Mott Children's Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Terri Voepel-Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References: