An interventional study of Educational Intervention in Pain, Postoperative, Medication Adherence and Opioid Use, sponsored by University of Michigan. Completed at 2 sites in United States. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 503 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
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Exclusion Criteria:
This group will receive the scenario-tailored STOMP educational feedback
Behavioral: Educational Intervention
This group will receive only standard of care information.
This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
Also known as: STOMP Intervention
Opioid Risk Perception
Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception)
Time frame: Baseline, day 14, 3 months post intervention
Opioid Misuse Intention Decisions
Number of participants with opioid misuse intentions and behaviors
Time frame: 3 months post intervention
Subjects recruited from 11/2019 through May 2021 from surgical clinic rosters at University of Michigan
| Milestone | Education Intervention | Control |
|---|---|---|
| Started | 282 | 221 |
| Completed | 258 | 201 |
| Not completed | 24 | 20 |
| Withdrew: Incomplete baseline; surgical complication; no opioid prescription | 24 | 20 |
Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception)
| score on a scale | Education Intervention | Control |
|---|---|---|
| Baseline | 31.4 ± 0.85 | 31.1 ± 1.01 |
| Day 14 | 32.8 ± .65 | 30.02 ± 1.12 |
| Month 3 | 31.0 ± .62 | 29.8 ± 1.21 |
Number of participants with opioid misuse intentions and behaviors
| Participants | Education Intervention | Control |
|---|---|---|
| Misuse Intentions | 47 | 38 |
| Misuse behavior | 18 | 12 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Education Intervention | 0/258 (0%) | 9/258 (3.5%) | 0/258 (0%) |
| Control | 0/201 (0%) | 6/201 (3%) | 0/201 (0%) |
| Event | Education Intervention | Control |
|---|---|---|
| HospitalizationSurgical and medical procedures | 9/258 | 6/201 |
| Age, Continuous(years) | Education Intervention | Control | Total |
|---|---|---|---|
| Mean | 19.1 ± 2.7 | 19.1 ± 2.8 | 19.1 ± 2.7 |
| Sex: Female, Male(Participants) | Education Intervention | Control | Total |
|---|---|---|---|
| Female | 134 | 104 | 238 |
| Male | 124 | 97 | 221 |
| Ethnicity (NIH/OMB)(Participants) | Education Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 16 | 7 | 23 |
| Not Hispanic or Latino | 242 | 194 | 436 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Education Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 3 | 5 |
| Asian | 16 | 15 | 31 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 22 | 13 | 35 |
| White | 207 | 163 | 370 |
| More than one race | 11 | 7 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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