An interventional study of Educational Intervention and Nudge in Pain, Postoperative, Medication Adherence and Opioid Use, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention
Behavioral: Educational Intervention · Behavioral: Nudge
This group will receive routine, standard of care information AND the behavioral Nudge intervention
Behavioral: Nudge
This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.
Behavioral: Educational Intervention
This group will receive only standard of care information and NO behavioral nudge intervention.
This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
Also known as: STOMP Intervention
Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids
Opioid-related Risk Knowledge
Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)
Time frame: Day 3 follow-up assessment
Opioid Risk Perception
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)
Time frame: Mean difference in score from baseline to follow-up assessments (Days 3 & 14)
Opioid Disposal Behavior
Number of parents (and percentage) who disposed of left-over opioids after use
Time frame: Day 14 (or after course completion)
Pain Interference (PROMIS)
The Parents PROMIS Pain Interference measure was used to capture pain interference with functioning (score range 0-30 with higher number indicating worse pain interference)
Time frame: Day 14
Analgesic Self-Efficacy
Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)
Time frame: Efficacy scores Day 14
Analgesic Use / Adherence
Total number of opioid doses administered
Time frame: Day 14
Analgesic Decision Competency
Number of participants who made the scenario-based decision to administer opioid to excessively sedated child
Time frame: Day 3
| Milestone | Education Intervention | Standard of Care |
|---|---|---|
| Started | 356 | 356 |
| Sub-randomized to nudge/nonudge | 253 | 266 |
| Completed | 298 | 308 |
| Not completed | 58 | 48 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 27 | 15 |
| Withdrew: No prescripion after surgery | 28 | 31 |
| Withdrew: Prolonged length of stay | 2 | 0 |
| Withdrew: Surgery related | 0 | 2 |
Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)
| Participants | Education Intervention | Standard of Care Education |
|---|---|---|
| Opioid-related Risk Knowledge | 287 | 289 |
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)
| units on a scale | Education Intervention | Standard of Care |
|---|---|---|
| Mean difference in perceived riskiness of keeping/sharing opioids day 3 | 0.35 (0.07 to 0.63) | 0.12 (-0.06 to 0.29) |
| Change in perceived riskiness keeping/sharing day 14 | 0.28 (0.07 to 0.50) | 0.14 (-0.06 to 0.33) |
Number of parents (and percentage) who disposed of left-over opioids after use
| Participants | Nudge + Educational Intervention | Nudge + Standard of Care | Educational Intervention Only (No Nudge) | Standard of Care Only (No Nudge) |
|---|---|---|---|---|
| Opioid Disposal Behavior | 48 | 44 | 40 | 25 |
The Parents PROMIS Pain Interference measure was used to capture pain interference with functioning (score range 0-30 with higher number indicating worse pain interference)
| units on a scale | Education Intervention | Standard of Care |
|---|---|---|
| Pain Interference (PROMIS) | 8.63 ± 8.39 | 8.06 ± 8.06 |
Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)
| units on a scale | Education Intervention | Standard of Care |
|---|---|---|
| Analgesic Self-Efficacy | 32.5 ± 3.22 | 32.2 ± 3.25 |
Total number of opioid doses administered
| Doses | Education Intervention | Standard of Care |
|---|---|---|
| Analgesic Use / Adherence | 8.6 ± 10.3 | 7.9 ± 8.6 |
Number of participants who made the scenario-based decision to administer opioid to excessively sedated child
| Participants | Education Intervention | Standard of Care Only |
|---|---|---|
| Analgesic Decision Competency | 43 | 64 |
Collected over All adverse events within 30 days of enrollment were recorded.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Education Intervention | 0/298 (0%) | 4/298 (1.3%) | 0/298 (0%) |
| Standard of Care | 0/308 (0%) | 3/308 (1%) | 0/308 (0%) |
| Event | Education Intervention | Standard of Care |
|---|---|---|
| DehydrationMetabolism and nutrition disorders | 1/298 | 1/308 |
| Postoperative hemorrhageSurgical and medical procedures | 1/298 | 1/308 |
| Deep vein thrombosisBlood and lymphatic system disorders | 1/298 | 0/308 |
| Adverse Drug ReactionGeneral disorders | 1/298 | 0/308 |
| Suspected postoperative infectionSurgical and medical procedures | 0/298 | 1/308 |
298 subjects (84%) completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects (87%) completed surveys required for analysis in the STANDARD OF CARE GROUP
| Age, Categorical(Participants) | Education Intervention | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 298 | 308 | 606 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Education Intervention | Standard of Care | Total |
|---|---|---|---|
| Female | 252 | 241 | 493 |
| Male | 46 | 67 | 113 |
| Ethnicity (NIH/OMB)(Participants) | Education Intervention | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 10 | 19 |
| Not Hispanic or Latino | 289 | 298 | 587 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Education Intervention | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 3 | 5 |
| Asian | 7 | 6 | 13 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 19 | 18 | 37 |
| White | 262 | 267 | 529 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 14 | 21 |
| Education Level(Participants) | Education Intervention | Standard of Care | Total |
|---|---|---|---|
| Some HS or HS complete | 38 | 31 | 69 |
| Some College | 60 | 57 | 117 |
| Assoc. Degree or Trade School | 62 | 54 | 116 |
| 4 Year College Graduate | 76 | 84 | 160 |
| Graduate School | 62 | 82 | 144 |
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