Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 21 - 99 |
| Updated: | 10/31/2018 |
| Start Date: | October 24, 2017 |
| End Date: | July 2020 |
| Contact: | Monica Weber, BSN |
| Email: | monij@med.umich.edu |
| Phone: | 734 936 0747 |
Scenario-tailored Opioid Messaging Program (STOMP): An Interactive Intervention to Prevent Opioid-related Adverse Drug Events in Children and Adolescents
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.
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.
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.
Inclusion Criteria:
- Parent (>=21yr) and child (5-17 yr) (dyad) who lives in the home and is prescribed an
opioid for postoperative pain management
- English speaking
Exclusion Criteria:
- Child is undergoing a non-elective procedure
- Child cannot self-report pain levels (i.e., is cognitively impaired)
- Child has a hematologic/oncologic condition
- Child has a kidney or liver conditions that precludes the usual analgesic prescription
pattern (opioid plus a non-opioid)
- Child has been taking opioids for prolonged pain pre-operatively (>2 weeks)
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