Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents

University of Michigan

Status: Completed

Conditions: Medication Adherence; Risk Reduction Behavior; Pain, Postoperative; Opioid Use; Knowledge, Attitudes, Practice

Treatments: Behavioral: Nudge; Behavioral: Educational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03287622

1R01DA044245-01A1 (U.S. NIH Grant/Contract)

00127009

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 712 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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712 participants in 4 patient groups

Education Intervention + Nudge

Experimental group

Description:

This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention

Treatment:

Behavioral: Educational Intervention

Behavioral: Nudge

Standard of Care + Nudge

Experimental group

Description:

This group will receive routine, standard of care information AND the behavioral Nudge intervention

Treatment:

Behavioral: Nudge

Educational Intervention no Nudge

Experimental group

Description:

This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.

Treatment:

Behavioral: Educational Intervention

Standard of Care no Nudge

No Intervention group

Description:

This group will receive only standard of care information and NO behavioral nudge intervention.