NCT03287622: STOMP

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

Completed NA Results posted Last updated 19 November 2020

What this trial tests

NA trial testing Educational Intervention in Pain, Postoperative in 712 participants. Completed in 30 September 2019.

Timeline

24 October 2017

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	prevention
Enrollment	712
Start date	24 October 2017
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Educational Intervention
• Nudge

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Medication Adherence — all drugs for Medication Adherence →
• Opioid Use — all drugs for Opioid Use →
• Knowledge, Attitudes, Practice — all drugs for Knowledge, Attitudes, Practice →

Sponsor

University of Michigan

Who can join

Adults 21 to 99, any sex, with Pain, Postoperative or Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid-related Risk Knowledge Primary · Day 3 follow-up assessment

Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)

Group	Value	95% CI
Education Intervention	287
Standard of Care Education	289

Opioid Risk Perception Primary · Mean difference in score from baseline to follow-up assessments (Days 3 & 14)

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)

Mean difference in perceived riskiness of keeping/sharing opioids day 3

Group	Value	95% CI
Education Intervention	0.35	0.07 – 0.63
Standard of Care	0.12	-0.06 – 0.29

Change in perceived riskiness keeping/sharing day 14

Group	Value	95% CI
Education Intervention	0.28	0.07 – 0.50
Standard of Care	0.14	-0.06 – 0.33

Opioid Disposal Behavior Secondary · Day 14 (or after course completion)

Number of parents (and percentage) who disposed of left-over opioids after use

Group	Value	95% CI
Nudge + Educational Intervention	48
Nudge + Standard of Care	44
Educational Intervention Only (No Nudge)	40
Standard of Care Only (No Nudge)	25

Pain Interference (PROMIS) Secondary · Day 14

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)

Group	Value	95% CI
Education Intervention	8.63	± 8.39
Standard of Care	8.06	± 8.06

Analgesic Self-Efficacy Secondary · Efficacy scores Day 14

Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)

Group	Value	95% CI
Education Intervention	32.5	± 3.22
Standard of Care	32.2	± 3.25

Analgesic Use / Adherence Secondary · Day 14

Total number of opioid doses administered

Group	Value	95% CI
Education Intervention	8.6	± 10.3
Standard of Care	7.9	± 8.6

Analgesic Decision Competency Secondary · Day 3

Number of participants who made the scenario-based decision to administer opioid to excessively sedated child

Group	Value	95% CI
Education Intervention	43
Standard of Care Only	64

Adverse events — posted to ClinicalTrials.gov

Time frame: All adverse events within 30 days of enrollment were recorded.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Education Intervention

Serious: 4/298 (1%)

Deaths: 0/298

Standard of Care

Serious: 3/308 (1%)

Deaths: 0/308

Serious adverse events (5 terms)

Reaction	System	Education Intervention	Standard of Care
Dehydration	Metabolism and nutrition disorders	—	—
Postoperative hemorrhage	Surgical and medical procedures	—	—
Suspected postoperative infection	Surgical and medical procedures	—	—
Deep vein thrombosis	Blood and lymphatic system disorders	—	—
Adverse Drug Reaction	General disorders	—	—

Most-reported serious reactions: Dehydration, Postoperative hemorrhage, Suspected postoperative infection, Deep vein thrombosis, Adverse Drug Reaction.

Data from ClinicalTrials.gov NCT03287622 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Behavioral Intervention and Disposal of Leftover Opioids: A Randomized Trial.
   Voepel-Lewis T, Farley FA, Grant J, Tait AR, et al · · 2020 · cited 26× · PMID 31871245 · DOI 10.1542/peds.2019-1431
2. Effect of a brief scenario-tailored educational program on parents' risk knowledge, perceptions, and decisions to administer prescribed opioids: a randomized controlled trial.
   Voepel-Lewis T, Malviya S, Grant JA, Dwyer S, et al · · 2021 · cited 6× · PMID 33009245 · DOI 10.1097/j.pain.0000000000002095
3. A Risk Education Program Decreases Leftover Prescription Opioid Retention: An RCT.
   Voepel-Lewis T, Boyd CJ, Tait AR, McCabe SE, et al · · 2022 · cited 3× · PMID 35909029 · DOI 10.1016/j.amepre.2022.04.035