Trial Outcomes & Findings for Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults (NCT NCT03863353)

NCT ID: NCT03863353

Last Updated: 2022-04-06

Results Overview

Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 503 participants
• Primary outcome timeframe: Baseline, day 14, 3 months post intervention
• Results posted on: 2022-04-06

Participant Flow

Subjects recruited from 11/2019 through May 2021 from surgical clinic rosters at University of Michigan

Enrollment number includes all who "Started" by signing the consent and were assigned to study groups. "Completed" indicates those who were analyzed. "Not completed includes those withdrawn after signing consent but prior to analyses. Reasons incomplete are indicated below (reasons included; alterations in surgical procedure or no opioid prescription dispensed).

Participant milestones

Measure	Education Intervention This group will receive the scenario-tailored STOMP educational feedback Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Control This group will receive only standard of care information.
Overall Study STARTED	282	221
Overall Study COMPLETED	258	201
Overall Study NOT COMPLETED	24	20

Reasons for withdrawal

Measure	Education Intervention This group will receive the scenario-tailored STOMP educational feedback Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Control This group will receive only standard of care information.
Overall Study incomplete baseline; surgical complication; no opioid prescription	24	20

Baseline Characteristics

Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults

Baseline characteristics by cohort

Measure	Education Intervention n=258 Participants This group will receive the scenario-tailored STOMP educational feedback Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Control n=201 Participants This group will receive only standard of care information.	Total n=459 Participants Total of all reporting groups
Age, Continuous	19.1 years STANDARD_DEVIATION 2.7 • n=5 Participants	19.1 years STANDARD_DEVIATION 2.8 • n=7 Participants	19.1 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	134 Participants n=5 Participants	104 Participants n=7 Participants	238 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	97 Participants n=7 Participants	221 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	242 Participants n=5 Participants	194 Participants n=7 Participants	436 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) White	207 Participants n=5 Participants	163 Participants n=7 Participants	370 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, day 14, 3 months post intervention

Population: All who completed at least one follow-up measurement of risk perception.

Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception)

Outcome measures

Measure	Education Intervention n=258 Participants This group will receive the scenario-tailored STOMP educational feedback Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Control n=201 Participants This group will receive only standard of care information.
Opioid Risk Perception Month 3	31.0 score on a scale Standard Deviation .62	29.8 score on a scale Standard Deviation 1.21
Opioid Risk Perception Baseline	31.4 score on a scale Standard Deviation 0.85	31.1 score on a scale Standard Deviation 1.01
Opioid Risk Perception Day 14	32.8 score on a scale Standard Deviation .65	30.02 score on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: 3 months post intervention

Population: Rest of the sample lost to follow-up at months 1-3

Number of participants with opioid misuse intentions and behaviors

Outcome measures

Measure	Education Intervention n=226 Participants This group will receive the scenario-tailored STOMP educational feedback Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Control n=173 Participants This group will receive only standard of care information.
Opioid Misuse Intention Decisions Misuse Intentions	47 Participants	38 Participants
Opioid Misuse Intention Decisions Misuse behavior	18 Participants	12 Participants

Adverse Events

Education Intervention

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Education Intervention n=258 participants at risk This group will receive the scenario-tailored STOMP educational feedback Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Control n=201 participants at risk This group will receive only standard of care information.
Surgical and medical procedures Hospitalization	3.5% 9/258 • Number of events 9 • 3 months Review of medical records, clinic visits etc.	3.0% 6/201 • Number of events 6 • 3 months Review of medical records, clinic visits etc.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Terri Voepel-Lewis

University of Michigan

Phone: 734-6466803

Email: terriv@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place