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

NCT03863353 | Completed Results DMC

• 2 other identifiers: HUM001473781R01DA044245-01A1
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 2

Brief Summary

Legitimate prescription opioid use during adolescence has been associated with later prescription opioid misuse and substance use disorder symptoms during adulthood. Thus, primary prevention interventions for older adolescents and young adults (15-24 yrs) at the time of prescribing are imperative. The goal of our research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition and informed decision-making among 15-24 year olds who are prescribed these agents for home use. Young adults and older adolescents who manage their own prescription pain medicines need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief. The proposed research will evaluate new strategies to help subjects learn about opioid risks and make safe and effective analgesic decisions. 355 subjects who are undergoing an elective surgical procedure will be recruited. Subjects will be randomized to receive the new educational routine information. Subjects' knowledge and perceptions will be evaluated at baseline and at critical times after surgery.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Opioid Risk Perception

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

  Baseline, day 14, 3 months post intervention

Secondary Outcomes (1)

• Opioid Misuse Intention Decisions

  3 months post intervention

Study Arms (2)

Education Intervention

EXPERIMENTAL

This group will receive the scenario-tailored STOMP educational feedback

Behavioral: Educational Intervention

Control

NO INTERVENTION

This group will receive only standard of care information.

Interventions

Educational Intervention BEHAVIORAL

This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.

Also known as: STOMP Intervention

Education Intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Undergoing an elective surgical procedure for which it is expected they will receive a prescription pain medicine for management of pain during recovery at home.

You may not qualify if:

• Undergoing non-elective procedure
• Cognitive impairment precluding self-reporting of pain
• Hematologic/oncologic condition
• Liver of kidney conditions precluding usual analgesic prescription patters (opioid plus a non-opioid)
• Use of opioids for prolonged pain pre-operatively (\<2 weeks)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Michigan, C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Medication Adherence; Behavior; Risk Reduction Behavior

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Dr. Terri Voepel-Lewis
• Organization: University of Michigan

terriv@umich.edu

734-6466803

Study Officials

• Terri Voepel-Lewis, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group assignment will be coded for subjects and data collectors. Subjects will be blinded to whether the information they receive is the Intervention vs. Control. Group assignment will coded on data entry and unblinded after analyses.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Model Details: randomized, controlled, factorial design

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 5, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 6, 2022
• Results First Posted: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)