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

NCT ID: NCT03863353

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-12-01

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.

Detailed Description

The goal of this research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition, informed decision-making including misuse among 15-24 year olds who are prescribed these agents for home use.

This is a randomized, controlled study design. The investigators will enroll emerging adults (aged 15-24 yrs) who are scheduled to undergo a surgical procedure and will be prescribed an opioid as part of their routine postoperative care. Comprehensive informed consent will be obtained.

No medical treatments will be altered for the purposes of this educational study. All participants will complete baseline surveys to assess their pain medicine familiarity, their opioid risk knowledge and perceptions, and their analgesic self-efficacy and their pain relief/ risk avoidance preferences. Participants will also be presented (via the survey platform) with several hypothetical (mock) scenarios and will be asked to make hypothetical decisions about how they would treat pain for each.

The Intervention group will receive tailored feedback and guidance after each scenario (i.e., the Scenario Tailored Opioid Messages) and the Control group will receive only routine analgesic risk and benefit information. Participants will complete the post-scenario/feedback surveys to re-assess opioid risk perceptions and self-efficacy and will complete brief health literacy surveys.

On days 7, 14 and at 1 and 3 months, participants will be resurveyed (via emailed qualtrics survey link or paper -whichever is preferred) about their opioid risk knowledge, perceptions, scenario decision making, analgesic self-efficacy and pain relief/risk avoidance preferences.

All surveys and datasheets will contain unique identifiers only. Identifiers will be maintained separately from survey data (linked only by unique identifier) to maintain privacy. Participants will receive up to $50 for participation.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Education Intervention

This group will receive the scenario-tailored STOMP educational feedback

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: BEHAVIORAL

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational Intervention

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

Intervention Type: BEHAVIORAL

Other Intervention Names

STOMP Intervention

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Terri Voepel-Lewis

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terri Voepel-Lewis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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

Ann Arbor, Michigan, United States

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1R01DA044245-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00147378

Identifier Type: -

Identifier Source: org_study_id