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

Primary Purpose

Pain, Postoperative, Medication Adherence, Opioid Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education Intervention

Control

Arm Description

This group will receive the scenario-tailored STOMP educational feedback

This group will receive only standard of care information.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Opioid Misuse Intention Decisions
Number of participants with opioid misuse intentions and behaviors

Full Information

First Posted
February 21, 2019
Last Updated
March 13, 2022
Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03863353
Brief Title
Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults
Acronym
STOMPYA
Official Title
Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Medication Adherence, Opioid Use, Knowledge, Attitudes, Practice, Risk Reduction Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
randomized, controlled, factorial design
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education Intervention
Arm Type
Experimental
Arm Description
This group will receive the scenario-tailored STOMP educational feedback
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive only standard of care information.
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
STOMP Intervention
Intervention Description
This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
Primary Outcome Measure Information:
Title
Opioid Risk Perception
Description
Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception)
Time Frame
Baseline, day 14, 3 months post intervention
Secondary Outcome Measure Information:
Title
Opioid Misuse Intention Decisions
Description
Number of participants with opioid misuse intentions and behaviors
Time Frame
3 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terri Voepel-Lewis, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan, C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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