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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03863353
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 503
• Locations: 2
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site: 251.5
• Patients Per Site Per Month: 10.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Medication Adherence; Opioid Use; Knowledge, Attitudes, Practice; Risk Reduction Behavior	Behavioral: Educational Intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 503 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: randomized, controlled, factorial designrandomized, controlled, factorial design
• Masking: Triple (Participant, Investigator, Outcomes 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.
• Primary Purpose: Prevention
• Official Title: Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults
• Actual Study Start Date: Nov 1, 2019
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Education Intervention This group will receive the scenario-tailored STOMP educational feedback	Behavioral: Educational Intervention; This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.; Other Names: STOMP Intervention
No Intervention: Control This group will receive only standard of care information.

Outcome Measures

Primary Outcome Measures

1. Opioid Risk Perception [Baseline, day 14, 3 months post intervention]

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

Secondary Outcome Measures

1. Opioid Misuse Intention Decisions [3 months post intervention]

   Number of participants with opioid misuse intentions and behaviors

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan, C.S. Mott Children's Hospital	Ann Arbor	Michigan	United States	48109
2	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Terri Voepel-Lewis, PhD, University of Michigan

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Aug 21, 2019

More Information

Publications

None provided.

• Responsible Party: Terri Voepel-Lewis, Prinicipal Investigator, University of Michigan
• ClinicalTrials.gov Identifier: NCT03863353
• Other Study ID Numbers: HUM00147378; 1R01DA044245-01A1
• First Posted: Mar 5, 2019
• Last Update Posted: Apr 6, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

Recruitment Details	Subjects recruited from 11/2019 through May 2021 from surgical clinic rosters at University of Michigan
Pre-assignment Detail	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).

Arm/Group Title	Education Intervention	Control
Arm/Group Description	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.	This group will receive only standard of care information.
Period Title: Overall Study
STARTED	282	221
COMPLETED	258	201
NOT COMPLETED	24	20

Baseline Characteristics

Arm/Group Title	Education Intervention	Control	Total
Arm/Group Description	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.	This group will receive only standard of care information.	Total of all reporting groups
Overall Participants	258	201	459
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.1 (2.7)	19.1 (2.8)	19.1 (2.7)
Sex: Female, Male (Count of Participants)
Female	134 51.9%	104 51.7%	238 51.9%
Male	124 48.1%	97 48.3%	221 48.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	16 6.2%	7 3.5%	23 5%
Not Hispanic or Latino	242 93.8%	194 96.5%	436 95%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.8%	3 1.5%	5 1.1%
Asian	16 6.2%	15 7.5%	31 6.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	22 8.5%	13 6.5%	35 7.6%
White	207 80.2%	163 81.1%	370 80.6%
More than one race	11 4.3%	7 3.5%	18 3.9%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Education Intervention	Control
Arm/Group Description	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.	This group will receive only standard of care information.
Measure Participants	258	201
Baseline	31.4 (0.85)	31.1 (1.01)
Day 14	32.8 (.65)	30.02 (1.12)
Month 3	31.0 (.62)	29.8 (1.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Education Intervention, Control
	Comments	Hypothesis was tested using multivariable regression models (generalized estimating equation)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments	Adjusted for repeated measures and effects of covariates
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Rebression coefficient
	Estimated Value	2.13
	Confidence Interval	(2-Sided) 95%; 0.86 to 3.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Opioid Misuse Intention Decisions
Description	Number of participants with opioid misuse intentions and behaviors
Time Frame	3 months post intervention

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Education Intervention	Control
Arm/Group Description	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.	This group will receive only standard of care information.
Measure Participants	226	173
Misuse Intentions	47 18.2%	38 18.9%
Misuse behavior	18 7%	12 6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Education Intervention, Control
	Comments	Logistic regression model examined the effect of the intervention on the outcome (collapsed intentions/behaviors)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.534
	Comments	adjusted for covariates
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	Review of medical records, clinic visits etc.
Arm/Group Title	Education Intervention		Control
Arm/Group Description	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.		This group will receive only standard of care information.
All Cause Mortality
	Education Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/258 (0%)		0/201 (0%)
Serious Adverse Events
	Education Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/258 (3.5%)		6/201 (3%)
Surgical and medical procedures
Hospitalization	9/258 (3.5%)	9	6/201 (3%)	6
Other (Not Including Serious) Adverse Events
	Education Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/258 (0%)		0/201 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.