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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA044245-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education Intervention | Experimental | This group will receive the scenario-tailored STOMP educational feedback |
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| Control | No Intervention | This group will receive only standard of care information. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Behavioral | This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Risk Perception | Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception) | Baseline, day 14, 3 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Misuse Intention Decisions | Number of participants with opioid misuse intentions and behaviors | 3 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terri Voepel-Lewis, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan, C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States | ||
| University of Michigan |
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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).
Subjects recruited from 11/2019 through May 2021 from surgical clinic rosters at University of Michigan
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 21, 2019 |
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randomized, controlled, factorial design
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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.
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| Ann Arbor |
| Michigan |
| 48109 |
| United States |
This group will receive only standard of care information. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control | This group will receive only standard of care information. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Opioid Risk Perception | Perceived riskiness of opioid misuse (0-40 where 40 indicates highest risk perception) | All who completed at least one follow-up measurement of risk perception. | Posted | Mean | Standard Deviation | score on a scale | Baseline, day 14, 3 months post intervention |
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| Secondary | Opioid Misuse Intention Decisions | Number of participants with opioid misuse intentions and behaviors | Rest of the sample lost to follow-up at months 1-3 | Posted | Count of Participants | Participants | 3 months post intervention |
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3 months
Review of medical records, clinic visits etc.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 258 | 9 | 258 | 0 | 258 |
| EG001 | Control | This group will receive only standard of care information. | 0 | 201 | 6 | 201 | 0 | 201 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Surgical and medical procedures | Systematic Assessment | Unexpected hospitalizations or return to emergency room |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terri Voepel-Lewis | University of Michigan | 734-6466803 | terriv@umich.edu |
| Dec 22, 2021 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D055118 | Medication Adherence |
| D001519 | Behavior |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Month 3 |
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