Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA044245-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Millions of children and adolescents are prescribed opioid pain relievers each year, placing them at risk for serious adverse events and misuse in the home setting. Parents who manage these medicines, therefore, need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief for their children. The proposed research will evaluate new strategies to help parents learn about opioid risks, make safe and effective analgesic decisions, and develop and demonstrate safe drug management behaviors. 840 parents and their children who are undergoing an elective surgical procedure will be recruited. Parents will be randomized to receive the new educational and practical behavioral strategy or routine information. Parents' knowledge and perceptions will be evaluated at baseline and at critical times after surgery. Parents' opioid handling and administration will also be assessed.
The overarching goal of this research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition, informed analgesic decision-making, and drug storage/disposal behaviors among parents of youth who are prescribed these agents for home use. The study aims are to determine whether the Scenario-Tailored Opioid Messaging Program (STOMP) will: 1) Improve parents' opioid risk understanding and their analgesic decision-making; 2) Enhance parents' analgesic self-efficacy, analgesic use, storage behaviors and their children's pain outcomes, and 3) To demonstrate that the STOMP plus provision of a simple method to get rid of left-over opioids will effectively nudge parents to safely dispose of left-over opioid analgesics. Parents whose children are prescribed opioids for acute, short-lived pain after surgery will be randomly assigned to receive our interventions or a routine provider informational interaction at the time of opioid prescribing. Parents will be surveyed about their opioid familiarity, knowledge, risk perceptions and common analgesic decision-making at baseline and after hospital discharge. Parents will also record their child's pain medication use and symptoms after discharge. Data will be analyzed to determine whether the STOMP educational intervention with or without the behavioral nudge intervention will enhance parents' risk perceptions, their decision-making skills and their opioid handling behaviors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education Intervention + Nudge | Experimental | This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention |
|
| Standard of Care + Nudge | Experimental | This group will receive routine, standard of care information AND the behavioral Nudge intervention |
|
| Educational Intervention no Nudge | Experimental | This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention. |
|
| Standard of Care no Nudge | No Intervention | This group will receive only standard of care information and NO behavioral nudge intervention. |
| 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-related Risk Knowledge | Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation) | Day 3 follow-up assessment |
| Opioid Risk Perception | Change in parent's perceived risk of keeping/sharing opioids (misuse) (Risk perceptions measured on scale from -4 to +4 where higher number reflects higher perception of riskiness; the outcome is measured as change in risk perception - positive change indicates that risk perception became greater) | Mean difference in score from baseline to follow-up assessments (Days 3 & 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Disposal Behavior | Number of parents (and percentage) who disposed of left-over opioids after use | Day 14 (or after course completion) |
| Pain Interference (PROMIS) | The Parents PROMIS Pain Interference measure was used to capture pain interference with functioning (score range 0-30 with higher number indicating worse pain interference) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35909029 | Derived | Voepel-Lewis T, Boyd CJ, Tait AR, McCabe SE, Zikmund-Fisher BJ. A Risk Education Program Decreases Leftover Prescription Opioid Retention: An RCT. Am J Prev Med. 2022 Oct;63(4):564-573. doi: 10.1016/j.amepre.2022.04.035. Epub 2022 Jul 28. | |
| 31871245 | Derived | Voepel-Lewis T, Farley FA, Grant J, Tait AR, Boyd CJ, McCabe SE, Weber M, Harbagh CM, Zikmund-Fisher BJ. Behavioral Intervention and Disposal of Leftover Opioids: A Randomized Trial. Pediatrics. 2020 Jan;145(1):e20191431. doi: 10.1542/peds.2019-1431. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Standard of Care | This group will receive routine, standard of care information |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
298 subjects (84%) completed surveys required for analysis in the INTERVENTION GROUP.
308 subjects (87%) completed surveys required for analysis in the STANDARD OF CARE GROUP
Not provided
| 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 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid-related Risk Knowledge | Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation) | These parents completed at least one follow-up assessment for risk awareness | Posted | Count of Participants | Participants | Day 3 follow-up assessment |
|
All adverse events within 30 days of enrollment were recorded.
All adverse effects were recorded according to the definition from clinicaltrials.gov. Of particular interest for this study were all analgesic-related side effects and parent calls and any return to the hospital. Clinic notes (30 days) were reviewed for surgical and analgesic-related calls or return visits to the clinic or hospital.
Not provided
| 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 received the scenario-tailored STOMP educational feedback. Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment | dehydration due to poor fluid intake at home |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terri Voepel-Lewis | University of Michigan | 734-646-6803 | terriv@umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2018 | Sep 25, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2018 | Sep 25, 2020 | Prot_SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
Four-armed, randomized, control, factorial design
Not provided
Not provided
Group assignment will be coded for parents and data collectors. Parents 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.
|
| Nudge | Behavioral | Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids |
|
| Day 14 |
| Analgesic Self-Efficacy | Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy) | Efficacy scores Day 14 |
| Analgesic Use / Adherence | Total number of opioid doses administered | Day 14 |
| Analgesic Decision Competency | Number of participants who made the scenario-based decision to administer opioid to excessively sedated child | Day 3 |
| No prescripion after surgery |
|
| prolonged Length of stay |
|
| surgery related |
|
This group will receive routine, standard of care information. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP | Count of Participants | Participants |
|
| Race (NIH/OMB) | 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
|
|
| Primary | Opioid Risk Perception | Change in parent's perceived risk of keeping/sharing opioids (misuse) (Risk perceptions measured on scale from -4 to +4 where higher number reflects higher perception of riskiness; the outcome is measured as change in risk perception - positive change indicates that risk perception became greater) | 296 in the Interventional Group completed at least one follow-up assessment and 281 in the Standard of Care group did so. | Posted | Mean | 95% Confidence Interval | units on a scale | Mean difference in score from baseline to follow-up assessments (Days 3 & 14) |
|
|
|
| Secondary | Opioid Disposal Behavior | Number of parents (and percentage) who disposed of left-over opioids after use | This subgroup analysis included parents that were randomized to four groups. | Posted | Count of Participants | Participants | Day 14 (or after course completion) |
|
|
|
| Secondary | Pain Interference (PROMIS) | The Parents PROMIS Pain Interference measure was used to capture pain interference with functioning (score range 0-30 with higher number indicating worse pain interference) | These are the parents that recorded a value in the follow-up diary/survey | Posted | Mean | Standard Deviation | units on a scale | Day 14 |
|
|
|
| Secondary | Analgesic Self-Efficacy | Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy) | Completion of at least one follow-up efficacy assessment | Posted | Mean | Standard Deviation | units on a scale | Efficacy scores Day 14 |
|
|
|
| Secondary | Analgesic Use / Adherence | Total number of opioid doses administered | These parents completed follow-up data regarding doses administered at home (completed diary or survey) | Posted | Mean | Standard Deviation | Doses | Day 14 |
|
|
|
| Secondary | Analgesic Decision Competency | Number of participants who made the scenario-based decision to administer opioid to excessively sedated child | Parents who completed at scenario decisions in Day 3 follow-up survey | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| 0 |
| 298 |
| 4 |
| 298 |
| 0 |
| 298 |
| EG001 | Standard of Care | This group received routine, standard of care information | 0 | 308 | 3 | 308 | 0 | 308 |
|
| Postoperative hemorrhage | Surgical and medical procedures | Systematic Assessment | Bleeding due to otorhinolaryngology procedure (postoperative bleeding) |
|
| Suspected postoperative infection | Surgical and medical procedures | Systematic Assessment | Fever, elevated white blood cell count; treated for postoperative infection |
|
| Deep vein thrombosis | Blood and lymphatic system disorders | Systematic Assessment | deep vein thrombosis after ortho surgery; treated with anticoagulation therapy |
|
| Adverse Drug Reaction | General disorders | Systematic Assessment | Child had reaction to a medication used for underlying condition (present preoperatively) |
|
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D011314 | Preventive Health Services |