Knowledge, Attitudes, Practice, Medication Adherence, Opioid Use, Pain, Postoperative, Risk Reduction Behavior
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALEducational Intervention
This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
BEHAVIORALNudge
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
Sponsors
National Institute on Drug Abuse (NIDA)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Four-armed, randomized, control, factorial design
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Parent (\>=21yr) and child (5-17 yr) (dyad) who lives in the home and is prescribed an opioid for postoperative pain management * English speaking
Exclusion criteria
* Child is undergoing a non-elective procedure * Child cannot self-report pain levels (i.e., is cognitively impaired) * Child has a hematologic/oncologic condition * Child has a kidney or liver conditions that precludes the usual analgesic prescription pattern (opioid plus a non-opioid) * Child has been taking opioids for prolonged pain pre-operatively (\>2 weeks)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid-related Risk Knowledge | Day 3 follow-up assessment | Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation) |
| Opioid Risk Perception | Mean difference in score from baseline to follow-up assessments (Days 3 & 14) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Self-Efficacy | Efficacy scores Day 14 | Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy) |
| Opioid Disposal Behavior | Day 14 (or after course completion) | Number of parents (and percentage) who disposed of left-over opioids after use |
| Analgesic Decision Competency | Day 3 | Number of participants who made the scenario-based decision to administer opioid to excessively sedated child |
| Analgesic Use / Adherence | Day 14 | Total number of opioid doses administered |
| Pain Interference (PROMIS) | Day 14 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 298 |
| Standard of Care This group will receive routine, standard of care information. | 308 |
| Total | 606 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 27 | 15 |
| Overall Study | No prescripion after surgery | 28 | 31 |
| Overall Study | prolonged Length of stay | 2 | 0 |
| Overall Study | surgery related | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Education Intervention | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 298 Participants | 308 Participants | 606 Participants |
| Education Level 4 Year College Graduate | 76 Participants | 84 Participants | 160 Participants |
| Education Level Assoc. Degree or Trade School | 62 Participants | 54 Participants | 116 Participants |
| Education Level Graduate School | 62 Participants | 82 Participants | 144 Participants |
| Education Level Some College | 60 Participants | 57 Participants | 117 Participants |
| Education Level Some HS or HS complete | 38 Participants | 31 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 10 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 289 Participants | 298 Participants | 587 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 18 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 14 Participants | 21 Participants |
| Race (NIH/OMB) White | 262 Participants | 267 Participants | 529 Participants |
| Sex: Female, Male Female | 252 Participants | 241 Participants | 493 Participants |
| Sex: Female, Male Male | 46 Participants | 67 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 298 | 0 / 308 |
| other Total, other adverse events | 0 / 298 | 0 / 308 |
| serious Total, serious adverse events | 4 / 298 | 3 / 308 |
Outcome results
Primary
Opioid-related Risk Knowledge
Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)
Time frame: Day 3 follow-up assessment
Population: These parents completed at least one follow-up assessment for risk awareness
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Education Intervention | Opioid-related Risk Knowledge | 287 Participants |
| Standard of Care Education | Opioid-related Risk Knowledge | 289 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)
Time frame: Mean difference in score from baseline to follow-up assessments (Days 3 & 14)
Population: 296 in the Interventional Group completed at least one follow-up assessment and 281 in the Standard of Care group did so.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Education Intervention | Opioid Risk Perception | Mean difference in perceived riskiness of keeping/sharing opioids day 3 | 0.35 units on a scale |
| Education Intervention | Opioid Risk Perception | Change in perceived riskiness keeping/sharing day 14 | 0.28 units on a scale |
| Standard of Care Education | Opioid Risk Perception | Mean difference in perceived riskiness of keeping/sharing opioids day 3 | 0.12 units on a scale |
| Standard of Care Education | Opioid Risk Perception | Change in perceived riskiness keeping/sharing day 14 | 0.14 units on a scale |
Secondary
Analgesic Decision Competency
Number of participants who made the scenario-based decision to administer opioid to excessively sedated child
Time frame: Day 3
Population: Parents who completed at scenario decisions in Day 3 follow-up survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Education Intervention | Analgesic Decision Competency | 43 Participants |
| Standard of Care Education | Analgesic Decision Competency | 64 Participants |
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)
Time frame: Efficacy scores Day 14
Population: Completion of at least one follow-up efficacy assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education Intervention | Analgesic Self-Efficacy | 32.5 units on a scale | Standard Deviation 3.22 |
| Standard of Care Education | Analgesic Self-Efficacy | 32.2 units on a scale | Standard Deviation 3.25 |
Secondary
Analgesic Use / Adherence
Total number of opioid doses administered
Time frame: Day 14
Population: These parents completed follow-up data regarding doses administered at home (completed diary or survey)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education Intervention | Analgesic Use / Adherence | 8.6 Doses | Standard Deviation 10.3 |
| Standard of Care Education | Analgesic Use / Adherence | 7.9 Doses | Standard Deviation 8.6 |
Secondary
Opioid Disposal Behavior
Number of parents (and percentage) who disposed of left-over opioids after use
Time frame: Day 14 (or after course completion)
Population: This subgroup analysis included parents that were randomized to four groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Education Intervention | Opioid Disposal Behavior | 48 Participants |
| Standard of Care Education | Opioid Disposal Behavior | 44 Participants |
| Educational Intervention Only (No Nudge) | Opioid Disposal Behavior | 40 Participants |
| Standard of Care Only (No Nudge) | Opioid Disposal Behavior | 25 Participants |
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)
Time frame: Day 14
Population: These are the parents that recorded a value in the follow-up diary/survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education Intervention | Pain Interference (PROMIS) | 8.63 units on a scale | Standard Deviation 8.39 |
| Standard of Care Education | Pain Interference (PROMIS) | 8.06 units on a scale | Standard Deviation 8.06 |