Trial Outcomes & Findings for Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents (NCT NCT03287622)

NCT ID: NCT03287622

Last Updated: 2020-11-19

Results Overview

Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 712 participants
• Primary outcome timeframe: Day 3 follow-up assessment
• Results posted on: 2020-11-19

Participant Flow

Participant milestones

Measure	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.	Standard of Care This group will receive routine, standard of care information
Overall Study STARTED	356	356
Overall Study Sub-randomized to Nudge/NoNudge	253	266
Overall Study COMPLETED	298	308
Overall Study NOT COMPLETED	58	48

Reasons for withdrawal

Measure	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.	Standard of Care This group will receive routine, standard of care information
Overall Study Withdrawal by Subject	1	0
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

Baseline Characteristics

298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP

Baseline characteristics by cohort

Measure	Education Intervention n=298 Participants 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.	Standard of Care n=308 Participants This group will receive routine, standard of care information.	Total n=606 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	298 Participants n=5 Participants	308 Participants n=7 Participants	606 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	252 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	241 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	493 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Sex: Female, Male Male	46 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	67 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	113 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	10 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	19 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Ethnicity (NIH/OMB) Not Hispanic or Latino	289 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	298 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	587 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	0 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	0 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	3 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	5 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Race (NIH/OMB) Asian	7 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	6 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	13 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	0 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	1 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	18 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	37 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Race (NIH/OMB) White	262 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	267 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	529 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	0 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	0 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	14 Participants n=7 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP	21 Participants n=5 Participants • 298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP
Education Level Some HS or HS complete	38 Participants n=5 Participants	31 Participants n=7 Participants	69 Participants n=5 Participants
Education Level Some College	60 Participants n=5 Participants	57 Participants n=7 Participants	117 Participants n=5 Participants
Education Level Assoc. Degree or Trade School	62 Participants n=5 Participants	54 Participants n=7 Participants	116 Participants n=5 Participants
Education Level 4 Year College Graduate	76 Participants n=5 Participants	84 Participants n=7 Participants	160 Participants n=5 Participants
Education Level Graduate School	62 Participants n=5 Participants	82 Participants n=7 Participants	144 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3 follow-up assessment

Population: These parents completed at least one follow-up assessment for risk awareness

Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)

Outcome measures

Measure	Education Intervention n=296 Participants 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.	Standard of Care Education n=308 Participants This group received routine, standard of care information.	Educational Intervention Only (No Nudge) This group received scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention. Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Standard of Care Only (No Nudge) This group received only standard of care information and NO behavioral nudge intervention.
Opioid-related Risk Knowledge	287 Participants	289 Participants	—	—

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Measure	Education Intervention n=296 Participants 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.	Standard of Care Education n=281 Participants This group received routine, standard of care information.	Educational Intervention Only (No Nudge) This group received scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention. Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Standard of Care Only (No Nudge) This group received only standard of care information and NO behavioral nudge intervention.
Opioid Risk Perception Change in perceived riskiness keeping/sharing day 14	0.28 units on a scale Interval 0.07 to 0.5	0.14 units on a scale Interval -0.06 to 0.33	—	—
Opioid Risk Perception Mean difference in perceived riskiness of keeping/sharing opioids day 3	0.35 units on a scale Interval 0.07 to 0.63	0.12 units on a scale Interval -0.06 to 0.29	—	—

SECONDARY outcome

Timeframe: Day 14 (or after course completion)

Population: This subgroup analysis included parents that were randomized to four groups.

Number of parents (and percentage) who disposed of left-over opioids after use

Outcome measures

Measure	Education Intervention n=124 Participants 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.	Standard of Care Education n=131 Participants This group received routine, standard of care information.	Educational Intervention Only (No Nudge) n=129 Participants This group received scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention. Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Standard of Care Only (No Nudge) n=133 Participants This group received only standard of care information and NO behavioral nudge intervention.
Opioid Disposal Behavior	48 Participants	44 Participants	40 Participants	25 Participants

SECONDARY outcome

Timeframe: Day 14

Population: These are the parents that recorded a value in the follow-up diary/survey

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)

Outcome measures

Measure	Education Intervention n=271 Participants 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.	Standard of Care Education n=292 Participants This group received routine, standard of care information.	Educational Intervention Only (No Nudge) This group received scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention. Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Standard of Care Only (No Nudge) This group received only standard of care information and NO behavioral nudge intervention.
Pain Interference (PROMIS)	8.63 units on a scale Standard Deviation 8.39	8.06 units on a scale Standard Deviation 8.06	—	—

SECONDARY outcome

Timeframe: Efficacy scores Day 14

Population: Completion of at least one follow-up efficacy assessment

Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)

Outcome measures

Measure	Education Intervention n=298 Participants 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.	Standard of Care Education n=308 Participants This group received routine, standard of care information.	Educational Intervention Only (No Nudge) This group received scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention. Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Standard of Care Only (No Nudge) This group received only standard of care information and NO behavioral nudge intervention.
Analgesic Self-Efficacy	32.5 units on a scale Standard Deviation 3.22	32.2 units on a scale Standard Deviation 3.25	—	—

SECONDARY outcome

Timeframe: Day 14

Population: These parents completed follow-up data regarding doses administered at home (completed diary or survey)

Total number of opioid doses administered

Outcome measures

Measure	Education Intervention n=292 Participants 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.	Standard of Care Education n=271 Participants This group received routine, standard of care information.	Educational Intervention Only (No Nudge) This group received scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention. Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Standard of Care Only (No Nudge) This group received only standard of care information and NO behavioral nudge intervention.
Analgesic Use / Adherence	8.6 Doses Standard Deviation 10.3	7.9 Doses Standard Deviation 8.6	—	—

SECONDARY outcome

Timeframe: Day 3

Population: Parents who completed at scenario decisions in Day 3 follow-up survey

Number of participants who made the scenario-based decision to administer opioid to excessively sedated child

Outcome measures

Measure	Education Intervention n=298 Participants 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.	Standard of Care Education n=308 Participants This group received routine, standard of care information.	Educational Intervention Only (No Nudge) This group received scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention. Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.	Standard of Care Only (No Nudge) This group received only standard of care information and NO behavioral nudge intervention.
Analgesic Decision Competency	43 Participants	64 Participants	—	—

Adverse Events

Education Intervention

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Education Intervention n=298 participants at risk 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.	Standard of Care n=308 participants at risk This group received routine, standard of care information
Metabolism and nutrition disorders Dehydration	0.34% 1/298 • Number of events 298 • 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.	0.32% 1/308 • Number of events 308 • 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.
Surgical and medical procedures Postoperative hemorrhage	0.34% 1/298 • Number of events 298 • 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.	0.32% 1/308 • Number of events 308 • 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.
Surgical and medical procedures Suspected postoperative infection	0.00% 0/298 • 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.	0.32% 1/308 • Number of events 308 • 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.
Blood and lymphatic system disorders Deep vein thrombosis	0.34% 1/298 • Number of events 298 • 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.	0.00% 0/308 • 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.
General disorders Adverse Drug Reaction	0.34% 1/298 • Number of events 298 • 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.	0.00% 0/308 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Terri Voepel-Lewis

University of Michigan

Phone: 734-646-6803

Email: terriv@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place