Trial Outcomes & Findings for Evaluating an eHealth Solution for Screening in Pediatric Care (NCT NCT04506294)

Last Updated: 2024-06-26

Results Overview

Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen Pain Measure score predicting rating \>= 6 on 6-week Numerical Rating Scale for Pain Intensity (NRSI) Pain at baseline: eScreen Pain Measure score (0-10) On-screen visual analog 'slider' - width \& color intensity increase from bottom to top, face of child's avatar (selected by child in eScreen system) anchors lower \& upper ends of slider with validated 'no pain' and 'most pain' facial expressions. On-screen instructions: "The bottom of this scale is no pain, and the top is the most pain you can imagine. Slide the marker to show how much pain you feel right now." Child uses touch screen to slide virtual marker, system derives score from 0.000 to 10.000 based on marker location. Pain severity at 6 weeks: NRSI \>= 6 Verbally-administered, child rates pain by choosing integer from 0 to 10 "where 0 = no pain or hurt and 10 = the most or worst pain/hurt" Rating \>=6 validated as clinically significant.

Recruitment status

COMPLETED

Study phase

Target enrollment

320 participants

Primary outcome timeframe

6 weeks

Results posted on

2024-06-26

Participant Flow

Recruited 320 participants (160 child/parent dyads) in two large academic medical centers, between March 2021 and April 2022.

No pre-assignment procedures other than baseline research assessment measures.

Participant milestones

Participant milestones
Measure	eScreen Group Ill/injured child and one parent are enrolled in the study. After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks. eScreen system: The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.	Usual Care Group Ill/injured child and one parent are enrolled in the study. Treatment as usual from baseline to 12 weeks. After completion of T3 assessment (\~12 weeks), child is given the option of accessing the game only (no screening). No parent information component is provided.
Overall Study STARTED	214	106
Overall Study COMPLETED	128	84
Overall Study NOT COMPLETED	86	22

Reasons for withdrawal

Reasons for withdrawal
Measure	eScreen Group Ill/injured child and one parent are enrolled in the study. After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks. eScreen system: The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.	Usual Care Group Ill/injured child and one parent are enrolled in the study. Treatment as usual from baseline to 12 weeks. After completion of T3 assessment (\~12 weeks), child is given the option of accessing the game only (no screening). No parent information component is provided.
Overall Study Lost to Follow-up	70	20
Overall Study Withdrawal by Subject	16	2

Baseline Characteristics

Evaluating an eHealth Solution for Screening in Pediatric Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	eScreen Group n=214 Participants Ill/injured child and one parent are enrolled in the study. After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks. eScreen system: The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.	Usual Care Group n=106 Participants Ill/injured child and one parent are enrolled in the study. Treatment as usual from baseline to 12 weeks. After completion of T3 assessment (\~12 weeks), child is given the option of accessing the game only (no screening). No parent information component is provided.	Total n=320 Participants Total of all reporting groups
Age, Customized age 8-17 (child participants)	107 Participants n=93 Participants	53 Participants n=4 Participants	160 Participants n=27 Participants
Age, Customized age 21-30 (parent participants)	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Age, Customized age 31-40 (parent participants)	36 Participants n=93 Participants	23 Participants n=4 Participants	59 Participants n=27 Participants
Age, Customized age 41-50 (parent participants)	45 Participants n=93 Participants	27 Participants n=4 Participants	72 Participants n=27 Participants
Age, Customized age 51-60 (parent participants)	13 Participants n=93 Participants	1 Participants n=4 Participants	14 Participants n=27 Participants
Age, Customized age 61-70 (parent participants)	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Age, Customized not reported (parent participants)	5 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants
Sex/Gender, Customized female - child	54 Participants n=93 Participants	26 Participants n=4 Participants	80 Participants n=27 Participants
Sex/Gender, Customized female - parent / guardian	97 Participants n=93 Participants	51 Participants n=4 Participants	148 Participants n=27 Participants
Sex/Gender, Customized male - child	53 Participants n=93 Participants	26 Participants n=4 Participants	79 Participants n=27 Participants
Sex/Gender, Customized male - parent / guardian	7 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants
Sex/Gender, Customized other - child	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Sex/Gender, Customized other - parent / guardian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex/Gender, Customized not reported - child	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex/Gender, Customized not reported - parent / guardian	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Black / African American - child	17 Participants n=93 Participants	13 Participants n=4 Participants	30 Participants n=27 Participants
Race/Ethnicity, Customized Black / African American - parent	17 Participants n=93 Participants	12 Participants n=4 Participants	29 Participants n=27 Participants
Race/Ethnicity, Customized White - child	70 Participants n=93 Participants	36 Participants n=4 Participants	106 Participants n=27 Participants
Race/Ethnicity, Customized White - parent / guardian	73 Participants n=93 Participants	38 Participants n=4 Participants	111 Participants n=27 Participants
Race/Ethnicity, Customized Asian - child	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized Asian - parent / guardian	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized American Indian / Alaska Native - child	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized American Indian / Alaska Native - parent / guardian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Multiple - child	9 Participants n=93 Participants	2 Participants n=4 Participants	11 Participants n=27 Participants
Race/Ethnicity, Customized Multiple - parent / guardian	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Other - child	7 Participants n=93 Participants	0 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized Other - parent / guardian	6 Participants n=93 Participants	0 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Not reported - child	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Not reported - parent / guardian	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: At 6 weeks no children reported NRSI \>=6 (ie clinically significant pain, thus planned analyses could not be conducted.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 weeks

Population: This outcome pertains only to children (not parents); only in the eScreen group.

Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen Pain Measure score predicting T score \>= 65 on 6-wk PROMIS Pain Interference scale Pain at baseline: eScreen Pain Measure score (0-10) On-screen visual analog 'slider' - width \& color intensity increase from bottom to top, face of child's avatar (selected by child in eScreen system) anchors lower \& upper ends of slider with validated 'no pain' and 'most pain' facial expressions. On-screen instructions: "The bottom of this scale is no pain, and the top is the most pain you can imagine. Slide the marker to show how much pain you feel right now." Child uses touch screen to slide virtual marker, system derives score from 0.000 to 10.000 based on marker location. Pain interference at 6 weeks: PROMIS Pediatric Pain Interference T score \>=65 Brief questionnaire - Child rates pain interference with daily activities over past 7 days. Ratings lead to normed T scores where \>=65 = significant interference.

Outcome measures

Outcome measures
Measure	eScreen Group n=45 Participants After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks. eScreen system: The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.	Usual Care Group Treatment as usual from baseline to 12 weeks. After completion of T3 assessment (\~12 weeks), child is given the option of accessing the game only (no screening). No parent information component is provided.
Validity of eScreen Pain Measure as Predictor of Child's Clinically Significant Pain Interference at 6 Weeks	.756 Probability Interval 0.613 to 0.9	—

PRIMARY outcome

Timeframe: 6 weeks

Population: This outcome pertains only to child participants, and only to those in eScreen group.

Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen PTSS Screener score predicting whether child meets symptom criteria for posttraumatic stress disorder (PTSD) on 6-wk Child PTSD Symptom Scale for DSM-5 \[CPSS-5\] eScreen PTSS Screener eScreen uses the Acute Stress Checklist for Children 6-item Short Form (ASC-6) to screen for posttraumatic stress symptoms (PTSS). Scores range from 0 to 12; higher scores indicate greater PTSS severity. Child PTSD Symptom Scale for DSM-5 (CPSS-5) 20-item questionnaire assesses DSM-5 criteria for posttraumatic stress disorder (PTSD), scored here to determine whether child meets symptom criteria for PTSD at 6 wks.

Outcome measures

Outcome measures
Measure	eScreen Group n=44 Participants After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks. eScreen system: The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.	Usual Care Group Treatment as usual from baseline to 12 weeks. After completion of T3 assessment (\~12 weeks), child is given the option of accessing the game only (no screening). No parent information component is provided.
Validity of eScreen Posttraumatic Stress Screen as Predictor of Posttraumatic Stress at 6 Weeks	.822 Probability Interval 0.65 to 0.994	—

PRIMARY outcome

Timeframe: 6 weeks

Population: This outcome pertains only to child participants, and only to those in the eScreen group.

Predictive validity - Area Under the Curve (AUC) in ROC analyses - baseline eScreen PTSS Screener score predicting whether or not child reports impairment from posttraumatic stress symptoms (PTSS) on 6-wk Child PTSD Symptom Scale for DSM-5 \[CPSS-5\] eScreen PTSS Screener eScreen uses the Acute Stress Checklist for Children 6-item Short Form (ASC-6) to screen for posttraumatic stress symptoms (PTSS). Scores range from 0 to 12; higher scores indicate greater PTSS severity. Child PTSD Symptom Scale for DSM-5 (CPSS-5) 7 items in the CPSS questionnaire assess impairment (in social/interpersonal or academic functioning or daily activities) related to posttraumatic stress symptoms. Impairment scored as present if child endorses impairment on any item at 6 wks.

Outcome measures

Outcome measures
Measure	eScreen Group n=44 Participants After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks. eScreen system: The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.	Usual Care Group Treatment as usual from baseline to 12 weeks. After completion of T3 assessment (\~12 weeks), child is given the option of accessing the game only (no screening). No parent information component is provided.
Validity of eScreen PTSS Screener as Predictor of Impairment From Posttraumatic Stress Symptoms at 6 Weeks	.691 Probability Interval 0.531 to 0.85	—

SECONDARY outcome

Timeframe: 6 weeks

Population: This outcome pertains only to parent participants.

Examine difference between eScreen and usual care groups on parents' self-rated confidence (at 6 weeks) related to managing child symptoms and recovery after discharge. Parent Confidence Scale - 9 Likert-scale items in which parents rate (from 1 to 5) the extent to which they have felt prepared to manage their ill or injured child's symptoms and recovery after hospital or clinic discharge. Summed total scores range from 5 to 45, higher scores indicate greater confidence.

Outcome measures

Outcome measures
Measure	eScreen Group n=68 Participants After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks. eScreen system: The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.	Usual Care Group n=43 Participants Treatment as usual from baseline to 12 weeks. After completion of T3 assessment (\~12 weeks), child is given the option of accessing the game only (no screening). No parent information component is provided.
Impact of eScreen System on Parent Confidence in Managing Child Symptoms and Recovery	39.6 score on a scale Standard Deviation 5.2	38.9 score on a scale Standard Deviation 6.9

Adverse Events

eScreen Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Kassam-Adams, PhD (Principal Investigator)

Children's Hospital of Philadelphia

Phone: 215-590-3118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place