Evaluation of Online Training Tools in Pediatric Resuscitation

Context: Each year, more than 30 million children are evaluated at >5,000 US Emergency
Departments (EDs); more than 85% present to general EDs. Pediatric resuscitation is
particularly high-stakes aspect of emergency care for which non-pediatric-specialized EDs are
often unprepared. Evidence shows differential outcomes as well, including a difference in
mortality in pediatric resuscitation between general EDs (40%) and pediatric EDs (22%). The
toll goes beyond physical health outcomes - about 1 in 6 seriously ill children (and their
parents) will go on to have persistent posttraumatic stress symptoms related to their medical
condition and treatment experiences.

BACKGROUND AND RATIONALE:

This research is part of a larger project to create and disseminate the "Self-Assessment
through Video Evaluation for Performance improvement in Emergency Department-based Pediatric
Resuscitation" (SAVE PEDS) Toolkit. This web-based resource will enable general emergency
departments (EDs) across the US to reliably self-assess, measure and iteratively improve
their performance in pediatric resuscitation via video review, assessment and debriefing of
simulated or actual patient care emergencies, and accessible training materials. The current
trial will test an online skills training module intended to be delivered as part of SAVE
PEDS. Aimed at healthcare professionals, the Family-centered & Trauma-informed Support in
Pediatric Resuscitation (FACETS: Pediatric Resuscitation) training combines didactic
information and scenario-based learning with opportunities for the learner to practice
applying his/her knowledge at key choice points in realistic pediatric resuscitation
scenarios.

Medical resuscitation is a high-stakes, fast-moving environment in which a variable team of
health care professionals and ancillary staff must work together seamlessly to maximize
patient outcomes. Pediatric resuscitation is a relatively rare occurrence across all
emergency care, and especially true in the general hospital where providers may have less
comfort and experience with the care of children, and hospitals have fewer pediatric-specific
resources. Yet the general hospital, where 85% of children are seen for emergency care, must
be constantly ready for the resuscitation of a critically ill/injured child.

Gaps are known to exist in accessibility of pediatric resuscitation equipment, resuscitation
skill performance and guideline adherence. The reported difference in mortality in pediatric
resuscitation between general (40%) and pediatric (22%) EDs may be directly related to these
gaps. Significant gaps also exist in the delivery of family-centered care (FCC) in the ED.
FCC has been defined as care that emphasizes respect for patient and family perspectives
regarding health care, and encouragement of patient and family participation in care and
decision-making. Only half of general EDs report having FCC policies for children. FCC can be
a particular challenge in the resuscitation setting, with many competing priorities for the
medical team's attention and focus.

For patients and families, pediatric resuscitation is an extremely stressful experience.
Symptoms of posttraumatic stress disorder (PTSD) are common in children (and family) in the
aftermath of pediatric critical illness and injury, and these symptoms have been associated
with medication non-adherence, lower quality of life and poorer functional outcomes. There is
strong support for the positive impact of family presence and family involvement in care /
decision-making - on patient safety, patient and family satisfaction, and child and family
emotional health. Meaningful implementation of FCC during resuscitation requires a set of
skills for which few ED providers have had systematic training. Providers in general EDs have
even fewer opportunities to learn or practice these skills as they relate to pediatric
resuscitation.

Study Design: this is a multi-site RCT

Setting/Participants include a total of 6-8 general EDs - in community or
non-pediatric-specialized hospitals - will participate. Within each ED, Investigators will
enroll individual health care professionals who are involved in pediatric resuscitation in
the ED.

Study Interventions and Measures:

Investigators will gather information on site level factors relative to hospital resources
and ED volumes to categorize and describe EDs.

Participants will complete demographics and pre-survey assessing self-rated confidence and
practice of FCC and pediatric resuscitation. 2-3 teams at each site will then participate in
two simulated pediatric resuscitation scenarios incorporating family presence. At
Intervention group sites, participants will then complete the online FCC training. At Control
group sites, participants will complete an online training on national pediatric readiness
standards for EDs. Teams will then complete two additional simulated scenarios, after which a
debriefing session will be held. Participants not present for the simulation sessions will
complete the intervention or control training online. Afterwards, participants will complete
a post-survey assessing self-rated confidence and practice of FCC and pediatric
resuscitation. Four to twelve weeks post-training, teams at each site will participate in two
additional simulation scenarios incorporating family presence.

STUDY OBJECTIVES

This randomized controlled trial (RCT) will be conducted in general ED settings, to evaluate
the impact of the FACETS: Pediatric Resuscitation training module on:

1. individual providers' confidence and use of FCC skills in pediatric resuscitation
(primary objective)

2. team performance of FCC and resuscitative care skills during simulated pediatric
resuscitations (secondary objective).

STUDY PLAN

Investigators will conduct an RCT of the FACETS online training module (intervention) vs. an
online training module reviewing pediatric readiness standards for all EDs (control) in six
to eight participating institutions that are general non-pediatric-specialized EDs.

Randomization of the participating EDs will occur at the site level, with half allocated to
the intervention condition and half to the control condition. All participants will be
blinded as to treatment condition and as to the specific study goal of evaluating FCC. Study
staff who rate team performance from videotaped simulated pediatric resuscitations will be
blinded as to study condition.

Within each institution, Investigators will enroll individual health care professionals who
are involved in pediatric resuscitation in the ED. An email invitation to all eligible staff
will include a link to study consent and to the study pre-survey, both administered via
REDCap.

All participants will complete the pre-training survey, either the intervention or the
control training module, and the post-training survey. A subset of participants (based on
availability) will additionally take part in in situ simulated pediatric resuscitation
scenarios, as part of a team, at their institution.

STUDY PROCEDURES

Pre-Baseline Visit (online) A. Online survey (REDCap), up to 4 weeks prior to training,
online questionnaires - self-report by individual providers. Time: 20-30 minutes.

Baseline Visit B. In situ simulations, team of providers participates in 2 simulated
pediatric resuscitation scenarios conducted in ED. Time: 1 - 1.5 hours C. Online training
module (intervention or control), individual providers will complete independently, a subset
of participants present for in situ study visit will complete online training module
individually between simulation sessions. Those not present for in situ study visit will
complete online training module on their own. Time: 1 hour D. Post training in situ
simulations, team of providers participates in 2 simulated pediatric resuscitation scenarios
conducted in ED. Time: 1 - 1.5 hours Follow-up Phase (online) E. Online survey (REDCap), up
to 6 weeks after online training module, online questionnaires - self-report by individual
providers. Time: 20-30 minutes

STATISTICAL CONSIDERATIONS

The primary endpoint is at the provider level: pre- to post-training changes in individual
providers' self-rated confidence in providing FCC in pediatric resuscitation. Investigators
will also examine pre- to post-training changes in self-reported use of FCC skills in
practice.

The secondary endpoint is at the site level: pre- to post-training changes in team
performance of FCC, as measured by the presence and quality of family-centered care behaviors
exhibited during video-recorded simulated pediatric resuscitation scenarios. Team performance
measures of technical and non-technical resuscitative care skills will also be examined as a
balancing measure to this endpoint.

Sample Size and Power Investigators will attempt to enroll all available providers meeting
inclusion criteria at each participating ED, and estimate that approximately 300 individual
participants will be enrolled, averaging 40-50 participants from each general ED site. Power
analysis is based on our analyses for the primary endpoint. A sample size of 300 individuals
(~150 per group) provides 80% power to detect a between-group effect size as small as .24
between groups in post-training scores, using ANCOVA.

Efficacy Analyses To evaluate the primary outcome, Investigators will examine scores on
self-report surveys completed by participants before and after training. Investigators will
calculate pre- to post-training change scores for individual providers, and summarize these
for the total sample and by treatment group. Investigators will examine training effects on
participant outcomes (self-rated confidence in providing FCC) by means of analysis of
covariance (ANCOVA). In each ANCOVA, study condition will be the grouping factor and the
corresponding pre-training score for the outcome measure will be included as a covariate.
ANCOVA allows us to examine the potential impact of key co-variates that may vary by group
despite random assignment to condition. Investigators will also estimate effect sizes for
each group for pre- to post-training change in self-rated confidence in FCC skills.
Investigators will then conduct parallel analyses for pre- to post-training changes in
self-rated use and intentions to use FCC skills in practice with pediatric patients.

To evaluate the secondary outcome, Investigators will rate team performance based on review
of video-recorded simulated pediatric resuscitations conducted before and after training.
Investigators will calculate each participating site's pre- to post-intervention change in
global ratings for each domain in specific aspect of FCC performance (FCC Assessment Tool),
averaged across simulations and teams at that site. Investigators will also assess pre- to
post-training changes in patient/scenario-specific resuscitative care (e.g., time to
important interventions, success in interventions, guideline-consistent care) and in team
performance (i.e. crew resource management, or CRM) using validated team performance measures
(CPT and BAT). This balancing measure will allow investigators to confirm that any observed
improvements in FCC do not come at the cost of poorer medical care.

Additional analyses To better understand training effects, Investigators will conduct
exploratory subgroup analyses within high- and low-resource ED settings. Investigators will
also conduct exploratory analyses to understand the potential impact of participation in
simulated practice on clinicians' technical and non-technical resuscitation skills.
Investigators will describe baseline and follow-up scores on confidence measures in these
areas, and examine pre- to post changes for the subset of participants who take part in the
simulation scenarios.

Inclusion Criteria:

- Males or females age 18 years and up.

- Healthcare providers at one of the six to eight general ED sites taking part in
resuscitations as part of their usual work-related duties

Exclusion Criteria:

- Not applicable - there are no specific exclusion criteria as all providers who take
part in resuscitations as part of their usual work-related duties are presumed to be
capable to take part in simulation and able to read in English at the level required
to complete online training.