Clinical trial NCT03640520: Evaluation of Online Training Tools in Pediatric Resuscitation
Official title: Randomized Controlled Trial (RCT) to Evaluate the Impact of Online Training Tools Related to Pediatric Resuscitation in General EDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family-centered Care in Pediatric Resuscitation
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2018-08-21
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigators will conduct an RCT of the FACETS online skills training module (intervention) vs. an online training module reviewing pediatric readiness standards for all EDs (control).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective is to conduct a randomized controlled trial (RCT) to assess the impact of an online skills training module on 1) individual providers' self-rated confidence and comfort with and current practice of family centered care (FCC) skills; and 2) assess team performance of FCC and resuscitative care skills during simulated pediatric resuscitation scenarios.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pre- to post-training changes in individual providers' self-rated confidence in providing FCC in pediatric resuscitation
timeFrame: Pre-training survey up to 4 weeks prior to training, Post-training survey up to 6 weeks after training
measure: Pre- to post-training changes in self-reported use of FCC skills in practice
timeFrame: Pre-training survey up to 4 weeks prior to training, Post-training survey up to 6 weeks after training
Secondary outcomes:
measure: Pre- to post-training changes in team performance of FCC
timeFrame: In situ simulations conducted immediately before and after training.
Other outcomes:
measure: Pre- to post-training changes in resuscitative care
timeFrame: In situ simulations conducted immediately before and after training.
measure: Pre- to post-training changes in resuscitative care and in teamwork / team performance
timeFrame: In situ simulations conducted immediately before and after training.
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Sage Myers, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Nancy Kassam-Adams, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Marc Auerbach, MD, FAAP, MSc
role: PRINCIPAL_INVESTIGATOR
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