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Clinical Trials/NCT03640520
NCT03640520CompletedNot Applicable

Randomized Controlled Trial (RCT) to Evaluate the Impact of Online Training Tools Related to Pediatric Resuscitation in General EDs

Children's Hospital of Philadelphia2 sites in 1 country547 target enrollmentStarted: January 31, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
547
Locations
2
Primary Endpoint
Pre- to post-training changes in self-reported use of FCC skills in practice

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Outcomes Assessor)

Masking Description

All participants on each team at each site will be blinded as to treatment condition and to the study goal of evaluating family centered care. Study staff who rate team performance of FCC from videotaped simulated pediatric resuscitations will also be blinded as to treatment condition.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Intervention

Experimental

Family-centered & Trauma-informed Support in Pediatric Resuscitation (FACETS: Pediatric Resuscitation) is an online skills training module for health care professionals involved in pediatric resuscitation in general EDs. The module combines didactic information and scenario-based learning with opportunities for the learner to practice applying their knowledge of Family Centered Care (FCC) practices at key choice points in realistic pediatric resuscitation case scenarios. Training content is guided by evidence regarding FCC practices that are effective in reducing concurrent and ongoing emotional distress in children and family members, and in promoting child and family involvement and satisfaction with care.

Intervention: FACETS: Pediatric Resuscitation (Other)

Control

Active Comparator

An online training module in which participants will receive information and policy education about national pediatric readiness standards for all EDs, including a brief mention of FCC as one of these standards, with no specific skills training in FCC. The module provides practice-relevant knowledge related to pediatric differences and pediatric readiness.

Intervention: Control (Other)

Outcomes

Primary Outcomes

Pre- to post-training changes in self-reported use of FCC skills in practice

Time Frame: Pre-training survey up to 4 weeks prior to training, Post-training survey up to 6 weeks after training

Pre-training survey up to 4 weeks prior to training, Post-training survey up to 6 weeks after training. The Use of FCC Practices survey is a 29 item questionnaire assessing for past practice of FCC skills (pre-survey) and intention to use those skills in the future (post-survey), via items adapted from the FPSCS measure described above. Responses are on a 1 to 7 scale, with 1 = never did this and 7 = did this every time. The Use of FCC Practices total score has a potential range of 29 to 203, with higher scores indicating greater use of, or intention to use, family-centered care skills in practice.

Pre- to post-training changes in individual providers' self-rated confidence in providing FCC in pediatric resuscitation

Time Frame: Pre-training survey up to 4 weeks prior to training, Post-training survey up to 6 weeks after training

Pre-training to post-training change in scores on the adapted Family Presence Self-Confidence Scale (FPSCS). The FPSCS is a 29-item scale assessing health care providers' confidence in assisting patients and family members during a resuscitation, and in continuing to provide consistent high quality care while family members are present. It is on 1 to 5 scale, with 1 = not at all confident, 3 = somewhat confident, and 5 = very confident. The FPSCS total score has a potential range of 29 to 145, with higher score indicating greater confidence.

Secondary Outcomes

  • Pre- to post-training changes in team performance of FCC(In situ simulations conducted immediately before and after training.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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