NCT03640520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
547

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 31, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

6.3 years

First QC Date

August 13, 2018

Last Update Submit

May 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

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

    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.

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

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

    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-training survey up to 4 weeks prior to training, Post-training survey up to 6 weeks after training

Secondary Outcomes (1)

  • Pre- to post-training changes in team performance of FCC

    In situ simulations conducted immediately before and after training.

Other Outcomes (2)

  • Pre- to post-training changes in resuscitative care

    In situ simulations conducted immediately before and after training.

  • Pre- to post-training changes in resuscitative care and in teamwork / team performance

    In situ simulations conducted immediately before and after training.

Study Arms (2)

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.

Other: FACETS: Pediatric Resuscitation

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.

Other: Control

Interventions

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 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
ControlOTHER

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 family-centered care 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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Sage Myers, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Nancy Kassam-Adams, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Marc Auerbach, MD, FAAP, MSc

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 21, 2018

Study Start

January 31, 2019

Primary Completion

May 13, 2025

Study Completion

May 13, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations