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OpenTrials
Completed

NCT Number: NCT03349541

Paediatric Resident Complex Care Curriculum RCT

Medical and technological advances have resulted in a growing cohort of children with medical complexity (CMC), many of whom would not have survived previously and are living and thriving within the community. These families have unique needs that have previously not been taught in the typical training programs for paediatricians. The goal of this project is to develop an evaluation of a national complex care curriculum and to identify whether dedicated educational modules have an impact on improving clinical performance and resident self-efficacy.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

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About this study

Rationale:

A structured program evaluation considering a hierarchy of outcomes is essential to determine whether improved training in complex care is associated with increased skills in this area, and whether these skills transfer to a clinical setting where they will influence quality of care for CMC.

A paediatric resident's sense of self-efficacy, or perceived capability, in caring for CMC is therefore important to foster for the graduating paediatrician to assume a leadership role in coordinating care, co-developing goals of care with families, advocating in the face of health challenges, and ultimately striving for high-quality clinical care for CMC.

We anticipate that participation in a complex care curriculum will result in sustained high performance on simulated clinical scenarios in complex care and increased resident self-efficacy in caring for CMC, compared to paediatric residents that have not participated in the curriculum. This study will examine if a standardized complex care curriculum for paediatric residents has a positive effect on the acquisition of key competencies in the care of CMC using a rigorous experimental research design. To our knowledge, this is the first national, standardized, population-specific curriculum for Canadian paediatric residents to be developed and evaluated with this systematic approach.

Study Objectives:

The overarching aim of this project is to develop a robust evaluation of the national complex care curriculum, and identify whether dedicated educational modules have an impact on improving clinical performance and resident self-efficacy.

Primary Research Question:

What is the comparative effectiveness of participation in a standardized curriculum on acquisition of clinical skills in complex care for paediatric residents, relative to paediatric residents receiving a standard educational session not related to complex care, evaluated by OSCE scores in a complex care scenario?

Secondary Objectives:

To explore changes in paediatric residents' sense of self-efficacy and comfort in caring for CMC following participation in the curriculum using semi-structured interviews.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Residents in their 1st to 4th postgraduate year of training in paediatrics (general paediatric stream and paediatric neurology stream who have regular attendance at the academic half-days), enrolled at the University of Toronto or the University of Ottawa.

Exclusion criteria

  • Residents who are enrolled in a subspecialty residency training

Treatment and study plan

Complex Care Curriculum

Other

A well-established approach to curriculum development was utilized to develop competency-based objectives aligned with the Canadian "CanMEDS" Physician Competency Framework, identify appropriate educational strategies and design relevant evaluations.

Primary outcomes

  1. Acquisition of clinical skills in Complex Care

    Time frame: Within 1-3 months from complex care educational training (day of the scheduled OSCE examination)

    This outcome will be measured by the score obtained on a standardized checklist for a complex care scenario in the Spring 2017 national paediatric in-training objective structured clinical examination (OSCE). The OSCE global score is out of 50, with a higher score representing a better performance. OSCE sub-scores related to specific components of the curriculum (tracheostomy care, common issues in complex medical care, and diagnosis and management) will be compared between groups.

Secondary outcomes

  1. Resident self-efficacy in the care of Children with Medical Complexity

    Time frame: Within 4 months from the complex care educational training

    This outcome will be explored through in-depth qualitative interviews.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Children's Hospital of Eastern Ontario
  • Montreal Children's Hospital of the MUHC

Registry information

Official study title

A Multicenter Randomized Trial of Curricular Modules in the Care of Children With Medical Complexity for Paediatric Residents

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2017
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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