Paediatric Resident Complex Care Curriculum RCT

Medical Education Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349541
• Other study ID #: 1000056104
• Status: Completed
• Phase: N/A
• First received: November 17, 2017
• Last updated: April 16, 2018
• Start date: February 1, 2017
• Est. completion date: April 3, 2018

Study information

• Verified date: April 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 3, 2018
• Est. primary completion date: April 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Children With Medical Complexity
• Complex Care
• Medical Education
• Pediatric Residents

Intervention

Other:
• Complex Care Curriculum
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.

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Children's Hospital of Eastern Ontario, Montreal Children's Hospital of the MUHC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of clinical skills in Complex Care	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.	Within 1-3 months from complex care educational training (day of the scheduled OSCE examination)
Secondary	Resident self-efficacy in the care of Children with Medical Complexity	This outcome will be explored through in-depth qualitative interviews.	Within 4 months from the complex care educational training