NCT03349541

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

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

Study Start

First participant enrolled

February 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

November 17, 2017

Last Update Submit

April 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Within 4 months from the complex care educational training

Study Arms (2)

Complex Care Curriculum Intervention

EXPERIMENTAL

Paediatric residents who are randomized to the intervention group will participate in the complex care curriculum during an academic half-day prior to the Objective Structured Clinical Examination (OSCE).

Other: Complex Care Curriculum

No intervention

NO INTERVENTION

Paediatric residents who are randomized to the control group will attend the regular academic half-day unrelated to complex care prior to the Objective Structured Clinical Examination (OSCE).

Interventions

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.

Complex Care Curriculum Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Residents who are enrolled in a subspecialty residency training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Medical Director of the Complex Care Program, Project Investigator, SickKids Research Institute, Assistant Professor, Department of Pediatrics, University of Toronto

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 21, 2017

Study Start

February 1, 2017

Primary Completion

April 3, 2018

Study Completion

April 3, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations