Paediatric Resident Complex Care Curriculum RCT

April 16, 2018 updated by: Julia Orkin, The Hospital for Sick Children

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

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Complex Care Curriculum Intervention
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).
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 1-3 months from complex care educational training (day of the scheduled OSCE examination)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 4 months from the complex care educational training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

April 3, 2018

Study Completion (Actual)

April 3, 2018

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1000056104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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