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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital of Eastern Ontario
Montreal Children's Hospital of the MUHC

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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