Direct Access Physiotherapy in the Pediatric Emergency Department (PedEDmsk)

April 1, 2024 updated by: Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre

Improving Access to Quality Care for Children and Adolescents Presenting to the Pediatric Emergency Department With Musculoskeletal Problems: a Pilot Randomized Control Trial

The goal of this clinical trial is to compare two methods of managing low acuity musculoskeletal complaints in children and adolescents ages 6 to 17.99 years in the pediatric emergency department. The main question it aims to answer is whether delivering care in two methods is feasible. Participants will receive care while in the emergency department and will be followed for a period of 1-month post-presentation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

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

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3S5
        • McGill University Health Center

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • aged 6.00-17.99 years of age
  • present to the Montreal Children's Hospital Emergency Department with a suspected MSK complaint, traumatic or not
  • are given a triage score of 3 (urgent), 4 (less urgent), or 5 (nonurgent) according to the Canadian Triage and Acuity Scale (CTAS)
  • are able to communicate in French or English

Exclusion Criteria:

  • present with a major MSK condition requiring urgent care (e.g., open fracture, open wound)
  • a red flag (e.g. progressive neurological disorder, infectious symptoms)
  • a co-morbid unstable condition.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
usual care
Other: usual care
assessment and treatment in usual care model
Experimental: Interdisciplinary
Interdisciplinary model for management of low acuity msk complaint
Other: Interdisciplinary management
assessment and treatment in an interdisciplinary model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of consent
Time Frame: through study completion an average of 4 weeks post-enrolment
rate of consented patients related to patients approached rate of randomization, feasibility of administration of outcomes
through study completion an average of 4 weeks post-enrolment
Completed outcome measures
Time Frame: through study completion an average of 4 weeks post-enrolment
proportion of participants who complete all outcome measures
through study completion an average of 4 weeks post-enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity on faces rating scale
Time Frame: through study completion an average of 4 weeks post-enrolment
Pain intensity on faces rating scale, scale from 0 to 10, with 10 being a worse score
through study completion an average of 4 weeks post-enrolment
Pain interference with function PROMIS scale
Time Frame: through study completion an average of 4 weeks post-enrolment
PROMIS Pediatric Pain Interference - Short Form 8a, 8 items scores from 1-5 with 5 being a worse outcome
through study completion an average of 4 weeks post-enrolment

Collaborators and Investigators

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

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)

September 18, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-9673

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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