PedEDmsk: Direct Access Physiotherapy in the Pediatric Emergency Department

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT06069011

Collaborator

(none)

Enrollment

Location

Arms

3.4

Anticipated Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Pain Musculoskeletal Diseases or Conditions	Other: Interdisciplinary management Other: usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 18, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Interdisciplinary

Interdisciplinary model for management of low acuity msk complaint

Other: Interdisciplinary management

assessment and treatment in an interdisciplinary model

Active Comparator: Usual care

usual care

Other: usual care

assessment and treatment in usual care model

Outcome Measures

Primary Outcome Measures

Rate of consent [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
Completed outcome measures [through study completion an average of 4 weeks post-enrolment]
proportion of participants who complete all outcome measures

Secondary Outcome Measures

Pain intensity on faces rating scale [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
Pain interference with function PROMIS scale [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McGill University Health Center	Montréal	Quebec	Canada	H4A 3S5

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Isabelle Gagnon, Senior Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

ClinicalTrials.gov Identifier:

NCT06069011

Other Study ID Numbers:

2024-9673

First Posted:

Oct 5, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Musculoskeletal Pain

Musculoskeletal Diseases

Emergencies

Study Results

No Results Posted as of Oct 5, 2023