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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04009369
Other study ID # MP-20-2019-4307
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2018
Est. completion date June 27, 2019

Study information

Verified date October 2020
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Emergency departments (ED) in several countries integrated physiotherapists in order to reduce wait times for patients with musculoskeletal disorders (MSKD). These initiatives have indeed reduced wait times, length of stay, time waited before seeing a professional and the prescription of unnecessary consultations and diagnostic tests. In Canada, such initiatives are marginal and their effects have not been studied. The objectives of the project are to evaluate the effects of physiotherapy management of patients with MSKD in ED compared to usual practice on clinical course of patients, use of services and resources, and waiting time and length of stay in ED. The hypothesis is that patients presenting with a MSKD to the ED with direct access to a physiotherapist will have better clinical outcomes and that use of services, waiting time, and length of stay are going to be inferior to those of the EP group.


Description:

Background and rationale: Emergency departments (ED) in several countries integrated physiotherapists, which led, for patients with musculoskeletal disorders (MSKD), to a reduction in wait times, length of stay, time waited before seeing a professional and the prescription of unnecessary consultations and diagnostic tests. Furthermore, early access to physiotherapy is associated with a decrease in pain and psychological symptoms and decreased risks of developing persistent pain. In Canada, such initiatives are still marginal and their effects have not been studied. Objectives: Evaluate the effects of direct access physiotherapy management of patients with MSKD in the ED compared to the usual management by the emergency physician on clinical course of patients (pain, quality of life and disability) and use of services and resources at one and three months, and waiting time and length of stay in the ED. Methods: A randomized controlled trial is currently in progress at the Centre hospitalier de l'Université Laval (CHUL). Two groups of 50 participants each are recruited over a six months period: one group with direct access to a physiotherapist (PT) in the ED and one control group with the usual access care to the emergency physician. Data is extracted from the patients' medical record, administrative data from the ED, self-administered forms given to the patients during their ED stay and either electronic or phone follow-ups (1 and 3 months). Data will be analysed using descriptive (demographic and clinical profiles) and inferential statistics (repeated ANOVA between groups across time points and Student T tests for independent samples). Importance of potential findings for MSK health: ED overcrowding causes prolonged lengths of stay, increased rates of patient leaving without being seen, increased medical errors, increased mortality among ambulatory and non-ambulatory patients and decreased patient satisfaction. This project will measure the effects of integrating PTs into the ED in a Canadian hospital setting and help identify ways to improve the current services offered to patients with a MSKD presenting to the ED. Direct access to PT may improve musculoskeletal health outcomes and support positive patient experience.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date June 27, 2019
Est. primary completion date June 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Triage category 3, 4 or 5 - Discharged home with a minor MSKD after ED care - Able to consent - Able to understand French and to complete the questionnaire either verbally or in writing Exclusion Criteria: - Major MSKD requiring urgent care - Presence of a red flag or an unstable clinical condition - Living in a long-term care facility

Study Design


Intervention

Other:
Direct access to a PT
Direct access to a PT in the ED immediately after triage and prior to physician assessment.

Locations

Country Name City State
Canada Centre Hospitalier de l'Université Laval (CHUL) Québec Quebec

Sponsors (4)

Lead Sponsor Collaborator
Rose Gagnon CHU de Quebec-Universite Laval, Integrated University Health and Social Services Center of the Capitale-Nationale, Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of Pain: Numeric Pain Rating Scale Scale ranging from 0 to 10 where 0 means no pain at all and 10 means the worst pain ever. Baseline, 1 and 3 months
Primary Pain Interference on Function: Brief Pain Inventory List of 10 items (work, sleep, general activity, etc.) represented on a scale ranging from 0 to 10 where 0 means "Does Not Interfere" and 10 means "Completely Interferes". Subscales are averaged and the resulting score is out of 10. A higher score means a higher interference of pain on function. Baseline, 1 and 3 months
Secondary Pain Catastrophizing: Pain Catastrophizing Scale List of 13 items (thoughts and feelings about pain) represented on a scale ranging from 0 to 4 where 0 means "Not at all" and 4 means "All the time". Subscales are summed and the resulting score is out of 52. A higher score means a higher tendency to catastrophise pain. Baseline
Secondary Interventions received by the participants : Standardized Form Form were every intervention received by the patient was checked as a "Yes" or "No" answer. (Advice, medication, technical aids, referral to another health professional, etc.) Baseline, 1 and 3 months
Secondary Diagnostic Tests : Standardized Form Form were every diagnostic test received by the patient was checked as a "Yes" or "No" answer. (X-ray, MRI, CT Scan, ultrasound, etc.) Baseline, 1 and 3 months
Secondary Consultations with Another Health Professional : Standardized Form Form were every consultation being prescribed to the patient was checked as a "Yes" or "No" answer. Baseline, 1 and 3 months
Secondary Satisfaction: Visit-Specific Satisfaction Instrument List of 7 items (Answers to your questions, Technical skills of the healthcare provider, etc.) represented on a scale ranging from 1 to 5 where 1 means "Excellent" and 5 means "Poor". Subscales are transformed in results out of 100 (1 = 100% and 5 = 0%), averaged and the resulting score is out of 100%. A higher score means higher satisfaction. Baseline
Secondary Wait Time Difference between beginning of the intervention and time of arrival between groups during their ED visit Baseline
Secondary Length of Stay Difference between departure time and time of arrival between groups during their ED visit Baseline
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