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Impacts of Physiotherapy Services in a Quebec Emergency Department

Primary Purpose

Musculoskeletal Pain, Musculoskeletal Diseases, Musculoskeletal Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Direct access to a PT
Sponsored by
Rose Gagnon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Health care access, Health services, Professional practices

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de l'Université Laval (CHUL)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Emergency Physician Group

Physical Therapist Group

Arm Description

Usual care by the EP without the intervention of the ED PT.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.)
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.)
Consultations with Another Health Professional : Standardized Form
Form were every consultation being prescribed to the patient was checked as a "Yes" or "No" answer.
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.
Wait Time
Difference between beginning of the intervention and time of arrival between groups during their ED visit
Length of Stay
Difference between departure time and time of arrival between groups during their ED visit

Full Information

First Posted
July 2, 2019
Last Updated
October 26, 2020
Sponsor
Rose Gagnon
Collaborators
CHU de Quebec-Universite Laval, Integrated University Health and Social Services Center of the Capitale-Nationale, Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT04009369
Brief Title
Impacts of Physiotherapy Services in a Quebec Emergency Department
Official Title
Impacts of Physiotherapy Services in a Quebec Emergency Department - Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
June 27, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rose Gagnon
Collaborators
CHU de Quebec-Universite Laval, Integrated University Health and Social Services Center of the Capitale-Nationale, Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Musculoskeletal Diseases, Musculoskeletal Injury
Keywords
Health care access, Health services, Professional practices

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emergency Physician Group
Arm Type
No Intervention
Arm Description
Usual care by the EP without the intervention of the ED PT.
Arm Title
Physical Therapist Group
Arm Type
Experimental
Arm Description
Direct access to a PT in the ED immediately after triage and prior to physician assessment.
Intervention Type
Other
Intervention Name(s)
Direct access to a PT
Intervention Description
Direct access to a PT in the ED immediately after triage and prior to physician assessment.
Primary Outcome Measure Information:
Title
Level of Pain: Numeric Pain Rating Scale
Description
Scale ranging from 0 to 10 where 0 means no pain at all and 10 means the worst pain ever.
Time Frame
Baseline, 1 and 3 months
Title
Pain Interference on Function: Brief Pain Inventory
Description
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.
Time Frame
Baseline, 1 and 3 months
Secondary Outcome Measure Information:
Title
Pain Catastrophizing: Pain Catastrophizing Scale
Description
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.
Time Frame
Baseline
Title
Interventions received by the participants : Standardized Form
Description
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.)
Time Frame
Baseline, 1 and 3 months
Title
Diagnostic Tests : Standardized Form
Description
Form were every diagnostic test received by the patient was checked as a "Yes" or "No" answer. (X-ray, MRI, CT Scan, ultrasound, etc.)
Time Frame
Baseline, 1 and 3 months
Title
Consultations with Another Health Professional : Standardized Form
Description
Form were every consultation being prescribed to the patient was checked as a "Yes" or "No" answer.
Time Frame
Baseline, 1 and 3 months
Title
Satisfaction: Visit-Specific Satisfaction Instrument
Description
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.
Time Frame
Baseline
Title
Wait Time
Description
Difference between beginning of the intervention and time of arrival between groups during their ED visit
Time Frame
Baseline
Title
Length of Stay
Description
Difference between departure time and time of arrival between groups during their ED visit
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rose Gagnon, MPT, MSc(c)
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université Laval (CHUL)
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33617696
Citation
Gagnon R, Perreault K, Berthelot S, Matifat E, Desmeules F, Achou B, Laroche MC, Van Neste C, Tremblay S, Leblond J, Hebert LJ. Direct-access physiotherapy to help manage patients with musculoskeletal disorders in an emergency department: Results of a randomized controlled trial. Acad Emerg Med. 2021 Aug;28(8):848-858. doi: 10.1111/acem.14237. Epub 2021 Apr 16.
Results Reference
derived

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Impacts of Physiotherapy Services in a Quebec Emergency Department

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