Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000782639
Ethics application status
Approved
Date submitted
19/06/2023
Date registered
18/07/2023
Date last updated
11/01/2024
Date data sharing statement initially provided
18/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
RESHAP-ED: comparing primary-contact physiotherapy with standard care for musculoskeletal conditions in emergency departments.
Scientific title
RESHAP-ED: A pragmatic, multicentre, two-arm, parallel randomised controlled trial comparing length of stay for primary-contact physiotherapy versus standard care (primary contact is doctor or nurse) for musculoskeletal conditions in emergency departments.
Secondary ID [1] 309609 0
None
Universal Trial Number (UTN)
U1111-1292-2883
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute musculoskeletal condition 329930 0
Condition category
Condition code
Musculoskeletal 326831 326831 0 0
Other muscular and skeletal disorders
Public Health 327368 327368 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pragmatic multicentre, two-arm, parallel randomised controlled trial with nested process and economic evaluations. The intervention group in this trial will be the primary-contact physiotherapist in the Hospital Emergency Department. The primary-contact physiotherapist will nominate themselves as the care provider in the Cerner FirstNet® system to indicate they are seeing the patient and then see the patient immediately. This process of recording who provides initial care in Cerner® is usual practice in emergency departments.
The physiotherapy intervention will consist of a senior level 4 physiotherapist individually assessing and managing the patient as primary contact in the Hospital Emergency Department. After their initial assessment, the primary-contact physiotherapist will choose the best course of management with consultation with the patient. Care for the low back pain cases will be provided according to recommendations from the Australian Low Back Pain Clinical Care Standard, and other musculoskeletal conditions will be managed via best practice as recommended by the Emergency Care Institute.
The primary-contact physiotherapist may consult a medical/nurse practitioner (collaborative model of care) or autonomously manage eligible patients. In the autonomous model of care, the physiotherapist is responsible for selecting eligible patients from the triage list, assessment, management, diagnosis, and discharge with no involvement of a medical/nurse practitioner. In the collaborative model of care, after selecting and assessing the patient, the primary-contact physiotherapist shares discharge and management decision making with a medical/nurse practitioner.
All patients will be provided a discharge plan, including timely follow-up in the outpatient setting. Outpatient care will be provided by existing outpatient services such as outpatient physiotherapy, specialist clinics if required, virtual hospitals, and GP clinics. About 40 patients allocated to the primary-contact physiotherapy group will be invited to participate in a 30-45 minute audio-recorded semi-structured qualitative interview by their treating primary-contact physiotherapist during the emergency department visit. We will report data from the first 40 patients who agree to participate. This semi-structure interview will be conducted by a member of the research team. About 40 clinicians will also be invited to participate in a 30-45 minute audio-recorded semi-structured qualitative interview.
Adherence to the intervention will be monitored using data from the electronic medical record.
Every patient enrolled in this study will be followed for a period of 42 days. We expect the total duration of this study to be four years.
The Australian Low Back Pain Clinical Care Standard (2022) can be accessed at: https://www.safetyandquality.gov.au/publications-and-resources/resource-library/low-back-pain-clinical-care-standard-2022.
Emergency Care Institute guidelines for other musculoskeletal conditions can be accessed at: https://aci.health.nsw.gov.au/networks/eci

Intervention code [1] 326034 0
Treatment: Other
Comparator / control treatment
The control group consists of primary-contact care pathway by a doctor and/or nurse practitioner. Those in the control group will not be seen by the primary-contact physiotherapist and will be left for the doctors or nurse practitioner to see. The doctors and/or nurse practitioners will allocate themselves as primary care provider in the Cerner FirstNet® system and see the patient as usual. This is usual practice in the emergency department. The care provided will be decided by the emergency department doctors and nurses, as per usual. Emergency doctors and/or nurses may refer the patient to see the physiotherapist in the emergency department as secondary-contact, or to the outpatient physiotherapy department after discharge. About 40 clinicians will also be invited to participate in a 30-45 minute audio-recorded semi-structured qualitative interview. This semi-structure interview will be conducted by a member of the research team.
Control group
Active

Outcomes
Primary outcome [1] 334685 0
The emergency department length of stay, which is defined as: the period between when the patient presents at an emergency department, and when the patient is recorded as having physically departed from the emergency department. This outcome will be assessed using data from the electronic medical record system.
Timepoint [1] 334685 0
Upon discharge from the emergency department visit, following randomisation.
Secondary outcome [1] 421649 0
Time to clinical care (i.e. time elapsed in minutes for each patient from presentation in the emergency department to the commencement of the emergency department non-admitted clinical care). This outcome will be assessed using data from the electronic medical record system.
Timepoint [1] 421649 0
Day 0 (emergency department visit) following randomisation.
Secondary outcome [2] 421650 0
Duration of clinical care (i.e. the period between when clinical care commences and the end of the non-admitted patient emergency department episode, i.e. physical departure from the emergency department). This outcome will be assessed using data from the electronic medical record system.
Timepoint [2] 421650 0
Upon discharge from the emergency department visit, following randomisation.
Secondary outcome [3] 421651 0
Proportion of patients whose emergency department length of stay (as defined above) is less than or equal to four hours (proportion completed within four hours). This outcome will be assessed using data from the electronic medical record system.
Timepoint [3] 421651 0
At conclusion of the study.
Secondary outcome [4] 421652 0
Proportion of patients 'seen on time' (i.e. the proportion of presentations for which the waiting time to commencement of clinical care was within the time specified in the definition of the triage category: urgent (within 30 minutes), semi-urgent (within 60 minutes), non-urgent (within 120 minutes). This outcome will be assessed using data from the electronic medical record system.
Timepoint [4] 421652 0
At conclusion of the study.
Secondary outcome [5] 421653 0
Proportion of patients admitted to EDSSU (Emergency Department Short Stay Unit). This outcome will be assessed using data from the electronic medical record system.
Timepoint [5] 421653 0
At conclusion of the study.
Secondary outcome [6] 421654 0
Proportion of patients admitted to hospital inpatient units. This outcome will be assessed using data from the electronic medical record system.
Timepoint [6] 421654 0
At conclusion of the study.
Secondary outcome [7] 421655 0
Proportion of patients that received imaging. This outcome will be assessed using data from the electronic medical record system.
Timepoint [7] 421655 0
At conclusion of the study.
Secondary outcome [8] 421656 0
Proportion of patients that received opioids. This outcome will be assessed using data from the electronic medical record system.
Timepoint [8] 421656 0
At conclusion of the study.
Secondary outcome [9] 421657 0
Proportion of patients that received gabapentinoids. This outcome will be assessed using data from the electronic medical record system.
Timepoint [9] 421657 0
At conclusion of the study.
Secondary outcome [10] 421658 0
Proportion of patients that received specialist consult within the emergency department. This outcome will be assessed using data from the electronic medical record system.
Timepoint [10] 421658 0
At conclusion of the study.
Secondary outcome [11] 421659 0
Proportion of patients referred to specialist clinic. This outcome will be assessed using data from the electronic medical record system.
Timepoint [11] 421659 0
At conclusion of the study.
Secondary outcome [12] 421660 0
Proportion of patients representing to the emergency department for the same chief complaint within 72 hours of discharge. This outcome will be assessed using data from the electronic medical record system.
Timepoint [12] 421660 0
At conclusion of the study.
Secondary outcome [13] 421661 0
Proportion of patients readmitted to hospital inpatient units for the same chief complaint within 30 days of index inpatient admission. This outcome will be assessed using data from the electronic medical record system.
Timepoint [13] 421661 0
At conclusion of the study.
Secondary outcome [14] 421662 0
Patient-reported outcome - Pain intensity (numeric rating scale, range 0–10).
Timepoint [14] 421662 0
At Day 1, Day 7, and Day 42 following randomisation.
Secondary outcome [15] 422906 0
Patient-reported outcome - Quality of life (Euro-Qol-5D).
Timepoint [15] 422906 0
At Day 1, Day 7, and Day 42 following randomisation.
Secondary outcome [16] 422907 0
Patient-reported outcome - Satisfaction with care (1 item from the Emergency Department Patient Experience of Care (EDPEC) Survey)
Timepoint [16] 422907 0
At Day 1 following randomisation.
Secondary outcome [17] 422914 0
Implementation outcomes: patients qualitative semi-structured interview.
- Acceptability
- Adoption
- Appropriateness
Timepoint [17] 422914 0
Patient's qualitative semi-structure interview - completed by patients between Day 1 and Day 42 post emergency department discharge following randomisation.
Secondary outcome [18] 423768 0
Implementation outcomes: clinicians qualitative semi-structured interview.
- Acceptability
- Adoption
- Appropriateness
Timepoint [18] 423768 0
Clinician's qualitative semi-structure interview - completed by clinicians after 50 patients are randomised at a participating site.
Secondary outcome [19] 423769 0
Implementation outcome: this outcomes will be assessed using data from the electronic medical record system that will be recorded in the trial logbook.

- Fidelity
Timepoint [19] 423769 0
At conclusion of the study
Secondary outcome [20] 424359 0
Implementation outcome: this outcomes will be assessed using data from the electronic medical record system that will be recorded in the trial logbook. The cost utility and cost-effectiveness analyses will be carried out to compare the value for money between the primary-contact physiotherapy pathway to the doctor/nurse pathway. We will collect data from the hospital records on healthcare use costs using presentation level costing data used for reporting and funding purposes by local health districts. Intervention costs will be collected from trial records. The effectiveness outcomes of the economic evaluation will be: i) quality adjusted life years (QALY) gained over 6 weeks (cost-utility analysis); ii) time spent in the emergency department avoided (cost-effectiveness analysis).

- Implementation cost
Timepoint [20] 424359 0
At conclusion of the study
Secondary outcome [21] 424366 0
Adverse events: Adverse events will be collected as following;
- On day 1, after emergency department discharge, participants will complete an online survey that will include a question prompting participants to report the occurrence of any adverse event during the emergency department stay. Participants experiencing an adverse event will have the opportunity to include more information about the adverse event as free text. Then, the investigators will review the clinical notes of participants reporting adverse events, extract adverse event data from the electronic medical records, and record the data in REDCap. The Medical Dictionary for Regulatory Activities (MedDRA) will be used to code adverse event data. A blinded independent assessor will review adverse event data and assign attribution to study interventions.
Timepoint [21] 424366 0
At Day 1, after emergency department discharge.

Eligibility
Key inclusion criteria
- Adult patient (equal or greater than 18 years);
- Presents to the emergency department with a simple musculoskeletal condition. This would include, but is not limited to, soft tissue injuries (joint, ligament, tendon or muscle pain), musculoskeletal neck and low back pain, closed peripheral fractures not requiring reduction or orthopaedic fixation (indicated from triage notes), spontaneously reduced joint dislocations; and
- Triage score 3 (urgent), 4 (semi-urgent) or 5 (non-urgent) as per Australian Triage Scale. Triage score 2 will also be included whenever an adult presents to the emergency department with an isolated joint dislocation including: shoulder, digit, patella or temporomandibular joint (indicated by triage notes).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Already assessed by a doctor or other primary-contact health practitioner in the emergency department as indicated on the Cerner FirstNet® list; or
- Any non-musculoskeletal/non-orthopaedic condition, such as open wounds, eye problems, foreign bodies, and poisonings; or
- Presentations outside the primary-contact physiotherapists’ working hours; or
- Triage notes indication of soft tissue injuries that may require surgical intervention; or
- Triage notes indication of fracture requiring reduction and/or surgical fixation; or
- Triage notes indication of signs or symptoms of serious pathology (for example: spinal fracture, cauda equina syndrome, malignancy, infection, inflammatory origin of pain); or
- Co-morbidities requiring immediate emergency care (for example: cardiac, respiratory; or psychiatric issues as indicated on the triage note).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Online randomisation using the REDCap software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using computer-generated random numbers in SAS. A 1:1 random allocation sequence will be generated using randomly permuted blocks of variable size (2 and 4).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: With a total sample size of 620 patients (310 per arm), the study will have 90% power to detect a difference of 30 minutes in emergency department length of stay assuming a standard-deviation of 115 minutes.
We do not anticipate any missing data for the primary outcome since length of stay is recorded systematically for every patient admitted to the emergency department.

Statistical Analysis Plan: The main analysis of the primary and secondary outcomes will be conducted by including all randomised patients analysed according to the group they were randomised to and regardless of protocol adherence (i.e. following the intention to treat (ITT) principle). The main analysis of length of stay will be performed using linear regression adjusted for hospital as a random effect. The effect of the intervention will be estimated as the adjusted mean difference and 95% confidence interval. While length of stay is unlikely to follow a normal distribution, the large sample size will allow us to make inference about the mean. In case of important heteroscedasticity, as assessed using a plot of residuals against fitted values, we will conduct a sensitivity analysis using a log-transformation.
A detailed analysis plan including mock tables will be developed prior to unblinding. Analyses pre-specified in the analysis plan will be programmed using randomly scrambled treatment allocations. Unblinded results will be presented to the study team once all analyses have been programmed and validated and the database locked.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
22/11/2023
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
620
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24681 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 24682 0
Grafton Base Hospital - Grafton
Recruitment hospital [3] 25196 0
The Sutherland Hospital - Caringbah
Recruitment hospital [4] 25197 0
Broken Hill Base Hospital - Broken Hill
Recruitment hospital [5] 25198 0
Ryde Hospital - Eastwood
Recruitment hospital [6] 25985 0
Gosford Hospital - Gosford
Recruitment hospital [7] 25986 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment postcode(s) [1] 40301 0
2050 - Camperdown
Recruitment postcode(s) [2] 40302 0
2460 - Grafton
Recruitment postcode(s) [3] 40866 0
2229 - Caringbah
Recruitment postcode(s) [4] 40867 0
2880 - Broken Hill
Recruitment postcode(s) [5] 40868 0
2122 - Eastwood
Recruitment postcode(s) [6] 41836 0
2250 - Gosford
Recruitment postcode(s) [7] 41837 0
2259 - Hamlyn Terrace

Funding & Sponsors
Funding source category [1] 313789 0
Government body
Name [1] 313789 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 313789 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 315622 0
None
Name [1] 315622 0
Address [1] 315622 0
Country [1] 315622 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312957 0
Sydney Local Health District HREC
Ethics committee address [1] 312957 0
Ethics committee country [1] 312957 0
Australia
Date submitted for ethics approval [1] 312957 0
24/04/2023
Approval date [1] 312957 0
13/06/2023
Ethics approval number [1] 312957 0
X23-0143

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126478 0
Dr Gustavo Machado
Address 126478 0
School of Public Health, The University of Sydney
Level 10, North, King George V Building, Missenden Rd, Camperdown NSW 2050
Country 126478 0
Australia
Phone 126478 0
+61 2 8627 6243
Fax 126478 0
+61 2 8627 6262
Email 126478 0
[email protected]
Contact person for public queries
Name 126479 0
Gustavo Machado
Address 126479 0
School of Public Health, The University of Sydney
Level 10, North, King George V Building, Missenden Rd, Camperdown NSW 2050
Country 126479 0
Australia
Phone 126479 0
+61 2 8627 6243
Fax 126479 0
+61 2 8627 6262
Email 126479 0
[email protected]
Contact person for scientific queries
Name 126480 0
Gustavo Machado
Address 126480 0
School of Public Health, The University of Sydney
Level 10, North, King George V Building, Missenden Rd, Camperdown NSW 2050
Country 126480 0
Australia
Phone 126480 0
+61 2 8627 6243
Fax 126480 0
+61 2 8627 6262
Email 126480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19108Study protocol  [email protected]
19109Statistical analysis plan  [email protected]
19110Ethical approval  [email protected] 385855-(Uploaded-13-06-2023-13-56-48)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.