None listed
Conditions
Brief summary
Background: With increasing numbers of people requiring follow-ups for their fractures, the burden on outpatient fracture clinics with limited resources has also increased, causing long clinic wait times, and productivity losses for patients and carers from missing school or work. Published studies have shown that virtual fracture clinics can manage patients with simple fractures, but robust evaluations of their safety, effectiveness and cost-effectiveness are lacking. Aim: To determine whether virtual care is non-inferior to in-person care for people with simple fractures through a prospective two-arm, parallel group randomised controlled trial, using a non-inferiority design; with nested economic and process evaluations, and semi-structured qualitative interviews with subset of patients. Primary objective: To determine whether virtual care produces non-inferior physical function outcomes compared to in-person care for patients with simple fractures at 12-weeks follow-up, measured using the Patient-Specific Functional Scale (PSFS). Secondary objectives: To compare the effects of virtual care and in-person care on pain (Numerical Rating Scale), patient-reported health-related quality of life (EuroQol 5D 5L), patient-reported experience (Generic Short Patient Experiences Questionnaire), cost-effectiveness, healthcare utilisation, medication use and safety (number of adverse events, number of serious adverse events) at 6- and 12-weeks follow-up. Study procedure: All patients referred to the virtual fracture clinic with simple fractures who agree to receive a follow-up at Royal Prince Alfred will be screened for eligibility. Participants who consent to the study will be randomised to receive follow-up fracture care through one of two existing clinics – a virtual fracture clinic (intervention group) or an in-person fracture clinic (control group). The intervention group will receive a standard fracture management fact sheet and have their follow-up care via phone or video calls with a physiotherapist. The in-person clinic (control group) will receive follow-up care at the in-person clinic with an orthopaedic doctor. All participants will complete a series of surveys as part of their clinical care. This study has received ethics approval and will commence recruitment in September 2023.
Interventions
Participants in the intervention group will receive care virtually.
Patients will be provided a follow-up appointment at the virtual fracture clinic within 5 days after their referral is received. Patients will be sent an email with the details of their appointment date/time, a Zoom link for the virtual consult, contact details of the clinic, and the respective fracture management fact sheet. The RPA Virtual Hospital's fact sheets explain the clinical condition, expectation of the recovery, ea
Participants in the intervention group will receive care virtually. Patients will be provided a follow-up appointment at the virtual fracture clinic within 5 days after their referral is received. Patients will be sent an email with the details of their appointment date/time, a Zoom link for the virtual consult, contact details of the clinic, and the respective fracture management fact sheet. The RPA Virtual Hospital's fact sheets explain the clinical condition, expectation of the recovery, early rehabilitation exercises, activity limitations, and clear information on care escalation. These fact sheets were adapted with permission from the Royal Melbourne Hospital, and were approved by the RPA Virtual Hospital's Consumer Group. All patients will be offered a video-consult with a physiotherapist unless they choose to have their review via phone. During the virtual consult, the physiotherapist will conduct a subjective and objective assessment, discuss the x-ray findings and provide a management plan. Patients will be offered the opportunity to ask questions prior to ending the consultation. The anticipated duration of the consult sessions will be approximately 30 minutes. An email summary of the consultation, along with the follow-up appointment details will be sent to the patient. A Physitrack link for tailored exercise videos and instructions may also be included in this email. Patients will be offered a follow-up virtual appointment at 2- and 6-weeks post-fracture, or based on clinical need. Patients can contact the physiotherapist via phone or email during business hours if they have any concerns during their care period. Most patients will be discharged at 6-weeks post-fracture if they have no other concerns. We will monitor patient adherence by the number of consults attended, and the number of adhoc patient contacts via phone or email with the clinic. The physiotherapist will organise an interpreter prior to the virtual consult if the patient requires assistance with language. Patients who identify as Aboriginal and/or Torres Strait Islander are also offered support from the Aboriginal Cultural Support Team as per current process.
Sponsors
RPA Virtual Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a. Acute (<6 weeks) simple fractures such as base of fifth metatarsal (foot), Weber A (ankle), Mason I radial head (elbow) or clavicle (collar bone). b. Aged 18 years or older, c. The condition can be managed using removable orthoses including tapes and bandages, d. Conditions in point (a) that are deemed appropriate for virtual management by the orthopaedic doctor, e. Patient has access to a phone and an active telephone number, f. Patient is within New South Wales at the time of consult, g. Patient is willing to participate and comply with the study requirements, h. A radiology scan showing or reporting the injury mentioned in point (a).
Exclusion criteria
a. Patients with complex or significantly displaced fracture, including pathological, open, unstable or spinal fractures, b. Patients requiring a cast or surgical management, c. Neurovascular concerns, d. Conditions not managed by RPA Hospital Orthopaedics Department, e. Patients who are unable to attend the in-person fracture clinic within the recommended follow-up time, f. Patients who opt-out of this study.
Outcome results
None listed