Does a new screening and referral process for people with a pelvic fracture reduce the frequency and severity of them experiencing symptoms of bladder, bowel and sexual dysfunction?

This multi-centre single blinded randomised control trial (RCT) will involve adults (18 years of age and over) who are admitted to either The Royal Melbourne Hospital or The Alfred Hospital under an orthopaedic or trauma bed card with at least one pelvic fracture or traumatic changes (e.g. diastasis) on imaging (managed either non-operatively or operatively). Due to the nature of the intervention in this study, it is not possible to blind participants however, the investigative team and data analysts will be blinded to the allocation of participants. Acute orthopaedic and trauma ward physiotherapists, doctors and in-charge nurses, as well as Trauma Clinical Nurse Consultants, will be responsible for identifying newly admitted patients with at least one pelvic fracture. In order to determine eligibility, the recruitment physiotherapists will complete the Screening Form for all potentially eligible patients admitted to the acute inpatient orthopaedic or trauma wards, using details obtained from the patient’s hospital record, liaising with the multidisciplinary team and/or conducting a verbal subjective examination face-to-face at the patient’s bedside or via telehealth. Once eligibility is confirmed, participants will be approached by the recruitment physiotherapist either face-to face at the bedside or via telehealth and provided with a verbal overview of the study procedures and commitment. Patients who are eligible and interested in participating in the study will then be provided with the Participant Informed Consent Form. The study physiotherapist will return either that afternoon (minimum 4 hours) or the following day and consenting participants will be required to confirm that they have read and understood the Participant Informed Consent Form (PICF) by signing and dating this document. The PICF details to patients that they will only be eligible for the RCT component if they present with PFD at 3 months post injury. The Initial Data Collection Form will be used to collect patient demographic details and other baseline data for all enrolled participants. These details will be obtained by study team members during the acute inpatient admission on the orthopaedic or trauma ward by utilising hospital records, liaising with the multidisciplinary team and/or by questioning the participant. All enrolled participants will complete the Australian Pelvic Floor Questionnaire (APFQ), with males who report being sexually active in the four weeks prior to their injury also required to complete the International Index of Erectile Function (IIEF-5). These questionnaires will be administered at baseline during the acute hospital admission independently via a smart device, verbally at the patient’s bedside, or via telehealth, with an electronic link to the study emailed to them. If the patient is not confident in using the smart device, they will be given the option of a paper copy. The APFQ and IIEF-5 (for males) will be re-administered at the 3-month time point for all participants either independently at home via a smart device or assisted via telehealth by either the recruitment physiotherapists or blinded independent study staff (other physiotherapists within the acute orthopaedic and trauma teams at both study sites) whom are not involved in treatment or data analysis. All scores will be entered and saved electronically in a custom-built REDCap database. 3-months post-injury, patients will be sent the questionnaire via email, with both an email and text message reminder after one week; and a phone call reminder one week later. Where multiple efforts to contact the participant fail, the study team will contact the participant’s Next of Kin to request a suitable time for follow-up. Attempts at making contact will cease after 6-weeks from the initial follow-up due date. The Follow Up Data Collection Form will also be administered at the 3-month time point via a weblink or telehealth using the same methods as above. This includes questions pertaining to ongoing issues or treatment of an orthopaedic nature, any assessment or treatment which has been sought or provided for PFD independent of this study, return to work status and any change to marital status. Only participants with PFD at 3 months post injury will be eligible for inclusion in the RCT component of the study. Participants will be identified as having PFD 3 months post injury if they have either i) an increase in overall APFQ score of 3 or more from their in-hospital scores; ii) an increase in any APFQ domain score of 1 or more from their in-hospital scores; or iii) an IIEF-5 score of 21 or less. Participants with PFD will then be randomised via randomisation stratified by fracture management (non-operative vs operative); study site; and gender; using a pre-uploaded randomisation schedule in REDCap. Allocation will thus be independent of treating therapists and medical specialists. All participants identified as having PFD will be required to use the iUFlow voiding bladder diary app or a paper bladder diary for 48- hours following randomisation at the 3-month mark and again within a 48-hour period leading up to their 12-month follow-up appointment. The information entered into this app automatically uploads to a database that is readily accessible to their treating clinician. Variables to be collected using this smart technology include frequency of micturition, severity of urinary urgency and episodes of urinary incontinence. All data entered into the iUFlow app can only be accessed by the study staff member (continence physiotherapist or urologist) whose contact details (email address) are entered into the app and cannot be accessed by a third party, thus there are no privacy concerns. The paper diary will be returned via email or post to study staff. This raw data will be entered into a separate confidential REDCap database, again using the participants unique study code (therefore will be de-identified) and provided to data analysts who will be blinded as to the allocation of the participants. Participants allocated to the intervention group will receive equivalent care to that of the control group and in addition, will be offered a referral to a specialised continence or urology service associated with the institution at which their initial injury was managed (The Royal Melbourne Hospital or The Alfred Hospital) for assessment and management of their PFD symptoms. Participants who choose to take up this referral will have the option of either face-to-face or telehealth consultation(s) with a pelvic floor physiotherapist or urology doctor (for males with erectile dysfunction). If the patient is geographically distanced from this service, they may be referred to a local public specialised continence or urology service, as is seen fit by the treating health professional. Intervention choices and number of appointments scheduled will be determined by the treating health professional and will be individually tailored for each participant, including treatment techniques with high quality supporting evidence such as pelvic floor muscle retraining and/or behavioural interventions. This will enable the prevalence and severity of PFD to be compared between control and intervention groups at 12 months post injury; and ascertain the natural history and resolution rate of PFD without intervention. Additionally, this will allow us to assess the efficacy of screening and referring these patients to a sub-acute continence or urology service at 3 months; and determine whether there is a change in resolution rate compared with usual care or natural history.