Evaluating a Transdisciplinary Supportive Care Model for Advanced Liver Disease: Results of the Liver Life Pilot Randomised Controlled Trial (RCT)

Study Setting and Participants: Participants and their carers were recruited from one regional tertiary (Site 1: John Hunter Hospital, Newcastle, NSW) and one rural referral hospital (Site 2: Tamworth Rural Referral Hospital, Tamworth, NSW) within a single local health district (LHD). Adult patients with Advanced Liver Disease (ALD), classified as Child-Pugh Score B or C, were recruited from inpatient and outpatient settings. Patients with or without a suspected or diagnosed hepatocellular carcinoma (HCC), and those awaiting liver transplantation, were eligible for the study. Patients who were post-transplantation or had previous or current engagement with palliative care services were excluded. Ethical approval was provided by the Hunter New England Ethics Committee [2020/ETH02259]. Randomisation and Data Management: Trial data were collected and managed using the REDCap electronic data capture tools hosted within Hunter New England Health District. Participants were randomised via REDCap in a 1:1 ratio to either the intervention or standard care group, stratified by trial site and Child-Pugh score (B or C). Semi-structured interviews with patients, carers and clinicians were performed before and at the conclusion of the trial, however this paper will focus exclusively on the quantitative component. This focus enables a rigorous evaluation of the intervention’s efficacy through objective, reproducible metrics essential for informing clinical decision-making and policy development in a high-stakes healthcare context. Intervention: Over the 90-day intervention, five additional allied health outpatient visits of approximately 45-minutes each, were conducted as a group consultation with all members of the supportive care multidisciplinary team, in addition to standard care. The supportive care multidisciplinary team comprised a nurse, social worker and dietitian from the existing hepatology team. Importantly, all clinicians came together with intervention participants in the same physical or virtual space during supportive care consultations. Within 48 hours prior to each of these appointments, participants completed surveys which captured areas of need or concern including symptom burden, quality of life, nutrition, and functional ability, carer burden and support needs. The outcomes of these surveys were discussion points (i.e. content) during the appointments. Participants attended visits at baseline, week 4, week 8 and week 12. Carers attended three visits: with the person they care for at baseline and week 12, and individually at week 6. Session attendance checklists were maintained to monitor adherence. Palliative care support from a consultant, advanced trainee or nurse practitioner, and input from an Aboriginal health worker or liaison officer were sought as appropriate. Consultations were delivered in-person or virtually, depending on participant needs. Standard care for control and intervention participants was the same, conducted in multidisciplinary outpatient clinic settings. Frequency of outpatient appointments at both sites was determined according to individual patient need with appointments on average occurring every 6 months. At Site 1, a fifteen-minute standard care outpatient appointment was held with either a Gastroenterologist (n=1), Hepatologist (n=1), Gastroenterology registrar (n=1), or Hepatology Nurse Practitioner (n=1) as the primary clinician. The primary clinician was allocated by the outpatient nurse coordinator on the day of the appointment, taking into consideration the patient's history, previous clinical consultations, and clinician availability. After review with the primary clinician, the patient had access to a dietitian (n=1) and social worker (n=1). Appointments with these clinicians were either planned or directed by the primary clinician on the day of the appointment, pending patient need. At Site 2, participants attended the outpatient appointment with a General Physician with gastroenterology training (n=2) as the primary clinician. The primary clinician was allocated by the outpatient nurse coordinator on the day of the appointment with consideration of patient history, previous clinical consultations, and clinician availability. After review with the primary clinician, the patient had access to a dietitian (n=1) and a clinical nurse consultant (CNC) (n=1). Appointments with these clinicians were either planned or directed by the primary clinician on the day of the appointment, pending patient need. Data Collection and Clinical Triggers for Intervention: Participant-reported measures were completed on a handheld electronic device within 48 hours prior to each supportive care consultation. Pre-determined clinical triggers for intervention were established prior to trial commencement in consultation with local clinical experts and were embedded in the REDCap database. These clinical triggers for intervention highlighted any participant-reported symptom or concern that elicited moderate or higher levels of distress or discomfort and prompted action from specific clinical roles within the supportive care multidisciplinary team. On completion of participant-reported measures, the REDCap database generated an automated summary report of measure outcomes, which was available to the clinical team in real time. The summary report and any voiced concerns of participants guided the content of each supportive care consultation. This aimed to facilitate participant-driven and timely symptom management, psychosocial care, or medical nutrition therapy, and reduce clinical inertia. A patient- or carer-initiated telephone support line facilitated ‘just-in-time’ access to the hepatology nurse or allied health co-ordinator, allowing interventions to be triggered between scheduled appointments as required.