EMERGE: An Ehealth Model of Care for Paediatric Patients and Families at the End-of-Treatment for Acute Lymphoblastic Leukaemia

This study will utilise a pragmatic hybrid, non-randomised controlled trial design to evaluate the implementation of a telehealth care program, facilitated by a nurse practitioner (NP) and psycho-social clinician (PSC). An extensive consumer engagement and healthcare service consultation process has been undertaken to inform the development of the program and informational resources to optimise implementation of the program beyond the study period as a clinical standard of care. The program will support young survivors of childhood acute lymphoblastic leukaemia (ALL) and their families through the early survivorship period and into long-term survivorship programs that provide transition to adult services. There are 2 participant groups in this trial: a. Intervention participants: Patients and their primary caregiver(s) b. Stakeholder representatives: Health-care professionals involved in the primary care of these patients Intervention participants will be patients aged between 2-18 years, and their primary caregiver(s), who are nearing the end of treatment for paediatric ALL at one of the Children's Cancer Centres at the Royal Children's Hospital (RCH) or Monash Children's Hospital (MCH) in Victoria, Australia. To ensure inclusivity, in this trial ALL will be taken to include patients with Lymphoblastic Lymphoma (LLy) who present with similar disease features and undergo identical treatment protocols to ALL patients. Given the high similarities shared by these disease entities, and for ease of reference, we will refer to all patients as having ALL in this protocol. The Emerge model specifically addresses several areas of need, and incorporates the recommendations of the paediatric oncology psychosocial standards developed in 2015 [1] by including four main components: 1. Screening: The Emerge clinicians will establish a risk profile for each patient/family at the end of active treatment. This will be based on an assessment of psychosocial risk, child/adolescent and parent factors and family adjustment/quality of life using validated questionnaires from multiple informants. Screening measures will be administered at baseline (pre-intervention) to inform the first telehealth session, and repeated pre-telehealth session 2 to inform the second consultation. These screening measures form the basis of the eHealth consultation but are not part of the evaluated outcomes for the study. The primary caregiver for the patient will be asked to fill in the screening measures for each timepoint. 2. Psychoeducation/Resource Provision: Psychoeducation and counselling will be provided directly by the Emerge nurse practitioner/clinical nurse consultant and psychosocial clinician during the scheduled telehealth session. An interdisciplinary survivorship care plan (SCP), treatment summary and tailored information will be provided to families based upon identified areas of need/risk. Referrals will be logged on the Emerge database and suitable local providers (e.g., general practitioner (GP), community psychologist, education services etc.) identified for the family. When appropriate, interventions/goals will be set to guide their engagement in a program. 3. Monitoring and Review: Follow-up surveys, goal/intervention adherence and health service utilisation will be monitored, with the Emerge clinicians reviewing this data on a routine basis in the 2 weeks prior to the telehealth consultations to determine risk level, referral needs and updated recommendations. Follow-up care will then be provided by the clinicians as required via telehealth appointments, face-to-face consultations, or communication with other healthcare providers in the 2-4 weeks post consultation (however this may vary depending on need and service requirements). 4. Specialist Intervention: For patients and families with significant risk factors (e.g. Targeted – moderate risk, and Clinical – high risk), referrals will be actioned to hospital or community-based specialists (e.g., clinical psychology, neuropsychology, occupational therapy, education liaison, medical oncologist etc.). The telehealth platform will allow for group consultations to be organised to assist with specialist support from the tertiary care team. For example, a joint consultation between the family, clinicians, and local GP may form an additional review session to provide an opportunity for clinicians to consult on care requirements, and key recommendations. Telehealth sessions will occur approximately 3-4 months apart for families in all risk categories (i.e., minimum 2 consultations per year at 3-months (Telehealth session 1) and 6-8 months (Telehealth session 2) following completion of treatment) and will be scaled up if required for those in the Targeted or Clinical groups. Each session will be approximately 1 hour in length. Patients/families will also be able to escalate their concerns to activate an additional telehealth or face-to-face session with their Emerge clinicians or specialist medical consultants (maximum of 4 sessions available over a 12-month period). The overall duration of the intervention for a participant will be 12-months post telehealth consultation 1. Clinicians will log the outcome of each telehealth session including: participants involved, length of session, topics discussed, use of screening tools, hours required in preparation and following the consultation, referrals made, follow-up required and actioned interventions. Several implementation outcomes will be collected pre-intervention, post telehealth session 1, post telehealth session 2 and at 12-months post-treatment completion for intervention participants including acceptability, satisfaction and service usage. In addition, stakeholder participants will complete questionnaires evaluating the acceptability, feasibility and appropriateness of the intervention at the commencement of the trial at their site and following 12-months of the intervention being open at their cancer centre. Participants may also attend an optional semi-structured qualitative interview 1-2 months post their second telehealth consultation to discuss the barriers and facilitators to implementation of the Emerge program and address the longer-term health care implications for program sustainability. This will be offered to a subset of participants who will be selected via alternating enrolments (every 3rd participant). Stakeholders will also be interviewed to discuss their experience of the Emerge program following the trial being open for 12 months at their site. [1] Wiener, L., et al., Standards for the Psychosocial Care of Children With Cancer and Their Families: An Introduction to the Special Issue. Pediatr Blood Cancer, 2015. 62 Suppl 5(Suppl 5): p. S419-24.