A ZERO2 Sub-Project: Implementation Study of a Paediatric Oncology Medicines Database (ProCure) to Improve Access to Targeted Therapies

Arm 1: ProCure and Implementation Support Package Brief Name: ProCure digital health intervention plus Implementation Support Package Physical or informational materials that will be used in the intervention: Participants in this arm receive access to ProCure, a clinician-facing paediatric oncology medicines database designed to streamline access to off-label targeted therapies, particularly through compassionate access pathways. Eligible clinicians include ZERO-affiliated paediatric oncologists and oncology pharmacists. Participants can use the ProCure search bar by typing in a therapy name, drug class, molecular target or any other key word to find a therapy of interest. Clicking on a therapy profile displayed on the search results page will provide the participant with therapy profile information, examples of previous successful access, information on application and access pathways, and integrated tools that allow clinicians to contact and share access information with the Drug Access Navigator (DAN). This information supports participants with the preparation and submission of drug access applications and informs their decision-making regarding therapy access. The DAN is a ZERO-affiliated senior oncology pharmacist who supports paediatric oncology professionals in navigating medicines access recommended through the ZERO2 study. Adherence to ProCure will be monitored using routine web analytics, including logins, pages viewed (e.g., therapy profiles), and records of application submissions. Additionally, self-reported data will be collected on participants' use of ProCure via surveys and semi-structured interviews. In addition to accessing ProCure, participants receive an Implementation Support Package (ISP). The ISP is the implementation strategy, consisting of different components, to support the use of ProCure. The ISP was developed using ProCure beta-testing findings (conducted prior to this trial in the ALIGN study; Sydney Children's Hospitals Network HREC Reference: 2021/ETH00583) and will be finalised through a focus group with paediatric oncology professionals during this trial to support uptake of ProCure into routine clinical workflows. The finalised ISP may include components such as educational resources (e.g., ProCure tutorial video, ProCure instruction manual), or 'ProCure champion' activities (e.g., ZERO-affiliated clinicians who receive online group training on using ProCure, or monthly ProCure touchpoints to discuss drug access processes with the DAN and other ProCure champions). Adherence to these components may be monitored through routine indicators such as attendance at training or touchpoint sessions, or receipt of ISP materials (e.g., via email). The specific monitoring strategies will be finalised as part of this trial following the focus group and ISP finalisation. Procedures, activities, and/or processes used: Participants register for ProCure after completing a baseline survey administered as part of this trial. Clinicians then use ProCure as needed when considering, preparing, and submitting applications for off-label targeted therapies recommended through the ZERO Molecular Tumour Board (MTB). Participants complete follow-up surveys at 6 and 12 months and participate in online semi-structured interviews at 6 months to support evaluation of ProCure and the ISP. The ISP is delivered by the implementation research team via online, remote methods, either individually or in groups (as appropriate following finalisation of the ISP). A focus group will be conducted online to finalise the ISP. Ten participants (a mix of paediatric oncologists and oncology pharmacists) will be recruited for one focus group to provide input on the components of the ISP, adhering to a semi-structured focus group schedule. The focus group schedule asks participants to provide structured feedback on each ISP component, including the component's anticipated usefulness and practicality. The focus group will be conducted by an implementation scientist on the research team. Participants will be selected on a first-come basis following recruitment, however re-selection may be undertaken to ensure representation from different regions of Australia. Ongoing support for drug access processes, including monitoring of ProCure activity and provision of application support, is provided by the DAN. All interactions with ProCure occur online, although paediatric oncology professionals may discuss its use within multidisciplinary settings such as ZERO MTBs or with the DAN. Who will deliver the intervention: The ISP will be delivered by the implementation research team. The DAN provides ongoing support for drug access processes and application review. The study team will administer the REDCap surveys via email and an implementation scientist from the research team will conduct the semi-structured interviews. Mode of delivery: ProCure is delivered digitally through a secure website accessed via computer or mobile device. The ISP is delivered remotely through online meetings, digital resources, and email communication. Number of times the intervention will be delivered and over what period of time: Participants have continuous access to ProCure for the full 12-month trial period. Engagement with ProCure is self-directed and based on clinical need. The ISP is provided at trial commencement to Arm 1 or on an as needed basis as decided upon at the focus group. Follow-up surveys occur at 6 and 12 months, and a semi-structured interview occurs at 6 months. Location where the intervention occurs: The intervention is implemented within routine paediatric oncology clinical environments across Australia and delivered entirely online. Participant assignment to Trial Arm A (ProCure + ISP) and Arm B (ProCure only) will be randomised upon completion of the pre-trial focus groups and prior to ProCure delivery to ZERO-affiliated paediatric oncology professionals.