The ADAPT Program to support the management of anxiety and depression in adult cancer patients: a cluster randomised trial to evaluate different implementation strategies.

A cluster randomised trial will be used to compare different implementation strategies to embed the 'Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients'* into routine care. Twelve cancer services in New South Wales will be recruited into this study. Six (Arm 1) will be randomised to receive one set of implementation strategies to support adherence to the Clinical Pathway into routine care and six (Arm 2) will be randomised to receive a differing set of implementation strategies to support adherence to the Clinical Pathway into routine care. The implementation strategies are targeted at cancer services and cancer service staff. Randomisation is at the cancer service level only, stratified by large versus small cancer services. *Clinical Pathway for the Screening, Assessment and Management of Anxiety and Depression in Adult Cancer Patients: Australian Guidelines. Butow, P. et al. Psycho-Oncology, 24 (9) pp 987 – 1001. The interventions for each study arm include: 1. The ADAPT Portal - an online, integrated management system that allows cancer service staff to operationalise the Clinical Pathway and has the following essential features and functions: i. Patient Registration, Management and Referral Cancer service patient details are entered into the Portal by cancer service staff. The Portal generates a screening date for each patient and alerts staff when patients are due to screen. The Portal generates a screening alert for patients every 3-months, and also at key points in their treatment. If a patient screens with high levels of depression and/or anxiety, the Portal alerts staff that the patient requires triage. After triage, the Portal alerts clinical staff as to the relevant step of the Clinical Pathway for each individual patient, and the appropriate referrals and support to offer. The Portal provides standardised templates for referral and feedback to/from mental health services when required. ii. Patient screening and education materials When cancer service staff register a patient's details in the Portal, the system generates a log-in for the patient. Patients may then log-in to their own individual pages within the Portal where they are systematically prompted to complete validated screening and assessment questionnaires online. Using their log-in, patients may also access patient information that explains the importance of screening for anxiety and depression, and the process involved for patients in the use of the Clinical Pathway. These patient information materials will also link to existing patient/caregiver resources about cancer-related anxiety and depression. iii. iCanADAPT Online therapy treatment programs Two programs delivering online psychological therapy have been developed by the ADAPT Program for patients with early stage or advanced stage cancer identified as having symptoms of anxiety and/ or depression. The therapy includes behavioural activation, cognitive restructuring and problem solving, attentional training and mindfulness strategies, completed in 6-8 sessions over 10-12 weeks. These online courses are available in the ADAPT Portal for patient self-referral or clinician referral. Patients who access these courses will be monitored by a clinical psychologist. iv. ADAPT Online Health Professional Education Modules Online education modules have been developed using evidence-based learning principles and spaced education to promote interactive learning. This education targets screening, assessing severity, making a referral - particularly when patients are reluctant - and empathic communication. Staff will be prompted to undertake annual refreshers by the portal. Modules will be available on eviQ, the most widely used Oncology education site in Australia, with links in the ADAPT Portal All sites will receive full access to the ADAPT Portal and training to use the Portal resources and systems. The study arms will differ as to the extent to which they receive the following implementation strategies (interventions): 2. Academic Detailing and Support: Initial staff training and support about the Clinical Pathway and use of the ADAPT Portal. Tailoring of the ADAPT Portal set up to fit individual service requirements, service and staff profile. 3. Awareness Campaigns: Roadshow and poster campaigns to inform cancer service staff about the Clinical Pathway and the Portal. 4. Champions: ADAPT program staff will work with sites to identify and support local Clinical Pathway and Portal Champions. 5. Education: Staff will be trained to use the Portal, in face-to-face training and also by engaging with User Guides and by seeking the support of the Local Champion. 6. Reporting: Reports will be provided to site Leads and Champions regarding use of the Portal and the Clinical Pathway issues and concerns. DELIVERY All interventions and available ongoing support throughout the study duration will be delivered by experienced health service research professionals, with train the trainer approaches for some aspects during a two-month site engagement and preparation period prior to services initiating implementation of the Clincial Pathway over a 12-month period. ADHERENCE MEASURES The primary endpoint of this study is adherence to the Clinical Pathway. This outcome will be measured using a study-developed measure, capturing information about screening, information provision, emotional support, triage, referral, uptake and progress review, as specified in the Clinical Pathway. Adherence will be calculated as a percentage of patients at each site whose care is considered adherent to the Clinical Pathway. This is based on individual calculations for each patient of a continuous score of 0-100 of appropriate critical components of the Clinical Pathway provided over the 12-month study period, transformed into a binary score of adherent or not adherent. This data will be obtained from patient records (with patient consent).