None listed
Conditions
Brief summary
Three-quarters of mental illnesses emerge before age 25 (Kessler et al. 2005), with suicide being the leading cause of death in Australians aged 15-24 (AIHW, 2020). General PRactitioners (GPs) play a critical role in reducing mental illness in this population because they are the most common health service used by Australian adolescents (ABS 2019d), and the primary pathway via which adolescents seek mental health care (Lawrence et al. 2015). However, although youth report a desire to be asked about their mental health (Turner et al. 2017), approximately half of all mental health problems in youth are not recognised by the GP (Haller et al. 2009; Hickie et al. 2007). New methods are urgently needed to help GPs better assist young people. Responding to the Australian Government’s call for the adoption of stepped-care models for primary mental health care, the Black Dog Institute developed a digital mental health screening and treatment-recommendation tool for GP practices. This tool, known as ‘StepCare’ (Proudfoot et al., 2019), has been rolled out to >100 GP practices across Australia, with more than 5,000 adults screened. More than 1,400 cases of anxiety and depression have been detected, 1 in 4 of whom were individuals who were previously undetected/untreated (Whitton et al., under review). The growing reputation StepCare, combined with increasing concerns over youth mental health, has prompted expressions of interest for a youth-focused service. In response, ‘Youth StepCare’ was developed, and a pilot trial was conducted in 2 general practices (Parker et al., 2020). Results showed that Youth StepCare was acceptable and feasible, and that 22% of cases of depression/anxiety identified were not receiving treatment. However several implementation barriers were identified. This study aims to conduct a larger-scale evaluation of Youth StepCare, incorporating modifications based on learnings from the pilot study and the adult StepCare service, and as well as a head-to-head comparison of two implementation models. This study is important because it constitutes a critical evaluation of a tool that may increase identification of mental health conditions in youth, thereby facilitating greater access to mental health services for this vulnerable population.
Interventions
Two interventions are being evaluated in this study: 1) A digital mental health screening and treatment-recommendation tool for adolescent patients attending general practice (‘Youth StepCare’) 2) An interactive, online implementation toolkit (‘ItFits Toolkit’) informed by Normative Process Theory, designed to facilitate integration of digital mental health tools into primary mental health care. DIGITAL MENTAL HEALTH SCREENING TOOL: YOUTH STEPCARE Developed by the Black Dog Institute, Youth StepCare is a digital mental health screening, treatment-recommendation, and symptom monitoring tool that aims to (a) improve the early detection and management of common mental health conditions in young patients (aged 15-17) attending general practices, and (b) facilitate greater uptake of digital mental health interventions in primary mental health care. Youth StepCare screens youth patients for depression and anxiety in the practice waiting area, and then provides general practitioners (GPs) with treatment recommendations based on the principles of stepped-care, with digital mental health interventions integrated into the treatment recommendations. The Youth StepCare tool is used as follows: 1. Registration and screening. Upon arrival to a participating general practice, youth patients aged 15-17 will be provided with a study information sheet and QR code by practice staff. The patient will be invited to sit in the waiting room and read information sheet. If the patient wishes to participate, they will then scan the QR code with their personal mobile device, which will direct them to the Youth StepCare landing page. Here, they will choose their GP from a drop-down box and confirm their age. They will subsequently demonstrate their capacity to provide informed consent (using the Gillick Competency Assessment), provide consent to participate in the trial, and will then register using a valid email address. Patients can also register a mobile phone number and indicate which mode of communication they prefer (email or SMS). These details will be used to send symptomatic patients mental health screening measures fortnightly. Participants will register their name and gender and then be asked two questions to determine whether they are attending their appointment for mental health reasons, or whether they have previously seen a doctor for mental health reasons. Next, they will be asked to answer questions about their mental health, including symptoms of anxiety, depression, and suicidal thinking. These are measured using validated psychometric questionnaires including the seven-item Generalised Anxiety Disorder Scale (GAD-7) and the nine-item Patient Health Questionnaire for depression (PHQ-9). Patients will receive immediate brief feedback on their screen before discussing their mental wellbeing further during their doctor’s appointment. 2. Treatment recommendation. Once a patient has completed their screening survey, a treatment recommendation report is generated and transmitted to the GP’s medical inbox. This treatment recommendation report first determines the patient’s overall symptom severity (nil/minimal, mild, moderate, severe) and then provides treatment recommendations that are matched to the patient’s symptom severity. Symptom severity is determined using empirically-defined cut-offs on the PHQ-9 and GAD-7, with the highest scoring scale determining the severity level: • Nil/minimal: PHQ-9 AND GAD-7 score 0-4 • Mild: PHQ-9 score 5-9 OR GAD-7 score 5-9 • Moderate: PHQ-9 score 10-19 OR GAD-7 score 10-14 • Severe: PHQ-9 score 20-27 OR GAD-7 score 15-21 The treatments recommended for each severity level are as follows: • Nil/minimal: No treatment • Mild: digital mental health intervention (Smooth Sailing program) • Moderate: digital mental health intervention (Smooth Sailing) AND referral to a Psychologist or local CAMHS team for psychological therapy. If psychological therapy not wanted or inappropriate, consider referral to a Child and Adolescent Psychiatrist for pharmacological treatment. • Severe: digital mental health intervention (Smooth Sailing) AND referral to a Psychologist or local CAMHS team for psychological therapy AND referral to a Child and Adolescent Psychiatrist for pharmacological treatment. Smooth sailing is a self-guided web-based psychoeducation program designed to help adolescents manage depression and anxiety. It provides adolescents with information about mental health, help-seeking, and where appropriate, self-directed online Cognitive Behavioural Therapy (CBT). It consists of six modules: mental health literacy; anxiety; depression; help-seeking for oneself; help-seeking for a friend; self-guided CBT. Smooth Sailing is integrated into Youth StepCare allowing GPs to recommend the program with a simple click. 3. GP Consultation and treatment plan. During the consultation, GPs are advised to discuss the mental health screening results with their patient and determine an appropriate treatment plan. GPs are asked to record the treatment plan provided to patients via a link accessed in the report. 4. Symptom monitoring. Patients who report mild, moderate, or severe mental health symptoms at the time of screening will be monitored every two weeks for 12-weeks to track symptom improvement. During fortnightly monitoring, patients will be sent a link via email or SMS to complete the anxiety and depression screening measures (GAD-7 and PHQ-9 [minus item 9, which asks about suicidality]) and to note what mental health treatment they had received in the past 2 weeks. In addition, GPs will receive a notification to their medical inbox if their patient: • shows a change in symptom severity (deterioration or improvement) between fortnightly assessments, • remains in the mild symptom range for four weeks • remains in the moderate symptom range for four weeks, • remains in the severe symptom range for four weeks, • or does not complete their fortnightly assessments. IMPLEMENTATION MODEL: ‘ITFITS TOOLKIT’ The ItFits Toolkit is a web-based Implementation tool that supports Implementers in developing, applying, and monitoring tailored Implementation strategies to integrate and embed iCBT services into routine mental health care. The ItFits Toolkit draws on research based around Normative Process Theory and the broader field of Implementation science. The ItFits Toolkit takes users through a series of up to four interactive online modules. For this trial, implementation will focus on the first three of these modules, which focus on: • Module 1: Setting implementation goals and identifying implementation barriers • Module 2: Identifying strategies to overcome implementation barriers • Module 3: Create a plan for carrying out these strategies Implementation via the ItFits Toolkit will involve an Implementation Lead, who is responsible for leading the implementation of Youth StepCare within the practices using the techniques outlined in the ItFits Toolkit. In addition, the Implementation Lead will be supported by a Core Team of four implementation and mental health experts based at the Black Dog Institute, who assist the Implementation Lead in identifying implementation barriers and generating solutions. Within each module, the ItFits Toolkit provides a systematically guided but flexible step-by-step process for the Implementation Lead to follow. For each module, the Implementation Lead and Core Team, works through three steps: (1) devise an initial plan, (2) have the plan reviewed by relevant stakeholders (GPs and practice staff) and then discuss with them their needs and priorities, and (3) finalise the plan based on the feedback from stakeholders. An important element of the ItFits Toolkit is engagement and consultation between the implementation team and stakeholders to ensure the best outcome. Both groups receive the Youth StepCare intervention. In one of the groups, implementation of Youth StepCare will occur via an implementation-as-usual approach. In the other group, implementation of Youth StepCare will occur via a process informed by the ItFits toolkit. The ItFits toolkit is used by the Implementation Lead only and not the practice staff, GPs or patients. The Implementation Lead will begin using the ItFits toolkit to inform their implementation of Youth StepCare. Accordingly, use of the ItFits toolkit and implementation of the Youth StepCare screening tool will occur in parallel. Implementation Leads will use the ItFits toolkit to inform their implementation for the entire duration of the trial. Accordingly, practices in the enhanced implementation arm will be exposed to implementation principles derived from the ItFits toolkit for the full 6 months that they have access to Youth StepCare. Three modules from the ItFits toolkit will be used by the Implementation Lead in the Enhanced Intervention arm to inform their approach to Youth StepCare implementation. They will use principles from ItFits toolkit Module 1 during their first training session with a practice, and after 2-3 months of using Youth StepCare, will conduct a second visit to the practice to apply principles from ItFits toolkits Modules 2 and 3. It is anticipated that each visit to the practice will take 1-2 hours. Adherence to the ItFits toolkit by the Implementation Lead will be monitored via recorded meetings between the Implementation Lead and Core Team. Independent raters will view the recordings to determine whether ItFits module content was or was not discussed, and whether discussion of module content proceeded in the manner described in the ItFits toolkit.
Sponsors
Study design
Eligibility
Inclusion criteria
General Practitioner eligibility criteria • Identified as treating young people in-person on a weekly basis, for any health condition; • Are using Best Practice or Medical Director Software; • Have WIFI available in the practice; • Have an overall internet speed of at least 10mbps; • Have HealthLink or MedicalObjects secure messaging service installed or willingness to have it installed; • Have the willingness to provide feedback on what type of care they recommend to youth patients with mental health problems. Practice Staff eligibility criteria: Practice staff (i.e. reception staff, practice nurses, practice managers) that have provided their consent will be invited to participate in the study. Adolescent Patient eligibility criteria: Young people presenting for an appointment to a participating GP at a participating practice will be invited to participate in the study if they are: • Aged 15 to 17; • Able to provide informed consent • Ability to understand English (read and spoken); • Have a valid email address and access to a mobile device
Exclusion criteria
General Practices: • General Practices currently using the adult StepCare digital screening service will be excluded. Adolescent Patients: • Previously screened within the past 6 months. • A GP determines a patient is not well enough to participate (e.g., vomiting, weak, cognitively impaired)