Title: Individualised assessment and management for brain injury app: widening access to resources for recovery (I am brain aware)
Funder: Department of Health and Social Care

Abstract: Background: In the UK >1 million people attend emergency departments (ED) annually with traumatic brain injury (TBI), of which the majority (>85%) are classified as mild. More than 30% of patients discharged directly home may experience significant sequelae, commonly known as post-concussion symptoms (PCS), which may last months to years after injury. There is little evidence to guide early management, and it is difficult to predict who would benefit from early interventions, in both clinical care and trials. The large numbers of patients prohibit unselected follow-up leading to a large unmet need for patients with persisting symptoms. Aim: My overall plan is to develop a deeper understanding of the nature and extent of the consequences of mTBI through an initial qualitative approach complemented by a systematic scientific review and thereby provide the basis for an empirically-guided, app-based support and intervention programme called PCS-AWARE. Methods: Work package (WP) 1: In-depth semi-structured interviews of patients, carers and other stakeholders will be performed to understand the key problems experienced after mTBI and important outcomes. WP2: A scoping review will be performed to map the current evidence base for the management of PCS. A co-design approach will be used with patients and other stakeholders to develop an evidence-based suite of information (PCS-AWARE) to facilitate self-management. WP3: Results from WP1 and a systematic review will identify key outcome domains. This will be used to formulate a Delphi questionnaire. A consensus meeting will be held to decide the standard core and patient reported outcomes creating a core outcome set, which includes patient perspectives, to use in this project and for broader use in future mTBI studies. WP4: Development of the 'I am brain aware' app which will be informed by the outputs of WP2 and WP3. Workshops, 'Think-aloud' interviews and prototype usability testing will occur to design it iteratively with patients and other stakeholders. A validation study for use of outcome measures in an app context will be performed. WP5: Feasibility study recruiting 200 patients (to ensure an adequate number of patients with PCS are recruited) from four representative EDs to assess uncertainties in recruitment, retention, and usability of the app. Approaches to facilitate selection of patients at high risk of PCS enabling future trials enrichment will be explored. Impact: If criteria are met this project will lead to a Medical Device Regulatory Trial. It will also provide important knowledge about mTBI sequelae, current evidence for management and a core outcome set which will facilitate a standard approach to studies. The app developed will provide support to patients and families, and facilitate communication with healthcare providers. It will also form the basis of other future mTBI studies including understanding the trajectory of mTBI, facilitate trial enrichment and enable efficient follow-up. My fellowship proposal will also equip me with a skill set to more fully engage patients in research, develop increased skills in qualitative research, enhance the delivery and implementation of future trials, and support my future leadership role in targeting interventions to improve patient outcomes.

Lay abstract: Background: In the UK >1 million people attend emergency departments (ED) annually with a traumatic brain injury (TBI), of which the majority (80 to 90%) are classified as mild. 'Mild' TBI should not be underestimated; more than 30% of patients discharged with this diagnosis experience significant, life-changing problems that can last months to years. These include severe fatigue, poor memory, headaches, and mental health issues (including anxiety, depression, and post-traumatic stress) often termed post-concussion symptoms (PCS). Currently the majority of patients are sent home with advice and no planned follow-up. There is an expectation that patients with persisting problems will seek help themselves. However, the nature of mild TBI (mTBI) makes this difficult, and often patients are lost to the care they need. This is an unmet healthcare need affecting millions of individuals worldwide each year. This fellowship addresses this critical issue: how can we identify and effectively reach patients who need treatment early? Overall research question: Can current best evidence and stakeholder involvement be used to develop an app capable of assisting patients to self-manage PCS, identify patients who would benefit from more formal follow-up and treatment, and create a platform for future clinical studies to improve patient outcomes? Plan: In the initial phase I will interview patients and other stakeholders to better understand their perspective on problems experienced after mTBI and which outcomes are essential to measure. In conjunction with patients and other stakeholders I will develop an evidence guided, app-based support and intervention programme called PCS-AWARE, to help patients self-manage PCS. mTBI studies are often difficult to compare due to different combinations of outcome measures collected, and these may not collect the information most important to patients. I will review the evidence for outcomes, gain stakeholder views including patients via a Delphi Study (a type of survey), and hold a consensus meeting to develop a Core Outcome Set (COS) for use in this and future studies.An app, 'I am brain aware' will be co-designed with patients and other stakeholders using the results of the above. The main purposes are: 1. To improve patient management after mTBI by providing information to support self-management of PCS, enable ongoing symptoms and problems to be recorded and monitored over time and aid communication with health care providers about ongoing problems. 2. To facilitate future research to understand mTBI by enabling patient recovery trajectories to be recorded in higher detail than previously possible allowing new insights and support collection of long-term outcome data without the need for in-person assessment. A feasibility study will be performed to assess the usability and acceptability of the app, and understand uncertainties in recruitment and retention, to inform the design of a future clinical trial. It will also test ways to improve selection of patients for future early intervention trials by identifying patients at higher risk of PCS, which will reduce the number of patients needed to participate. This project will develop the first management option available for use patients after mTBI that could potentially be delivered efficiently and cost-effectively at scale. If found effective at improving patient outcomes in a future definitive trial it could have a significant impact on reducing the longer-term problems experienced by this often-forgotten patient group. Public & patient involvement: The proposal has been co-designed with PPI members to address key concerns expressed by patients and carers i.e. the current lack of routine follow-up, and long-term symptom management. PPI will continue throughout the project including a specific PPI group and representatives on the study steering committee. Patient perspectives will be integrated in all aspects of design, implementation and results including dissemination.

Research activity codes: 2.5 RESEARCH DESIGN AND METHODOLOGIES (AETIOLOGY);7.3 MANAGEMENT AND DECISION MAKING
Health categories: NEUROLOGICAL;MENTAL HEALTH