Lean Assessment Process Methodology for Evaluating the Clinical Need and Assessing Technology Acceptance in the Context of Adopting a New Digital Therapeutic for Depression in Routine Clinical Practice in the NHS in England

OBJECTIVES: To explore the unmet clinical need, stakeholders’ perspective, perceived usefulness and barriers to adoption of a novel digital therapeutic (DTx) for depression in the depression pathway in the NHS in England using Lean Assessment Process (LAP) Methodology as an early Health Technology Assessment.

METHODS: The Lean Assessment Process (LAP) methodology is a structured process that provides input to healthcare innovators from stakeholders across the care pathway and involves experts in human factors, health economics and market access working closely with innovators to engage with key stakeholders in the care pathway. Using LAP methodology, a feasibility study was conducted by Health Innovation Oxford to understand the clinical need and barriers to adoption of a Dtx based on a novel cognitive emotional training as a treatment for depression. Semi-structured interviews were conducted using a combination of qualitative and quantitative questions. Twenty end-users working in the treatment and management decisions within the depression care pathway were interviewed across 12 NHS trusts and their insights were analyzed thematically to assess their perceived usefulness and acceptance of the new DTx in the depression care pathway.

RESULTS: The LAP study showed that stakeholders believed that there was a clinical need for a new DTX based on a novel cognitive emotional training in the current depression pathway, particularly to support people with depression whose needs are not met by the treatment modalities currently available. The study identified the care settings where the new Dtx would be best placed and highlighted the key elements to consider. Users’ preferences and potential barriers to adoption were also brought to light.

CONCLUSIONS: Using LAP, the value proposition of the novel DTX was assessed and key elements to consider were identified. Based on the results of this study, a pilot study is currently taking place, and will inform the future economic evaluation and adoption strategies.