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P1 Preventing Medication Harm

The study will follow the MRC framework for developing and evaluating complex interventions, ensuring a robust, iterative, and co-designed approach to identifying, evaluating, and implementing patient-facing technologies (PFTs) for medication review (MR) preparation and prescribing optimisation in people with multiple long-term conditions (MLTCs) and polypharmacy. Our methodology integrates scoping, rapid evaluation, feasibility testing, and stakeholder engagement to assess the acceptability and impact of PFTs within clinical practice.

1. Scoping Workshops

Objective: To engage with patients, carers and healthcare professionals to explore perceptions, usability, and barriers to adoption of PFTs that may support MR.

Methodology:

  • Participant recruitment: Individuals aged 18+ with mental and physical MLTCs and prescribed more than 5 regular medications, recruited via clinical networks, patient advocacy groups, and community organisations.

  • Workshop structure:

    • Workshop 1: Focus groups with patients and carers to explore experiences with medications, challenges in MR, and potential benefits of PFTs.
    • Workshop 2: Professionals and system-level stakeholders to identify priorities for MR optimisation and assess technological readiness.
    • Workshop 3: Joint co-design session to map patient priorities and technological opportunities.

  • Data collection: Audio-recorded discussions, thematic analysis of transcripts using NVivo.

  • Output: A prioritised list of medication-related concerns and requirements that PFTs should address.

2. Rapid Evidence Synthesis

Objective: To map existing PFTs and their applications in MR preparation and actioning, assessing adaptability and scalability.

Methodology: * Umbrella review: Systematic search of databases (MEDLINE, EMBASE, CINAHL, Cochrane, IEEE Xplore) for reviews on PFTs supporting medication optimisation. * Systematic review of primary studies: Where evidence gaps exist, targeted searches for empirical studies evaluating patient-facing MR technologies. * Inclusion criteria: * Population: Adults with co-existing mental and physical health conditions * Intervention: Digital technologies designed to aid medication self-management, MR preparation and prescription optimisation from both clinician and patient perspective * Outcomes: Patient engagement, usability, effectiveness in medication concordance and optimisation.

  • Data extraction & synthesis:

    • Standardised data extraction form capturing study design, PFT functionality, reported effectiveness, and implementation barriers.
    • Visual mapping of evidence to illustrate PFT scalability, adaptability, and gaps in knowledge.

  • Stakeholder ranking: PPIE members and clinical experts will rate and rank PFTs based on feasibility and potential impact.

3. Feasibility Study

Objective: To test the acceptability and implementation potential of selected PFTs in real-world settings.

Study Design: Prospective observational feasibility study using a mixed-methods approach. Methodology: * Participant recruitment: * Adults aged 18+ with mental and physical MLTCs, prescribed ≥5 medications. * 10 participants per group for short-term feasibility testing (2-4 weeks). * 20 participants per group in extended feasibility trials (6-12 weeks).

  • Intervention: Patient-prioritised PFTs, including:

    • Wearables (e.g., BP, pulse, oxygen saturation, ECG monitoring including QTc interval).
    • Ambient sensors (e.g., sleep, fall risk monitoring).
    • Conversational AI (e.g., symptom tracking, medication experience reporting).

  • Comparator: Standard care.

  • Outcome measures:
    • Primary: Acceptability, usability, equitable uptake, engagement levels.
    • Secondary: Accuracy of data collected, impact on MR preparation and actioning.
    • Process evaluation: Semi-structured interviews with participants and healthcare professionals to explore experiences, barriers, and facilitators.

  • Analysis:

    • Quantitative: Descriptive statistics (engagement metrics, concordance rates), comparative analysis where appropriate.
    • Qualitative: Thematic analysis of participant interviews, triangulated with usage data.

  • Iterative testing:

    • Cyclical refinement of PFT-assisted MR preparation tools based on user feedback.
    • Technologies demonstrating high acceptability and engagement will progress to larger-scale feasibility testing.