Nurse-led Medicines' Monitoring in Care Homes: a Process Evaluation
Condition: Dementia
MeSH terms: Dementia
Study type: Observational

Summary: 
      Lay Summary:

      The investigators have shown in randomised controlled trials and observation studies that
      structured nurse-led medicines' monitoring using the WWADR Profile benefits patients, for
      example, by reducing pain and sedation and identifying high risk cardiovascular conditions.
      The investigators now aim to understand what is needed to sustain implementation of the WWADR
      Profile in routine practice and explore future directions.

      The participants of the investigators previous research, 5 newly recruited care homes, and
      stakeholders - care home managers, carers, healthcare professionals, and service users - will
      be asked to contribute interviews, observations and reflective diaries/ accounts. The
      investigators are interested in their experiences of medication use, medication management,
      adverse effects and barriers and facilitators of medicine monitoring, and how electronic
      devices can enhance nurse-led monitoring.
    

Detailed description: 
      Background:

      Between 1 in 4 and 1 in 25 people benefit from their prescribed medicines (Schork 2015).
      However, adverse drug reactions (ADRs, known as side effects) occur in 7.8% (7.2-8.4%)
      patients in community (or ambulatory) care (Hakkarainen et al 2013). Most of these are
      preventable (Hakkarainen et al 2013, NICE 2015). Adverse drug events (ADE), which include
      ADRs and under-prescribing, and medicines' mismanagement are responsible for 8% of healthcare
      spend in the USA, $213bn (Aitkin & Valkova 2013) and 9.5% of direct costs in Sweden.

      The West Wales ADR Profiles for medicines' monitoring has improved quality of care by
      reducing the prescription of mental health medicines and identifying and addressing
      previously unsuspected adverse effects, such as coupled beats and severe hypertension (Jordan
      2002, et al 2002), infections (Gabe el al 2014), chest pain and valproate-induced
      pancreatitis (Jones et al 2016), and, in care homes, drug-induced Parkinson's (Jordan et al
      2014), pain, nausea and behaviour problems (Jordan et al 2015). The investigators now need to
      know how the intervention can embed in practice and governance frameworks, and benefit from
      pharmacist involvement and new monitoring devices.

      Aims and objectives:

      The investigators aim to explore

        1. What is needed to sustain implementation of the WWADR Profile in routine practice

        2. How it might be enhanced by a) pharmacist involvement and b) digitisation and new
           monitoring technology c) new profiles in other areas, such as respiratory medicine, pain
           control, falls.

      Research Design A qualitative process evaluation and audit of interest

      Duration 9 months from approval date

      Location Care homes in Abertawe Bro Morgannwg University Health Board U.K.

      The investigators have received full approval from the West Wales Research Ethics
      Committee,Committee (reference 16/WA/038, IRAS ID 213050), to carry out this study. Written
      informed consent will be sought for all interviews, observations (service users and nurses),
      and reviews of reflective diaries or accounts. Copies of the consent forms will be placed in
      service users' records or given to the interviewees, as appropriate, and stored by the
      research team in a locked cabinet in a locked office. Participants or their consultees will
      be free to withdraw or retract their data at any time. Swansea University are the study
      sponsors and provide indemnity cover.

      Recruitment All 5 care homes from the previous trial (Jordan et al 2015) and 5 new care homes
      have opted to participate.

      Methods:

      The investigators will use interviews, observations and reflective diaries/ accounts with the
      participants of 5 previous research sites, and 5 newly recruited care homes.

      The investigators propose to explore 2 additions to nurse-led medicines' monitoring:

        -  Cluster pharmacist or study pharmacist review completed Profiles in a pilot

        -  Combining administration with the Multiparametric sensor systems (Yang et al 2015) or
           electronic version of the Profiles in an audit of interest.

      Data Handling- All data will be anonymised immediately, and kept strictly confidential.
      Participants and care homes will be assigned study numbers, and personal names will only
      appear on consent forms. A file linking care homes' names and addresses to study numbers will
      be stored in a password protected file on a password protected computer in a locked office
      used only by the PI. Service users' ages, sex, medicines and medical conditions will be
      recorded. Professionals' roles and length of service will be recorded. Data will be managed
      in accordance with the Data Protection Act 1998, the Caldicott Guardian, the Research
      Governance Framework for Health & Care Research Wales, and the Research Ethics' Committee.
      Study documents will be stored in locked filing cabinets in a locked office for sole use of
      the PI. All study data will be anonymised before being entered into electronic files, which
      will be stored on pass-word protected computers for sole use of the researchers.

      Consent- Prospective service user participants will be approached by their nurses. onsent to
      participation will be obtained by a qualified member of staff who is aware of the Mental
      Capacity Act 2005. For those without capacity to consent, as this is not a CTIMP, their
      consultees will be approached for advice regarding involvement. For many participants the
      consultee is a relative in regular contact; however, some service users have no regular
      visitors, and rely on professional support. Information sheets (in English and Welsh) and
      verbal information will be offered and potential participants will be given at least a week
      to decide whether to be observed or interviewed. Residents (or their family or consultees) to
      be observed will be asked to sign consent to non-participant observation and review of case
      notes.

      Service users' and carers' views will be obtained as part of this project.

      Anticipated outcome: The enhanced Profiles will offer a measure of care quality that matters
      to service users for example, pain, sedation, food and fluid intake and a sustainable
      strategy to improve care quality by: a) regular systematic review and transfer of information
      to pharmacists and prescribers (Francis 2013, Andrews and Butler 2014, Older People's
      Commissioner 2014, Flynn 2015); b) integration with NHS services e.g. contacts with
      prescribers, GPs, dentists and opticians; c) pharmacist reviews to optimise medication
      regimens for participants.

      Outcomes to be reported:

      Number and nature of problems addressed (including prescription changes)and understanding of
      any changes needed to optimise clinical gain and sustain implementation.
    

Intervention name(s): West Wales Adverse Drug Reaction (WWADR) Profile; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Nurse-led medicines' monitoring in care homes: a process evaluation of the impact and sustainability of the West Wales Adverse Drug Reaction (WWADR) Profile and pharmacist involvement; usual care
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators will work with healthcare professionals and service users involved in
        care homes in South West Wales.

        The target population for nurse-led medicines' monitoring is care home service users
        receiving at least one of: antipsychotics, anti-epileptics/ mood stabilisers,
        antidepressants, anxiolytics or hypnotics (benzodiazepines or Z drugs). Up to 3 service
        users per care home will be observed. Care homes will be invited to participate in the
        pilot work with pharmacists.
      
Keywords: Cognitive impairment; antipsychotics; antidepressants