Title
Nurse-led medication monitoring for patients with dementia in care homes in South West Wales: a feasibility study for a stepped wedge trial

Lead researcher
Dr Sue Jordan, College of Human and Health Sciences, Swansea University

Co-applicants
Marie Gabe (researcher) BN., BSc., RN.
Ian Russell, Professor of Clinical Trials, Director WWORTH
Peter Huxley, Professor of Social Work; Director MHRNC
Mick Dennis, Professor of Psychiatry for Older People & Honorary Consultant in Liaison Psychiatry for Older People.
Robert Colgate, FRCPsych. Consultant Psychiatrist, Princess of Wales Hospital
Ceri Phillips, Professor of Health Economics
Alan Watkins, Senior lecturer in statistics
Sherrill Snelgrove PhD, M.Phil, BSc, RGN, lecturer in psychology applied to nursing
Gerwyn Panes RMN., MSc., BSc., LPE (PGCE). Co-ordinator BN nursing mental health
Chris Baker PhD, BSc Econ (Hons) FETC, RN

Research question
Whether it is feasible to conduct a RCT of nurse-led medication monitoring in people with dementia in the care home setting using the West Wales ADR* (WWADR) profile.

Hypothesis
That by using the monitoring tool, previously unsuspected ADR-related problems will be identified, with the consequence of improved clinical outcomes.

Aims
  1. Establish rates of recruitment, retention, compliance and cross-over.
  2. Ensure feasibility of reporting changes in documentation for:
    • Amelioration of problems found using the profile.
    • Problems found and actions taken using the profile.
    • Medication review/ changes.
    • Patients with different severity of illness.  
  3. Develop clinical endpoints for a full trial, such as measures to capture changes in patients’ functioning.
  4. Calculate intra-cluster correlation coefficient (ICC), and any time delay to patient benefits.
  5. Explore the basis for cost-effectiveness analysis.
  6. Report views of care home staff.
Patient safety is a priority for healthcare organisations, but there are underlying weaknesses in current practice, particularly monitoring for known adverse effects of prescribed drugs1,2. 4-6% of hospital admissions are due to adverse drug reactions*3, most of which are preventable4,5. The leading cause is failure to monitor, rather than poor prescribing6-10.

25-50% of people with dementia in the UK are prescribed antipsychotic medication,11 but there is international variation.12 For people with dementia, some antipsychotics reduce aggression and psychosis13-15, particularly amongst those most severely agitated16. However, in older people, antipsychotics are associated with: increased overall mortality17-19, worsening cognitive impairment20, hip fracture21-22, diabetes23 and stroke11. Withdrawal of medication reduces falls24, and improves verbal fluency14, but aggressive behaviour may return25.

Over one third of care home residents receive antidepressants26. Depressive co-morbidity is common amongst those with dementia and anti-depressants have known benefits. However, their use amongst older adults is associated with serious adverse events27: bleeding28, violent behaviour29, falls30, and fractures21,31. In older adults, more subtle adverse effects, such as polyuria, insomnia or wandering may predominate, which will only be uncovered by structured monitoring32.

10-20% patients with Alzheimer’s suffer seizures. Older adults are particularly vulnerable to CNS depression and other adverse effects of AEDs33.

Study design summary
Stepped-wedge cluster RCT1,2 of structured nurse-led medication monitoring in 5 care homes (local authority and independent sector) at 3-week intervals (figure.1), each with 10 participating patients meeting the criteria below (from pre-pilot data). 30 participants are considered sufficient in pilot studies3.

Inclusion criteria for patients: diagnosis of dementia or dementia sub-type; receiving at least one of antipsychotic, anti-epileptic or antidepressant medication; willing and able to give informed, signed consent either personally or via their guardian.
Exclusion criteria: insufficiently well, as judged by their nurses; age<18.

Total awarded
£23,077