Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines

Abstract

IntroductionImproved medicines’ management could lead to real and sustainable improvements to the care of older adults. The overuse of mental health medicines has featured in many reports, and insufficient patient monitoring has been identified as an important cause of medicine-related harms. Nurse-led monitoring using the structured adverse drug reaction (ADRe) profile identifies and addresses the adverse effects of mental health medicines. Our study investigates clinical impact and what is needed to sustain utilisation in routine practice in care homes.Methods and analysisThis process evaluation will use interviews and observations with the participants of all five homes involved in earlier research, and five newly recruited homes caring for people prescribed mental health medicines. The ADRe profile is implemented by nurses, within existing resources, to check for signs and symptoms of ADRs, initiate amelioration and share findings with pharmacists and prescribers for medication review. Outcome measures are the numbers and nature of problems addressed and understanding of changes needed to optimise clinical gain and sustain implementation. Data will be collected by 30 observations and 30 semistructured interviews. Clinical gains will be described and narrated. Interview analysis will be based on the constant comparative method.Ethics and disseminationEthical approval was conferred by the National Health Service Wales Research Ethics Committee. If the ADRe profile can be sustained in routine practice, it has potential to (1) improve the lives of patients, for example, by reducing pain and sedation, and (2) assist in early identification of problems caused by ADRs. Therefore, in addition to peer-reviewed publications and conferences, we shall communicate our findings to healthcare professionals, policy-makers and sector regulators.Trial registration numberNCT03110471.