BackgroundPeople with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines’ monitoring.DesignPragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines’ monitoring versus usual care.SettingFive UK private sector care homesParticipants41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.InterventionNurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step.OutcomesProblems addressed and changes in medicines prescribed.Data Collection and AnalysisInformation was collected from participants’ notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.ResultsFive of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57–4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78–8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80–235.90] and 5.12 [1.45–18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15–17.22).ConclusionThe WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.Trial Registration ISRCTN 48133332

IntroductionPreventable adverse effects of medicines often pass unnoticed, but lead to real harm.InterventionNurse-led monitoring using the structured Adverse Drug Reaction (ADRe) Profile identifies and addresses adverse effects of mental health medicines.ObjectivesThis study investigated the implementation and clinical impact of ADRe, and barriers to and facilitators of sustained utilisation in routine practice.MethodsAdministration of ADRe was observed for 30 residents prescribed mental health medicines in ten care homes. The study pharmacist reviewed completed ADRes against medication records. Policy context was explored in 30 interviews with service users, nurse managers and strategic leads in Wales.ResultsResidents were aged 60–95, and prescribed 1–17 (median 9 [interquartile range (IQR) 7–13]) medicines. ADRe identified a median of 18 [IQR 11.5–23] problems per resident and nurses made 2 [1–2] changes to care per resident. For example: falls were reported for 9 residents, and care was modified for 5; pain was identified in 8 residents, and alleviated for 7; all 6 residents recognised as dyspnoeic were referred to prescribers. Nurses referred 17 of 30 residents to prescribers. Pharmacists recommended review for all 30. Doubts about administering ADRe, sometimes expressed by people who had not yet used it, diminished as it became familiar. ADRe was needed to bridge communication between resident, nurses and prescribers. When barriers of time, complacency, and doctors’ non-availability were overcome, reporting with ADRe made prescribers more likely to heed nurses’ concerns regarding residents’ welfare. Clinical gains were facilitated by one-to-one time, staff-resident relationships, and unification of documentation.ImplicationsTo our knowledge, ADRe is the only instrument that brings a full account of patients’ problems to medication reviews. This juxtaposition of signs and symptoms against prescriptions facilitates dose adjustments and de-prescribing and leads to: reduced pain and sedation; early identification of problems linked to ADRs, such as falls; and timely medication reviews e.g. for dyspnoea.

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.

It is thought that integrating health and social care provision can improve services, yet few evaluations of integrated health and social care initiatives have focused on changes in clinical outcomes and used comparator groups. The aim of this pilot study was to identify whether attendance at an integrated health and social care day unit (IHSCDU) affected selected 2 outcomes of functional mobility, number of prescribed medications and physical and psychological well-being. A secondary aim was to examine the utility of the tools to measure these outcomes in this context; the feasibility of the recruitment and retention strategy and the utility of the comparator group. A before-and after comparison design was used with nonrandomised intervention and comparator arms. The intervention arm comprised 30 service users attending the IHSCDU and the comparator arm comprised 33 service users on a community nursing caseload. Measures of functional mobility (Barthel's Index) and physical and psychological well-being (SF-12) were taken from all participants in both arms at three data collection points: baseline, four and nine months later, between November 2010 and September 2012. Participants and outcomes were identified prospectively and in both arms, the individual was the unit of assignment. No significant changes were noted in functional mobility and psychological well-being and the number of medications prescribed increased in both arms. There was a trend towards a significant difference between study arms in the change in the SF-12 physical health outcome measure and this outcome measure could be usefully explored in future studies. The recruitment and retention strategy was feasible although our comparator group had some limitations in not being closely matched in terms of age, functional mobility and mental wellbeing.