Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial

People 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.Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines' monitoring versus usual care.Five UK private sector care homes.41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.Nurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step.Problems addressed and changes in medicines prescribed.Information 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.Five 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).The 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.ISRCTN 48133332

Recruitment, Retention, Demographics and Prescription medicines at study entry.

<p>* Categorisation follows a needs assessment. Service users are assessed by NHS nurses and designated as needing nursing care or residential care. Assessments are usually based on the Royal College of Nursing’s (2004) ‘Nursing assessment and Older People An RCN Toolkit’. London, RCN: <a href="http://www.rcn.org.uk/__data/assets/pdf_file/0010/78616/002310.pdf" target="_blank">http://www.rcn.org.uk/__data/assets/pdf_file/0010/78616/002310.pdf</a></p><p><b>**</b> Any combination preparations were counted as a single item. Enumerating the active ingredients of each product would have been impractical, particularly for antacids and multivitamins.</p><p>Recruitment, Retention, Demographics and Prescription medicines at study entry.</p

Total number of problems addressed per participant at each step in each site.

<p>Bold text indicates roll-out of medicines’ monitoring and Profile administration 1 month before these data collection points (occasions when researchers extracted data from participants’ records). n = number of service users in the site. One participant from site 4 passed away between steps 3 & 4. One participant from site 5 was hospitalised between steps 3 & 4. Participants joined site 5 at steps 2 and 3. Problems explored are listed in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.t005" target="_blank">Table 5</a> and on the Profile, <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.s001" target="_blank">S1 appendix</a>. Fuller versions of these tables, including medians and 25^th = 75^th centiles are in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.s005" target="_blank">S1</a> and <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.s006" target="_blank">S2</a> tables.</p

Patient monitoring: number of participants with documentation of each problem.

<p>* Guidelines appended to the Profile offered definitions of acceptable ranges of measurement and standards. Guidelines are available on request.</p><p>2 participants joined late and 2 were lost to the study.</p

The medication chain.

<p>The medication chain.</p

Number of prescribed medicines in each step for each site.

<p>Bold text indicates roll-out of medicines’ monitoring and Profile administration 1 month before these data collection points (occasions when researchers extracted data from participants’ records). n = number of service users in the site. One participant from site 4 passed away between steps 3 & 4. One participant from site 5 was hospitalised between steps 3 & 4. Participants joined site 5 at steps 2 and 3. Problems explored are listed in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.t005" target="_blank">Table 5</a> and on the Profile, <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.s001" target="_blank">S1 Appendix</a>. Fuller versions of these tables, including medians and 25^th = 75^th centiles are in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.s007" target="_blank">S3 table</a>.</p

Problems addressed with and without the Profile: total numbers and examples.

<p>Visits to dentists and opticians were compared ‘before and after’ (see analysis and <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.t006" target="_blank">Table 6</a>). ADLs—activities of daily living.</p

Numbers of participants with any change made to any of their prescribed medications at each step in each site.

<p>Bold text indicates roll-out of medicines’ monitoring and Profile administration 1 month before these data collection points (occasions when researchers extracted data from participants’ records). n = number of service users in the site. One participant from site 4 passed away between steps 3 & 4. One participant from site 5 was hospitalised between steps 3 & 4. Participants joined site 5 at steps 2 and 3. Problems explored are listed in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.t005" target="_blank">Table 5</a> and on the Profile, <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.s001" target="_blank">S1 Appendix</a>. Fuller versions of these tables, including medians and 25^th = 75^th centiles are in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0140203#pone.0140203.s007" target="_blank">S3 Table</a>.</p

Case Reports of benefits of Profile use.

<p>Case Reports of benefits of Profile use.</p

Profile Effect on selected outcomes: adjusted analyses.

<p>* adjusted for Step, age, number of medicines at baseline, antipsychotics, antiepileptics, antidepressants and SSRIs at baseline;</p><p>** ICC, intracluster correlation coefficient, based on raw data;</p><p>† number of medicines recorded as prescribed at baseline.</p><p>Notes: D = raw, observed (unadjusted) difference in the same units as the variable; β = β coefficient of profile effect or effect size in the same units as variable; OR = raw (unadjusted odds ratio); aOR = adjusted Odds Ratio, exponent of β. ADL = activities of daily living. n represents the number of data collection points.</p