The implementation of the serial trial intervention for pain and challenging behaviour in advanced dementia patients (STA OP!): a clustered randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Pain (physical discomfort) and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention (STI) and established that this protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA OP!) in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression, and quality of life. This article outlines the study protocol.</p> <p>Methods/Design</p> <p>The study is a cluster randomized controlled trial in 168 older people (aged >65 years) with mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to either the intervention condition (training and implementation of the STA OP!-protocol) or the control condition (general training focusing on challenging behaviour and pain, but without the step-wise approach). Measurements take place at baseline, after 3 months (end of the STA OP! training period) and after 6 months.</p> <p>Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH)), and pain (measure with the Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D) and the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI) pain scale). Secondary outcome measures include symptoms of depression (Cornell and MDS-RAI depression scale), Quality of Live (Qualidem), changes in prescriptions of analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen, reminiscence therapy).</p> <p>Discussion</p> <p>The transfer from the American design to the Dutch design involved several changes due to the different organisation of healthcare systems. Specific strengths and limitations of the study are discussed.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1967">NTR1967</a></p

Persistent use of Analgesic Medications in Mild-to-Moderate Alzheimer's Disease.: Persistent analgesic use in Alzheimer's disease

International audienceBACKGROUND AND OBJECTIVES: Previous studies have reported a lower use of analgesics in patients with Alzheimer's disease (AD) than in non-AD elderly. To date, no study has focused on persistent analgesic use in patients with mild-to-moderate AD. METHODS: The "Réseau sur la maladie d'Alzheimer Français" (REAL.FR) cohort study enrolled community-dwelling patients with mild-to-moderate AD. Persistent analgesic use was defined as the consumption of at least one analgesic drug during two consecutive visits (6 months). Associated factors were identified in a nested case-control study. RESULTS: In REAL.FR, 595 patients were present during at least two consecutive visits [mean age = 77.5 ± 6.8 years, mini-mental state examination (MMSE) = 20.1 ± 4.2]. Prevalence of persistent analgesic use was 13.1 % (95 % CI = 10.4-15.9). The incidence of persistent analgesic use was 5.9/100 patient-years (95 % CI = 5.2-6.6). Women (adjusted odds ratio [OR] = 3.1, 95 % CI = 1.2-8.1), patients with musculoskeletal disorders (OR = 3.4, 95 % CI = 1.6-7.3) and patients treated with numerous medications (OR = 3.0, 95 % CI = 1.5-5.8) were more likely to use analgesics persistently. Statistically significant associations were found with disease duration and disease progression but not with AD severity at baseline. CONCLUSIONS: Our results suggest a low use of analgesics in AD patients, which could vary with AD progression