ObjectiveThe primary objective of the study was to measure the impact of an observational pain assessment dementia tool on time from ED arrival to first dose of analgesic medicine.MethodsA multisite cluster randomised controlled trial was conducted to test the Pain Assessment in Advanced Dementia (PAINAD) tool. Patients aged 65 years or older suspected of a long bone fracture were screened for cognitive impairment using the Six-Item Screening (SIS) tool. Patients scoring 4 or less on SIS (intervention sites) were assessed for pain using PAINAD. Control sites, assessed pain using standard methods. The primary outcome was time to first dose of analgesia and was analysed on an intention-to-treat basis with a sensitivity analysis.ResultsWe enrolled 602 patients, of which 323 (54%) were at intervention sites (n=4). The median time to analgesia was 82 min (IQR 45–151 min). There was no statistically significant difference in median time to analgesia for intervention 83 (IQR 48–158 min) and non-intervention 82 min (IQR 41–147 min) sites (p=0.414). After adjusting for age, fracture type, arrival mode and triage category, there remained no significant difference in time to analgesia (HR 0.97, 95% CI 0.80 to 1.17, p=0.74). Of the 602 patients enrolled, 273 actually had cognitive impairment. A sensitivity analysis demonstrated patients at intervention sites received analgesia 13 min sooner (90 vs 103 min, p=0.91).ConclusionUse of the PAINAD was not associated with a shorter time to analgesia, although there was a clinically important but non-significant improvement in the cognitively impaired patient group. Further research is needed to address this clinically important and complex issue.
The German day-care study: multicomponent non-drug therapy for people with cognitive impairment in day-care centres supplemented with caregiver counselling (DeTaMAKS) – study protocol of a cluster-randomised controlled trial
