Objective The 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.
Methods A 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.
Results We 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).
Conclusion Use 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.
- cognitive impairment
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Contributors MF, LC and GA conceived the study, designed the trial and obtained the research funding. MF, LC and GA supervised the conduct of the trial and data collection. MF oversaw recruitment of participating sites and managed the quality of data collection. GA provided statistical advice on the study design, sample and analysis of the data. MF, LC and GA were involved in the drafting and revision of the manuscript. MF takes responsibility for the paper as a whole.
Funding This research was supported by the Emergency Care Institute and the Agency for Clinical Innovation (ACI/D12/1275) New South Wales. Neither body has had any role in the conduct of the research nor the preparation of the manuscript.
Competing interests None declared.
Ethics approval Approval was obtained from the hospitals’ health districts’ Human Research Ethics Committees (HREC 1212-430M) and operated according to the guidelines of the National Health and Medical Research Council of Australia.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement According to ethical requirements data sharing is not available.
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