scholarly journals Can an observational pain assessment tool improve time to analgesia for cognitively impaired older persons? A cluster randomised controlled trial

2017 ◽  
Vol 35 (1) ◽  
pp. 33-38 ◽  
Author(s):  
Margaret Fry ◽  
Lynn Chenoweth ◽  
Glenn Arendts
Keyword(s):  
Sensitivity Analysis ◽  
Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Pain Assessment ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cognitively Impaired ◽  
Cluster Randomised ◽  
Significant Difference ◽  
Randomised Controlled

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.

scholarly journals The DemWG study: reducing the risk of hospitalisation through a complex intervention for people with dementia and mild cognitive impairment (MCI) in German shared-housing arrangements: study protocol of a prospective, mixed-methods, multicentre, cluster-randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041891
Author(s):  
André Kratzer ◽  
Jennifer Scheel ◽  
Karin Wolf-Ostermann ◽  
Annika Schmidt ◽  
Katrin Ratz ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mixed Methods ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
People With Dementia ◽  
Randomised Controlled

IntroductionShared-housing arrangements (SHAs) are small, home-like care environments in Germany. Residents are predominantly people with dementia. The risk for all-cause hospitalisation is consistently higher for people with dementia compared with people without dementia and there is currently no evidence-based intervention to reduce the risk of hospitalisation. Thus, the DemWG study investigates whether a complex intervention is effective in reducing hospitalisation (primary outcome), behavioural and psychological symptoms of dementia and falls and for stabilising cognitive functioning and quality of life in people with dementia and mild cognitive impairment (MCI) in German SHAs.Methods and analysisBased on the UK Medical Research Council framework ‘Developing and evaluating complex interventions’, a prospective, mixed-methods, multicentre, cluster-randomised controlled trial combining primary and secondary data analyses as well as quantitative and qualitative research methods is being conducted. The intervention consists of three parts: (A) education of nursing staff in SHAs; (B) awareness raising and continuing medical education (CME) of general practitioners; (C) multicomponent non-pharmacological group intervention MAKS-mk+ (‘m’=motor training; ‘k’=cognitive training; ‘+’=fall prevention) for people with dementia and MCI. Randomisation is stratified by the German federal states and type of setting (rural vs urban). Neither the trained professionals nor the participants are blinded. Data are collected at baseline and after 6, 12 and 18 months with standardised instruments. Quantitative data will be analysed by multivariate analyses according to the general linear model, qualitative data using qualitative content analysis. Recruitment is still ongoing until 31 December 2020.Ethics and disseminationAll procedures were approved by the Ethics Committee of the University of Bremen (Ref. 2019-18-06-3). Informed consent will be obtained before enrolment of participants. Due to findings of previous randomised controlled trials, serious adverse events are not expected. Results will be disseminated in peer-reviewed journal publications and conference presentations.Trial registration numberISRCTN89825211.

scholarly journals Safer prescribing and care for the elderly (SPACE): cluster randomised controlled trial in general practice

BJGP Open ◽  
2021 ◽  
pp. BJGPO.2021.0129
Author(s):  
Katharine Ann Wallis ◽  
Carolyn Raina Elley ◽  
Simon A. Moyes ◽  
Arier Lee ◽  
Joanna Frances Hikaka ◽  
...  
Keyword(s):  
General Practice ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Increased Risk ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Automated Search

BackgroundSafer prescribing in general practice may help to decrease preventable adverse drug events (ADE) and related hospitalisations.AimTo test effect of SPACE on high-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and/or antiplatelet medicines and related hospitalisations.Design & settingPragmatic cluster randomised controlled trial in general practice. Participants were patients at increased risk of ADEs from NSAIDs and/or antiplatelet medicines at baseline. SPACE comprises automated search to generate for each general practitioner (GP)a list of patients with high-risk prescribing; pharmacist outreach to provide education and one-on-one review of list with GP; and automated letter inviting patients to seek medication review with their GP.MethodPrimary outcome was difference in high-risk prescribing of NSAIDs and/or antiplatelet medicines at 6 months; secondary outcomes included high-risk prescribing for gastrointestinal, renal or cardiac ADEs separately; 12-month outcomes; and related ADE hospitalisations.ResultsWe recruited 39 practices with 205 GPs and 191,593 patients including 21,877 (11.4%) participants, 1,479 (6.8%) with high-risk prescribing. High-risk prescribing improved in both groups at 6 and 12 months compared with baseline. At 6 months, there was no significant difference between groups (OR: 0.99 (0.87, 1.13)) although SPACE improved more for gastrointestinal ADEs (0.81 (0.68, 0.96)). At 12 months, the control group improved more (OR: 1.29 (1.11, 1.49)). There was no significant difference for related hospitalisations.ConclusionFurther work is needed to identify scalable interventions that support safer prescribing in general practice. The use of automated search and feedback plus letter to patient warrants further exploration.

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