Rachel Breen

A cluster randomized controlled trial of a structured training programme for caregivers of inpatients after stroke (TRACS)

Rationale The majority of stroke patients are discharged home dependent on informal caregivers, usually family members, to provide assistance with activities of daily living, including bathing, dressing, and toileting. Many caregivers feel unprepared for this role, and this may have a detrimental effect on both the patient and caregiver. Aims To evaluate whether a structured, competency-based training programme for caregivers improves physical and psychological outcomes for patients and their caregivers after disabling stroke, and to determine if such a training programme is cost-effective. Design A cluster randomized controlled trial. The trial aims to recruit 25 patient and caregiver dyads from each of the 36 participating stroke rehabilitation units. Stroke units have been randomized to either the intervention or control group with randomization stratified by geographical region and quality of care. The intervention is the London Stroke Carer Training Course developed and evaluated in a previous single-centre study. The London Stroke Carer Training Course comprises a number of caregiver training sessions and competency assessment delivered while the patient is in the hospital and one follow-up session after discharge. The multidisciplinary teams in the units randomized to the intervention group have been trained to incorporate delivery of the London Stroke Carer Training Course into ward practice, while those randomized to the control group have continued to provide usual care according to national guidelines. Study outcomes The primary outcomes are extended activities of daily living for the patient and caregiver burden measured at six-months after recruitment. Secondary outcomes include mood and cost-effectiveness, with final follow-up at 12 months.

Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care

Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305.

Predicting Risk of Serious Bacterial Infections in Febrile Children in the Emergency Department

Multinomial regression is used to model the risk of SBIs in febrile children in the ED. BACKGROUND: Improving the diagnosis of serious bacterial infections (SBIs) in the children’s emergency department is a clinical priority. Early recognition reduces morbidity and mortality, and supporting clinicians in ruling out SBIs may limit unnecessary admissions and antibiotic use. METHODS: A prospective, diagnostic accuracy study of clinical and biomarker variables in the diagnosis of SBIs (pneumonia or other SBI) in febrile children <16 years old. A diagnostic model was derived by using multinomial logistic regression and internally validated. External validation of a published model was undertaken, followed by model updating and extension by the inclusion of procalcitonin and resistin. RESULTS: There were 1101 children studied, of whom 264 had an SBI. A diagnostic model discriminated well between pneumonia and no SBI (concordance statistic 0.84, 95% confidence interval 0.78–0.90) and between other SBIs and no SBI (0.77, 95% confidence interval 0.71–0.83) on internal validation. A published model discriminated well on external validation. Model updating yielded good calibration with good performance at both high-risk (positive likelihood ratios: 6.46 and 5.13 for pneumonia and other SBI, respectively) and low-risk (negative likelihood ratios: 0.16 and 0.13, respectively) thresholds. Extending the model with procalcitonin and resistin yielded improvements in discrimination. CONCLUSIONS: Diagnostic models discriminated well between pneumonia, other SBIs, and no SBI in febrile children in the emergency department. Improvements in the classification of nonevents have the potential to reduce unnecessary hospital admissions and improve antibiotic prescribing. The benefits of this improved risk prediction should be further evaluated in robust impact studies.

Protocol of a cluster randomized trial evaluation of a patient and carer-centered system of longer-term stroke care (LoTS care)

Rationale Despite recognition of the importance of the longer-term consequences of stroke, services addressing these needs remain poorly developed. There are persuasive arguments that a community-based orientation to poststroke care, to assess, support, and coordinate relevant services, might be more helpful in minimizing longer-term stroke morbidity. To address this, an evidence-based system of care has been developed that aims to meet the longer-term needs for stroke survivors and their carers living at home in the community. Aims The study aims to evaluate the clinical and cost-effectiveness of a purposely developed system of care for stroke patients and their carers living in the community. Design This is a cluster randomized, controlled trial. The trial aimed to recruit 800 patients (and their carers, if appropriate) in 32 stroke services across the United Kingdom. The system of care is delivered by health professionals undertaking a community-based liaison or coordinating role for stroke patients (termed ‘stroke care coordinators’). Stroke care coordinators in stroke services randomized to the intervention group were trained to deliver the system of care, while those randomised to the control group continued to deliver current practice. Study outcomes The primary outcome is patient emotional health measured using the General Health Questionnaire 12 at six-months after recruitment. Secondary outcomes include cost-effectiveness, patient functional health and carer emotional health, with final follow-up at 12 months. Current status Thirty-two stroke services were randomized and 800 patients and 208 carers were recruited from 29 services. Follow-up is ongoing, and trial results are expected in early 2013.