A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491]

Background  

Patients with stroke should have access to a continuum of care from organized stroke units in the acute phase, to appropriate rehabilitation and secondary prevention measures. Moreover to improve the outcomes for acute stroke patients from an organizational perspective, the use of multidisciplinary teams and the delivery of continuous stroke education both to the professionals and to the public, and the implementation of evidence-based stroke care are recommended. Clinical pathways are complex interventions that can be used for this purpose. However in stroke care the use of clinical pathways remains questionable because little prospective controlled data has demonstrated their effectiveness. The purpose of this study is to determine whether clinical pathways could improve the quality of the care provided to the patients affected by stroke in hospital and through the continuum of the care.     

Antenatal non-medical risk assessment and care pathways to improve pregnancy outcomes: a cluster randomised controlled trial

Social deprivation negatively affects health outcomes but receives little attention in obstetric risk selection. We investigated whether a combination of (1) risk assessment focused on non-medical risk factors, lifestyle factors, and medical risk factors, with (2) subsequent institution of risk-specific care pathways, and (3) multidisciplinary consultation between care providers from the curative and the public health sector reduced adverse pregnancy outcomes among women in selected urban areas in the Netherlands. We conducted a cluster randomised controlled trial in 14 urban municipalities across the Netherlands. Prior to the randomisation, municipalities were ranked and paired according to their expected proportion of pregnant women at risk for adverse outcomes at birth. The primary outcome was delivery of a preterm and/or small for gestational age (SGA) baby, analysed with multilevel mixed-effects logistic regression analysis adjusting for clustering and individual baseline characteristics. A total of 33 community midwife practices and nine hospitals participated throughout the study. Data from 4302 participants was included in the Intention To Treat (ITT) analysis. The intervention had no demonstrable impact on the primary outcome: adjusted odds ratio (aOR) 1.17 (95% CI 0.84–1.63). Among the secondary outcomes, the intervention improved the detection of threatening preterm delivery and fetal growth restriction during pregnancy [aOR 1.27 (95% CI 1.01–1.61)]. Implementation of additional non-medical risk assessment and preventive strategies into general practices is feasible but did not decrease the incidence of preterm and/or SGA birth in the index pregnancy in deprived urban areas.Trial registration Netherlands National Trial Register (NTR-3367).     

The bacteriology of pneumonia diagnosed in Western Australian emergency departments

We used Western Australian emergency department data linked to hospital morbidity, death and microbiology data to describe the bacteriology of pneumonia according to age. The 'atypical' organisms and viruses were not assessed. A total of 6908 patients over a 3-year period were given an emergency department diagnosis of pneumonia, 76.9% were admitted and 6.3% died in hospital. Blood was cultured from 52.9% of patients with 6.4% growing potential pathogens. Streptococcus pneumoniae was the most common organism isolated and accounted for 92% of pathogens in those aged <15 years. Isolation of Enterobacteriaceae species tended to increase with age and accounted for around 25% of isolates from the elderly. Sputum was cultured from 25.3% of patients and bacteria were isolated from 30.3% of samples, commonly Haemophilus influenzae and S. pneumoniae. Isolates from sputum showed no distinct trend across age groups. These patterns question the value of routine blood and sputum cultures and have implications for empiric therapy for the elderly.     

Prevention through Activity in Kindergarten Trial (PAKT): A cluster randomised controlled trial to assess the effects of an activity intervention in preschool children

Background  

Physical activity and motor skills acquisition are of high importance for health-related prevention and a normal development in childhood. However, few intervention studies exist in preschool children focussing on an increase in physical activity and motor skills. Proof of positive effects is available but not consistent.     

A novel school-based intervention to improve nutrition knowledge in children: cluster randomised controlled trial

Background  

Improving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a novel educational intervention to increase nutrition knowledge among primary school children.     

Assessing the impact of a restorative home care service in New Zealand: a cluster randomised controlled trial

Due to the ageing population, there is an increased demand for home care services. Restorative care is one approach to improving home care services, although there is little evidence to support its use in the community setting. The objective of this trial was to evaluate the impact of a restorative home care service for community-dwelling older people. The study was a cluster randomised controlled trial undertaken at a home care agency in New Zealand. The study period was from December 2005 to May 2007. Older people were interviewed face-to-face at baseline, four and 7 months. A total of 186 older people who received assistance from a home care agency participated in the study, 93 received restorative home care and 93 older people received usual home care. The primary outcome measure was change in health-related quality of life (measured by the Short Form 36 [SF36] Health Survey). Secondary outcomes were the physical, mental, and social well-being of older people (Nottingham Extended Activities of Daily Living, Timed Up and Go, Mastery scale, Duke Social Support Index). Findings revealed that compared with usual care, the intervention demonstrated a statistically significant benefit in health-related quality of life (SF36) at 7 months for older people (mean difference 3.8, 95% CI -0.0 to 7.7, P = 0.05). There were no changes in other scale measurements for older people in either group over time. There was a statistically significant difference in the number of older people in the intervention group identified for reduced hours or discharge (29%) compared with the control group (0%) (P < 0.001). In conclusion, a restorative home care service may be of benefit to older people, and improves home care service efficacy.     

A randomised controlled trial. Shifting boundaries of doctors and physiotherapists in orthopaedic outpatient departments

OBJECTIVE: To evaluate the effectiveness and cost effectiveness of specially trained physiotherapists in the assessment and management of defined referrals to hospital orthopaedic departments. DESIGN: Randomised controlled trial. SETTING: Orthopaedic outpatient departments in two hospitals. SUBJECTS: 481 patients with musculoskeletal problems referred for specialist orthopaedic opinion. INTERVENTIONS: Initial assessment and management undertaken by post-Fellowship junior orthopaedic surgeons, or by specially trained physiotherapists working in an extended role (orthopaedic physiotherapy specialists). MAIN OUTCOME MEASURES: Patient centred measures of pain, functional disability and perceived handicap. RESULTS: A total of 654 patients were eligible to join the trial, 481 (73.6%) gave their consent to be randomised. The two arms (doctor n = 244, physiotherapist n = 237) were similar at baseline. Baseline and follow up questionnaires were completed by 383 patients (79.6%). The mean time to follow up was 5.6 months after randomisation, with similar distributions of intervals to follow up in both arms. The only outcome for which there was a statistically or clinically important difference between arms was in a measure of patient satisfaction, which favoured the physiotherapist arm. A cost minimisation analysis showed no significant differences in direct costs to the patient or NHS primary care costs. Direct hospital costs were lower (p < 0.00001) in the physiotherapist arm (mean cost per patient = 256 Pounds, n = 232), as they were less likely to order radiographs and to refer patients for orthopaedic surgery than were the junior doctors (mean cost per patient in arm = 498 Pounds, n = 238). CONCLUSIONS: On the basis of the patient centred outcomes measured in this randomised trial, orthopaedic physiotherapy specialists are as effective as post-Fellowship junior staff and clinical assistant orthopaedic surgeons in the initial assessment and management of new referrals to outpatient orthopaedic departments, and generate lower initial direct hospital costs.     

Physical activity to prevent obesity in young children: cluster randomised controlled trial

Physical activity to prevent obesity in young children: cluster randomised controlled trial . Reilly , J. J. , Kelly , L. , Montgomery , C. , Williamson , A. , Fisher , A. , McColl , J. H. , Lo Conte , R. , Paton , J. Y. & Grant , S. ( 2006 ) British Medical Journal , 333 , 1041 DOI: 10.1136/bmj.38979.623773.55.     

A randomized controlled trial to assess the psychological impact of a family history screening questionnaire in general practice

BACKGROUND: It has been postulated that systematic enquiry about patients' family histories of inherited illnesses would lead to a population of 'worried well'. OBJECTIVE: The purpose of the present study was to evaluate if the use of a family history screening questionnaire (FHSQ) as part of a general practice health check leads to psychological distress. METHOD: We conducted a randomized controlled trial of a self-administered FHSQ in a single general practice. Individuals who had not had a health check within the previous 2 years were randomized within three age group strata to intervention group (receiving health check and FHSQ) or control group (only receiving health check). A total of 156 patients were offered health checks; 100 accepted and 76 of them were followed through to the 3-month end point. Responses to the six-item Spielberger State-Trait Anxiety Inventory (STAI), Perception of Health questionnaire and Family History Concern questionnaire were compared between intervention and control groups. RESULTS: A two-way analysis of variance on the STAI scores 1 and 2 weeks after the health check with baseline scores as a covariate showed that at both times anxiety was higher in the intervention group than in the controls (F = 6.4; d.f. = 1,73; P = 0.014). Three months later, there was no significant difference between the two groups. The Perception of Health questionnaire only showed a significant result at 1 week, the intervention group having a more pessimistic response to the question eliciting patient's concerns about future health (P = 0.025). CONCLUSION: Short-term psychological distress due to the family history screening questionnaire was identified but did not persist.