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The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial.

ABSTRACT: Proximal femur fracture (PFF) is associated with considerable morbidity and mortality. The European Quality of Care Pathway (EQCP) study on PFF (NCT00962910) was designed to determine how care pathways (CP) for hospital treatment of PFF affect consistency of care, adherence to evidence-based key interventions, and clinical outcome.An international cluster-randomized controlled trial (cRCT) will be performed in Belgium, Ireland, Italy and Portugal. Based on power analyses, a sample of 44 hospital teams and 437 patients per arm will be included in the study. In the control arm, usual care will be provided. Experimental teams will implement a care pathway which will include three active components: a formative evaluation of quality and organization of the care setting, a set of evidence-based key interventions, and support of the development and implementation of the CP. Main outcome will be the six-month mortality rate.The EQCP study constitutes the first international cRCT on care pathways. The EQCP project was designed as both a research and a quality improvement project and will provide a real-world framework for process evaluation to improve our understanding of why and when CP can really work.NCT00962910.

SUBMITTER: Vanhaecht K

PROVIDER: S-EPMC3528433 | biostudies-literature | 2012 May

REPOSITORIES: biostudies-literature

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The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial.

Vanhaecht Kris K Sermeus Walter W Peers Jan J Lodewijckx Cathy C Deneckere Svin S Leigheb Fabrizio F Boonen Steven S Sermon An A Boto Paulo P Mendes Rita Veloso RV Panella Massimiliano M

BMC health services research 20120524

<h4>Background</h4>Proximal femur fracture (PFF) is associated with considerable morbidity and mortality. The European Quality of Care Pathway (EQCP) study on PFF (NCT00962910) was designed to determine how care pathways (CP) for hospital treatment of PFF affect consistency of care, adherence to evidence-based key interventions, and clinical outcome.<h4>Methods/design</h4>An international cluster-randomized controlled trial (cRCT) will be performed in Belgium, Ireland, Italy and Portugal. Based ...[more]

PMID: 22640531

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Project description:We have characterised 997 hip fracture patients from a representative 45 Spanish hospitals, and followed them up prospectively for up to 4 months. Despite suboptimal surgical delays (average 59.1 hours), in-hospital mortality was lower than in Northern European cohorts. The secondary fracture prevention gap is unacceptably high at 85%.PurposeTo characterise inpatient care, complications, and 4-month mortality following a hip or proximal femur fracture in Spain.MethodsDesign: prospective cohort study. Consecutive sample of patients ≥ 50 years old admitted in a representative 45 hospitals for a hip or proximal femur fragility fracture, from June 2014 to June 2016 and followed up for 4 months post-fracture. Patient characteristics, site of fracture, in-patient care (including secondary fracture prevention) and complications, and 4-month mortality are described.ResultsA total of 997 subjects (765 women) of mean (standard deviation) age 83.6 (8.4) years were included. Previous history of fracture/s (36.9%) and falls (43%) were common, and 10-year FRAX-estimated major and hip fracture risks were 15.2% (9.0%) and 8.5% (7.6%) respectively. Inter-trochanteric (44.6%) and displaced intra-capsular (28.0%) were the most common fracture sites, and fixation with short intramedullary nail (38.6%) with spinal anaesthesia (75.5%) the most common procedures. Surgery and rehabilitation were initiated within a mean 59.1 (56.7) and 61.9 (55.1) hours respectively, and average length of stay was 11.5 (9.3) days. Antithrombotic and antibiotic prophylaxis were given to 99.8% and 98.2% respectively, whilst only 12.4% received secondary fracture prevention at discharge. Common complications included delirium (36.1 %) and kidney failure (14.1%), with in-hospital and 4-month mortality of 2.1% and 11% respectively.ConclusionsDespite suboptimal surgical delay, post-hip fracture mortality is low in Spanish hospitals. The secondary fracture prevention gap is unacceptably high at > 85%, in spite of virtually universal anti-thrombotic and antibiotic prophylaxis.

Project description: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.Two-arm, cluster-randomized trial with hospitals and rehabilitation long-term care facilities as randomization units. 14 units will be randomized either to arm 1 (clinical pathway) or to arm 2 (no intervention, usual care). The sample will include 238 in each group, this gives a power of 80%, at 5% significance level. The primary outcome measure is 30-days mortality. The impact of the clinical pathways along the continuum of care will also be analyzed by comparing the length of hospital stay, the hospital re-admissions rates, the institutionalization rates after hospital discharge, the patients' dependency levels, and complication rates. The quality of the care provided to the patients will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and rehabilitation, and by the use of key quality indicators at discharge. The implementation of organized care will be also evaluated.The management of patients affected by stroke involves the expertise of several professionals, which can result in poor coordination or inefficiencies in patient treatment, and clinical pathways can significantly improve the outcomes of these patients. It is proposed that this study will test a new hypothesis and provide evidence of how clinical pathways can work.ClinicalTrials.gov ID [NCT00673491].

Project description:BackgroundHip fractures are a common and costly health problem, resulting in significant morbidity and mortality, as well as high costs for healthcare systems, especially for the elderly. Implementing surgical preventive strategies has the potential to improve the quality of life and reduce the burden on healthcare resources, particularly in the long term. However, there are currently limited guidelines for standardizing hip fracture prophylaxis practices.MethodsThis study used a cost-effectiveness analysis with a finite-state Markov model and cohort simulation to evaluate the primary and secondary surgical prevention of hip fractures in the elderly. Patients aged 60 to 90 years were simulated in two different models (A and B) to assess prevention at different levels. Model A assumed prophylaxis was performed during the fracture operation on the contralateral side, while Model B included individuals with high fracture risk factors. Costs were obtained from the Centers for Medicare & Medicaid Services, and transition probabilities and health state utilities were derived from available literature. The baseline assumption was a 10% reduction in fracture risk after prophylaxis. A sensitivity analysis was also conducted to assess the reliability and variability of the results.ResultsWith a 10% fracture risk reduction, model A costs between $8,850 and $46,940 per quality-adjusted life-year ($/QALY). Additionally, it proved most cost-effective in the age range between 61 and 81 years. The sensitivity analysis established that a reduction of ≥ 2.8% is needed for prophylaxis to be definitely cost-effective. The cost-effectiveness at the secondary prevention level was most sensitive to the cost of the contralateral side's prophylaxis, the patient's age, and fracture treatment cost. For high-risk patients with no fracture history, the cost-effectiveness of a preventive strategy depends on their risk profile. In the baseline analysis, the incremental cost-effectiveness ratio at the primary prevention level varied between $11,000/QALY and $74,000/QALY, which is below the defined willingness to pay threshold.ConclusionDue to the high cost of hip fracture treatment and its increased morbidity, surgical prophylaxis strategies have demonstrated that they can significantly relieve the healthcare system. Various key assumptions facilitated the modeling, allowing for adequate room for uncertainty. Further research is needed to evaluate health-state-associated risks.

Project description:BackgroundCOVID-19 infection first emerged in December 2019 in China and has since rapidly spread to become a worldwide pandemic. Orthopaedic surgery suffered a significant decline in the volume of surgical cases, while the orthopaedic trauma services maintained or increased the activity. Emergency operations for proximal femur fractures (PFF) in the elderly population assumed levels comparable to before the pandemic, with the 1-year mortality rate ranging from 14% to 36%.AimsTo determine whether patients with PFF affected by COVID-19 have a higher risk of postoperative mortality through a systematic review and meta-analysis.MethodsPubMed, Web of Science, Scopus and BMC were searched from January 2020 to January 2021 to identify original studies reporting the mortality in COVID-19 patients after PFF surgery. Study and participants' characteristics, mortality rate and odds ratio (OR) were extracted. Risk of bias assessment was carried, and visual inspection of the funnel plot was used to assess publication bias. A random-effects model for meta-analysis was adopted.ResultsAmong 656 articles that came from the search query and hand-search, 10 articles were eligible after applying inclusion and exclusion criteria. Overall, the sum of the study participants was 1882, with 351 COVID-19 positive patients (18.7%) and a total number of 117 deaths, with an overall mortality rate of 33.3%. The mortality rate of COVID-19 positive patients varied from 14.8% to 60% and was higher than of those without COVID-19, with OR ranging from 2.424 to 72.00. The inverse variance method showed an OR = 3.652. All studies showed a statistically significant p-value.ConclusionsThe postoperative mortality in hip fracture patients with concomitant COVID-19 was 3.65 times higher than the mortality in non-COVID patients. The currently available literature demonstrates that COVID-19 infection represents a substantial risk factor for postoperative mortality in the already susceptible hip fracture population.

Dataset Information

The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial.

Publications

The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial.

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