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A Methodological Description of a Randomised Controlled Trial Comparing Hospital-Based Care and Hospital-Based Home Care when a Child is Newly Diagnosed with Type 1 Diabetes.

ABSTRACT: AIM AND OBJECTIVE:To describe the study design of a randomised controlled trial with the aim of comparing two different regimes for children with newly diagnosed type 1 diabetes; hospital-based care and hospital-based home care. BACKGROUND:Procedures for hospital admission and sojourn in connection with diagnose vary greatly worldwide and the existing evidence is insufficient to allow for any conclusive determination of whether hospital-based or home-based care is the best alternative for most families. Comparative studies with adequate power and outcome measurements, as well as measurements of cost-effectiveness are needed. DESIGN:The study design was based on the Medical Research Council framework for complex interventions. After two to three days with hospital-based care, children between the ages of 3 and 16 were randomised to receive either continued hospital-based care for a total of 1-2 weeks or hospital-based home care, which refers to specialist care in a home-based setting. The trial started in March 2008 at a University Hospital in Sweden and was closed in September 2011 when a sufficient number of children according to power calculation, were included. The primary outcome was the child's metabolic control during the following two years. Secondary outcomes were set to evaluate the family and child situation as well as the organisation of care. DISCUSSION:Childhood diabetes requires families and children to learn to perform multiple daily tasks. Even though intervention in health care is complex with several interacting components entailing practical and methodological difficulties, there is nonetheless, a need for randomised controlled trials in order to evaluate and develop better systems for the learning processes of families that can lead to long-term improvement in adherence and outcome. TRIAL REGISTRATION:Trial Register NCT00804232.

SUBMITTER: Tiberg I

PROVIDER: S-EPMC3263442 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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A Methodological Description of a Randomised Controlled Trial Comparing Hospital-Based Care and Hospital-Based Home Care when a Child is Newly Diagnosed with Type 1 Diabetes.

Tiberg Irén I Carlsson Annelie A Hallström Inger I

The open nursing journal 20111118

<h4>Aim and objective</h4>To describe the study design of a randomised controlled trial with the aim of comparing two different regimes for children with newly diagnosed type 1 diabetes; hospital-based care and hospital-based home care.<h4>Background</h4>Procedures for hospital admission and sojourn in connection with diagnose vary greatly worldwide and the existing evidence is insufficient to allow for any conclusive determination of whether hospital-based or home-based care is the best alterna ...[more]

PMID: 22371819

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Project description:BackgroundThe policy in a number of countries is to provide people with a terminal illness the choice of dying at home. This policy is supported by surveys indicating that the general public and people with a terminal illness would prefer to receive end-of-life care at home. This is the fourth update of the original review.ObjectivesTo determine if providing home-based end-of-life care reduces the likelihood of dying in hospital and what effect this has on patients' symptoms, quality of life, health service costs, and caregivers, compared with inpatient hospital or hospice care.Search methodsWe searched the following databases until April 2015: Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), Ovid MEDLINE(R) (from 1950), EMBASE (from 1980), CINAHL (from 1982), and EconLit (from 1969). We checked the reference lists of potentially relevant articles identified and handsearched palliative care publications, clinical trials registries, and a database of systematic reviews for related trials (PDQ-Evidence 2015).Selection criteriaRandomised controlled trials, interrupted time series, or controlled before and after studies evaluating the effectiveness of home-based end-of-life care with inpatient hospital or hospice care for people aged 18 years and older.Data collection and analysisTwo review authors independently extracted data and assessed study quality. We combined the published data for dichotomous outcomes using fixed-effect Mantel-Haenszel meta-analysis. When combining outcome data was not possible, we reported the results from individual studies.Main resultsWe included four trials in this review and did not identify new studies from the search in April 2015. Home-based end-of-life care increased the likelihood of dying at home compared with usual care (risk ratio (RR) 1.33, 95% confidence interval (CI) 1.14 to 1.55, P = 0.0002; Chi(2) = 1.72, df = 2, P = 0.42, I(2) = 0%; 3 trials; N = 652; high quality evidence). Admission to hospital while receiving home-based end-of-life care varied between trials, and this was reflected by a high level of statistical heterogeneity in this analysis (range RR 0.62 to RR 2.61; 4 trials; N = 823; moderate quality evidence). Home-based end-of-life care may slightly improve patient satisfaction at one-month follow-up and reduce it at six-month follow-up (2 trials; low quality evidence). The effect on caregivers is uncertain (2 trials; low quality evidence). The intervention may slightly reduce healthcare costs (2 trials, low quality evidence). No trial reported costs to patients and caregivers.Authors' conclusionsThe evidence included in this review supports the use of home-based end-of-life care programmes for increasing the number of people who will die at home, although the numbers of people admitted to hospital while receiving end-of-life care should be monitored. Future research should systematically assess the impact of home-based end-of-life care on caregivers.

Project description:OBJECTIVES:To evaluate hospital-level variability in resource utilization and mortality in children with new leukemia who require ICU support, and identify factors associated with variation. DESIGN:Retrospective cohort study. SETTING:Children's hospitals contributing to the Pediatric Health Information Systems administrative database from 1999 to 2011. PATIENTS:Inpatients less than 25 years old with newly diagnosed acute lymphocytic leukemia or acute myeloid leukemia requiring ICU support (n = 1,754). INTERVENTIONS, MEASUREMENTS, AND MAIN RESULTS:Evaluated exposures included leukemia type, year of diagnosis, and hospital-wide proportion of patients with public insurance. The main outcome was hospital mortality. Wide variability existed in the ICU resources used across hospitals. Combined acute lymphocytic leukemia and acute myeloid leukemia mortality varied by hospital from 0% (95% CI, 0-14.8%) to 42.9% (95% CI, 17.7-71.1%). A mixed-effects model with a hospital-level random effect suggests significant variation across hospitals in mortality (p = 0.007). When including patient and hospital factors as fixed effects into the model, younger age, acute myeloid leukemia versus acute lymphocytic leukemia diagnosis, leukemia diagnosis prior to 2005, hospital-wide proportion of public insurance patients, and hospital-level proportion of leukemia patients receiving ICU care are significantly associated with mortality. The variation across hospitals remains significant with all patient factors included (p = 0.021) but is no longer significant after adjusting for the hospital-level factors proportion of public insurance and proportion receiving ICU care (p = 0.48). CONCLUSIONS:Wide hospital-level variability in ICU resource utilization and mortality exists in the care of children with leukemia requiring ICU support. Hospital payer mix is associated with some mortality variability. Additional study into how ICU support could be standardized through clinical practice guidelines, impact of payer mix on hospital resources allocation to the ICU, and subsequent impact on patient outcomes is warranted.

Project description:BackgroundPractices regarding hospitalisation of children at diagnosis of type 1 diabetes vary both within countries and internationally, and high-quality evidence of best practice is scarce. The objective of this study was to close some of the gaps in evidence by comparing two alternative regimens for children diagnosed with type 1 diabetes: hospital-based care and hospital-based home care (HBHC), referring to specialist care in a home-based setting.MethodsA randomised controlled trial, including 60 children aged 3-15 years, took place at a university hospital in Sweden. When the children were medically stable, they were randomised to either the traditional, hospital-based care or to HBHC.ResultsTwo years after diagnosis there were no differences in HbA1c (p = 0.777), in episodes of severe hypoglycaemia (p = 0.167), or in insulin U/kg/24 h (p = 0.269). Over 24 months, there were no statistically significant differences between groups in how parents' reported the impact of paediatric chronic health condition on family (p = 0.138) or in parents' self-reported health-related quality of life (p = 0.067). However, there was a statistically significant difference regarding healthcare satisfaction, favouring HBHC (p = 0.002). In total, healthcare costs (direct costs) were significantly lower in the HBHC group but no statistically significant difference between the two groups in estimated lost production (indirect costs) for the family as a whole. Whereas mothers had a significantly lower value of lost production, when their children were treated within the HBHC regime, fathers had a higher, but not a significantly higher value. The results indicate that HBHC might be a cost-effective strategy in a healthcare sector perspective. When using the wider societal perspective, no difference in cost effectiveness or cost utility was found.ConclusionsOverall, there are only a few, well-designed and controlled studies that compare hospital care to different models of home care. The results of this study provide empirical support for the safety and feasibility of HBHC when a child is diagnosed with type 1 diabetes. Our results further indicate that the model of care may have an impact on families' daily living, not only during the initial period of care but for a longer period of time.Trial registrationClinicalTrials.gov with identity number NCT00804232 , December 2008.

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A Methodological Description of a Randomised Controlled Trial Comparing Hospital-Based Care and Hospital-Based Home Care when a Child is Newly Diagnosed with Type 1 Diabetes.

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A Methodological Description of a Randomised Controlled Trial Comparing Hospital-Based Care and Hospital-Based Home Care when a Child is Newly Diagnosed with Type 1 Diabetes.

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