Dataset Information

Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO): rationale and design.

ABSTRACT: BACKGROUND:More than 6200 End Stage Renal Disease patients in the Netherlands are dependent on dialysis, either performed at home or in a dialysis centre. Visiting a dialysis centre three times a week is considered a large burden by many patients. However, recent data regarding the effects of dialysis at home on quality of life, clinical outcomes, and costs compared with in-centre haemodialysis are lacking. METHODS:The Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO) is a nationwide, prospective, observational cohort study that will include adult patients starting with a form of dialysis. Health-related quality of life, as the primary outcome, clinical outcomes and costs, as secondary outcomes, will be measured every 3-6?months in patients on home dialysis, and compared with a control group consisting of in-centre haemodialysis patients. During a 3-year period 800 home dialysis patients (600 peritoneal dialysis and 200 home haemodialysis patients) and a comparison group of 800 in-centre haemodialysis patients will be included from 53 Dutch dialysis centres (covering 96% of Dutch centres) and 1 Belgian dialysis centre (covering 4% of Flemish centres). DISCUSSION:DOMESTICO will prospectively investigate the effect of home dialysis therapies on health-related quality of life, clinical outcomes and costs, in comparison with in-centre haemodialysis. The findings of this study are expected to ameliorate the shared decision-making process and give more guidance to healthcare professionals, in particular to assess which type of patients may benefit most from home dialysis. TRIAL REGISTRATION:The DOMESTICO study is registered with the National Trial Register on (number: NL6519 , date of registration: 22 August 2017) and the Central Committee on Research Involving Human Subjects (CCMO) (number: NL63277.029.17).

SUBMITTER: van Eck van der Sluijs A

PROVIDER: S-EPMC6751675 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO): rationale and design.

van Eck van der Sluijs A A Bonenkamp A A AA Dekker F W FW Abrahams A C AC van Jaarsveld B C BC

BMC nephrology 20190918 1

<h4>Background</h4>More than 6200 End Stage Renal Disease patients in the Netherlands are dependent on dialysis, either performed at home or in a dialysis centre. Visiting a dialysis centre three times a week is considered a large burden by many patients. However, recent data regarding the effects of dialysis at home on quality of life, clinical outcomes, and costs compared with in-centre haemodialysis are lacking.<h4>Methods</h4>The Dutch nOcturnal and hoME dialysis Study To Improve Clinical Ou ...[more]

PMID: 31533665

Similar Datasets

Project description:BackgroundThe incidence and prevalence of older patients with kidney failure who are dependent on dialysis is increasing. However, observational studies showed limited or no benefit of dialysis on mortality in subgroups of these patients when compared to conservative care. As the focus is shifting towards health-related quality of life (HRQoL), current evidence of effects of conservative care or dialysis on HRQoL in older patients is both limited and biased. Dialysis comes with both high treatment burden for patients and high costs for society; better identification of patients who might not benefit from dialysis could result in significant cost savings. The aim of this prospective study is to compare HRQoL, clinical outcomes, and costs between conservative care and dialysis in older patients.MethodsThe DIALysis or not: Outcomes in older kidney patients with GerIatriC Assessment (DIALOGICA) study is a prospective, observational cohort study that started in February 2020. It aims to include 1500 patients from 25 Dutch and Belgian centres. Patients aged ≥70 years with an eGFR of 10-15 mL/min/1.73m2 are enrolled in the first stage of the study. When dialysis is initiated or eGFR drops to 10 mL/min/1.73m2 or lower, the second stage of the study commences. In both stages nephrogeriatric assessments will be performed annually, consisting of questionnaires and tests to assess most common geriatric domains, i.e. functional, psychological, somatic, and social status. The primary outcome is HRQoL, measured with the Twelve-item Short-Form Health Survey. Secondary outcomes are clinical outcomes (mortality, hospitalisation, functional status, cognitive functioning, frailty), cost-effectiveness, and decisional regret. All outcomes are (repeated) measures during the first year of the second stage. The total follow-up will be a maximum of 4 years with a minimum of 1 year in the second stage.DiscussionBy generating more insight in the effects of conservative care and dialysis on HRQoL, clinical outcomes, and costs, findings of this study will help patients and physicians make a shared decision on the best individual treatment option for kidney failure.Trial registrationThe study was registered in the Netherlands Trial Register ( NL-8352 ) on 5 February 2020.

Project description:Background and objectivesData on racial disparities in home dialysis utilization and outcomes are lacking in Canada, where health care is universally available.Design, setting, participants, & measurementsWe studied patients starting maintenance dialysis between 1996 and 2012 in the Canadian Organ Replacement Register, stratified by race: white, Asian, black, Aboriginal, Indian subcontinent, and other. The association between race and treatment with home dialysis was examined using generalized linear models. Secondary outcomes assessed racial differences in all-cause mortality and technique failure using a Fine and Gray competing risk model.Results66,600 patients initiated chronic dialysis between 1996 and 2012. Compared with whites (n=46,092), treatment with home dialysis was lower among Aboriginals (n=3866; adjusted relative risk, RR, 0.71; 95% confidence interval, CI, 0.66 to 0.76) and higher in Asians (n=4157; adjusted RR, 1.28; 95% CI, 1.22 to 1.35) and others (n=2170; adjusted RR, 1.12; 95% CI, 1.04 to 1.20) but similar in blacks (n=2143) and subcontinent Indians (n=2809). Black (adjusted hazard ratio, HR, 1.31; 95% CI, 1.16 to 1.48) and Aboriginal (adjusted HR, 1.19; 95% CI, 1.06 to 1.33) patients treated with peritoneal dialysis had a significantly higher adjusted risk of technique failure compared with whites, whereas Asians had a lower risk (adjusted HR, 0.89; 95% CI, 0.82 to 0.99). In patients on peritoneal dialysis, the risk of death was significantly lower in Asians (adjusted HR, 0.83; 95% CI, 0.75 to 0.92), blacks (adjusted HR, 0.71; 95% CI, 0.59 to 0.85), and others (adjusted HR, 0.79; 95% CI, 0.68 to 0.92) but higher in Aboriginals (adjusted HR, 1.16; 95% CI, 1.02 to 1.32) compared with whites. Among patients on home hemodialysis, no significant racial differences in patient and technique survival were observed, which may be limited by the low number of events among each subgroups.ConclusionsWith the exception of Aboriginals, all racial minority groups in Canada were as likely to be treated with home dialysis compared with whites. However, significant racial differences exist in outcomes.

Project description:BackgroundThe transition from choosing to initiating home dialysis therapies (HDTs) is not clearly standardized for patients and staff, causing increased anxiety and suboptimal self-management for chronic kidney disease (CKD) patients. At BC Renal, a "Transition to HDTs" guidebook (the Guide) was designed, outlining a step-wise approach to transitioning to HDTs for patients, to help address some of these concerns.ObjectiveWe used the Logic Model evaluation framework to assess the value of the Guide to improve patient and staff experience with transitioning to HDTs.DesignThis is a prospective cohort quality improvement study.SettingThis study took place at home dialysis programs in British Columbia, Canada, with 2 pilot sites and 2 control sites.PatientsPatients above age 18 who attended kidney care clinics and identified HDT as their renal replacement treatment of choice were included in this study.MeasurementsPatient demographics were obtained from British Columbia Renal Patient Records and Outcomes Management Information System, with differences analyzed using Mann-Whitney U test and chi-square test where applicable. Patient surveys were based on Likert rating scales, analyzed using Cochran-Armitage trend test. All tests were 2-sided, with P < .05 considered significant.MethodsThe study enrolled patients from December 2018 to April 2019 at 2 pilot and 2 control sites. Patients were followed up for 8 months. The intervention strategies included (1) training of front-line staff to use the Guide and (2) dissemination of the guide to patients. Evaluation tools measuring data at baseline and at the 8-month point included (1) qualitative and quantitative patient surveys, (2) qualitative staff surveys, (3) structured feedback session with renal care staff, and (4) transition rate and time between choosing and starting a HDT.ResultsIn total, 108 patients were enrolled: 43 patients at pilot sites and 65 in control sites. Twenty-three of 65 in control vs 18 of 43 in pilot transitioned to a HDT by 8-month follow-up. Transition time was 80 vs 89 days in pilot vs control group, but it was not statistically different (P = .37). The proportion of patients that transitioned to a HDT was 42% vs 35% in pilot vs control group (P = .497). Patients' anxiety, illness knowledge, and activation of resources were not significantly different between patients who successfully transitioned at control and pilot sites. During interviews, patients confirmed that the Guide was effective and helped retain knowledge. The staff felt that the intervention did not increase their workload and that the Guide was a good communication tool, but was used inconsistently.LimitationsWe had a small sample size and limited number of patients enrolled who chose home hemodialysis, with none in the control group. The results are therefore more applicable to peritoneal dialysis.ConclusionsThe Logic Model was useful to evaluate our multi-intervention strategy. While there were no statistically significant differences in transition time, rate, and patient anxiety with or without the Guide, qualitative opinions from patients indicate that the Guide was a useful supplement. In addition, feedback from renal care staff suggested that the Guide served as a framework for communicating the transition process with patients, and was perceived as a useful tool. Future work is required to standardize the Guide's utilization.Trial registrationAs this is a quality improvement evaluation study, trial registration is not applicable.

Dataset Information

Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO): rationale and design.

Publications

Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO): rationale and design.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets