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Patient cohort and settings The protocol for this trial and supporting CONSORT checklist are available as supporting information; see Checklist S1 and Protocol S1. This is an analysis of a subset population from our previously reported randomized cohort (Clinical Trials.gov NCT00644046) [16]. Briefly, the cohort includes predialysis CKD patients with an estimated glomerular filtration rate (eGFR) of <60 mL⋅min−1⋅1.73 m−2 (determined by using the Modification of Diet in Renal Disease equation) who visited the nephrology outpatient clinics of the Department of Nephrology, Chang Gung Memorial Hospital, Keelung, from July 2007 and followed up to June 30, 2011. Patients aged 18–80 years and without renal graft failure were included in the study after obtaining informed consent from them. A total of 2280 patients were enrolled in the study and were randomly divided into the MPE group and the non-MPE group by using a random table at study entry. Four hundred and five patients reached ESRD needing hemodialysis after a mean follow-up of 33±2.6 months (232 patients in the MPE group and 213 patients in the non-MPE group, as shown in Figure 1). The medical expenditure and utilization in the first 6 months of initiation of hemodialysis in these 425 patients were accurately recorded and compared between MPE and non-MPE patients. Medical service utilization was calculated as the frequency of outpatient visits and the frequency and length of hospitalization. Outpatient visits were categorized as outpatient services, preventive care (e.g., influenza vaccination and dietary counseling), and emergency services. Medical service expenditures included outpatient expenditures (all costs including physicians' and nursing fees, examinations, surgery, and medication) and inpatient expenditures (all costs including laboratory testing, imaging testing, medications, surgery and consulting, ward and administrative, nasogastric tube feeding, and hemodialysis fees). The expenditures for each participant were totaled to compute the sum of ambulatory and inpatient medical service utilization costs and expenditures. The analysis of costs in this study only included those medical costs for which our hospitals made reimbursement claims to the NHI. The salaries, overheads, and administrative costs of the care team were not included. This study was approved by the ethics committee of the institutional review board of Chang Gung Memorial Hospital (Number: 100-0040A3, 96-0408B) and was conducted according to the principles expressed in the Declaration of Helsinki. All patients provided written informed consent. The registration of our cohort at Clinical Trials.gov was delayed by administrative issues (set up of Core Lab, employment of research assistance). The authors confirm that all ongoing and related trials for this drug/intervention were registered.
Figure data removed from full text. Figure identifier and caption: 10.1371/journal.pone.0112820.g001 Enrolment scheme and patient status. MPE: multidisciplinary predialysis education.
The MPE program was implemented in May 2006 at the Keelung Center. The team comprised a nurse for case management, social workers, dietitians, hemodialysis, peritoneal dialysis patient volunteers and 10 nephrologists. The program consisted of an integrated course involving individual lectures on renal health, delivered by the case-management nurse, according to the guidelines given in a standardized instruction booklet. The lectures focused on nutrition, lifestyle, nephrotoxin avoidance, dietary principles, and pharmacological regimens. Furthermore, the case-management nurse contacted the patients to ensure timely follow-up. Standardized interactive educational sessions were periodically conducted wherein all patients were interviewed depending on their CKD stage, determined earlier by using the NKF/DOQI guideline. Stage III or IV CKD patients were followed up every 3 months, and stage V CKD patients were followed up on a monthly basis. For stage III CKD patients, the program consisted of lectures on healthy renal function, the clinical presentation of uremia, risk factors and complications associated with renal progression, and an introduction to the various renal replacement therapies (i.e., hemodialysis, peritoneal dialysis, and renal transplantation). For stage IV CKD patients, the program included discussions on the management of complications associated with CKD, indications of renal replacement therapy, and the evaluation of vascular or peritoneal access. Patients with stage V CKD were monitored for timely initiation of renal replacement therapies, the care of vascular or peritoneal access, dialysis-associated complications, and registration for inclusion in the renal transplantation waiting list. All patients received dietary counseling biannually from a dietitian. In addition, the case-management nurse often contacted the participants by telephone to encourage them to inform their nephrologists of their symptoms and to reinforce the importance of medical visits. The MPE program was discontinued once renal replacement therapies were initiated for these patients.
The same group of nephrologists instructed all participants about renal function, the evaluation of laboratory data, and clinical indicators of chronic renal failure, as well as about the strategies for its management and treatment. Furthermore, the nephrologists explained the general principles of hemodialysis and peritoneal dialysis when the patients exhibited an eGFR of <30 mL⋅min−1⋅1.73 m−2 (stage IV CKD). All patients were provided with written instructions. The nephrologists evaluated the comorbidity factors influencing each patient's condition before referral to a nurse specializing in hemodialysis or peritoneal dialysis. The nursing staff provided instructions for daily living and explained the criteria used for hemodialysis and peritoneal dialysis selection, and the difference between the two modalities.
Descriptive statistics were expressed as the mean (standard deviation) or median (interquartile range). Discrete variables were presented in terms of frequencies and percentages. The normality of numerical variables was tested using the Kolmogorov-Smirnov method, and an appropriate transformation was considered before statistical testing. The Student t-test or Mann-Whitney U-test was applied to compare mean or median values among the groups. The association between categorical variables was analyzed by using the χ2 test. Multiple linear regression analysis was applied to calculate the unstandardized coefficients associated with MPE in both inpatient and total medical cost. All statistical tests were two-tailed, and a p value <0.05 was considered to be statistically significant. Data were analyzed by using SPSS 17.0 for Windows XP (SPSS Inc., Chicago, IL, USA).
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