Introduction
Diverse digital health solutions have emerged with the development of information and communication technology [1]. Many digital health technologies have been rapidly adopted during the coronavirus disease 2019 (COVID-19) outbreak. Telehealth visits in the United States have increased to 52.7 million in 2020 from 0.84 million in 2019 [2], and the volume of remote patient monitoring has experienced a substantial surge, surpassing pre-pandemic levels by more than four-fold [3]. The Ministry of Health and Welfare of Korea initiated a home care program in December 2019, just before the COVID-19 pandemic [4]. The program included face-to-face educational consultations conducted by medical staff and remote patient monitoring using telephone calls or bidirectional messenger services. By continuously monitoring patients remotely, a multidisciplinary care team aimed to increase access to medical support and guide self-care to enhance patients’ quality of life. Considering that the most common purposes of digital health used during COVID-19 were clinical care (49.7%), follow-up care (15.3%), and medical education (9.9%) [5], the newly launched home care program contains the necessary digital health service content. Among the diverse diseases for which home care programs in Korea are currently available, this study focused on patients with end-stage renal disease (ESRD) undergoing peritoneal dialysis (PD), which was the first disease to be included in the home care program. It is necessary to evaluate the clinical effectiveness of the program for the first time in Korea to verify whether the newly launched home care program is socially worthwhile.
In 2020, the prevalence of ESRD in Korea was reported to be 145,006. Among them, 81.0% (117,398 patients) were undergoing hemodialysis (HD), 15.1% (21,884 patients) had received renal transplantation, and 3.9% (5,724 patients) were undergoing PD [6]. Many studies have addressed the benefits of home-based dialysis, including flexible scheduling [7], increased effectiveness in younger patients with fewer comorbidities [8], increased survival rates [9], improved cardiovascular outcomes and risk factors [10], and reduced COVID-19 incidence rates compared to in-center dialysis [11]. Unlike patients on HD who receive medical support during regular hospital visits, patients undergoing PD are responsible for self-care at home. The 2-month interval between hospital visits can make it difficult to identify medical issues, potentially leading to increased patient anxiety and related complications [12]. Therefore, the implementation of remote monitoring by medical staff may encourage hesitant patients with ESRD to change their minds. Evaluating the effectiveness of a newly implemented home care program using digital technologies is crucial in addressing care gaps.
Considering the close association between peritonitis, a common PD complication, and depression and poor quality of life [13], it is imperative to investigate the impact of the home care program on reducing peritonitis incidence. Previous studies have asserted the effectiveness of home care [10], text messaging [14,15], and patient education [16], but further clinical studies with a longer study period are needed to demonstrate the impacts of home care programs on the prevention of associated complications (peritonitis). To address this, we aimed to demonstrate the long-term clinical effectiveness of a home care program. As interest in adopting digital health continues to grow, the results of this study will serve as valuable evidence in understanding the rationale for accepting and expanding home care programs.
Methods
Study design
This retrospective cohort study was designed as a pre–post study to analyze the clinical impact of a PD home care program in a single tertiary care hospital. We measured outcomes before (pre-home care) and after (post-home care) program implementation. The program contains face-to-face educational consultations when patients with PD visit the hospital, as well as remote monitoring care services when they are at home. We selected 241 patients with PD who were reimbursed at least once for a home care program between June 2017 and May 2022. We then excluded 51 patients who were reimbursed for consultation before choosing their dialysis modality, as this was not directly related to the intervention. Additionally, four patients who were enrolled in the program after May 2022 and had no post-home care outcomes were also excluded. A total number of 186 patients with PD were included in the final analysis (Fig. 1). The collected 5-year data were used to identify clinical changes after the home care program by analyzing the following: 1) changes in the incidence of peritonitis over 4 years; 2) changes in clinical laboratory test results according to the proportion of patients who achieved the target range over 2 years; and 3) changes in clinical laboratory test results over 4 years.
Home care program
The home care program for patients with PD was initiated by the Ministry of Health and Welfare of Korea to continuously manage patients who need regular care for infection prevention and to avoid potential risks that may occur due to medical gaps. The program [4] started in December 2019 and targeted patients with PD with stage 5 chronic kidney disease (International Classification of Diseases, 10th Revision code N18.5) who agreed to participate. Once enrolled in the program, patients could be reimbursed for three types of medical services: Education 1, Education 2, and Monitoring services. The Education 1 code allowed for reimbursement when physicians conducted face-to-face educational consultations for 15 minutes. The Education 2 code covered face-to-face educational consultations conducted by physicians or nurses for 20 minutes. Reimbursement for the remote “Monitoring” code was applicable when medical staff remotely monitored a patient’s condition using bidirectional messenger services. Details of home care program services are described in Table 1. In this study, we excluded Education 1 (claim code: IB511) cases, as these were not specifically intended for patients with PD but rather encompassed all patients with ESRD.
Data and variables
Clinical data recorded during the study period (June 2017 to May 2022) were extracted from the Severance Clinical Research Analysis Portal service of Severance Hospital (Seoul, Korea). The electronic medical records contained no personally identifiable information. The requirement for informed consent was waived due to the retrospective nature of this study.
Demographic (sex and age) and clinical (PD duration) independent variables were categorized into two groups for subgroup analyses. The dependent variables and clinical outcomes of 1) peritonitis and 2) clinical laboratory test results, including hemoglobin (Hb, g/dL), calcium (Ca, mg/dL), phosphorus (P, mg/dL), potassium (K, mEq/L), and intact parathyroid hormone (iPTH, pg/mL) levels, were collected. The clinical laboratory test variables were collected as categorical data, indicating whether the target range was achieved (coded as 1) or not (coded as 0), as well as continuous data. The clinical target ranges for each variable were established according to the internal criteria: Hb (10.0–11.5 g/dL), Ca (8.5–10.5 mg/dL), P (2.8–4.5 mg/dL), K (3.5–5.5 mEq/L), and iPTH (150–300 pg/mL).
Statistical analyses
Data are presented as means ± standard deviations for continuous variables and as percentages (%) for categorical parameters. Chi-square tests were conducted for the in- and out-of-range groups to examine the proportion of patients who achieved the clinical target range. This was to assess the short-term effectiveness of the home care program. For the long-term effectiveness, interrupted time series (ITS) analyses [17,18] using an ordinary least squares linear regression model were performed. Data were aggregated according to the time intervals for both the peritonitis and clinical laboratory test results in order to evaluate the long-term clinical effectiveness of home care interventions. Due to variations in the enrollment dates of patients in the home care program, we adjusted the time point of the intervention for each patient. This resulted in a baseline period consisting of 2 years of data prior to the adoption of the intervention, and a post-home care period consisting of 2 years of data at 1-month intervals. Full linear regression ITS models were constructed, and the parsimonious model was adjusted for peritonitis analyses. The ITS models used in this study are described by the following equations:
Results of the full regression model
Yt= β0+(β1× T)+(β2×Dt)+(β3×TDt)+εt
Results of the parsimonious model
Yt'= β0+(β1×T)+(β3×TDt)+εt
where,
Yt the results of the full regression model at time t
Yt’ the results of the parsimonious model at time t
β0 the baseline level at T = 0
β1 the changes in outcome per time unit increase (pre-home care trend)
β2 the level of change after the home care intervention
β3 the changed trend (slope) after the intervention (post-home care trend)
T the 1-month interval since the start of the study
Dt the dummy variable (0 for pre-home care and 1 for post-home care) at time t
TDt a time interval of 1-month after the intervention at time t
All analyses were performed using R Statistical Software (version 4.2.1; R Core Team 2022), RStudio Software (version 2022.07.1; RStudio Team 2022), and IBM SPSS for Windows version 26.0 (IBM Corp). The statistical significance level was set at p < 0.05.
Results
General characteristics
Table 2 shows the general characteristics of the 186 patients with PD who were enrolled in the home care program at the single center. The mean age of the population was 54.7 years, with a standard deviation of 13.6 years. The average duration since the start date was 6.6 ± 4.4 years. We divided the population into subgroups based on sex (male vs. female), age (<55 years vs. ≥55 years), and PD durations (<6 years vs. ≥6 years) for detailed analysis. Patients with PD were enrolled in the home care program in June 2020. To determine the patients’ exposure to the home care program, we identified the number of reimbursement cases. The average number of reimbursed cases was 0.42 ± 0.47 times for Education 1 (conducted by physicians), 3.54 ± 1.31 times for Education 2 (executed by other medical staff), and 7.15 ± 2.45 times for remote monitoring care (phone calls by medical staff). The following baseline clinical outcomes at the time of home care program enrollment were reviewed: Hb (10.20 g/dL), Ca (8.96 mg/dL), P (5.18 mg/dL), K (4.45 mEq/L), and iPTH (243.0 pg/mL).
Changes in the incidence of peritonitis over the 4 years
Table 3 shows the overall results of the ITS analyses, representing the changes in monthly peritonitis incidence. The baseline value was 8.892 cases per 1,000 patient-months (standard error, 3.383; p = 0.01), which continuously increased to 0.409 cases per 1,000 patient-months (p for baseline trend = 0.10). After starting the home care program, the incidence increased by 2.538 per 1,000 patient-months, without statistical significance (p for level change = 0.61). However, the incidence trend significantly decreased by 0.898 cases per 1,000 patient-months (p = 0.01). Additionally, we conducted further analyses by eliminating the nonsignificant variable (“Prepost [β2]”) and using the most parsimonious regression model, which included the Constant (β0), Time (β1), and TimeSince (β3) variables. In terms of subgroup analysis by sex, the male group showed no significant changes, whereas the incidence trend in the female group significantly decreased by 1.251 cases per 1,000 patient-months after starting the home care program (p for trend change = 0.02). When analyzed by age subgroups, patients with PD aged >55 years showed significant improvement in the incidence of peritonitis (the trend declined by 1.439 cases per 1,000 patient-months, p = 0.01). Similarly, in the subgroup analysis based on PD duration, patients with PD with a duration of more than 6 years showed significant improvement in the incidence of peritonitis, with a decreasing trend of 1.289 cases per 1,000 patient-months after the home care intervention (p for trend change = 0.02). Graphical summaries of changes in the incidence of peritonitis are presented in Fig. 2.
Changes in the proportion achieving the target range over the 2 years
The overall percentages of those achieving the target range are shown in Fig. 3. The percentage of in-range Ca significantly increased by 4.9%p (from 63.6% pre-home care to 68.6% post-home care, p = 0.003). The target Hb and P levels were maintained at 34.7% (from 33.5% in the pre-home care group, p = 0.48) and 36.0% (from 33.2% in the pre-home care group, p = 0.09), respectively. In addition, the proportion of those achieving the target K was maintained at 83.6% without statistically significant changes (p = 0.22). Finally, unlike other measures, the proportion of the populations achieving the target parathyroid hormone range significantly decreased by 6.6%p (from 36.5% to 29.9% in the overall population, p = 0.005). The subgroup analyses for sex, age, and PD duration are summarized in Supplementary Figs. 1 to 3 (available online).
Changes in the trends of the clinical laboratory test results over the 4 years
We performed ITS analyses to identify changes in clinical laboratory test results over time (Table 4). Specifically, within a time interval of 1 month, we assessed the clinical outcomes reported in the pre-home care (2 years) and post-home care (2 years) periods. The Hb level in the pre-home care period significantly decreased by 0.023 g/dL per month (p for baseline trend = 0.007). After adopting the home care program, the value immediately increased by 0.490 g/dL (p for level change = 0.006), and its month-to-month value increased by 0.016 g/dL (p for trend change = 0.20). The Ca and P levels showed no significant changes in the pre-home care period (–0.006 mg/dL, p = 0.15 and 0.007 mg/dL, p = 0.13, respectively). In terms of K levels, the monthly trend in the pre-home care period significantly declined by 0.008 mEq/L per month (p for baseline trend = 0.02). However, there was a slight increase in both the level and slope of K after the home care intervention, although these changes were not statistically significant. Conversely, parathyroid hormone levels significantly increased by 2.829 pg/mL per month (p for trend change = 0.02) after the home care intervention. The results of the subgroup analyses (sex, age, and PD duration) are shown in Supplementary Tables 1 to 3 (available online).
Discussion
With the increasing interest in implementing digital health [1,19,20], our study offers evidence justifying the clinical effectiveness of adopting digital health services in the analysis of a PD home care program. To follow up on potential complications in patients with PD, we used long-term (5-year) hospital data to examine the clinical effectiveness of the home care program.
Considering that complications are a major concern for patients with PD when choosing their dialysis modality [21], we analyzed any changes in the incidence of peritonitis after adopting the home care program using long-term data. In addition, we evaluated the clinical laboratory test results that accumulated when patients visited the hospital every 2 months. These test results provided valuable insights into the effectiveness of improved self-care practices among patients with PD.
Through the utilization of ITS analyses and the evaluation of the proportion of patients achieving the clinical target range, we were able to demonstrate the trend of clinical outcome changes among patients with PD. However, it is important to interpret the results of the ITS analyses cautiously. We analyzed hospital data at the aggregate level to observe the overall changes in the incidence of peritonitis over 4 years, rather than at the individual patient level. In addition, the population size at each (monthly) time point varied and decreased over time.
To further expand on the research conducted by the Health Insurance Review and Assessment Service in Korea [21], which aimed to identify the short-term effectiveness of home care programs, our study continued this research to determine their long-term effectiveness. We found that the home care program examined helped maintain or improve both the incidence of peritonitis and the percentage of patients reaching the target range for clinical laboratory test results. Furthermore, subgroup analyses revealed significant improvements in the female population as well as among older patients and those with longer PD vintages. Notably, patients with ESRD have a 2.6 to 3.2 times higher risk of cognitive impairment compared to non-ESRD populations [22]. Therefore, patients who are older and have longer PD vintages require comprehensive education on dialysis, nutrition, and exercise guidelines. Therefore, this remote home care program served as a valuable resource for patients with PD, helping them adhere to crucial dialysis steps and bridging the medical gap between regular hospital visits.
The percentage of subjects reaching the iPTH target range was the only clinical laboratory result that decreased after the implementation of the home care program. This may be because iPTH continues to rise due to secondary hyperparathyroidism in patients with ESRD when PD vintages become longer [23,24]. According to the results of the subgroup analysis (refer to Supplementary Fig. 3, available online), the proportion of patients achieving an in-range iPTH was consistently maintained in the longer PD vintage compared to the shorter vintage. Notably, previous studies have indicated that 47% of patients had abnormal iPTH levels (514.9 pg/mL on average), a high prevalence of hyperparathyroidism, and increased iPTH levels during follow-up [25]. Moreover, even with increasing iPTH values, the changes in our data (with a 15.7% increase from 242.0 to 287.0 pg/mL) are considerable compared to a previous study [26] that followed the iPTH trends in patients over 2 years (demonstrating a 64.4% increase from 94.3 to 264.0 pg/mL). Furthermore, we observed large individual variations in iPTH levels (pg/mL), emphasizing the importance of considering aggregated data individually. Although an increase in iPTH levels would typically correspond to worsening clinical parameters, our data demonstrated that other values, such as Hb, P, and K, were maintained or even improved, whereas Ca levels showed improvement from the initial value. Despite the inherent nature of iPTH, other parameters can be managed with home care programs by providing education, reminders, and guidelines for nutrition and exercise to patients with PD. However, further studies comparing home care and usual care groups are recommended to demonstrate the impact of these types of programs on iPTH outcomes.
After the COVID-19 pandemic, New York City health officials implemented telehealth visits for patients undergoing home dialysis using platforms such as Zoom for Healthcare or FaceTime. In particular, patients with PD used a remote patient management platform, and home dialysis nurses visited patients’ homes if needed (such as when requiring blood samples) [27]. Unlike non-billable medical services, Korea’s home care program provides reimbursement for these telehealth services. Based on the 2020 satisfaction surveys (n = 398) of our home care program [21], 97.6 and 100% of patients with automated PD and continuous ambulatory PD (CAPD), respectively, were satisfied with the medical staff’s early detection of symptoms, and the majority wished to continue the home care program (93.7%).
Although our study demonstrates the clinical effectiveness of the home care program, there is still a need to strengthen its service content and systems. To improve patient self-care behaviors, an integrated and patient-centered monitoring app containing bidirectional messengers and data management functions can motivate patients [28] to manage their diseases by themselves and simultaneously enhance medical staff productivity. Considering that CAPD requires a high level of self-management, the app can provide updated educational content and reminders for patients to adhere to their lifestyle guidelines. Regular updates to the educational content would ensure that patients receive the most current information and guidance.
Many digital health solutions are being prepared for the post-pandemic world [29], and remote monitoring care from medical staff is necessary for patients with PD who require integrated self-care management throughout their lifetime. The key question for adopting remote patient monitoring technologies for patients with PD is whether they can help reduce the rates of technique failure, which mainly occur due to peritonitis [30]. The reduction in peritonitis incidence observed in the home care program underscores its significance for patients with ESRD when making informed decisions about the type of renal replacement therapy. However, further attention is required when implementing digital health solutions for the older population [31,32], as this population may face challenges with digital technologies, including a lack of confidence/experience in e-health, struggles using a small screen and text, and troubleshooting issues [33]. However, when digital health resources are limited, it is recommended to focus on female patients, older individuals, and those with longer PD vintages, as these individuals demonstrated compliance and improvement after the home care program in our study. Additionally, older individuals are often motivated to learn and feel confident when they receive dedicated support [33].
This study has several limitations that should be interpreted with caution. First, our data included only 186 patients with PD, which may not reflect the demographic characteristics of all patients with PD in Korea. Second, our clinical effectiveness analyses used data from a single tertiary care hospital. The regular follow-up interval for PD patients in our case is every 2 months, but this frequency may not reflect routine practices in all hospitals. Different healthcare facilities may adopt varying schedules for regular check-ups, so caution should be exercised when making broad generalizations at the national level. Moreover, as a tertiary care hospital, our institution may treat patients with more severe conditions, leading to higher healthcare expenditures and potentially worse clinical outcomes. Additionally, hospitals typically have sufficient medical staff and high-quality infrastructure, enabling them to provide a home care program without supplementing any additional resources. Third, we could not establish a control group that was not involved in the home care program, as every patient with PD in our center was enrolled in the program. Therefore, we could not compare the differences between these types of groups. Instead, we compared the pre-home care and post-home care groups using a single-arm, pre–post study design. Also, the incidence of peritonitis can be influenced by several factors including patients’ comorbidity, education level, socioeconomic status, level of physical activity, and history of prior peritonitis. In this study, we were unable to identify additional factors beyond sex, age, and PD duration. Finally, as mentioned in the discussion of the study results, the outcomes for iPTH could not be compared with those of a non-home care group. Instead, we relied on interpreting their potential implications based on previous studies. Further research is warranted to establish the effectiveness of home care programs, specifically on iPTH levels. Notably, our study like many other studies conducted during the COVID-19 pandemic, may have been affected by unnoticeable interruptions resulting from the unique circumstances of the COVID-19 pandemic.
Despite the above limitations, this is the first study to demonstrate the long-term clinical effectiveness of a PD home care program in Korea. We demonstrated the clinical effectiveness using long-term clinical data and discovered that the program reduced the incidence of peritonitis and improved laboratory test results. Therefore, considering the social demands for remote medical services after the COVID-19 pandemic, our study proved that the implementation of home care programs for patients with PD is clinically effective, especially for the female, older, and longer PD vintage patients. With the profound clinical and social implications of our study, the implementation of home care programs for patients with PD is undoubtedly justified. However, future endeavors should focus on developing optimized systems and methods to enhance the operational efficiency and scalability of such programs, leveraging advanced digital technologies. Further research is warranted to establish the ultimate framework for running home care programs effectively and maximizing their benefits.
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