La telemedicina e il monitoraggio da remoto in dialisi peritoneale migliora gli outcome clinici, la qualità di vita e l’efficienza dei costi

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Introduction

Peritoneal dialysis (PD) is a widely used renal replacement therapy allowing end-stage renal disease patients to undergo a home-based treatment. However, patients still require periodic hospital visits to receive a full assessment of treatment adequacy [1]. The autonomy of the technique and the lack of real-time monitoring represent the reason for poor adherence, ranging from 5% to 20% in automated peritoneal dialysis (APD) prescriptions, representing a significant risk factor for mortality and hospitalizations [2].

In the last decades, a web-based system for remote monitoring (RM) was introduced in the clinical practice, allowing for patient monitoring at home [3, 4].

During the COVID-19 pandemic, social distancing and regulatory waivers from state governments under the Public Health Emergency provided further opportunities for home dialysis patients to access telemedicine [5, 6].

Recently, it has been reported that the use of RM in APD was associated with lower hospitalization rates and length of hospital stay [7].

Moreover, a recent study assessed the impact of RM-APD interventions in terms of all Standardized Outcomes in Nephrology in peritoneal dialysis (SONG-PD) clinical outcomes, revealing that the RM was associated with a better technique survival [8].

Despite the advantages, PD has minimal use in developed countries, due to the reimbursement system, the patients’ or caregivers’ fear regarding the ability to learn the use of dialysis devices, or consider the home care as a burden for the family [9].

This study evaluated the impact of the telemedicine and the remote monitoring on PD, evaluating the safety of the patient managed at home, the quality of the medical and nursing services analysing clinical parameters, such as infectious complications and hospitalizations, also assessing the effects on the quality of life.

 

Patients and Methods

Study design

73 patients undergoing PD at the Nephrology and Dialysis Unit of the Papardo Hospital in Messina were enrolled, from January 2016 to September 2023.

All the patients enrolled in our study were treated by the APD technique (HomeChoice; Baxter Healthcare Corporation, Deerfield, IL, USA). In particular, 39 patients (APD group) were followed with scheduled medical and nursing visits at the hospital centre, daily for a week after the implantation of the peritoneal catheter, and monthly after starting treatment at home.

The data related to this group refers to the period before the use of remote controlling applied to the APD patients, enrolled from 2016 until 2020.

The remaining 34 patients (RM-APD group) received complete assistance at home, since the end of the training, followed at home with remote control. In particular, the medical and nursing team trained patients and their caregivers for telemedicine management and remote monitoring, through video call and telephone contacts.

All data related to PD have been collected through the Claria software and the Share Source platform (Baxter, Italy), such as daily peritoneal ultrafiltration volume, adherence to therapy, defined as the real time of connection compared to the medical prescription, and the dialysis time, expressed as minutes/week performed according to the prescription. Clinical and PD data of the APD group have been collected from individual patient medical charts.

All the clinical events have been recorded, such as peritonitis, infections, COVID-19 infections, hospitalizations, and conversion to HD treatment.

All patients received a Short Form Health Survey 36 (SF-36) questionnaire, concerning the quality of life assessment, at the beginning and at the end of the study.

In addition, the same questionnaire was administered to 30 hemodialyzed patients, similar in sex, age, comorbidity and age of dialysis. 

Follow-up period and outcomes

The start of the observation period for both groups was the end of the training period, with a follow-up of 6 months.

During the videocalls or telephone contacts, nurses and nephrologists evaluated specific clinical check-points, such as residual diuresis, pressure values, weight, and blood glucose control in diabetic patients.

Data related to PD treatment, such as daily ultrafiltration rate and dialytic time, or clinical signs and symptoms of hypervolemia, such as edema, shortness of breath, cough were then recorded.

The staff evaluated, through the videocall, the exit-site and the catheter status, and its placement. Moreover, all these data were discussed with the patient and his caregiver, changing in real time both medical and dialysis therapy.

Economic analyses

The costs of PD and HD techniques were evaluated by analysing the data of the competing bidding process of the Eastern Sicily for PD and HD treatments, to which the Papardo Hospital of Messina joined with Protocol Note 32595 of 11/07/2021and protocol Note 66 of 25/01/2022, respectively.

The cost of health care professionals has been assessed according to the National Collective Labour Agreements (CCNL).

Statistical analysis

Statistical analyses were performed with NCSS for Windows (version 4.0), the Med-Calc (version 20.115; MedCalc Software Acacialaan, Ostend, Belgium) software, and the GraphPad Prism (version 9.4.1; GraphPad Software, Inc., San Diego, CA, USA) package. Baseline characteristics were reported as frequencies with percentages for categorical variables and medians with interquartile ranges for continuous variables. Differences between groups were established by unpaired t-test or by ANOVA followed by Bonferroni’s test for normally distributed values and by Kruskal-Wallis analysis followed by Dunn’s test for nonparametric values.

The study was approved by the local ethical committee of the University of Messina (Protocol number 20-20). Each patient recruited for the study gave written consent before enrolment.

 

Results

Patients’ characteristics

The characteristics of the entire cohort of patients enrolled in the study are given in Table 1.

	PD (n: 73)	APD (n: 39)	RM-APD (n: 34)	p
Age	69.2 ± 14.5	69 ± 17.1	69 ± 11	0.62
Gender, M/F	50/23	28/11	22/12	0.22
Diabetes, n (%)	23 (31)	15 (38)	8 (23)	0.71
Hypertension, n (%)	51 (79)	29 (74)	22 (67)	0.17
Heart failure, n (%)	12 (16)	8 (20)	4 (12)	0.31
Smoke, n (%)	8 (11)	5 (13)	3 (9)	0.58
Hospitalization, n	24	17	7	0.03
Exit site infection, n	11	8	3	0.04
Peritonitis, n	10	8	2	0.03
Switch to HD, n	13	10	3	0.04

Table 1. Characteristics of the study population. Abbreviations: PD: peritoneal Dialysis; APD: automatized peritoneal dialysis without remote monitoring; RM-APD: automatized peritoneal dialysis with remote monitoring; HD: hemodialysis.

Clinical and dialytic data

At the end of the follow-up period, we found no differences in terms of adherence, accuracy and dialysis efficacy between the two groups, as well as there were no statistically significant differences for clinical data such as pressure monitoring, weight and glycemic control. RM-APD patients need less unscheduled outpatient visits if compared to the APD group. The hospital access was due to machine malfunction or issues related to the peritoneal catheter.

At home, the main actions performed by the staff in RM-APD patients, were focused on the correct use of the catheter and the exit-site management.

In particular, preventive actions were performed in real-time, with a better clinical outcome, reducing unplanned outpatient and emergency visits, and improving, not least, the interaction between the patient, the caregiver and the healthcare personnel. Moreover, the dialysis prescription was modified more frequently in the RM-APD group in real-time, if compared with the modifications performed during the monthly visit in APD patients, in terms of UF change, rest time and duration of treatment, achieving a better personalization of the dialytic treatment.

Hospitalization

33% of DP patients were hospitalized for causes related to the dialysis technique. In particular, 10 patients were admitted for infectious diseases related to peritonitis, while 2 patients were hospitalized for leakage and repositioning of the peritoneal catheter.

The remaining patients were hospitalized due to fluid overload, cardiac and/or pulmonary failure. The number of hospitalizations was statistically lower in the RM-APD group than APD patients (7 vs 17; p: 0.03) (Figure 1).

Switch from DP to HD

During the follow-up period, 13 patients were switched from the PD technique to HD.

In particular, 2 patients had recurrent peritonitis, 7 patients did not obtain an adequate ultrafiltration rate with consequent fluid overload, 1 patient had a peritoneal catheter dysfunction and 3 patients were treated by HD during surgical procedures not related to PD. 10 patients belonged to the ADP group, whereas the remaining 3 patients had a remote control (p: 0.04) (Figure 2).

Moreover, in these latter the drop out was related to surgical procedures and to a fluid overload, revealing that the telemedicine and the remote-control approach has proven safe in the management of these patients, not being a cause of dialysis technique failure.

PD and Covid-19 Infection

We enrolled 34 patients during the Covid pandemic, from 2021 to 2022. Of them, 12 patients (34%) had a Covid infection and only 3 patients were hospitalized, not determining a drop-out of the PD technique.

This epidemiological datum is statistically better if compared to the rate of Covid-related infections of HD patients observed in our same Centre (31 patients vs 12; p: 0.02), with a hospitalization required in 70% of cases (70% vs 15% of PD patients; p:0.001) (Figure 3).

Moreover, the HD patients had a poor prognosis, evaluating a higher mortality rate

(52%).

Quality of Life

We revealed that the PD patients had a better psycho-physical state, with better scores in physical performance (p = 0.02) and psycho-emotional well-being (p = 0.001), performing social functions more adequately than HD patients (p = 0.01).

The final result is a better perception of health in general in PD patients, notwithstanding an increased physical limitation due to psycho-emotional causes (p: 0.03). Instead, we found no statistically significant differences in the sphere of vitality, defined as the perception of fatigue in carrying out normal daily activities, and the sphere of pain (p > 0.05) (Figure 4).

Table 2 summarizes the scores obtained in relation to the individual categories of the questionnaire.

SF-36 Item	MR-ADP n: 34	HD n: 30	p
Physical Functioning	58 ± 2.5	38 ± 2.7	0.02
Role Limitations (Physical)	37 ± 4.6	38 ± 2.8	0.22
Role Limitations (Emotional)	35 ± 5.7	49 ± 6.2	0.03
Energy of Vitality	52 ± 7.8	55 ± 4.9	0.31
Mental Health	88 ± 2.9	59 ± 9.3	0.001
Social Functioning	77 ± 7.8	55 ± 8.1	0.01
Pain	77 ± 12.5	62 ± 9.8	0.09
General Health Perceptions	53 ± 14.6	38 ± 8.9	0.02
Change in health over the last year	54 ± 6.7	50 ± 5.5	0.42

Table 2. SF-36 scores in PD and HD patients. Abbreviations: SF-36: 36-Item Short Form Survey; PD: peritoneal dialysis; HD: hemodialysis; RM-APD: automatized peritoneal dialysis with remote monitoring.

Economic Analyses

At our Centre, a remote-assisted PD program at home predicted costs of 958 €/patient/month, or 11,496 €/patient/year, including the supply of the telemedicine system, the dialysis instrumentation and the cost of the medical-nursing staff involved.

This financial commitment was found to be about a third of what was required for the management of a tri-weekly HD patient, whose average annual cost was about 50,000 €/patient/year.

Moreover, this economic difference did not include the human labour capital, which defined as the cost of losing production capacity due to the renal disease and the related disabilities, such as the need for early retirement or continued absence from work.

This condition could be not involving PD patients, performing the dialysis session during the night, working during the day.

In addition, the home dialysis reduces indirect costs, such as those due to the transport system, around 5,000 €/patient/year, per journey from home to hospital dialysis service.

 

Discussion

We demonstrated that the telemedicine and the remote monitoring system of the PD patient is safe. Moreover, this method allows for early and preventive medical and nursing staff actions, improving patient outcomes, as suggested by the Italian Society of Nephrology and the International Society of Peritoneal Dialysis guidelines and recommendations.

RM-APD patients had fewer clinical or technical problems, with better problem-solving by the healthcare staff at an early stage, preventing the hospitalization, improving the compliance to the therapy and the quality of life.

The crisis of the national Healthcare System caused by the Covid-19 pandemic forced and accelerated the use of remote monitoring in our patients, growing-up the telemedicine system. Control strategies have been developed to assess the adherence and the compliance to the therapy, evaluating the real administered treatment time and the prescribed dialysis dose, performing preventive, personalized measures in real time that improved patient outcomes, such as better care, quality of life and, last but not least, cost reduction. Our data showed that the number of hospitalizations for PD-related causes was lower in the remotely managed group, positively impacting the reduction of the number of catheter-related complications and infectious episodes, such as peritonitis.

This condition resulted in a reduced number of PD interruption and HD transition, as observed in the APD group, not remotely controlled, in which the high drop out of the method towards HD was related to the high episodes of peritonitis and issues related to the catheter.

Furthermore, the remote monitoring, detecting inadequate ultrafiltration rate or scarce depurative efficacy, gave the possibility to correct the dialysis prescription in real time, achieving a personalized treatment, reducing the causes of drop-out due to dialysis inefficiency.

Carrying out the daily activities has been the most highlighted factor by our patients, contributing to the improvement of their quality of life and of their caregivers.

However, the physical limitations due to the psycho-emotional problems can be explained as a patient’s fear of being managed remotely, in solitude at home.

This datum should be a specific objective of the medical and nursing team to improve training, communications, encouraging the patient, trying to improve the psycho-emotional area.

We have assessed that the home-management of PD patients contributed to a lower prevalence of Covid-19 infection, if compared to HD patients, forced to a greater risk of exposure to the virus, during the transport to the Centre and due to the contact with other patients and health professionals.

 

Limitations

This is a retrospective, monocentric study with a relatively low number of patients. Prospective and randomized studies are needed to confirm our data.

 

Conclusion

The telemedicine and the remote control have opened new ways to increase the number of patients who can perform PD treatment at home safely, reducing the infective risk and the rate of hospitalization. PD patients and their caregivers are characterized by an improved quality of life if compared to HD patients. PD technique leads to a reduction in costs for the healthcare system with not negligible economic implications.

 

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