The MACCS platform is a comprehensive telemedicine concept aiming at better outcomes after kidney transplantation by sharing key medical information between patients and physicians. A telemedicine team reviews incoming data to detect potential complications and to improve adherence in kidney transplant recipients to achieve better long-term outcomes.
The MACCS (Medical Assistant for Chronic Care Service) platform enables secure sharing of key medical information between patients after kidney transplantation and physicians. Patients provide information such as vital signs, well-being, and medication intake via smartphone apps. The information is transferred directly into a database and electronic health record at the kidney transplant center, which is used for routine patient care and research. Physicians can send an updated medication plan and laboratory data directly to the patient app via this secure platform. Other features of the app are medical messages and video consultations. Consequently, the patient is better-informed, and self-management is facilitated. In addition, the transplant center and the patient’s local nephrologist automatically exchange notes, medical reports, laboratory values, and medication data via the platform. A telemedicine team reviews all incoming data on a dashboard and takes action, if necessary. Tools to identify patients at risk for complications are under development. The platform exchanges data via a standardized secure interface (Health Level 7 (HL7), Fast Healthcare Interoperability Resources (FHIR)). The standardized data exchange based on HL7 FHIR guarantees interoperability with other eHealth solutions and allows rapid scalability to other chronic diseases. The underlying data protection concept is in concordance with the latest European General Data Protection Regulation. Enrollment started in February 2020, and 131 kidney transplant recipients are actively participating as of July 2020. Two large German health insurance companies are currently funding the telemedicine services of the project. The deployment for other chronic kidney diseases and solid organ transplant recipients is planned. In conclusion, the platform is designed to enable home monitoring and automatic data exchange, empower patients, reduce hospitalizations, and improve adherence, and outcomes after kidney transplantation.
Kidney transplantation is the treatment of choice for patients with end-stage renal disease (ESRD) as it prolongs life, improves quality of life (QoL), and saves money and resources compared to maintenance dialysis1,2. QoL is defined as the general well-being of individuals, and health-related QoL (HRQoL) is an assessment of how the individual's well-being may be affected over time by a disease, disability, or disorder3. Recently, QoL, HRQoL, and specific patient-reported outcomes were considered core outcome domains for kidney transplantation, which have become critically important to patients, health professionals, and regulatory agencies4,5. Kidney transplant recipients (KTR) must change their lifestyle after transplantation, adhere to a complex medication schedule, and perform regular self-assessments6. The regular intake of immunosuppressive therapy is of utmost importance to ensure adequate drug blood levels7. Extremely low blood concentrations may result in under-immunosuppression, increasing the risk for rejection or the development of donor-specific antibodies (DSA). Acute rejections and DSA are major causes for graft loss. Extremely high blood concentrations of immunosuppressants may result in over-immunosuppression increasing the risk for drug-related side effects, infections, and malignancies. Therefore, strict adherence and regular control of laboratory values is necessary to adjust immunosuppressive therapy within a narrow therapeutic range.
Other frequent complications of immunosuppressive drugs include diabetes and hypertension, which can lead to costly hospitalizations and reduced QoL. To achieve better transplant survival, close monitoring and adherence are essential. Studies in the general population suggest that only ~50% of patients in the Western world are fully adherent to their medication schedule8. It has been suggested that approximately 20%-30% of graft losses in KTR are linked to non-adherence9,10. There are many reasons for non-adherence including insufficient communication, misunderstanding, and forgetfulness11. Key pillars for better adherence are good and clear communication and an unambiguous written medication plan10. Other important factors for adherence are an individually adapted explanation of the therapeutic concept and the understanding of medication and disease. Patient empowerment, which enables patients to better take care of their health, is the basis for better adherence and behavioral changes12. Being adherent to medication and to a self-assessment plan is crucial for long-term success after kidney transplantation13.
The kidney transplant center at Charité cares for KTR from the metropolitan area of Berlin and Brandenburg. Many patients travel several hours for a consultation. Long travel times are an important problem in the care of KTR14, especially for elderly and frail patients, and also for those who have to manage a family and are working. Other hurdles are travel costs, inconvenience, and loss of working hours15. Therefore, the Berlin kidney transplant center and local nephrologists (physicians in private practice) share the care after kidney transplantation, which raises the problem of missing or incomplete information during a consultation. To minimize information loss, automatic and safe exchange of key data is needed16. However, to date, data have been stored in different data silos with no interoperability. Today, data exchange relies on telephone, letters, fax, or e-mails with limited data protection and is highly dependent on individuals. Thus, loss of information and incomplete data are common problems, and automatic, secure data exchange according to European (EU) General Data Protection Regulation (GDPR) remains a rare exception.
Several eHealth solutions have been suggested to support patients after transplantation to better utilize the potential of digitalization for the healthcare of this vulnerable patient group17. Early detection of complications allows early intervention by a telemedicine team, resulting in less severe complications, less hospitalizations, or a shorter length of hospital stay, as shown in other telemedicine projects18,19,20,21. A high hospitalization rate is observed in the transplant population22. Approximately one-third of KTR are hospitalized annually with average costs of ~6,600 Euro per hospitalization. As a consequence, telemedicine-driven early interventions offer the opportunity to reduce hospitalizations and, by this means, reduce costs and improve QoL. One interesting target is to improve adherence, e.g., with the help of apps or telemedicine concepts. Due to the permanent availability of apps for smartphones, such apps can be included in interventions that aim to increase adherence. DeVito et al. demonstrated in a randomized controlled trial (RCT) that a user-centered app for lung transplant recipients with regular self-assessments, reminder function, remote vital sign monitoring, and an automatic decision support tool could improve adherence to therapy. But they did not observe significant differences regarding the 12-month hospitalization rate and mortality23.
Schmid et al. conducted an RCT with a comprehensive telemedicine concept after kidney transplantation. They found a significantly higher adherence rate and a dramatic reduction in hospitalizations and costs20,21. These results were confirmed by Lee et al. who reported significantly lower readmission rates within the first 90 days after liver transplantation than the standard of care with the use of additional telemedicine support through smart tablets19. Their telemedicine features consisted of using Bluetooth devices to remotely monitor vital signs, drug reminders, regular self-assessments, as well as access to educational sessions, text messaging and video conferencing tools. Better QoL, general health, and physical function were observed in patients in the telemedicine group. Adherence was excellent (86%) with respect to remote vital signs, but was only 45% for messaging or videoconferencing. However, not all studies could demonstrate positive effects of apps or eHealth solutions17,19. Han et al. investigated an app with a medication reminder, intake documentation, and shared laboratory values, which also provided information about immunosuppressive therapy. They did not observe any significant difference in adherence between intervention and control groups in KTR, most likely due to high drop-out rates. In this RCT, only 47% used the app after 1 month24.
The secure and interoperable MACCS platform for KTR was developed to address the limitations of current post-transplant care, namely the need for close monitoring, regular self-assessments, decreasing adherence, and loss of information between physicians. The platform enables patients to share vital signs, daily medication intake protocols, blood glucose, messages, and well-being with the transplant center via an app (see the Table of Materials). Well-being is captured by a simple question ("how are you feeling today?") and a 5-point Likert scale with different emojis (smileys) reflecting the current mood of the patient. In the transplant center, all data are stored directly in the electronic health record (EHR) called TBase25. The EHR is tailored for the needs of transplanted patients, is used for regular post-transplant care, and automatically integrates all relevant data from the hospital, outpatient visits, and transplant-specific data such as donor data, ischemia times, and human leukocyte antigen mismatches. A telemedicine dashboard was implemented in the EHR for an easy review of incoming data by the telemedicine team.
The EHR is connected via a secure HL7 FHIR interface with an FHIR server (platform) outside the firewall of the transplant center, which transfers pseudonymized data from the transplant EHR (TBase) to the patient app. This allows the transplant center to send secure messages, laboratory data, and medication plans directly to the patient´s smartphone. Another important partner in the telemedicine project provides specialized software for local nephrologists and has a market share of ~65% in Germany (see the Table of Materials). The software connects to the HL7 FHIR server and allows direct communication between the transplant center and local nephrologists. The shared data include laboratory values, medical letters, test results, vital signs, and medication plans. With the use of an automatic data exchange, the platform aims to eliminate loss of information, as well as manual, incomplete, insecure, or late data transmission. By this means, workload is reduced, and time-consuming tasks and errors are eliminated to create significant efficiency gains. The platform also facilitates communication between physicians through an easy exchange of notes to prevent information gaps. Another advantage is the fact that data are transmitted directly into the software of the physicians to be used for daily routine. Thus, physicians only work with familiar software and do not need to use different software tools (Figure 1).
The concept of the project is GDPR-compliant, and all of the data are protected according to the highest European standards. Individual data are visible for approved medical personnel only. All information is encrypted and transferred according to HL7 FHIR standards. The patient can give and deny access rights to other physicians through the app and can cancel participation at any time. Data are transmitted only after written informed consent and after a complex onboarding process (digital inclusion process). It is important to mention that all services of the platform are offered as an additional service to patients, free of charge. Thus, patients can choose between regular care or regular care plus telemedicine services. The project started to enroll patients in February 2020, and the additional telemedicine services are supported by two large health insurance companies.
In summary, a comprehensive telemedicine platform for KTR was established. Initially, the German Federal Ministry of Economy and Energy (BMWi) funded the project as part of the open call "Smart Service World" to stimulate the growing number of smart services in healthcare. The basic concept is similar to other comprehensive telemedicine systems18,19,23,26,27. Compared to most telemedicine concepts, the advantages of the platform include its interoperability through standardized HL7 FHIR interfaces and GDPR compliance. The platform has no specific hardware requirements. The apps are free of charge and allow straightforward and easy use. The possibility for an easy multi-channel communication with the telemedicine team might also increase the use of the app for home monitoring. Patients use their regular scale and blood pressure device at home, and no costly and complicated Bluetooth devices are needed. Another innovative feature of the platform is the direct involvement of local nephrologists. Patients are usually treated by a combination of tertiary kidney transplant centers and local nephrologists, who already know the patient from dialysis or predialysis times.
As patients frequently visit their local nephrologists, a comprehensive platform for KTR should also automatically incorporate the local nephrologists to prevent information gaps. Importantly, the platform also implements automatic safe data exchange and communication with local nephrologists, who can use their regular software and have a direct added benefit due to automatic data exchange with the transplant center. In contrast to similar eHealth solutions, the platform is fully integrated into the workflow of the transplant center and the local nephrologist. The platform also fully integrates the local nephrologist in the data exchange of key variables and provides extensive, safe, and easy communication tools for physicians and patients. The direct benefits for users should increase acceptance and reinforce regular use. Further improvements of the platform are under development, and after establishment of an advanced stable platform, a prospective RCT on KTR is planned to provide solid evidence for better outcomes and cost effectiveness.
The protocol follows the current guidelines of the ethics and data protection committees at Charité – Universitätsmedizin Berlin and is in compliance with current EU GDPR.
1. Perspective of the telemedicine team
2. Perspective of local nephrologists
3. Perspective of patients
In the first 5 months between February and July 2020, 172 KTR matched the inclusion criteria and were asked to participate (Table 1). Out of 172 participants, seven needed to borrow a smartphone (four did not own one, three needed a new one); all other patients owned a smartphone. The app does not need wireless access (Wi-Fi) as data can be transferred by mobile phone via regular telecommunication services, and 2/172 patients were equipped with a subscriber identity module (SIM) card for mobile data transfer. Thirty-three patients (19%) declined for various reasons (Figure 2). Some patients did not have Wi-Fi or mobile data and therefore, did not want to participate.
One patient was excluded due to poor cognitive function as they were unable to handle the app. However, one patient with severe visual impairment and one blind patient were successfully enrolled, and five patients participated with the help of their relatives. Two patients participated from abroad, although they do not have easy access to mobile data or Wi-Fi. They transfer data from time to time, when they visit friends with Wi-Fi access or go to Wi-Fi access points in town. In the end, 139 patients were finally enrolled. Of these, 8 patients (5.7%) withdrew, and 131 patients are still participating in the project. The demographic characteristics are shown in Table 5, and a first overview of incoming data is depicted in Table 6. In total, 29,089 entries were transmitted on 8,954 observation days from 131 active participating KTR, which resulted in 3.4 entries per day and per patient.
Figure 1: Data flow of the MACCS project. Abbreviations: EHR = electronic health record; MACCS = Medical Assistant for Chronic Care Service. Please click here to view a larger version of this figure.
Figure 2: Screening and drop-outs between February 28, 2020 and July 27, 2020. Please click here to view a larger version of this figure.
Inclusion criteria | Kidney transplantation and/or pancreas transplantation |
Age > 18 years | |
Exclusion criteria | Cognitive or language barriers |
Primary outcomes | Strengthen the communication between patients and medical professionals to support adherence, reduce hospitalizations, and improve outcomes |
Secondary outcomes | |
Role of telemedicine team | Telemedicine team supports adherence and empowerment and aims to detect complications more quickly by regular evaluation of remote vital signs, well-being, sharing of laboratory values and medication plans, medication tracking, and medical support through better communication with a user-centered smartphone app. |
Telemedicine team | Medical experts: |
1 physician for 600 patients | |
1 nurse for 300 patients | |
Other personnel: | |
1 assistant (administration) | |
1 software developer | |
Expectations on participation | 90% participation in KTR with transplantation less than 1 year ago |
Approximately 75% participation in KTR with transplantation less than 1 year ago |
Table 1: Key information of the MACCS project. Abbreviations: MACCS = Medical Assistant for Chronic Care Service; KTR = kidney transplant recipients.
Telemedicine services, app | Telemedicine team |
Any time | 8 a.m. – 4 p.m. on working days |
Transmission and documentation of vital signs, well-being, blood sugar (for diabetic patients) |
Review of vital signs, laboratory values, and well-being on working days |
Display of medication plan | Review of medication changes |
Display of laboratory values | Medical hotline |
Tracking of medication intake | Review of adherence |
Reminder of medication intake | Recognition of non-adherence |
Messages to transplant center | Intervention and individualized lessons |
Video consultations with transplant center |
Phone calls and medical messages (questions, problems, assistance, receipts, appointments) |
Video consultations | |
Semi-structured onboarding of patients (including technical aspects, education, self-assessment, important symptoms, medication plan, handling of medical emergencies) |
|
Onboarding of home nephrologists | |
Technical support for patients and home nephrologists |
|
Acute medical problems and symptoms as well as emergency care remain unchanged and are provided by physicians on call, home nephrologists, and emergency rooms. |
Table 2: Core features of telemedically supported case management.
Priorization | Nurse … | Physician … | Senior nephrologists … | Local nephrologists … |
1. | reviews critical vital signs | contacts patients with critical values | guides critical cases | receives data from transplant center |
2. | informs physician on duty | discusses critical cases with transplant team's senior nephrologist | provides support for clinical questions | reviews incoming data |
3. | calls critical patients | takes action if needed (e.g., contacts local nephrologist, emergency room) | reviews problematic cases | performs onboarding process for new patients |
4. | reviews well-being status | reviews problematic cases with telemedicine nurse | contacts local nephrologists | can call telemedicine team in case of technical problems |
5. | calls patients, if they are not feeling good | reviews cases with transplant team and senior nephrologist | trains the telemedicine team | can call telemedicine team in case of medical questions |
6. | discusses critical patients with physician on duty | reviews incoming messages and laboratory data | trains the transplant team | may receive calls from telemedicine team regarding problematic patients |
7. | reviews less critical vital signs | follows problematic cases | trains the local nephrologists | can discuss problematic patients with telemedicine team, transplant center, or senior nephrologist |
8. | reviews incoming medical messages | answers incoming calls from patients and local nephrologists | evaluates and supports further development | may receive regular training on project |
9. | reviews patients with missing data | includes data of patients | may participate in evaluation and feedback process | |
10. | calls patients, who did not transfer data according to schedule | trains and includes local nephrologists | ||
11. | discusses problematic cases with physician on duty | evaluates project and feedback | ||
12. | reviews normal vital signs | |||
13. | answers incoming calls from patients and local nephrologists | |||
14. | identifies potentially eligible patients for onboarding | |||
15. | includes potentially eligible patients | |||
16. | evaluates services and feedbacks |
Table 3: Priorization of tasks of telemedicine team and local nephrologists.
critical | suspicious | normal | suspicious | critical | |
Systolic blood pressure | <90 mmHg | <100 mmHg | 100 – 129 mmHg | 130 – 180 mmHg | >180 mmHg |
Diastolic blood pressure | <50 mmHg | 50 – 59 mmHg | 60 – 89 mmHg | 90 – 100 mmHg | >100 mmHg |
Heart rate (beats per min, bpm) | <50 | 50 – 59 | 60 – 89 | 90 – 120 | >120 |
Temperature | <33.5 °C | 33.5 -36.2 °C | 36.3 – 37.4 °C | 37.5 – 38.0 °C | >38.0 °C |
Change in weight over 1 day | >(-1.5) kg | (-1.5) – (-0.5) kg | ± 0.5 kg | 0.5 – 1.5 kg | >1.5 kg |
Change in weight over 3 days | >(-2.5) kg | (-2.5) – (-1.0) kg | ±1.0 kg | 1.0 – 2.5 kg | >2.5 kg |
Change in weight over 8 days | >(-3.0) kg | (-3.0) – (-1.5) kg | 1.5 – 3.0 kg | >3.0 kg | |
Well-being | 1 to 2 points | 3 to 4 points | 5 points |
Table 4: Assessment of vital signs.
Characteristics | N=131 | |
Age – years | ||
Mean (Min. – Max.) | 50.7 (20 – 83) | |
Male sex – % | 59.5 | |
Transplantation – no. (%) | ||
1st transplantation | 110 (84%) | |
2nd transplantation | 20 (15.3%) | |
3rd transplantation | 1 (0.8%) | |
Combined pancreas transplantation | 5 (3.8) | |
Days after last kidney transplantation – no. | ||
Median (Range) | 2.249 (29 – 11.039) | |
Inclusion of de novo kidney transplant patients | ||
Number | 20 | |
Underlying disease – no. (%) | ||
Glomerulonephritis | 62 (47.3) | |
ADPKD | 12 (9.2) | |
Diabetic nephropathy | 7 (5.3) | |
Alport syndrome | 6 (4.6) | |
Hypertensive nephropathy | 5 (3.8) | |
Other | 39 (29.8) |
Table 5: Demographic and clinical characteristics of participating patients. Abbreviations: Min = minimum; Max = maximum; ADPKD = autosomal dominant polycystic kidney disease.
Characteristic | N=131 |
Received vital signs – no. | |
Temperature | 5,979 |
Blood pressure | 7,656 |
Blood sugar | 1,524 |
Well-being | 761 |
Weight | 5,394 |
Heart rate | 7,775 |
Sum | 29,089 |
Observation days – no. | |
Sum | 8,539 |
Median (Min., Max.) | 68 (1 – 150) |
Entries per patient and day | 3.4 |
Table 6: Number of vital signs received during the observation period.
A comprehensive telemedicine platform was created to improve the care of KTR. The platform was readily accepted by patients with excellent participation in sending vital signs from home. To develop the platform and to provide these services to patients, extensive software engineering was necessary. Critical steps included (a) constant software development with the involvement of all stakeholders from the beginning, and (b) a comprehensive data protection concept, which was achieved with the help of a specialized law firm. This iterative process resulted in the release of several new versions of the different software components and apps, which were engineered toward a more patient-centered design. Key factors for the successful implementation of new features were close communication through weekly meetings, constant troubleshooting, involvement of the users, and quick problem-solving. During the initial development process, several workshops were organized with participation of all user groups (including patients) to find the best software design and to prioritize the most important features for a basic first version of the platform. In these workshops, patient engagement focused on acceptance issues, usability, identification of key features, and patient burden for documentation. Additional interviews with clinicians, local nephrologists, and patients helped to shape the project toward the needs of the different users. An extensive literature search provided additional insights17.
Interoperability is of crucial importance for future development, acceptance, and scalability. Therefore, the most advanced interoperability standard, namely, HL7 FHIR, was implemented. This allows further development in an open-source environment and the utilization of the large HL7 FHIR community for rapid adaptation of future needs (e.g., to integrate wearables or other apps) and a seamless integration into other eHealth solutions (e.g., EHR of hospitals and health insurance companies, different physicians' software) or a larger eHealth framework (e.g., GEMATIK, the future German patient health record). Another important feature of HL7 FHIR-derived communication is the availability of highest data privacy. An extensive data protection concept was developed based on informed consent and secure data transfer of only pseudonymized data according to strict EU GDPR. Because development of the platform takes place in a separate developer container, and researchers only have access to pseudonymized data on the replication server, regular developers and scientists have no access to the live system with patient data. The partner, who hosts the FHIR server, has access only to pseudonymized patient data. The key for pseudonymization is separated and transferred during the onboarding process to the patient app, where the patient can administer access rights. All servers with patient data are localized within the EU according to the latest GDPR. Thus, patient confidentiality is already protected by virtue of the platform design.
However, an app can only help if it is used, similar to drugs or other interventions in healthcare. Therefore, a simple and intuitive user experience in combination with regular reinforcement, e.g., through the telemedicine team is needed to ensure effective intervention. If patients feel that they benefit directly from the app (e.g., through additional communication services, ease of documentation, reminder function), they will use it more often. In this regard, patient empowerment, flexibility, adjustment to individual needs, and teaching are critical to achieve a constant and regular use of the app. As a consequence, constant assessment of use, acceptance, and attrition rates as well as a thorough analysis of problems is needed for a steady improvement of the platform to achieve the goal of better patient care. Last, but not least, the successful implementation of the platform relies on the "human factor", namely, the usability of the system, its effect on the workload, and the interaction of the telemedicine team with the patients as well as their local nephrologists. The platform is one of the first to include local physicians and thus enables a seamless treatment with all information on hand to the treating physician, irrespective of the location. The data exchange between physicians is facilitated by the high interoperability of the HL7 FHIR communication standard. The system allows all physicians to work with their regular software, with no need for additional software and passwords, which is a prerequisite for good acceptance. An extension of the platform to other individual healthcare providers such as pharmacists, physiotherapists, other medical specialties, or hospitals, is a goal for the near future.
Another important aspect was close communication with healthcare providers, who are strongly interested in digital pilot projects, which have the potential to save costs and improve outcomes. Because healthcare providers were part of the initial consortium, those discussions had already taken place in the early stages of the development process. As a consequence, a detailed analysis of healthcare costs after kidney transplantation and potential cost reductions were performed right from the beginning. It showed hospitalizations and premature graft loss, with return to dialysis being the most important cost factor in this patient group. Importantly, both factors also have direct adverse consequences on patients' QoL. It is obvious that fewer hospitalizations and graft losses are associated with cost reductions and at the same time, directly improve QoL. As non-adherence is an important factor for long-term graft survival, the concept aims to strengthen adherence through multiple ways, e.g., efficient communication, medication reminders, and better self-assessments. Ultimately, all these factors should help to assist in behavioral changes, to better detect health indicators, and empower the patient to better manage the chronic disease. Although educational and behavioral interventions to increase adherence are promising, the effect size seems small28. Thus, multifaceted and individualized interventions for better empowerment of patients are important for better efficacy29 and must eventually be combined with novel eHealth interventions17,19,30. Similar to other comprehensive telemedicine projects18,19,21,23,26,27, this should lead to improved adherence and a more timely detection of adverse events.
As demonstrated by another German group, such a comprehensive telemedicine project is cost-effective, may reduce hospitalizations, and prolong graft survival, and therefore avoid costly dialysis treatment20. The group in Freiburg observed a dramatic 60% reduction in unplanned hospitalizations, resulting in a cost reduction of approximately 5,000 Euros in the first year after transplantation. Even when the authors accounted for the telemedicine costs, they could demonstrate cost savings of approximately 2,000 Euros per patient in the first year after transplantation. These assumptions are currently being evaluated by regular prospective assessments of key performance indicators such as adherence, rejection, development of DSA, graft loss, emergency room visits, and hospitalizations18. Based on the convincing evidence from other studies18,19,20,21, two large German health insurance companies decided to support the MACCS project. Hopefully, more insurance companies will participate in the future. Ultimately, a prospective randomized trial is needed to demonstrate the effect of the telemedicine concept on patient adherence, QoL, hospitalizations, cost reductions, and long-term outcome.
A potential limitation is the fact that the platform depends on the willingness of the participants to regularly use the apps and ultimately integrate the apps into their daily routine. To achieve high acceptance, extensive educational sessions were established during the onboarding process, and new participants were called on the day after inclusion. Technical support is provided by the telemedicine team to patients who are not familiar with apps. Another limitation is the fact that the system relies on manual patient data entry, with the potential for typing errors. Patients may also get annoyed by having to repeatedly enter data into the app. Automatic data entry of vital signs with Bluetooth devices would improve data quality and comfort but adds complexity and costs. In the first version of the platform, complexity and costs were reduced by utilizing the patient´s own scale and blood pressure devices. In addition, the app was optimized for flexible manual data entry. Another inherent limitation is the fact that data entry of the patients has to be trusted, in particular, regarding the intake of their medication. However, the precise evaluation of true adherence is difficult, and concepts for adherence measurements, which rely on more technical solutions, are not yet standard.
In the future, it is planned to incorporate Bluetooth Internet of Things (IoT) devices for automatic and more precise data transfer. An interesting option to improve adherence is a Bluetooth-connected pillbox, which tracks the opening of a pillbox, but does not track the actual swallowing of a pill. Thus, similar to self-reporting, there is still uncertainty with regard to medication intake31. It is also possible to directly track swallowed pills, which are attached to a sensor. After activation in the stomach, the sensor transmits a signal to a smartphone via a patch attached to the belly. However, as the use of the patch was associated with discomfort, further research is needed to develop the system for routine care32,33. At the end of the day, patients are responsible for their actions. The goal is not to perfectly track non-adherence, but instead to assist and empower patients for better adherence. The platform provides drug reminders, easy communication tools, information on the latest medication plan, laboratory values on the smartphone, a helpline, and a telemedicine team, and thereby creates an environment for maximal assistance to fulfill the tasks for optimal outcomes.
In the first version of the platform, the most important features, which were defined and prioritized with all stakeholders during a design and development process, were implemented. The focus was to incorporate features with a proven impact on adherence as well as those with high feasibility and medical relevance (e.g., medication reminder, medical messages, medication plan, laboratory values of highest interest). In addition, for automatic data transfer, the main pillar for successful implementation of such a transfer is the "human factor", namely, a competent telemedicine team, which has to train, support, and communicate with patients and local nephrologists. The constant communication with the telemedicine team motivates patients to stay in the project. To deal with all the incoming data and the high information load, the team developed a strictly structured daily schedule, focusing on the most urgent problems first. Furthermore, the telemedicine team is in close contact with the regular medical team involved in post-transplant care for an integrated care. Steady improvement of the telemedicine features with stepwise implementation of new features, according to the needs of the participants, is planned. Therefore, regular assessments of satisfaction and problems are of utmost importance, to define areas that need improvement.
As a next step during the current COVID-19 pandemic, a full integration of video consultations is planned. In a further step, a platform for educational purposes will be created, which can provide important content regarding transplantation and immunosuppression to patients in an easily accessible way. Other planned features for the patients are a better graphic display of vital signs and adherence as well as simple statistics for concise information and better illustration. In addition, expansion to other software systems to integrate other nephrologists and general practitioners is planned. The development of secure, web-based access would allow physicians to get access to patient data. Such web-based access could also serve as an emergency access for physicians to retrieve medical history and medical records through a temporarily activated emergency access to the platform. Another long-term goal is the development of a dashboard for antibiotic stewardship for better treatment of frequent urinary tract infections. Currently, a telemedicine unit within Charité is supervising patients and deciding, on a case-by-case basis, when patients reach critical thresholds. The additional workload requires additional manpower. Whether the additional tasks are performed by an increased healthcare team or by a separate telemedicine team is a matter of debate and depends on the local situation. However, extensive daily communication between all involved healthcare professionals and a structured therapeutic approach are essential for uniform and successful treatment.
Communication with patients is time-consuming and creates a high workload and may lead to "information overload". Thus, communication and the identification of the most critical patients are the bottlenecks in the current approach. The integration of novel artificial intelligence (AI)-driven technologies for automated communication on routine questions and automated detection of the most critical patients would reduce the workload of the telemedicine team and help focus on the most urgent cases. As monitoring is time- and cost-intensive, automated monitoring systems based on complex-event detection modules are key technologies to fuel the healthcare sector productivity in combination with individual risk predictions to focus limited resources on the most vulnerable patients. However, only approved AI components will be implemented after profound evaluation. Using the text interface of the existing patient app, automatic assessment of patient requests is planned so that urgent messages can be processed more quickly by medical staff. Noncritical patient requests as well as reminders and support can be provided by a chatbot component improving clinical workflow. Intelligent apps will be added to the open platform, e.g., for diabetic patients, as post-transplant diabetes is frequent and poor diabetic control affects long-term outcomes. Such apps may give personal advice to patients with regard to food intake and activity.
Another key feature of the platform in the future will be the connection with multiple IoT devices. Automatic data entry from IoT devices and wearables will reduce the burden for the patients to document data daily and will allow for a real-time analysis of patient activity, heart rate, and even electrocardiograms at home. Furthermore, point-of-care measurements with innovative laboratory devices may be added for home monitoring. To handle increased data volumes, Big Data and AI technologies are needed to detect critical situations, which would optimize the operational workflow of the telemedicine staff and lead to fewer patient constraints. In the end, such real-time analytics of IoT data streams and chat extractions will allow for a true real-time integrated decision making by using all of the data available from the patient (including medical history, patient record, IoT devices, and chat communications) and hence, for more timely identification of critical situations. The extension of the platform with educational content, personalized advice, and real-time information extracted from all available data sources will allow a more fine-grained overview of the patients' situation and automated warnings that will ease the tasks and workload of physicians and also allow for more patient-centered care through 24/7 communication and reminder functions. Such a system is also highly attractive for other conditions. Transferring the concept to other chronically ill patients and their particular requirements is being pursued.
The authors have nothing to disclose.
BMWi funded the MACSS (Medical Allround-Care Service Solutions) as part of the funding project "Smart Service World". In addition, the H2020 EU project "BigMedilytics" as well as the health insurance companies AOK Nordost and Techniker Krankenkasse are supporting the project.
comjoodoc EASY app | comjoo business solutions GmbH | Patient app for patients to share information with the transplant center | |
HL7 FHIR standard | Medworxs.io | Provider of MACCS API | |
FHIR server | Medworxs.io | Host of MACCS patform | |
NEPHRO7 | MedVision AG | Electronic health record of home nephrologists | |
myTherapy | smartpatient GmbH | Patient app for medication intake and alternative transmission of vital signs and well being | |
TBase | Charité – Universitätsmedizin Berlin | Electronic health record of outpatient care center at Charité |