Name: digital home-monitoring of patients after kidney transplantation: the maccs platform
Uploaded: 2021-04-12T12:30:00
Description: Watch this Scientific Journal Video about Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform at JoVE.com

BMWi funded the MACSS (Medical Allround-Care Service Solutions) as part of the funding project &#34;Smart Service World&#34;. In addition, the H2020 EU project &#34;BigMedilytics&#34; as well as the health insurance companies AOK Nordost and Techniker Krankenkasse are supporting the project.

The protocol follows the current guidelines of the ethics and data protection committees at Charit&#233; - Universit&#228;tsmedizin Berlin and is in compliance with current EU GDPR.
1. Perspective of the telemedicine team
<ol>
	<li>Screening for patients 
	NOTE: Key data of the project are provided in Table 1.
	<ol>
		<li>Ask the nurse to screen incoming outpatients or patients on the ward for eligibility. Ask the telemedicine team (nurse and physician) to talk to patie...

<ol>
	<li>Kramer, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+European+Renal+Association+-+European+Dialysis+and+Transplant+Association+(ERA-EDTA)+Registry+Annual+Report+2015:+a+summary.">The European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Registry Annual Report 2015: a summary.</a> Clinical Kidney Journal. 11 (1), 108-122 (2018).</li><li>Haller, M., Gutjahr, G., Kramar, R., Harnoncourt, F., Oberbauer, R. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Cost-effectiveness+analysis+of+renal+replacement+therapy+in+Austria.">Cost-effectiveness analysis of renal replacement therapy in Austria.</a> Nephrology, Dialysis, Transplantation: Official Publication of the European Dialysis and Transplant Association - European Renal Association. 26 (9), 2988-2995 (2011).</li><li>Quality of life (healthcare). Wikipedia, The Free Encyclopedia Available from: <a target="_blank" href="https://en.wikipedia.org/wiki/Quality_of_life_(healthcare)">https://en.wikipedia.org/wiki/Quality_of_life_(healthcare)</a> (2020)</li><li>Sautenet, B., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Developing+consensus-based+priority+outcome+domains+for+trials+in+kidney+transplantation:+a+multinational+delphi+survey+with+patients,+caregivers,+and+health+professionals.">Developing consensus-based priority outcome domains for trials in kidney transplantation: a multinational delphi survey with patients, caregivers, and health professionals.</a> Transplantation. 101 (8), 1875-1886 (2017).</li><li>Tong, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Toward+establishing+core+outcome+domains+for+trials+in+kidney+transplantation:+report+of+the+standardized+outcomes+in+nephrology-kidney+transplantation+consensus+workshops.">Toward establishing core outcome domains for trials in kidney transplantation: report of the standardized outcomes in nephrology-kidney transplantation consensus workshops.</a> Transplantation. 101 (8), 1887-1896 (2017).</li><li>De Geest, S., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Incidence,+determinants,+and+consequences+of+subclinical+noncompliance+with+immunosuppressive+therapy+in+renal+transplant+recipients.">Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients.</a> Transplantation. 59 (3), 340-347 (1995).</li><li>Posadas Salas, M. A., Srinivas, T. R. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Update+on+the+clinical+utility+of+once-daily+tacrolimus+in+the+management+of+transplantation.">Update on the clinical utility of once-daily tacrolimus in the management of transplantation.</a> Drug Design, Development and Therapy. 8, 1183-1194 (2014).</li><li>Haynes, R. B., McDonald, H., Garg, A. X., Montague, P. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Interventions+for+helping+patients+to+follow+prescriptions+for+medications.">Interventions for helping patients to follow prescriptions for medications.</a> The Cochrane Database of Systematic Reviews. (2), (2002).</li><li>Fine, R. N., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Nonadherence+consensus+conference+summary+report.">Nonadherence consensus conference summary report.</a> American Journal of Transplantation: Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 9 (1), 35-41 (2009).</li><li>Neuberger, J. M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Practical+recommendations+for+long-term+management+of+modifiable+risks+in+kidney+and+liver+transplant+recipients:+a+guidance+report+and+clinical+checklist+by+the+Consensus+on+Managing+Modifiable+Risk+in+Transplantation+(COMMIT)+group.">Practical recommendations for long-term management of modifiable risks in kidney and liver transplant recipients: a guidance report and clinical checklist by the Consensus on Managing Modifiable Risk in Transplantation (COMMIT) group.</a> Transplantation. 101 (4), 1-56 (2017).</li><li>Gordon, E. J., Gallant, M., Sehgal, A. R., Conti, D., Siminoff, L. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Medication-taking+among+adult+renal+transplant+recipients:+barriers+and+strategies.">Medication-taking among adult renal transplant recipients: barriers and strategies.</a> Transplant International: Official Journal of the European Society for Organ Transplantation. 22 (5), 534-545 (2009).</li><li>Zanetti-Yabur, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Exploring+the+usage+of+a+mobile+phone+application+in+transplanted+patients+to+encourage+medication+compliance+and+education.">Exploring the usage of a mobile phone application in transplanted patients to encourage medication compliance and education.</a> American Journal of Surgery. 214 (4), 743-747 (2017).</li><li>Shellmer, D. A., Dew, M. A., Mazariegos, G., DeVito Dabbs, A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Development+and+field+testing+of+Teen+Pocket+PATH((R)),+a+mobile+health+application+to+improve+medication+adherence+in+adolescent+solid+organ+recipients.">Development and field testing of Teen Pocket PATH((R)), a mobile health application to improve medication adherence in adolescent solid organ recipients.</a> Pediatric Transplantation. 20 (1), 130-140 (2016).</li><li>Trnka, P., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+retrospective+review+of+telehealth+services+for+children+referred+to+a+paediatric+nephrologist.">A retrospective review of telehealth services for children referred to a paediatric nephrologist.</a> BMC Nephrology. 16, 125 (2015).</li><li>Andrew, N., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Telehealth+model+of+care+for+routine+follow+up+of+renal+transplant+recipients+in+a+tertiary+centre:+A+case+study.">Telehealth model of care for routine follow up of renal transplant recipients in a tertiary centre: A case study.</a> Journal of Telemedicine and Telecare. 26 (4), 232-238 (2020).</li><li>Duettmann, W., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Digital+management+after+kidney+transplantation:+What+is+MACCS.">Digital management after kidney transplantation: What is MACCS.</a> Kidney and Hypertension Diseases. 49 (2020), 7 (2020).</li><li>Duettmann, W., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=eHealth+in+transplantation.">eHealth in transplantation.</a> Transplant International: Official Journal of the European Society for Organ Transplantation. , (2020).</li><li>Koehler, F., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Efficacy+of+telemedical+interventional+management+in+patients+with+heart+failure+(TIM-HF2):+a+randomised,+controlled,+parallel-group,+unmasked+trial.">Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.</a> Lancet. 392 (10152), 1047-1057 (2018).</li><li>Lee, T. C., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Telemedicine+based+remote+home+monitoring+after+liver+transplantation:+results+of+a+randomized+prospective+trial.">Telemedicine based remote home monitoring after liver transplantation: results of a randomized prospective trial.</a> Annals of Surgery. 270 (3), 564-572 (2019).</li><li>Kaier, K., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Results+of+a+randomized+controlled+trial+analyzing+telemedically+supported+case+management+in+the+first+year+after+living+donor+kidney+transplantation+-+a+budget+impact+analysis+from+the+healthcare+perspective.">Results of a randomized controlled trial analyzing telemedically supported case management in the first year after living donor kidney transplantation - a budget impact analysis from the healthcare perspective.</a> Health Economics Review. 7 (1), 1 (2017).</li><li>Schmid, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Telemedically+supported+case+management+of+living-donor+renal+transplant+recipients+to+optimize+routine+evidence-based+aftercare:+a+single-center+randomized+controlled+trial.">Telemedically supported case management of living-donor renal transplant recipients to optimize routine evidence-based aftercare: a single-center randomized controlled trial.</a> American journal of transplantation: Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 17 (6), 1594-1605 (2017).</li><li>Duettmann, W. H., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Evaluation+of+main+diagnoses+of+kidney+transplant+recipients+and+DRG-costs+in+German+health+care+system.">Evaluation of main diagnoses of kidney transplant recipients and DRG-costs in German health care system.</a> Nephrology Dialysis Transplantation. 34, (2019).</li><li>DeVito Dabbs, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+randomized+controlled+trial+of+a+mobile+health+intervention+to+promote+self-management+after+lung+transplantation.">A randomized controlled trial of a mobile health intervention to promote self-management after lung transplantation.</a> American Journal of Transplantation: Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 16 (7), 2172-2180 (2016).</li><li>Han, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Mobile+medication+manager+application+to+improve+adherence+with+immunosuppressive+therapy+in+renal+transplant+recipients:+A+randomized+controlled+trial.">Mobile medication manager application to improve adherence with immunosuppressive therapy in renal transplant recipients: A randomized controlled trial.</a> PloS One. 14 (11), 0224595 (2019).</li><li>Schmidt, D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=TBase+-+an+Integrated+Electronic+Health+Record+and+Research+Database+for+Kidney+Transplant+Recipients.">TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients.</a> J. Vis. Exp. , e61971 (2021).</li><li>Jiang, Y., Sereika, S. M., DeVito Dabbs, A., Handler, S. M., Schlenk, E. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Using+mobile+health+technology+to+deliver+decision+support+for+self-monitoring+after+lung+transplantation.">Using mobile health technology to deliver decision support for self-monitoring after lung transplantation.</a> International Journal of Medical Informatics. 94, 164-171 (2016).</li><li>Rosenberger, E. M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Long-term+follow-up+of+a+randomized+controlled+trial+evaluating+a+mobile+health+intervention+for+self-management+in+lung+transplant+recipients.">Long-term follow-up of a randomized controlled trial evaluating a mobile health intervention for self-management in lung transplant recipients.</a> American Journal of Transplantation: Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 17 (5), 1286-1293 (2017).</li><li>Mathes, T., Grosspietsch, K., Neugebauer, E. A. M., Pieper, D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Interventions+to+increase+adherence+in+patients+taking+immunosuppressive+drugs+after+kidney+transplantation:+a+systematic+review+of+controlled+trials.">Interventions to increase adherence in patients taking immunosuppressive drugs after kidney transplantation: a systematic review of controlled trials.</a> Systematic Reviews. 6 (1), 236 (2017).</li><li>Pruette, C. S., Amaral, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Empowering+patients+to+adhere+to+their+treatment+regimens:+A+multifaceted+approach.">Empowering patients to adhere to their treatment regimens: A multifaceted approach.</a> Pediatric Transplantation. , 13849 (2020).</li><li>Lee, H., Shin, B. C., Seo, J. M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Effectiveness+of+eHealth+interventions+for+improving+medication+adherence+of+organ+transplant+patients:+A+systematic+review+and+meta-analysis.">Effectiveness of eHealth interventions for improving medication adherence of organ transplant patients: A systematic review and meta-analysis.</a> PloS One. 15 (11), 0241857 (2020).</li><li>Jandovitz, N., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Telemedicine+pharmacy+services+implementation+in+organ+transplantation+at+a+metropolitan+academic+medical+center.">Telemedicine pharmacy services implementation in organ transplantation at a metropolitan academic medical center.</a> Digital Health. 4, (2018).</li><li>Triplett, K. N., El-Behadli, A. F., Masood, S. S., Sullivan, S., Desai, D. M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Digital+medicine+program+with+pediatric+solid+organ+transplant+patients:+Perceived+benefits+and+challenges.">Digital medicine program with pediatric solid organ transplant patients: Perceived benefits and challenges.</a> Pediatric Transplantation. 23 (7), 13555 (2019).</li><li>Eisenberger, U., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Medication+adherence+assessment:+high+accuracy+of+the+new+Ingestible+Sensor+System+in+kidney+transplants.">Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants.</a> Transplantation. 96 (3), 245-250 (2013).</li></ol>

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...

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&#39;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 Charit&#233; 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 (&#34;how are you feeling today?&#34;) 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&#180;s smartphone.&#160;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 &#34;Smart Service World&#34; 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.

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>comjoodoc EASY app</td>
			<td>comjoo business solutions GmbH</td>
			<td></td>
			<td>Patient app for patients to share information with the transplant center</td>
		</tr>
		<tr>
			<td>HL7 FHIR standard</td>
			<td>Medworxs.io</td>
			<td></td>
			<td>Provider of MACCS API</td>
		</tr>
		<tr>
			<td>FHIR server</td>
			<td>Medworxs.io</td>
			<td></td>
			<td>Host of MACCS patform</td>
		</tr>
		<tr>
			<td>NEPHRO7</td>
			<td>MedVision AG</td>
			<td></td>
			<td>Electronic health record of home nephrologists</td>
		</tr>
		<tr>
			<td>myTherapy</td>
			<td>smartpatient GmbH</td>
			<td></td>
			<td>Patient app for medication intake and alternative transmission of vital signs and well being</td>
		</tr>
		<tr>
			<td>TBase</td>
			<td>Charit&#233; - Universit&#228;tsmedizin Berlin</td>
			<td></td>
			<td>Electronic health record of outpatient care center at Charit&#233;</td>
		</tr>
	</tbody>
</table>

digital home-monitoring of patients after kidney transplantation: the maccs platform

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.

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 tran...

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Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform

The MACCS platform&#160;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 ...

We established a telemedicine care for patients after kidney transplantation, including a team consisting of experienced medical professionals. If vital signs exceed critical values, or messages indicate that something is happening with the patients, care can be adapted quickly to the needs of the patients. The telemedicine team also supports routine clinical care and improves the communication between patients and physicians in charge.The development of this platform, which is still ongoing, takes into account the opinion of patients and different medical professionals. In addition, we adhere to the current GDPR. Begin by training the patient.Show them where to find laboratory values and how they are presented, how to find the text messaging function, and how to send a message, how to start a video consultation, and how to find a medication plan, and confirm medication intake. Demonstrate how to submit vital signs, blood sugar, well-being status, and confirm, or decline medication intake. Train the patient how to take the immunosuppressive drugs correctly, and how to measure heart rate and blood pressure.Set the patient's current body weight in the telemedicine dashboard by clicking on the Therapeutic Plan button. Fill in weight in kilograms, and click on Confirm Data. Define the therapeutic plan for home measurements with the patient, and fill out the frequency table in TBase.Discuss with the patients when to contact them to remind them to forward data, and encourage the patients to call in case of medical, or technical problems. On the next day, check whether data have been received, and call patients to explain that the data have arrived, asking about any technical issues they may have faced. Start the day with a structured process in reviewing incoming vital signs in the telemedicine dashboard.Filter patients according to their critical values, and if necessary, call the patient, or discuss the case with a physician from the telemedicine team. Review well-being data. Call patients if the well-being score is low, or if it decreases by more than two points.Consult a telemedicine team physician if the reason for the decrease in well-being is critical. Review less critical, but suspicious values, and discuss these cases with a physician. Control incoming medical messages and take action if necessary.Document all calls and activities in the telemedicine dashboard chart. Identify patients who did not document data in the app as previously agreed. Call the patients and ask about potential technical problems as the reason for missing the data.If technical data transmission is working, remind the patient to regularly forward data as agreed. Answer incoming calls from patients and local nephrologists. Ask patients at regular intervals about satisfaction with the telemedicine survey and usability of the app.Document this information, which is forwarded to the development team for evaluation and continuous improvement. Review reports from the nurses on critical values, such as high blood pressure. In severe cases, contact the senior nephrologist of the transplant team, or the physician who saw the patient during the last inpatient stay.Call the patient, take medical history, and give advice. Follow the patient closely over the next days if a change of medication, or an unclear situation has occurred. During the onboarding process, listen to the telemedicine team and ask questions.Give signed consent, and download the app with the help of the nurse. After receiving the initial login data from the nurse, change the login data and confirm participation digitally. Enter the new login data into the app, and push Sign In.After the app opens, enter the well-being status, and click on the Send button.Observe the buzzing sound and the confirmation sign and send the result from app to computer. Measure the blood pressure, enter the data into the app, and push the Send button. Observe the buzzing sound and the green banner pop-up showing vital data sent.Look at the show history list, and observe the table with all the values and transmission information. Open the communication page, and send a text message to the nurse. Start a video session by clicking the Video button.Open the lab results page, and look at recent laboratory data. Open the medication page, scroll through the medication plan, and confirm medication intake. Set the alert function for timely medication intake.After the nurse explains how the medication plan can be forwarded and printed out, log out of the app. At home, open the app and enter the vital signs. Look at laboratory values, medication plan, and confirm medication intake.Send a text message and perform a video consultation. Enter login data in the registration page, and look at the consent page, where consent was given for data transfer to the local nephrologist, and where consent can be easily withdrawn. In the first five months between February and July 2020, 172 kidney transplant recipients matched the inclusion criteria, and were asked to participate.Out of 172 participants, seven needed to borrow a smartphone. 33 patients declined for various reasons. In the end, 139 patients were enrolled.Of these, eight patients withdrew, and 131 patients are still participating in the project. The demographic characteristics of the participants are shown here. 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 per patient.The MACCS platform fits into a digital infrastructure. It includes data transmission to medical professionals at highly specialized outpatient care centers, patients, and physicians in private practice. We even programmed APIs to safely provide the data into the different EHRs.

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