APD and its new frontier. Roberto Pecoits-Filho, MD, PhD, FACP, FASN

Transcription

1 APD and its new frontier Roberto Pecoits-Filho, MD, PhD, FACP, FASN

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4 STARCH Study Phase IV Randomised (1:1) Parallel groups Multi-centre Nephrol Dial Transpl 2015 Nov;30(11): Non-diabetic APD patients Icodextrin 7.5%, long dwell Glucose 2.5%, long dwell STARCH, A Study to Evaluate the Effects of Icodextrin versus 2.5% Dianeal on Insulin Resistance in Non-Diabetic APD Patients [August 2014]

5 STARCH: Study Design Screening (n=64) Randomised (n=60) Excluded (n=4) Not willing to participate (n=4) Control group (n=27) Intervention group (n=33) Drop-out (n=10) Lost to follow up (n=3) Exit-site infection (n=2) Peritonitis (n=2) Transplantation (n=1) Death (n=1) UF failure (n=1) Drop-out (n=16) Transplantation (n=6) Lost to follow up (n=4) Peritonitis (n=2) Exit-site infection (n=2) Hernia (n=1) Gastroesophageal reflux (n=1) UF, ultrafiltration Analysed (n=17) Analysed (n=17) Nephrol Dial Transpl 2015 Nov;30(11):

6 Description Of The Primary Outcome For Changes In HOMA Index As treated Intention to treat days 90 days 0 45 days 90 days Control n=22 n=17 Icodextrin n=24 n=17 p value Control n=26 n=26 Icodextrin n=30 n=230 p value Nephrol Dial Transpl 2015 Nov;30(11):

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8 Inclusion criteria: At least 10 patients; Baxter system; Total: 122 Centers Retrospective data at admission Monthly prospective date Monthly Follow up Endpoint Transplant Recovery of RF Transfer to HD Death Largest PD cohort study in LA 10,000 patients 7 years of follow up

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18 The relationships between APD machine use and icodextrin dialysate use and PD incidence. Yi-Chun Lin et al. BMJ Open 2017;7:e by British Medical Journal Publishing Group

19 Poor PD Technique Survival and Time on Therapy Negatively Impacts Clinician Confidence in PD 1-4 Patient Confidence in PD 1-4 PD Take-on Rates 1. Cafazzo JA, Leonard K, Easty AC, Rossos PG, Chan CT. The user-centered approach in the development of a complex hospital-at-home intervention. Stud Health Technol Inform 2009;143: Cafazzo JA, Leonard K, Easty AC, Rossos PG, Chan CT. Patient-Perceived Barriers to the Adoption of Nocturnal Home Hemodialysis. Clin J Am Soc Nephrol 2009;4: Wong J et al. Patients Experiences with Learning a Complex Medical Device for the Self-Administration of Nocturnal Home Hemodialysis. Nephrol Nurs J 2009;36(1): Cafazzo JA, Leonard K, Easty AC, Rossos PG, Chan CT. Patient perceptions of remote monitoring for nocturnal home hemodialysis.hemodial Int 2010;14:

20 Non-Adherence to PD Prescription and Technique Survival Am J Kidney Dis 1998; 31: Am J Kidney Dis 2000; 35: Non- Adherence was à priori defined as patient performance of <90% of prescribed PD therapy 20

21 Impact of Non-Adherence to Prescribed PD Therapy <90% Adherence to Prescribed PD Therapy is associated with: Significant increase in technique failure Significant increase in peritonitis rates Significant increase in hospitalization and days hospitalized Significant increase in rate of death Identification of non-adherent patients depends on monthly inventory assessment J Bernardini, M Nagy, B Piraino. Pattern of Noncompliance with Dialysis Exchanges in Peritoneal Dialysis Patients. Am J Kidney Dis 2000; 35: J Bernardini, B Piraino. Compliance in CAPD and CCPD Patients as Measured by Supply Inventories During Home Visits. Am J Kidney Dis 1998; 31:

22 Impact of Non-Adherence to Prescribed PD Therapy What can be done knowing that: Non-adherence is associated with poor clinical outcomes Identification of patient non-adherence would allow clinicians the opportunity to intervene, potentially avoiding adverse clinical outcomes Performing inventory assessments to assess adherence is onerous, time-consuming, and not routinely performed? 22

23 Discrepancies between Actual versus Prescribed Automated Peritoneal Dialysis Prescription: Identification Using APD Cycler-Embedded Remote Patient Management (RPM) Technology JA Sloand, CA Firanek, D Wiebenson, M Gellens, R Drummond-Gatesman, Mario Salas Baxter Healthcare Corporation Deerfield, IL, USA Abstract ID: March 23, 2017

24 Remote Patient Monitoring and Management (RPM) Remote patient monitoring refers to: A wide variety of technologies designed to [remotely] monitor and manage a range of health conditions to alert HCPs about potential changes in health conditions. weight scales, glucometers, and BP monitors Video-chat Implantable 24

25 For Patients on Home Dialysis: Remote Patient Management PD-cycler embedded remote patient management platform Treatment data is automatically collected after each PD session Allowing healthcare providers to securely view their patients recently completed home dialysis-related treatment data Allowing Healthcare providers to act on this information by directly contacting the patient and/or remotely adjusting their patients home device settings 25

26 For Patients on Home Dialysis Remote Patient Management PD-cycler embedded remote patient management platform Treatment data is automatically collected after each PD session Allowing healthcare providers to securely view their patients recently completed home dialysis-related treatment data Allowing Healthcare providers to act on this information by directly contacting the patient and/or remotely adjusting their patients home device settings 26

27 Sharesource Clinician Dashboard: Setting flag alerts 27

28 Sharesource: The only existing Global Two-Way Remote Management Platform for Home Dialysis Patient s Home Clinic Portal Data Center Cellular Modem Cloud-based Server System Baxter Portal Customer service/tech service De-identified Aggregate Data Patient Portal 28

29 Discrepancies between Actual versus Prescribed Automated Peritoneal Dialysis Prescription Research Objectives: Understand differences between actual versus prescribed APD prescriptions using the de-identified Sharesource database Prescriptive parameters examined included: Actual number of days patients performed APD/wk (i.e. days/week) Actual versus prescribed treatment times (i.e. minutes on APD versus minutes prescribed) Actual versus prescribed dwell (and drain) times 29

30 Sharesource Data Analysis of Adherence Used the Sharesource database for patients who had been on either Amia or Claria APD cyclers (Sharesource-embedded) for at least 3 months of treatment Claria-SS (Nov 2015 through Dec 2016); Amia-SS (Dec 2015 Jan 2017) Assumed prescription of 7 treatments/week and 30 treatments/month Unable to discern incident from prevalent patients in the database. Claria Exclusion Subjects with >30 day gaps in treatment were omitted From the initial treatment, any treatments occurring in the first 14 days were omitted and considered as training. Sites in Germany were omitted (given practice s: i.e. IPD 3x/week) Records from the Baxter Education Center were omitted. Amia Exclusion Subjects with >30 day gaps in treatment were omitted From the initial treatment, any treatments occurring in the first 14 days were omitted and considered as training. 30

31 Number of Patients Sharesource: Identification of Missed Treatments Number of patients with at least 3 months of therapy who Missed Treatments in the first month Combined Amia and Claria Sharesource (n=943) 31% 22% 11% 13% 11% 6% 6% Missed Treatments N=943 Combined Sharesource Results: 30% (279) of patients missed > four treatments (>10% of prescribed therapy) 11% (107) of patients missed > 9 treatments. 31

32 Number of Patients Number of Patients Sharesource: Identification of Missed Treatments Number of patients with at least 3 months of therapy who Missed Treatments in the first month Amia Sharesource (n=544) Claria Sharesource (n=399) % 25% 12% 13% 11% 7% 6% Missed Treatments % 16% 13% 12% 9% 6% 5% Missed Treatments Individual Sharesource (SS) Results: ~30% of both Amia-SS (164) and Claria-SS (115) patients and missed > 4 treatments (>10% of prescribed therapy) 11-12% of Amia-SS (60) and Claria-SS (47) patients, respectively, missed > 9 treatments. 32

33 Number of Patients Sharesource: Identification of Shortened Treatments Number of patients with at least 3 months of treatment who missed significant (actual/prescribed) by week of treatment Treatment Time per week Combined Amia and Claria Sharesource (n=943) 59% 57% 51% 54% Weeks on Therapy Combined Sharesource Results at 1, 2, 4 and 6 weeks: >100 min >200 min >300 min Similar percentages of missed treatment times occurred over all weeks evaluated. ~28% of patients (264) had >100 minutes (min) less actual therapy time than prescribed ~11% of patients (103) had >300 min less actual therapy time* than prescribed Treatment Time Missed/wk 28% 11% * For nocturnal therapy of 9 hours x 7 days/week: 3,780 minutes 300/3,780 = 8% of prescribed cycler therapy 33

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37 SONG-PD Steering Group David Johnson (Chair) University of Queensland, Australia Angela Wang The University of Hong Kong, Hong Kong Edwina Brown Imperial College London, United Kingdom Gillian Brunier University of Toronto, Canada Jeffrey Perl University of Toronto, Canada Jie Dong Peking University, China Martin Wilkie NHS Sheffield Teaching Hospital, United Kingdom Rajnish Mehrotra University of Washington, United States Roberto Pecoits-Filho Pontificia Universidade Catolica do Parana, Brazil Sarala Naicker Wits University, South Africa Sue-Ann Dunning Australia Tony Dunning Southbank TAFE, Australia Project coordinator: Karine Manera, The University of Sydney

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