Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis
NCT ID: NCT02755610
Last Updated: 2024-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
880 participants
INTERVENTIONAL
2016-05-02
2024-05-31
Brief Summary
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Detailed Description
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PD Product Check List was developed based on the 28 routine steps of standard orientation manual for new Thai PD patients. Of these, step 2 (weighting the PD solution bag), step 3 (checking expiration date, volume, glucose concentration, clarity, and color, step 27 (weighting the PD solution bag), and step 28 (recording time, volume, and any abnormality encountered) are relevant to product defect report.
This cluster randomized trial will be conducted in 22 PD centers (anticipated 20-25 prevalent and 10-15 incidence PD cases per center) to answer the primary research question: is the checklist intervention effective in reducing peritonitis rate? The secondary research questions will also be considered: does the checklist help increase the number of product defect report?
Peritonitis incidence rate is the primary outcome, defined based on the International Society for Peritoneal Dialysis (ISPD) 2010 recommendation. Product defect incidence is the secondary outcome, measured by a number of incidence of product defect reported by the patients. Given no standard definition, a PD solution product will be considered defective if it is expired on the day of use, incorrect glucose concentration, abnormal clarity or color, physical abnormality of the box and/or the bag, or loose connector.
Because of the nature of the intervention, blinding is not possible. Cluster randomization will be performed to allocate 11 PD centers to the study group and the other 11 PD centers to control group. While all subjects will receive standard PD care, subjects in the study group will also receive the checklist plus a 30-minute orientation of how to use the checklist.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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PD Product Check List
PD Product Check List was developed based on the 28 routine steps of standard orientation manual for new Thai PD patients. Of these, step 2 (weighting the PD solution bag), step 3 (checking expiration date, volume, glucose concentration, clarity, and color, step 27 (weighting the PD solution bag), and step 28 (recording time, volume, and any abnormality encountered) are relevant to product defect report.
PD Product Check List
PD Product Check List was developed based on the 28 routine steps of standard orientation manual for new Thai PD patients. Of these, step 2 (weighting the PD solution bag), step 3 (checking expiration date, volume, glucose concentration, clarity, and color, step 27 (weighting the PD solution bag), and step 28 (recording time, volume, and any abnormality encountered) are relevant to product defect report.
Control
Standard care
No interventions assigned to this group
Interventions
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PD Product Check List
PD Product Check List was developed based on the 28 routine steps of standard orientation manual for new Thai PD patients. Of these, step 2 (weighting the PD solution bag), step 3 (checking expiration date, volume, glucose concentration, clarity, and color, step 27 (weighting the PD solution bag), and step 28 (recording time, volume, and any abnormality encountered) are relevant to product defect report.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* ESRD patients who receive emergency peritoneal dialysis
* Illiterate ESRD patients or their caregivers
18 Years
ALL
No
Sponsors
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National Research Council of Thailand
OTHER_GOV
Chulalongkorn University
OTHER
Responsible Party
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Principal Investigators
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Krit Pongpirul, MD,MPH,PhD.
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Locations
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Faculty of Medicine, Chulalongkorn University
Bangkok, , Thailand
Countries
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References
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Dhanakijcharoen P, Sirivongs D, Aruyapitipan S, Chuengsaman P, Lumpaopong A. The "PD First" policy in Thailand: three-years experiences (2008-2011). J Med Assoc Thai. 2011 Sep;94 Suppl 4:S153-61.
Praditpornsilpa K, Lekhyananda S, Premasathian N, Kingwatanakul P, Lumpaopong A, Gojaseni P, Sakulsaengprapha A, Prasithsirikul W, Phakdeekitcharoen B, Lelamali K, Teepprasan T, Aumanaphong C, Leerawat B, Pongpiyadej J, Srangsomvong S, Kanjanabuch T, Eiam-Ong S, Vareesaengthip K, Lumlertkul D. Prevalence trend of renal replacement therapy in Thailand: impact of health economics policy. J Med Assoc Thai. 2011 Sep;94 Suppl 4:S1-6.
Liu FX, Gao X, Inglese G, Chuengsaman P, Pecoits-Filho R, Yu A. A Global Overview of the Impact of Peritoneal Dialysis First or Favored Policies: An Opinion. Perit Dial Int. 2015 Jul-Aug;35(4):406-20. doi: 10.3747/pdi.2013.00204. Epub 2014 Jul 31.
Wong HS, Ong LM, Lim TO, Hooi LS, Morad Z, Ghazalli R, Shaariah W, Lim YN, Ahmad G, Goh BL, Liaw L, Pee S, Lee ML. A randomized, multicenter, open-label trial to determine peritonitis rate, product defect, and technique survival between ANDY-Disc and UltraBag in patients on CAPD. Am J Kidney Dis. 2006 Sep;48(3):464-72. doi: 10.1053/j.ajkd.2006.05.008.
Kanjanabuch T, Chancharoenthana W, Katavetin P, Sritippayawan S, Praditpornsilpa K, Ariyapitipan S, Eiam-Ong S, Dhanakijcharoen P, Lumlertgul D. The incidence of peritoneal dialysis-related infection in Thailand: a nationwide survey. J Med Assoc Thai. 2011 Sep;94 Suppl 4:S7-12.
Amornnimit W, Pongpirul K, Sampatanukul P, Tungsanga K, Tosukhowong P, Kanjanabuch T. Black-stained peritoneal dialysis tubing: a national survey. Perit Dial Int. 2013 Nov-Dec;33(6):704-7. doi: 10.3747/pdi.2012.00167. No abstract available.
Pongpirul K, Pongpirul WA, Kanjanabuch T. Potential causes of black-stained peritoneal dialysis tubing: an analysis from nurse practitioner's prospect. BMC Res Notes. 2014 Jul 6;7:434. doi: 10.1186/1756-0500-7-434.
Treamtrakanpon W, Katavetin P, Yimsangyad K, Keawsinark P, Sanganunttakan S, Pandon S, Buddeewong D, Prakot A, Khumsupo C, Thamsutee N, Yaibuaiam R, Khumwong S, Towannang P, Theerasin Y, Mahatnan N, Eiam-Ong S, Kanjanabuch T. From the "PD First" policy to the innovation in PD care. J Med Assoc Thai. 2011 Sep;94 Suppl 4:S13-8.
Bernardini J, Price V, Figueiredo A; International Society for Peritoneal Dialysis (ISPD) Nursing Liaison Committee. Peritoneal dialysis patient training, 2006. Perit Dial Int. 2006 Nov-Dec;26(6):625-32. No abstract available.
Perl J, Davies SJ, Lambie M, Pisoni RL, McCullough K, Johnson DW, Sloand JA, Prichard S, Kawanishi H, Tentori F, Robinson BM. The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis. Perit Dial Int. 2016 May-Jun;36(3):297-307. doi: 10.3747/pdi.2014.00288. Epub 2015 Nov 2.
Li PK, Szeto CC, Piraino B, Bernardini J, Figueiredo AE, Gupta A, Johnson DW, Kuijper EJ, Lye WC, Salzer W, Schaefer F, Struijk DG; International Society for Peritoneal Dialysis. Peritoneal dialysis-related infections recommendations: 2010 update. Perit Dial Int. 2010 Jul-Aug;30(4):393-423. doi: 10.3747/pdi.2010.00049. No abstract available.
Vonesh EF. Modelling peritonitis rates and associated risk factors for individuals on continuous ambulatory peritoneal dialysis. Stat Med. 1990 Mar;9(3):263-71. doi: 10.1002/sim.4780090309.
Related Links
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The Peritoneal Dialysis Outcomes and Practice Patterns Study
Other Identifiers
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CLIP-SP
Identifier Type: -
Identifier Source: org_study_id
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