Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis

NCT02755610 | Unknown

• 1 other identifier: CLIP-SP
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief Summary

Peritoneal Dialysis (PD) has been the main method of treatment for Thai End-Stage Renal Disease (ESRD) patients under the "PD First" policy of the Universal Coverage (UC) scheme. The increased demand has resulted in not only supply chain logistical problems, but also product quality concerns. Peritonitis, the main complication and checklist cause of failure in Continuous Ambulatory Peritoneal Dialysis (CAPD) patients, could be caused by a product defect. This cluster randomized trial will be conducted in 22 randomly selected PD centers in Thailand to assess if a checklist intervention could reduce peritonitis rate and increase the number of checklist product defect report.

Conditions

End-Stage Kidney Disease; Peritonitis

Keywords

Peritoneal Dialysis; Checklist

Outcome Measures

Primary Outcomes (1)

• Peritonitis Incidence Rate

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Product Defect Incidence

  through study completion, an average of 1 year

Study Arms (2)

PD Product Check List

EXPERIMENTAL

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.

Other: PD Product Check List

Control

NO INTERVENTION

Standard care

Interventions

PD Product Check List OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ESRD patients who start peritoneal dialysis not longer than one month and participate in PDOPPS study

You may not qualify if:

• ESRD patients who receive only hemodialysis
• ESRD patients who receive emergency peritoneal dialysis
• Illiterate ESRD patients or their caregivers

Sponsors & Collaborators

• Chulalongkorn University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (12)

• 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.

  PMID: 22043584 BACKGROUND

• 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.

  PMID: 22043559 BACKGROUND

• 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.

  PMID: 25082840 BACKGROUND

• 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.

  PMID: 16931220 BACKGROUND

• 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.

  PMID: 22043560 BACKGROUND

• 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.

  PMID: 24335129 BACKGROUND

• 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.

  PMID: 24997794 BACKGROUND

• 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.

  PMID: 22043561 BACKGROUND

• 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.

  PMID: 17047225 BACKGROUND

• 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.

  PMID: 26526049 BACKGROUND

• 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.

  PMID: 20628102 BACKGROUND

• 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.

  PMID: 2188325 BACKGROUND

Related Links

• The Peritoneal Dialysis Outcomes and Practice Patterns Study

MeSH Terms

Conditions

Kidney Failure, Chronic; Peritonitis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Krit Pongpirul, MD,MPH,PhD.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in the Study Arm receive standard care and a paper check list to record product defect information Participants in the Control Arm receive standard care

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: April 29, 2016
• Study Start: May 2, 2016
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)