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

Not Applicable

Active, not recruiting

• Conditions: End-Stage Kidney Disease; Peritonitis
• Interventions: Other: PD Product Check List

• Registration Number: NCT02755610
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

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 main cause of failure in CAPD patients, could be caused by a product defect.

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.

Study Timeline

• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-29
• Study Start: 2016-05-02
• Status Verified: 2023-08
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD Product Check List	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.

Primary Outcome Measures

Name	Time	Method
Peritonitis Incidence Rate	through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Product Defect Incidence	through study completion, an average of 1 year

Trial Locations

Locations (1)

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand