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Targeted Education ApproaCH t...

Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial

Last Updated: 2024-05-10

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2025-04-30

Brief Summary

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For many patients peritoneal dialysis (PD) is the preferred form of dialysis to treat kidney disease as it provides greater flexibility and the ability to dialyse at home. However, PD use in Australia has been decreasing over the last 10 years. A big reason for this drop is the risk of infection. The best way to prevent PD related infections is to make sure that patients have good training in PD techniques. The researchers of this study have developed TEACH-PD, a new education package for training both PD nurses and PD patients.

The aim of this study is to find out whether TEACH-PD training reduces the number of PD related infections.

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Detailed Description

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End stage kidney disease is fatal unless treated with dialysis or transplant. Peritoneal dialysis (PD) is a core dialysis modality offering home-based care for patients. PD utilization is frequently threatened beyond 5 years for most patients due to PD-related infections. Patient training is a critical cornerstone of mitigating infection risk and maximizing PD durability (technique survival), but training practices are characterized by a lack of standardization and severe heterogeneity.

There is no high-level evidence to inform PD training. Accordingly, a structured program encompassing how and what to teach PD patients at the inception of PD treatment has the potential to reduce serious PD-related infections, extend the longevity of PD, support cost-effective home-based dialysis care, and reduce costs and health service utilization associated with hospitalization and transition to haemodialysis. TEACH-PD is a standardised modular curriculum for both PD nurse trainers and patients that has been collaboratively developed by renal nurses, doctors, educationalists and patients, aligned to current International Society for Peritoneal Dialysis (ISPD) guidelines, utilizing modern adult learning principles. The TEACH-PD program is feasible and acceptable, as demonstrated in a successful pilot study.

The primary objective of TEACH-PD CRCT (Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes - a Cluster Randomised Controlled Trial) is to determine whether implementation of standardised training modules based on ISPD guidelines targeting both PD trainers and patients results in a longer time to the composite end-point of exit site infections, tunnel infections and peritonitis in incident PD patients compared to existing training practices.

TEACH-PD is a registry-based, pragmatic, multi-center, multinational trial, randomising PD units to implementing TEACH-PD training modules targeted at PD trainers and incident PD patients versus standard existing practices.

An estimated 1,500 patient new to PD will be recruited from at least approximately 42-44 PD units in Australia and New Zealand.The study is being coordinated by the University of Queensland (operating through the Australasian Kidney Trial Network).

The TEACH-PD training modules have been developed by a core group of renal nurses from the HOME Network in conjunction with senior medical clinicians from the Australasian Kidney Trials Network, eLearning curriculum developers, consumer representatives, and education experts, in line with the ISPD guidelines, utilizing modern adult learning principles and best practice eLearning techniques. The modules will be implemented at PD units in Australia and New Zealand to formally evaluate whether, compared with standard care, a standardised training curriculum will reduce the rate of PD-related infections and improve technique survival, resulting in better outcomes for patients receiving PD and significant cost-savings to the community.

Conditions

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Kidney Disease, Chronic Peritoneal Dialysis Catheter-Associated Peritonitis Peritoneal Dialysis Catheter Exit Site Infection Peritoneal Dialysis Catheter Tunnel Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TEACH-PD Training Curriculum

All patients at sites randomized to this arm will receive the TEACH-PD Training Curriculum

Group Type EXPERIMENTAL

TEACH-PD Training Curriculum

Intervention Type BEHAVIORAL

The TEACH-PD training modules have been developed by a core group of renal nurses from the HOME Network in conjunction with senior medical clinicians from the Australasian Kidney Trials Network, eLearning curriculum developers, consumer representatives, and education experts, in line with the International Society for Peritoneal Dialysis guidelines, utilizing modern adult learning principles and best practice eLearning techniques.

Current Standard PD Training

All patients at sites randomized to this arm will receive the unit's current PD training materials and plan

Group Type ACTIVE_COMPARATOR

Current standard PD training

Intervention Type BEHAVIORAL

Current PD training materials and plan

Interventions

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TEACH-PD Training Curriculum

Intervention Type BEHAVIORAL

Current standard PD training

Current PD training materials and plan

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients new to PD;
* Patients \> 18 years of age,
* Need to undergo PD training;
* Are able to provide informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil C Boudville, Prof

Role: STUDY_CHAIR

University of Western Australia & Sir Charles Gairdner Hospital

Josephine S Chow, Prof

Role: STUDY_CHAIR

South Western Sydney Local Health District

Yeoungjee Cho, PhD

Role: STUDY_DIRECTOR

Queensland Health/Princess Alexandra Hospital

Locations

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Canberra Hospital

Canberra, Australian Capital Territory, Australia

Site Status

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status

Gosford Hospital

Gosford, New South Wales, Australia

Site Status

Lismore Hospital

Lismore, New South Wales, Australia

Site Status

Orange Hospital

Orange, New South Wales, Australia

Site Status