Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial (TEACH-PD)

A Pragmatic, Registry-based, International, Cluster-randomized Controlled Trial Examining the Use of TEACH-PD Training Modules for Incident PD Patients Versus Existing Practices on the Rate of PD-related Infections

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.

Study Overview

• Status: Completed
• Conditions: Kidney Disease, Chronic; Peritoneal Dialysis Catheter Exit Site Infection; Peritoneal Dialysis Catheter-Associated Peritonitis; Peritoneal Dialysis Catheter Tunnel Infection
• Intervention / Treatment: Behavioral: TEACH-PD Training Curriculum; Behavioral: Current standard PD training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1462
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia
      • Canberra Hospital
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney
    • Gosford, New South Wales, Australia
      • Gosford Hospital
    • Lismore, New South Wales, Australia
      • Lismore Hospital
    • Orange, New South Wales, Australia
      • Orange Hospital
    • St Leonards, New South Wales, Australia
      • Royal North Shore Hospital
    • Sydney, New South Wales, Australia
      • St George Hospital
    • Sydney, New South Wales, Australia
      • Liverpool Hospital
    • Sydney, New South Wales, Australia
      • Prince of Wales Hospital
    • Sydney, New South Wales, Australia
      • Nepean/Blacktown Hospital
    • Sydney, New South Wales, Australia
      • Royal Prince Alfred/Concord Hospital
    • Tamworth, New South Wales, Australia
      • Tamworth Hospital
    • Tweed Heads, New South Wales, Australia, 2485
      • The Tweed Hospital
  • Northern Territory
    • Darwin, Northern Territory, Australia, 0810
      • Royal Darwin Hospital
  • Queensland
    • Brisbane, Queensland, Australia
      • Princess Alexandra Hospital
    • Cairns, Queensland, Australia
      • Cairns Hospital
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
    • Mackay, Queensland, Australia, 4740
      • Mackay Base Hospital
    • Meadowbrook, Queensland, Australia
      • Logan Hospital
    • Nambour, Queensland, Australia
      • Sunshine Coast University Hospital
    • Southport, Queensland, Australia
      • Gold Coast University Hospital
    • Toowoomba, Queensland, Australia
      • Toowoomba Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Royal Adelaide Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
    • Launceston, Tasmania, Australia, 7250
      • Launceston General Hospital
  • Victoria
    • Dandenong, Victoria, Australia
      • Monash Health
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
    • Geelong, Victoria, Australia, 3220
      • Barwon Health
    • Heidelberg, Victoria, Australia
      • Austin Health
    • Melbourne, Victoria, Australia
      • Royal Melbourne Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital
• New Zealand
  • Auckland, New Zealand
    • Middlemore Hospital
  • Auckland, New Zealand
    • Auckland Hospital
  • Auckland, New Zealand, 0620
    • North Shore Hospital
  • Auckland, New Zealand, 0610
    • Waitakere Hospital
  • Blenheim, New Zealand, 7201
    • Wairau Hospital
  • Christchurch, New Zealand
    • Christchurch Hospital
  • Dunedin, New Zealand
    • Dunedin Hospital
  • Gisborne, New Zealand, 4010
    • Gisborne Hospital
  • Hamilton, New Zealand, 3204
    • Waikato Hospital
  • Hastings, New Zealand
    • Hawke's Bay Hospital
  • Nelson, New Zealand, 7010
    • Nelson Hospital
  • New Plymouth, New Zealand
    • Taranaki Hospital
  • Palmerston North, New Zealand
    • Palmerston North/Whanganui Hospital
  • Wellington, New Zealand, 6021
    • Wellington Hospital
  • Whangarei, New Zealand
    • Whangarei Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEACH-PD Training Curriculum; All patients at sites randomized to this arm will receive the TEACH-PD Training Curriculum	Behavioral: TEACH-PD Training Curriculum; 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.
Active Comparator: Current Standard PD Training; All patients at sites randomized to this arm will receive the unit's current PD training materials and plan	Behavioral: Current standard PD training; Current PD training materials and plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first occurrence of any PD-related infection	Time to the first occurrence of any PD-related infection including exit site infection, tunnel infection or peritonitis	From the PD start date until first PD-related infection, assessed up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first exit site infection	Time to first exit site infection	From the PD start date until first exit site infection, assessed up to 4 years
Time to first tunnel infection	Time to first tunnel infection	From the PD start date until first tunnel infection, assessed up to 4 years
Time to first episode of peritonitis	Time to first episode of peritonitis	From the PD start date until first peritonitis episode, assessed up to 4 years
Time to infection-associated catheter removal	Time to infection-associated catheter removal	From the PD start date until first infection-associated catheter removal, assessed up to 4 years
Incidence of technique failure - 30 days	Incidence of technique failure defined as transfer to haemodialysis for greater than 30-days and/or death within this time	Assessed at 30 days after transfer to HD or if death occurs within this period
Incidence of technique failure - 180 days	Incidence of technique failure defined as transfer to haemodialysis for greater than 180-days and/or death within this time	Assessed at 180 days after transfer to HD or if death occurs within this period
Incidence of all-cause hospitalization	Incidence of all-cause hospitalization collected via health department hospitalization data linkage	Assessed from the PD start date, over up to 4 years
Incidence of all-cause mortality	Incidence of all-cause mortality	Assessed from the PD start date, over up to 4 years
Participant Quality of Life questionnaire	Participant-reported Quality of Life measured using EQ-5D-5L (EuroQol-5 dimensions questionnaire). EQ-5D-5L measures quality of life using 2 methods - a descriptive scale and a Visual Analogue Scale. The descriptive scale comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/ depression). Each dimension has 5 measurement levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Numbers associated with levels can be used to report an index score. The VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).	Completed at baseline, 6, 12, 18 and 24 months
Health-care cost-effectiveness analysis	Difference in the incremental cost per Quality Adjusted Life Years gained between treatment arms	Assessed from the PD start date, over up to 4 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life participation questionnaire	Life participation measured using PROMIS (patient-reported outcomes measurement information system) Short Form - Ability to participate in social roles and activities 6a. PROMIS will measure 6 dimensions (trouble with leisure activities, trouble doing family activities, trouble doing work, trouble doing activities with friends, limiting fun with others and limiting activities with friends). Each dimension has 5 measurement levels: Always (1), Usually, (2), Sometimes (3), Rarely (4) and Never (5).	Completed at baseline and 24 months

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: The HOME Network; Australia and New Zealand Dialysis and Transplant Registry; New Zealand Peritoneal Dialysis Registry
• Investigators: Study Chair: Neil C Boudville, Prof, University of Western Australia & Sir Charles Gairdner Hospital; Study Chair: Josephine S Chow, Prof, South Western Sydney Local Health District; Study Director: Yeoungjee Cho, PhD, Queensland Health/Princess Alexandra Hospital

Publications and helpful links

General Publications

• Chow JSF, Boudville N, Cho Y, Palmer S, Pascoe EM, Hawley CM, Reidlinger DM, Hickey LE, Stastny R, Valks A, Vergara L, Movva R, Kiriwandeniya C, Candler H, Mihala G, Buisman B, Equinox KL, Figueiredo AE, Fuge T, Howard K, Howell M, Jaure A, Jose MD, Lee A, Miguel SS, Moodie JA, Nguyen TT, Pinlac G, Reynolds A, Saweirs WWM, Steiner-Lim GZ, TeWhare B, Tomlins M, Upjohn M, Voss D, Walker RC, Wilson J, Johnson DW. Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol. Trials. 2023 Nov 14;24(1):730. doi: 10.1186/s13063-023-07715-0.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Training
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: AKTN 17.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
• IPD Sharing Time Frame: Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in the investigator's University's data warehouse but without investigator support other than deposited metadata.
• IPD Sharing Access Criteria: An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No