Clinical trial NCT03816111: Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Disease, Chronic
Peritoneal Dialysis Catheter-Associated Peritonitis
Peritoneal Dialysis Catheter Exit Site Infection
Peritoneal Dialysis Catheter Tunnel Infection
Keywords: Training
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: The HOME Network
name: Australia and New Zealand Dialysis and Transplant Registry
name: New Zealand Peritoneal Dialysis Registry
First posted: 2019-01-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Time to the first occurrence of any PD-related infection
timeFrame: From the PD start date until first PD-related infection, assessed up to 4 years
Secondary outcomes:
measure: Time to first exit site infection
timeFrame: From the PD start date until first exit site infection, assessed up to 4 years
measure: Time to first tunnel infection
timeFrame: From the PD start date until first tunnel infection, assessed up to 4 years
measure: Time to first episode of peritonitis
timeFrame: From the PD start date until first peritonitis episode, assessed up to 4 years
measure: Time to infection-associated catheter removal
timeFrame: From the PD start date until first infection-associated catheter removal, assessed up to 4 years
measure: Incidence of technique failure - 30 days
timeFrame: Assessed at 30 days after transfer to HD or if death occurs within this period
measure: Incidence of technique failure - 180 days
timeFrame: Assessed at 180 days after transfer to HD or if death occurs within this period
measure: Incidence of all-cause hospitalization
timeFrame: Assessed from the PD start date, over up to 4 years
measure: Incidence of all-cause mortality
timeFrame: Assessed from the PD start date, over up to 4 years
measure: Participant Quality of Life questionnaire
timeFrame: Completed at baseline, 6, 12, 18 and 24 months
measure: Health-care cost-effectiveness analysis
timeFrame: Assessed from the PD start date, over up to 4 years
Other outcomes:
measure: Life participation questionnaire
timeFrame: Completed at baseline and 24 months
Locations:
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Hospital
state: New South Wales
city: Orange
country: Australia
facility: Orange Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Nepean/Blacktown Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred/Concord Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Tamworth
country: Australia
facility: Tamworth Hospital
state: New South Wales
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
state: New South Wales
city: Darwin
country: Australia
facility: Royal Darwin Hospital
state: Northern Territory
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Mackay
country: Australia
facility: Mackay Base Hospital
state: Queensland
city: Meadowbrook
country: Australia
facility: Logan Hospital
state: Queensland
city: Nambour
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Toowoomba
country: Australia
facility: Toowoomba Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Dandenong
country: Australia
facility: Monash Health
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Waitakere Hospital
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Blenheim
country: New Zealand
facility: Wairau Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Gisborne
country: New Zealand
facility: Gisborne Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Hastings
country: New Zealand
facility: Hawke's Bay Hospital
city: Nelson
country: New Zealand
facility: Nelson Hospital
city: New Plymouth
country: New Zealand
facility: Taranaki Hospital
city: Palmerston North
country: New Zealand
facility: Palmerston North/Whanganui Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Whangarei
country: New Zealand
facility: Whangarei Hospital
Study officials:
affiliation: University of Western Australia & Sir Charles Gairdner Hospital
name: Neil C Boudville, Prof
role: STUDY_CHAIR
affiliation: South Western Sydney Local Health District
name: Josephine S Chow, Prof
role: STUDY_CHAIR
affiliation: Queensland Health/Princess Alexandra Hospital
name: Yeoungjee Cho, PhD
role: STUDY_DIRECTOR
References: