Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial

Kidney Disease, Chronic Clinical Trial

— TEACH-PD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03816111
• Other study ID #: AKTN 17.03
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: August 2022
• Source: The University of Queensland
• Contact: Yeoungjee Cho, PhD
• Phone: +61 7 3176 2732
• Email: Yeoungjee.Cho[@]health.qld.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: April 30, 2025
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Kidney Disease, Chronic
• Kidney Diseases
• Peritoneal Dialysis Catheter Exit Site Infection
• Peritoneal Dialysis Catheter Tunnel Infection
• Peritoneal Dialysis Catheter-Associated Peritonitis
• Peritonitis
• Renal Insufficiency, Chronic

Intervention

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.
• Current standard PD training
Current PD training materials and plan

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
The University of Queensland	Australia and New Zealand Dialysis and Transplant Registry, New Zealand Peritoneal Dialysis Registry, The HOME Network

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Time to first tunnel infection	Time to first tunnel infection	From the PD start date until first tunnel infection, assessed up to 4 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of all-cause mortality	Incidence of all-cause mortality	Assessed from the PD start date, over up to 4 years
Secondary	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
Secondary	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