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

Sponsor

The University of Queensland (Other)

Overall Status

Recruiting

CT.gov ID

NCT03816111

Collaborator

The HOME Network (Other), Australia and New Zealand Dialysis and Transplant Registry (Other), New Zealand Peritoneal Dialysis Registry (Other)

1,500

Enrollment

Locations

Arms

69.3

Anticipated Duration (Months)

31.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Disease, Chronic Peritoneal Dialysis Catheter-Associated Peritonitis Peritoneal Dialysis Catheter Exit Site Infection Peritoneal Dialysis Catheter Tunnel Infection	Behavioral: TEACH-PD Training Curriculum Behavioral: Current standard PD training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jul 22, 2019

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Time to first exit site infection [From the PD start date until first exit site infection, assessed up to 4 years]
Time to first exit site infection
Time to first tunnel infection [From the PD start date until first tunnel infection, assessed up to 4 years]
Time to first tunnel infection
Time to first episode of peritonitis [From the PD start date until first peritonitis episode, assessed up to 4 years]
Time to first episode of peritonitis
Time to infection-associated catheter removal [From the PD start date until first infection-associated catheter removal, assessed up to 4 years]
Time to infection-associated catheter removal
Incidence of technique failure - 30 days [Assessed at 30 days after transfer to HD or if death occurs within this period]
Incidence of technique failure defined as transfer to haemodialysis for greater than 30-days and/or death within this time
Incidence of technique failure - 180 days [Assessed at 180 days after transfer to HD or if death occurs within this period]
Incidence of technique failure defined as transfer to haemodialysis for greater than 180-days and/or death within this time
Incidence of all-cause hospitalization [Assessed from the PD start date, over up to 4 years]
Incidence of all-cause hospitalization collected via health department hospitalization data linkage
Incidence of all-cause mortality [Assessed from the PD start date, over up to 4 years]
Incidence of all-cause mortality
Participant Quality of Life questionnaire [Completed at baseline, 6, 12, 18 and 24 months]
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).
Health-care cost-effectiveness analysis [Assessed from the PD start date, over up to 4 years]
Difference in the incremental cost per Quality Adjusted Life Years gained between treatment arms

Other Outcome Measures

Life participation questionnaire [Completed at baseline and 24 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Canberra Hospital	Canberra	Australian Capital Territory	Australia
2	St Vincent's Hospital Sydney	Darlinghurst	New South Wales	Australia	2010
3	Gosford Hospital	Gosford	New South Wales	Australia
4	Lismore Hospital	Lismore	New South Wales	Australia
5	Orange Hospital	Orange	New South Wales	Australia
6	Royal North Shore Hospital	St Leonards	New South Wales	Australia
7	Liverpool Hospital	Sydney	New South Wales	Australia
8	Nepean/Blacktown Hospital	Sydney	New South Wales	Australia
9	Prince of Wales Hospital	Sydney	New South Wales	Australia
10	Royal Prince Alfred/Concord Hospital	Sydney	New South Wales	Australia
11	St George Hospital	Sydney	New South Wales	Australia
12	Tamworth Hospital	Tamworth	New South Wales	Australia
13	The Tweed Hospital	Tweed Heads	New South Wales	Australia	2485
14	Royal Darwin Hospital	Darwin	Northern Territory	Australia	0810
15	Princess Alexandra Hospital	Brisbane	Queensland	Australia
16	Cairns Hospital	Cairns	Queensland	Australia
17	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	4029
18	Mackay Base Hospital	Mackay	Queensland	Australia	4740
19	Logan Hospital	Meadowbrook	Queensland	Australia
20	Sunshine Coast University Hospital	Nambour	Queensland	Australia
21	Gold Coast University Hospital	Southport	Queensland	Australia
22	Toowoomba Hospital	Toowoomba	Queensland	Australia
23	Royal Adelaide Hospital	Adelaide	South Australia	Australia
24	Royal Hobart Hospital	Hobart	Tasmania	Australia	7000
25	Launceston General Hospital	Launceston	Tasmania	Australia	7250
26	Monash Health	Dandenong	Victoria	Australia
27	St Vincent's Hospital Melbourne	Fitzroy	Victoria	Australia	3065
28	Barwon Health	Geelong	Victoria	Australia	3220
29	Austin Health	Heidelberg	Victoria	Australia
30	Royal Melbourne Hospital	Melbourne	Victoria	Australia
31	Fiona Stanley Hospital	Murdoch	Western Australia	Australia	6150
32	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
33	Royal Perth Hospital	Perth	Western Australia	Australia	6000
34	Waitakere Hospital	Auckland		New Zealand	0610
35	North Shore Hospital	Auckland		New Zealand	0620
36	Auckland Hospital	Auckland		New Zealand
37	Middlemore Hospital	Auckland		New Zealand
38	Wairau Hospital	Blenheim		New Zealand	7201
39	Christchurch Hospital	Christchurch		New Zealand
40	Dunedin Hospital	Dunedin		New Zealand
41	Gisborne Hospital	Gisborne		New Zealand	4010
42	Waikato Hospital	Hamilton		New Zealand	3204
43	Hawke's Bay Hospital	Hastings		New Zealand
44	Nelson Hospital	Nelson		New Zealand	7010
45	Taranaki Hospital	New Plymouth		New Zealand
46	Palmerston North/Whanganui Hospital	Palmerston North		New Zealand
47	Wellington Hospital	Wellington		New Zealand	6021
48	Whangarei Hospital	Whangarei		New Zealand

Sponsors and Collaborators

The University of Queensland
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