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Trial registered on ANZCTR


Registration number
ACTRN12617001012369
Ethics application status
Approved
Date submitted
6/07/2017
Date registered
14/07/2017
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Date results information initially provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) - Pilot Study
Scientific title
An investigator-initiated, single-armed, non-randomised, pilot study assessing the use of training modules for both nurse trainers and incident patients undertaking Peritoneal Dialysis training
Secondary ID [1] 292375 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TEACH-PD pilot study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 303937 0
Condition category
Condition code
Renal and Urogenital 303292 303292 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention - experimental for PD Trainers
The TEACH-PD Train the Trainer Programme is based on the International Society for Peritoneal Dialysis guidelines for teaching PD to patients and caregivers. All modules take a conversation approach which models patient-to-trainer feedback cycles . The programme requires all trainers complete the following activities within one month of on-site induction visit.

1. Induction Visit ( 1- 2 hours):
This on-site meeting, presented by the investigators, will introduce the TEACH-PD curriculum including its learning outcomes, the online modules, overview of the patient training manuals, and an outline of assessment.
PD Trainers must fulfill a pre-requisite knowledge requirement before starting the Module 1A. This will be assessed using an 20 multiple choice question test on-line covering topics of What is PD, PD complication and problem solving and integrating PD into the patient home.

2. Two interactive web-based training modules (each module 2 hours to complete) :
• Module 1A – Home dialysis training – an overview
• Module 1B – Personalised approaches to home dialysis training
Learning after each module will assessed using a 20 question multiple choice test.

3. Two Interactive web-based Case Study based modules (each study 30 – 60 min to complete):
Learning from each case study will be assessed via a 6 question multiple-choice test. Trainers will then develop a Patient summary report and Personalised lesson plan for one of the patients described in the case studies. The report and lesson plan will be assessed by an in-unit mentor / accredited assessor and feedback will be provided.

4. Nurse Competency Checklist:
This final assessment will be completed in partnership with the in-unit mentor / accredited assessor as a record of them having completed all parts of the TEACH-PD programme (above) and a list of practical competencies that must be demonstrated during hands-on training within the PD training unit.

Intervention - experimental for PD patients

Eligible PD patients will be trained by a TEACH-PD Trainer using the Patient Manuals and via practical demonstrations. The 2 manuals include:
• Manual 1: Getting Ready for Peritoneal Dialysis has been designed to provide the patient with information that is helpful as they are getting ready to go onto PD. This includes information about preparation of the home environment and equipment they will require.
• Manual 2: Peritoneal Dialysis Training and Competencies has been designed to provide the patient with information that is helpful as they are moving into PD training and preparing to go home on PD. It includes an overview of PD and how to perform a PD exchange safely.

PD Trainers will conduct patient training at the hospital, clinic or within the patient’s home according to local policy and patient preference . Duration required for PD patients to complete the newly developed curriculum will be one of the outcomes being measured in this pilot study.
Intervention code [1] 298554 0
Treatment: Other
Comparator / control treatment
There is no control intervention to be used in this pilot study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302673 0
Overall satisfaction with the training modules and materials will be assessed via specifically developed satisfaction questionnaires
Timepoint [1] 302673 0
For PD Trainers - After completion of TEACH-PD training modules and after the completion of training of each PD patient
For PD patients - After completing TEACH-PD training
Primary outcome [2] 302674 0
The descriptive thematic groupings around the expectations, perspectives and experiences TEACH-PD training participants collected via semi-structured interviews
Timepoint [2] 302674 0
Both PD trainers and patients - Before and after TEACH-PD training
Secondary outcome [1] 336723 0
PD Trainer - The participants opinion of the online modules using a specifically developed participant questionnaire
Timepoint [1] 336723 0
After completion of TEACH-PD training modules
Secondary outcome [2] 336724 0
PD patients – Rate of PD related complications (including episodes of peritonitis, exit site infections, tunnel infections and PD technique failure) collected via regular SAE reporting.
Timepoint [2] 336724 0
Up to 30 days after TEACH-PD training

Eligibility
Key inclusion criteria
To be eligible to participate in this trial as a PD Trainer, the participant must satisfy the following criteria:
1. Registered Nurse at the John Hunter or Wollongong Hospital PD Units and will be involved in training new PD patients during the trial period;
2. Willing to undertake the TEACH-PD curriculum;
3. Able to meet pre-requisite knowledge standards.
To be eligible to participate in this trial as a PD patient, the participant must satisfy the following inclusion criteria:
1. Adult aged over 18 years of age;
2. Incident patient due to undertake PD training for the first time;
3. To be trained by a PD Trainer who has completed the TEACH-PD curriculum;
4. Able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
Results will be presented as descriptive statistics: number (percent) for categorical variables; mean (standard deviation) for continuous variables. Given the objectives of this pilot study and the small number of participants, no tests of statistical significance will be performed or confidence intervals calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8493 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 9624 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 16580 0
2305 - New Lambton
Recruitment postcode(s) [2] 18381 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 296930 0
Government body
Name [1] 296930 0
National Health and Medical Research Council (NHMRC) Program Grant
Address [1] 296930 0
Research Committee Secretariat NHMRC
GPO Box 1421
Canberra ACT 2601
Country [1] 296930 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Kidney Trial Network
Address
Australasian Kidney Trials Network,
Faculty of Medicine (CHSR), The University of Queensland
Level 5, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 295936 0
None
Name [1] 295936 0
Address [1] 295936 0
Country [1] 295936 0
Other collaborator category [1] 279636 0
Other Collaborative groups
Name [1] 279636 0
The Home Network
Address [1] 279636 0
The HOME Network is a national initiative which brings together healthcare professionals in the field of home dialysis to identify and address the barriers that currently inhibit optimal utilisation of home dialysis in Australia.

Website: www.homenetwork.net.au
Email: contact@homenetwork.net.au
Country [1] 279636 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299276 0
Hunter New England HREC
Ethics committee address [1] 299276 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 299276 0
Australia
Date submitted for ethics approval [1] 299276 0
31/08/2017
Approval date [1] 299276 0
11/10/2017
Ethics approval number [1] 299276 0
HREC/17/HNE/423

Summary
Brief summary
There is an increasing number of people developing end-stage kidney disease in Australia every year. Peritoneal dialysis (PD) is the most cost-effective and user friendly form of dialysis, yet the rate of PD utilisation in Australia has been steadily falling since 2003. A major contributor to low referral rates by physicians to PD and relatively high rates of PD technique failure is PD related peritonitis. Studies in a number of countries have shown that peritonitis rates vary greatly between PD units (between 5 to 20 fold variation). With PD critically dependent on patient self-management, research is required into potentially modifiable peritonitis risk factors, including patient training.

The primary objective of the TEACH-PD (Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes) pilot study is to refine the TEACH-PD training modules for PD patients and trainers.

TEACH-PD pilot study is an investigator-initiated, single-armed, non-randomised, pilot trial assessing the use of training modules for both PD nurse trainers and incident PD patients undertaking PD training. A total of 10 PD trainers will be enrolled and at least 1 PD patient per trainer and at least 10 English speaking patients (between 10 and 20 patients in total) from PD units at John Hunter Hospital, New South Wales and Logan Hospital in Queensland.

PD trainers will complete “train the trainer” modules during the study which have a focus on adult learning principals and be provided with Patient Training Manuals. Once the PD trainers are assessed for competency with the modules, the trainers will then instruct the incident PD patient using the Patient Training Manuals and practical demonstrations.
The primary objective of this pilot study is to further refine the TEACH-PD training modules designed for PD trainers and patients.

The TEACH-PD training modules were developed by the Home Network, a group of health professionals focused on identifying and addressing barriers to home dialysis. The study is being coordinated by the Australasian Kidney Trial Network (AKTN).
Trial website
https://aktn.org.au/teach-pd/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76114 0
A/Prof Josephine Chow
Address 76114 0
Clinical Innovation & Business Unit
Liverpool Hospital
Clinical Streams Office
Liverpool BC NSW 1871
Country 76114 0
Australia
Phone 76114 0
02 8738 3713
Fax 76114 0
02 8738 8332
Email 76114 0
Josephine.Chow@health.nsw.gov.au
Contact person for public queries
Name 76115 0
Ms Peta-Anne Paul-Brent
Address 76115 0
Australasian Kidney Trials Network
The University of Queensland
Level 5, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country 76115 0
Australia
Phone 76115 0
+61 7 3443 7017
Fax 76115 0
+61 7 3103 4622
Email 76115 0
teachpd@uq.edu.au
Contact person for scientific queries
Name 76116 0
Ms Peta-Anne Paul-Brent
Address 76116 0
Australasian Kidney Trials Network
The University of Queensland
Level 5, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country 76116 0
Australia
Phone 76116 0
+61 7 3443 7017
Fax 76116 0
+61 7 3103 4622
Email 76116 0
teachpd@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary