ANZCTR - Registration

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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

3/12/2020

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]

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

Condition category

Condition code

Renal and Urogenital

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]

Treatment: Other

Comparator / control treatment

There is no control intervention to be used in this pilot study.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Overall satisfaction with the training modules and materials will be assessed via specifically developed satisfaction questionnaires

Timepoint [1]

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]

The descriptive thematic groupings around the expectations, perspectives and experiences TEACH-PD training participants collected via semi-structured interviews

Timepoint [2]

Both PD trainers and patients - Before and after TEACH-PD training

Secondary outcome [1]

PD Trainer - The participants opinion of the online modules using a specifically developed participant questionnaire

Timepoint [1]

After completion of TEACH-PD training modules

Secondary outcome [2]

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]

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

Sex

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

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

30/10/2017

Actual

5/12/2017

Date of last participant enrolment

Anticipated

25/05/2018

Actual

1/05/2018

Date of last data collection

Anticipated

9/07/2018

Actual

26/06/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital - New Lambton

Recruitment hospital [2]

Wollongong Hospital - Wollongong

Recruitment postcode(s) [1]

2305 - New Lambton

Recruitment postcode(s) [2]

2500 - Wollongong

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC) Program Grant

Address [1]

Research Committee Secretariat NHMRC
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

The Home Network

Address [1]

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: [email protected]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England HREC

Ethics committee address [1]

Locked Bag 1
New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/08/2017

Approval date [1]

11/10/2017

Ethics approval number [1]

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

Chow, J. S., Adams, K., Cho, Y., Choi, P., Equinox, K.-L., Figueiredo, A. E., … Boudville, N. C. (2020). Targeted Education ApproaCH to improve Peritoneal Dialysis Outcomes (TEACH-PD): A feasibility study. Peritoneal Dialysis International, 40(2), 153–163. https://doi.org/10.1177/0896860819887283

Public notes

Contacts

Principal investigator

Name

A/Prof Josephine Chow

Address

Clinical Innovation & Business Unit
Liverpool Hospital
Clinical Streams Office
Liverpool BC NSW 1871

Country

Australia

Phone

02 8738 3713

Fax

02 8738 8332

[email protected]

Contact person for public queries

Name

Ms Peta-Anne Paul-Brent

Address

Australasian Kidney Trials Network
The University of Queensland
Level 5, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 3443 7017

Fax

+61 7 3103 4622

[email protected]

Contact person for scientific queries

Name

Ms Peta-Anne Paul-Brent

Address

Australasian Kidney Trials Network
The University of Queensland
Level 5, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 3443 7017

Fax

+61 7 3103 4622

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Chow, J. S., Adams, K., Cho, Y., Choi, P., Equinox... [More Details]	373264-(Uploaded-29-06-2020-14-45-45)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Targeted Education ApproaCH to improve Peritoneal Dialysis Outcomes (TEACH-PD): A feasibility study.	2020	https://dx.doi.org/10.1177/0896860819887283

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically