ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000601437

Ethics application status

Approved

Date submitted

8/04/2016

Date registered

10/05/2016

Date last updated

13/12/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Supporting the provision of palliative care in the home environment: a proof of concept study

Scientific title

Supporting the provision of palliative care in the home environment: A proof of concept study of a palliative carers education package (PrECEPt)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

PrECPt

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Palliative care in the home environment

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Feasibility Testing of PrECEPt learning materials by carers

Carers supporting someone with nutrition/hydration and pain management issues will be invited to test PrECEPt, to determine proof of concept for this novel approach to carer education.

PrECEPt is an innovative distance learning package. The package uses blended learning to present two modules (pain, and nutrition/hydration). Written materials including information, reflections and hints/tips are combined with video vignettes which illustrate care-giving scenarios, offering practical illustrations of problems and potential solutions.
The package embeds three levels of information: basic, moderate and advanced. Caregivers decide themselves how much they wish to engage and at what level with the materials.

Carers will be mailed the package and, in the covering letter, encouraged to engage with the materials over a six week period. Data will be gathered on their engagement, to document dose, intensity and amount of engagement.

Intervention code [1]

Other interventions

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Self-efficacy will be measured using the Ugalde tool (Ugalde et al. 2013). This is a 21 item, four factor, self-report questionniare which has been validated in cancer carers. The four factors are: resilience, self-maintenance, emotional connectivity and instrumental caregiving. Test-retest reliability and internal consistency were excellent (0.73-0.85, and 0.81-0.94 respectively).

Timepoint [1]

Baseline and immediately after intervention completion

Secondary outcome [1]

Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). This is a 41 item scale to measure the extent of cancer caregiving tasks and consequences, and the caregivers' needs (mainly concerning information from and communication and contact with the health care professionals) (Lund et al. 2012).

Timepoint [1]

Baseline and immediately after intervention completion

Secondary outcome [2]

The Preparedness for Caregiving Scale (Archbold et al. 1990). This is an eight item questionnaire that assesses how ready caregivers perceive they are for their role. Reliability was acceptable with Cronbach’s alphas ranging from 0.86 to 0.92 (Archbold and Stewart 1993). Caregiver competence refers to the perceived adequacy of an individual’s performance as a caregiver.

Timepoint [2]

Baseline and immediately after intervention completion

Secondary outcome [3]

A further bespoke questionnaire has been designed to capture core data on use and feedback on the educational materials.

Timepoint [3]

Baseline and immediately after intervention completion

Secondary outcome [4]

Post-intervention interviews will be conducted with key informant healthcare professionals (n = 4), and carers who completed the educational materials (n=16)
Interviews will elicit views on the acceptability and feasibility of the intervention; for example, eligibility criteria, method of recruitment, timing of offering the intervention in relation to the patient’s trajectory, duration of intervention. Four staff at the recruiting site will also be interviewed to gain feedback on recruitment processes, and the impact of the trial on interactions with the staff team (for example capturing information on whether more/different informational queries were received).

Timepoint [4]

Post-intervention

Eligibility

Key inclusion criteria

Inclusion criteria for the carers taking part in the study:
(i) Recognised as the main carer for a patient receiving specialist palliative care
(ii) Supporting someone with nutrition/hydration and/or pain management needs
(iii) Aged over 18 years, and able to give informed consent
(iv) First language is English
(v) Patient’s life expectancy >12 weeks
(vi) Resident at home (not in residential aged care or receiving end-of-life care as an inpatient).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

We will exclude children and/or young people (i.e.<18) people who do not have the capacity to provide informed consent to take part in the research. Advice from the recruiting clinicians will be taken on individuals. We will also exclude people who do not have a good command of the English language, since this is a small proof of concept trial without resource to have the materials translated.

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)

Allocation concealment will not be used, as this is a single-group non-RCT design.

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

This is not a randomised trial, consequently there is no sequence generation required.

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

Efficacy

Statistical methods / analysis

Data from the primary and subsidiary outcome measures will be analysed using descriptive statistics. If adequate data is generated, then basic inferential statistics (t-tests) will be used to identify statistically significant changes in outcomes.

Analysis of the adherence checklist data will proceed using frequency counts to identify those areas addressed most and least frequently.

Qualitative interview data will be analysed thematically (Braun and Clarke 2006). Interviews will be digitally recorded, transcribed and managed using NVivo (version 10) software.

All data will be used to inform the refinement of the educational materials, and methodological parameters for a later scaled-up trial, including assessment of the feasibility and acceptability of the approach. Analysis of eligibility, and recruitment rates, will allow for national estimates to be calculated on number of potentially eligible carers across Australia.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/08/2016

Actual

1/08/2016

Date of last participant enrolment

Anticipated

14/09/2016

Actual

14/09/2016

Date of last data collection

Anticipated

Actual

31/10/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment hospital [1]

Calvary Public Hospital ACT - Bruce

Recruitment postcode(s) [1]

2600 - Barton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

ACT Health

Address [1]

3, 11 Moore St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

223 Antill Street, Watson, Canberra, 2602, ACT.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Calvary Human Research Ethics Committee

Ethics committee address [1]

Cnr Belconnen Way & Haydon Drive
Bruce ACT 2617

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/01/2016

Approval date [1]

10/03/2016

Ethics approval number [1]

2-2016

Summary

Brief summary

Families are viewed as a ‘unit of care’ in palliative services, meaning that carers’ needs are identified and addressed in order to further support the welfare of the patient. Practical educational interventions for carers are needed (Bee et al).; however it is not known which educational methods are acceptable and how high-quality information can be delivered at a national level, with limited cost implications.

A significant gap in supporting carers is determining how high-quality relevant information can be delivered at a national level, with limited cost implications, using educational methods which are acceptable to carers. 

This study involves intervention development and an embedded proof of concept study. 

In this study we aim to:
1.	Design an innovative distance-learning educational package (PrECEPt: PalliativE Carers Education Package). Two modules, identified as priorities in the literature (pain and nutrition/hydration), will be developed. 
2.	Determine ideal content, learning style preferences (e.g. balance of videos/ vignettes/ quizzes), mode of delivery (online/printed), level of detail/complexity.
3.	Determine the acceptability and feasibility of the educational package to carer and healthcare professionals
4.	To understand the processes involved in delivery of the key components of PrECEPt including: recruitment processes for a full-scale study; data collection procedures/completion rates; queries directed to the hospice from carers involved in the feasibility work.
5.	Determine sample size, recruitment and randomisation processes for a definitive trial. 

We theorise that carer self-efficacy will increase through providing greater information, skills and confidence.  We anticipate the education will benefit patients through more competent and supported carers.

References
Bee, P.E., Barnes, P. & Lucker, K. (2009) A systematic review of informal caregivers' needs in providing home-based end-of-life care to people with cancer. Journal of Clinical Nursing, 18(10), 1379-1393.

Trial website

Trial related presentations / publications

Forbat, L,. Haraldsdottir, E,. Lewis, M,. Hepburn, K. Supporting the provision of palliative care in the home environment: A proof of concept single arm trial of a palliative carers education package (PrECEPt). BMJ Open. 
http://bmjopen.bmj.com/content/6/10/e012681.short?g=w_open_current_tab

Public notes

Attachments [1]

/AnzctrAttachments/370466-BMJ Open_PrECEPt carer education protocol.pdf (Protocol)

Contacts

Principal investigator

Name

Prof Liz Forbat

Address

Australian Catholic University
223 Antill St, Watson ACT 2602

Country

Australia

Phone

+61 475978476

Fax

Elizabeth.Forbat@acu.edu.au

Contact person for public queries

Name

Liz Forbat

Address

Australian Catholic University
223 Antill St, Watson ACT 2602

Country

Australia

Phone

+61 4 7597 8476

Fax

Elizabeth.Forbat@acu.edu.au

Contact person for scientific queries

Name

Liz Forbat

Address

Australian Catholic University
223 Antill St, Watson ACT 2602

Country

Australia

Phone

+61 4 7597 8476

Fax

Elizabeth.Forbat@acu.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Supporting the provision of palliative care in the home environment: A proof-of-concept single-arm trial of a PalliativE Carers Education Package (PrECEPt).	2016	https://dx.doi.org/10.1136/bmjopen-2016-012681

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

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Documents added automatically