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Trial registered on ANZCTR


Registration number
ACTRN12614001174673
Ethics application status
Approved
Date submitted
20/10/2014
Date registered
7/11/2014
Date last updated
6/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing an outreach support program for family carers of older people discharged from an acute medical assessment unit: Cost consequences for the Western Australian health care system
Scientific title
Do family caregivers receiving a hospital outreach support program experience greater improvement in preparedness to care than family caregivers receiving usual support - and does this lead to reduced hospital use by patients and hence lower health care costs?
Secondary ID [1] 285591 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family caregivers' preparedness to care 293337 0
Family carers' general health 293431 0
Family caregivers' strain 293433 0
Family caregivers' well-being 298342 0
Family caregivers' stress 298343 0
Family caregivers' positive appraisals of caregiving 298344 0
Condition category
Condition code
Other 293600 293600 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Family carers in the intervention group will receive standard care plus the Further Enabling Care at Home (FECH) program, implemented by a nurse. Contacts will be by telephone, after discharge. The Nurse will make initial contact with the family carer within one week of the discharge (Contact 1, approx 15 minutes). This contact will include the FECH Nurse introducing him/herself, explaining the intervention, and scheduling Contact 2 (approx 30 minutes) within the next few days to (a) determine and respond to the extent to which the family carer understands the copy of the discharge letter to the GP that is provided to them; (b) administer Carer Support Needs Assessment Tool* to the family carer, resulting in the carer’s self-identified and prioritised support needs; and (c) initiate responses to the three prioritised needs, helping ensure family carers’ linkage and engagement with appropriate existing resources. A few days after this appointment, the FECH Nurse will check to determine if access to support has been achieved as planned, advising as appropriate (Contact 3, approx 15 minutes).

This program will be delivered over a 6 week period.

*Ewing G, Brundle C, Payne S, Grande G. The Carer Support Needs Assessment Tool (CSNAT) for use in palliative and end-of-life care at home: A validation study. Journal of Pain and Symptom Management 2013;46(3):395-405.
Intervention code [1] 290464 0
Treatment: Other
Comparator / control treatment
Standard ‘care’ includes the provision of a letter from the unit’s physician to the GP; a copy is provided to the patient. Medications are provided/organised by the pharmacist.. ‘At risk’ carers receive social work assessment and links to services. Services put in place for patients may include a variety of care packages or programs. Information packs from Carers’ Australia are made available in patients’ hospital rooms.
Control group
Active

Outcomes
Primary outcome [1] 293412 0
Family carers' Preparedness to care measured by the Preparedness for Caregiving Scale
Reference:
Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Research in Nursing & Health 1990;13(6):375-84
Timepoint [1] 293412 0
Will be measured within 4 days of discharge, 15-21 days after the discharge, 6 weeks after the discharge
Secondary outcome [1] 310975 0
Composite outcome - Family appraisal of caregiving (includes strain, well-being, stress, and positive appraisals of caregiving) measured using the Family Appraisal of Caregiving Questionnaire - Palliative Care
Reference: Cooper, B., Kinsella, G. J. and Picton, C. (2006), Development and initial validation of a family appraisal of caregiving questionnaire for palliative care. Psycho-Oncology, 15: 613–622. doi: 10.1002/pon.1001
Timepoint [1] 310975 0
Up to 4 days post-discharge, 15-21 days post-discharge, 6 weeks post-discharge
Secondary outcome [2] 310976 0
Family carers' General health, measured by the SF12

Reference:
Ware JE, Kosinski M, Keller SD. How to Score the SF-12 Physical and Mental Health Summary Scales. . 2nd ed. Boston: The Health Institute, New England Medical Center, 1995
Timepoint [2] 310976 0
Up to 4 days post-discharge, 15-21 days post-discharge, 6 weeks post-discharge
Secondary outcome [3] 310977 0
Patients' (ie, care recipients') use of hospital system using administrative data already collected and supplied to us by the Western Australian Data Linkage Unit
Timepoint [3] 310977 0
For at least 3 months after the index separation from hospital
Secondary outcome [4] 310978 0
Cost of consequences for the healthcare system using cost consequence analysis that considers both costs of delivering the intervention and the costs of patients' use of the hospital and ambulance system.
Timepoint [4] 310978 0
For at least 3 months after the index separation from hospital
Secondary outcome [5] 314445 0
Carer ratings of the patient's symptoms using the Symptom Assessment Scale
Reference:
Aoun S, Monterosso L, Kristjanson K, McConigley R. Measuring symptom distress in palliative care: Psychometric properties of the Symptom Assessment Scale (SAS). Palliative Medicine. 2011;14(3):315-21
Timepoint [5] 314445 0
Within 4 days of discharge, 15-21 days after the discharge, 6 weeks after the discharge.
Secondary outcome [6] 314446 0
Carer ratings evaluating the dependence of the patient in 10 activities using the Barthel Activities of Daily Living Index.
Reference:
Collin C, Wade D, Davies S, T. HV. The Barthel ADL Index: A reliability study. Int Disability Study. 1988;10:61-3.
Timepoint [6] 314446 0
Up to 4 days post-discharge, 15-21 days post-discharge, 6 weeks post discharge.

Eligibility
Key inclusion criteria
Dyads of older people (aged 70+) discharged home from the Medical Assessment Unit during the recruitment period and their adult (aged 18+), English speaking, carers (one per patient). Carers are family members or friends who provide unpaid personal care, support and assistance. Dyads already recruited into the study will be excluded from further recruitment upon any subsequent readmissions.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Dyads will be excluded when patients are not going directly home from the Unit.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. A list of treatment allocations was prepared prior to study commencement by a person external to the study.
2. Unit staff will provide family carer contact details to the Research Officer with the family carers’ permission.
3. The Research Officer will approach all eligible patients and their family carers (consecutive admissions) in, or via telephone contact from, the Medical Assessment Unit during a 6-month recruitment period, requesting informed consent to participation (from admission until up to 3 working days after the discharge).
4. When patients are too unwell or lack capacity to consider consent, a waiver of consent allows inclusion in the study of their health system usage data.
5. Assignment to the control or intervention group will be achieved after recruitment by a designated person not involved in recruitment or quantitative data collection reading from the pre-prepared treatment allocation list.
6. The allocation list will be kept securely in a location to which the Research Officer has no access.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation list will contain a study number (whole number, starting from one), and a code to indicate the group (intervention or control). The list will be generated using a computer-generated random number, organised so that recruitment to the two study arms occurs at an approximately equal rate. This will be done by using a blocking strategy, whereby half of the numbers within each block will be allocated to each treatment. In this way, there will be an equal number of patients/their carers recruited to each study arm at the end of each block. Block length will be randomly selected to be an even number (‘permuted random blocks’ strategy).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Carer outcome. Outcome analysis will be conducted using Intention to Treat. The change in preparedness to care will be calculated for each carer. An initial t-test will compare changes between treatment groups. If changes in scores are not normally distributed, a non-parametric method may be used. In the (unlikely) event that groups differ on the basis of baseline variables, a regression model will be used instead of the t-test, so that these potentially confounding variables are taken into account. A random effects regression model will be used to examine the change in Preparedness for Caregiving Scale score over all three data collection periods (instead of just baseline/end of study). This model will be used so that correlations between measurements made on the same participants can be taken into account. The model can be extended to adjust for other potentially confounding variables.
Patient outcomes will be compared between groups using t-tests or regression models. For example, the total length of hospital stay will be calculated and compared between groups using a t-test (after log-transformation of the data if indicated). Number of re-admissions to hospital or presentations to ED will be compared using the same method. A regression model will be used to take into account potentially confounding variables (if relevant). The association between change in preparedness and change in health care utilisation will be evaluated using carer outcomes linked to the administrative data.
Economic analysis. Costs of the program will be evaluated using prospective data collection for each patient/carer dyad (cases and controls) and will include the costs associated with the intervention and outcomes using a WA health system perspective. These (intervention plus usual care) costs will be compared with the cost of usual care alone. Costs associated with outcomes for patients include:
a. Cost of ED visits
b. Cost of in-patient hospitalisation
c. Cost of Ambulance use

Inpatient costs will be calculated using Diagnostic Related Group costings. Cost of ED attendances will be based on urgency related/disposition group costings. Costs and outcomes associated with delivering the intervention will be compared using cost-consequence analysis. We will use decision tree analysis to evaluate cost-consequence separately for each outcome.

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)
WA
Recruitment hospital [1] 3059 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 290120 0
Government body
Name [1] 290120 0
State Health Research Advisory Council
Address [1] 290120 0
C/o Research Development Unit
Department of Health
PO Box 8172
Perth Business Centre, WA 6849

Country [1] 290120 0
Australia
Funding source category [2] 293317 0
University
Name [2] 293317 0
Curtin University
Address [2] 293317 0
GPO BOX U1987, Perth, WA 6845
Country [2] 293317 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO BOX U1987
Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 288834 0
Hospital
Name [1] 288834 0
Sir Charles Gairdner Hospital's Centre for Nursing Research
Address [1] 288834 0
17 Monash Avenue, Nedlands Western Australia 6009
Country [1] 288834 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291831 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [1] 291831 0
Department of Health WA Human Research Ethics Committee
Level 1, C block
189 Royal Street EAST PERTH WA 6004
Ethics committee country [1] 291831 0
Australia
Date submitted for ethics approval [1] 291831 0
19/11/2014
Approval date [1] 291831 0
19/01/2015
Ethics approval number [1] 291831 0
2014/78
Ethics committee name [2] 291832 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [2] 291832 0
2nd Floor, A Block
Sir Charles Gairdner Hospital Nedlands WA 6009
Ethics committee country [2] 291832 0
Australia
Date submitted for ethics approval [2] 291832 0
25/11/2014
Approval date [2] 291832 0
22/01/2015
Ethics approval number [2] 291832 0
2014-133
Ethics committee name [3] 291833 0
Curtin University Research Ethics Committee
Ethics committee address [3] 291833 0
The Secretary, HREC
Office of Research and Development
PO Box U1987
Perth WA 6845
Ethics committee country [3] 291833 0
Date submitted for ethics approval [3] 291833 0
28/10/2014
Approval date [3] 291833 0
28/01/2015
Ethics approval number [3] 291833 0
2014/78

Summary
Brief summary
We will trial a family carer support program following the discharge of older patients (recipients of family care) from the Sir Charles Gairdner Hospital Medical Assessment Unit. To do this, we will assign family carers to receive either usual care or usual care plus the support program. We will compare outcomes between the two groups in terms of:
a. family preparedness to sustain the caregiving role
b. re-presentations and readmissions of care recipients to any Western Australian hospital - and length of stay when readmissions do occur
c. costs to the healthcare system.
We will also seek feedback on the program from family carers, patients, and the hospital staff.
Trial website
Trial related presentations / publications
Public notes
Approval from the Data Linkage Branch of the Department of Health of Western Australia received February 15 2015. Approval Number DLB201502.04.
Research governance approval obtained from the Sir Charles Gairdner Hospital Research Governance Office January 22 2015.
Research governance approval obtained from Curtin University March 4 2015.

Contacts
Principal investigator
Name 52206 0
A/Prof Christine Toye
Address 52206 0
School of Nursing, Midwifery and Paramedicine, Curtin University GPO BOX U1987 Perth, WA 6845
Country 52206 0
Australia
Phone 52206 0
61-8-9266 1756
Fax 52206 0
Email 52206 0
c.toye@curtin.edu.au
Contact person for public queries
Name 52207 0
A/Prof Christine Toye
Address 52207 0
School of Nursing, Midwifery and Paramedicine, Curtin University GPO BOX U1987 Perth, WA 6845
Country 52207 0
Australia
Phone 52207 0
61-8-9266 1756
Fax 52207 0
Email 52207 0
c.toye@curtin.edu.au
Contact person for scientific queries
Name 52208 0
A/Prof Christine Toye
Address 52208 0
School of Nursing, Midwifery and Paramedicine, Curtin University GPO BOX U1987 Perth, WA 6845
Country 52208 0
Australia
Phone 52208 0
61-8-9266 1756
Fax 52208 0
Email 52208 0
c.toye@curtin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary