Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000060943
Ethics application status
Approved
Date submitted
17/10/2019
Date registered
24/01/2020
Date last updated
28/01/2024
Date data sharing statement initially provided
24/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Further Enabling Care at Home (FECH) post-discharge program as a way to support carers of older hospital patients
Scientific title
Multicentre randomised controlled trial: caregiver, patient, and system outcomes from a program supporting informal caregivers of older people discharged home from hospital
Secondary ID [1] 299430 0
Nil
Universal Trial Number (UTN)
U1111-1233-6521
Trial acronym
FECH Trial
Linked study record
This record is a follow-up study from ACTRN12614001174673

Health condition
Health condition(s) or problem(s) studied:
Ageing 315603 0
Condition category
Condition code
Public Health 312961 312961 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Further Enabling Care at Home (FECH) program is a post-discharge telephone caregiving support program for carers of older medical patients discharged home from hospital.

There are three manuals used in the support of this program: a FECH training manual for preparing those who will deliver the intervention (FECH nurses), a FECH implementation manual to support the FECH Nurses in their role, and a resource manual (tailored to each of the two states involved) that documents resources available to provide support for carers, including resources that can help them learn more about the care recipient's health condition (eg, Carers WA, Alzheimers WA, Motor Neurone Disease Association).

Training is to be delivered to FECH Nurses over three days and will include:
(a) determining the extent and type of discharge information provided to the carer, any clarification needed or additional information required (delivered by a nurse with an acute care background);
(b) using the Carer Support Needs Assessment Tool (CSNAT) approach(1) (delivered by a nurse with expertise in carer support plus a palliative care researcher who has trialled this tool in palliative home care);
(c) embedding a problem-solving approach for carers so that it can be used in the longer term, after the program has ended (delivered by a psychologist with special expertise in this area); and
(d) types of resources that may be helpful to carers (delivered by a nurse with a background in carer support).
Attendance lists will be kept to document FECH Nurse training attendance and FECH Nurses will be required to attest to their having completed the required on-line training prior to the face-to-face training.

The CSNAT approach is used as part of the FECH program, to help carers identify their own needs, and the FECH Nurses undertake CSNAT training online at http://csnat.org/training/as well as during the training described above. The online CSNAT training also provides access to an online CSNAT toolkit.

The FECH program is a telephone based, post-hospital-discharge, hospital outreach protocol implemented for individual carers by one or more specially prepared FECH nurses with acute gerontological nursing care experience and substantial knowledge on how to navigate the home care ‘system’ and home caregiving resources. Phone calls (therapeutic contacts) are supplemented with email and mail correspondence, as agreed with the carer, when resources or information are provided by the nurse, rather than accessed directly by the carer from other sources. The program will be delivered over 6 months, to embed the processes of carers:
(a) reflecting upon the current caregiving situation,
(b) identifying and prioritising new or ongoing support needs, and
(c) implementing a problem-solving approach to address these support needs.

The intention is that carers will then have the problem-solving skills to continue without support from the FECH nurse.

The FECH program involves six contacts by the FECH nurse with the carer over the six months after the care recipient’s discharge home from hospital (at 1 and 2 weeks after discharge, then at 1, 2, 4, and 6 months post discharge).
During Contact 1, the FECH nurse first elicits the carer’s understanding of information provided to them, at the time of the discharge, by the hospital. This occurs during a brief telephone interview lasting, on average, 15 minutes. If the carer demonstrates insufficient understanding of discharge information to form the basis for caregiving, as determined by the nurse when this is explored during the interview, the FECH nurse guides the carer to access the information required. The Carer Support Needs Assessment Tool (CSNAT) (1) is provided to the carer, usually by mail, but with an email option, to allow the carer time to reflect upon the included items before Contact 2 occurs.

At Contact 2, the FECH nurse guides the carer through the reflective CSNAT approach, using the CSNAT to identify and prioritise their support needs, then devising ways in which up to three prioritised needs will be addressed using problem solving techniques. This contact (first time of using the CSNAT approach) takes 45 minutes on average.

At Contacts 3-6, each taking 30 minutes on average, the carer is prompted to reflect upon the extent to which support was accessed as planned since the previous contact, then again uses the CSNAT approach combined with problem-solving to identify, prioritise, and address remaining or additional support needs. Each contact point provides an opportunity to reinforce the problem-solving skills learnt.

One of the aims of the intervention is to provide carers with problem solving skills that they can continue to use after the end of the intervention period. FECH nurses will emphasise the time-limited nature of their contact, and in each session encourage carers to actively use the skills discussed for identified problems, or the broader problem of future planning. At the last FECH nurse contact, carers and the nurse will review the strategies and resources used, highlighting which were most useful, and refreshing any skills that the carer feels unsure about. Carers will also be provided with an individualized summary sheet of the skills they can use, together with written resources.

Process evaluation of FECH program implementation will address fidelity, safety, reach, and dose. Data will be collected by the FECH Nurses and recorded in hard copy then entered into an electronic database. Each nurse will document:
(a) adherence to or deviation from planned FECH processes:
(b) information provided to carers and the resources to which they were referred,
(c) the extent to which carers engaged with resources (numbers and types of resources, how and when accessed, with what result [as planned or not and if not, why]);
(d) any safety concerns identified by the FECH nurse and how these were managed; and
(e) time taken to implement processes.
Contextual factors that may be barriers to, or facilitators of, the effectiveness of the FECH program will also be recorded in the database.

The extent to which implementation occurs as planned (fidelity) will be monitored, with steps taken by the investigators to ensure that this is maintained as soon as any indication of likely deviation is noted. To ensure this, one of the FECH program telephone calls will be recorded for each of the carers assigned to the intervention group. The State Project Managers will ensure that recordings are made of each of the 6 FECH contacts in approximately even numbers. Every 3 months during the FECH implementation period, a random audit and review of 5% of these recordings will be undertaken by one investigator, with feedback provided to the relevant State Project Manager and FECH nurses. In addition, (a) the State Project Manager will meet with the FECH Nurses on at least a fortnightly basis during the program to ascertain and address any threats to fidelity and (b) each State Project Manager will let the other know whenever a threat to fidelity has been determined in their state so that the action taken to address this threat is addressed in a similar manner in both states (as is appropriate).

The extent of support accessed (dose) will be determined in two ways:
(a) time spent during FECH contacts and
(b) the extent to which identified needs are met as planned.
Program reach will be established by comparing characteristics of those dyads assigned to receive the FECH program and continuing until program completion with characteristics of ‘non-completers’, taking into consideration reasons for withdrawal.

References:
1. Ewing G, Austin L, Diffin J, Grande G. Developing a person-centred approach to carer assessment and support. Br J Community Nurs. 2015;20(12):580-4.
Intervention code [1] 315679 0
Prevention
Comparator / control treatment
'Usual post-discharge care' is the control condition. Usual discharge care at all of the included hospitals includes the patient and/or carer receiving:
(a) a copy of the discharge letter,
(b) medications or prescriptions and related advice,
(c) referral letters and/or outpatient appointments,
(d) information about treatments to be carried out at home (e.g., wound dressings), and
(e) information about care packages or programs put in place.
Social work input for carers is not routine but occurs in instances prioritised by the social work department.
Control group
Active

Outcomes
Primary outcome [1] 321540 0
Change in carers' self-reported Health Related Quality of Life (HRQoL) expressed in terms of AQol-8D scores*

*Richardson J., Iezzi A., Khan M.A., A. M. Validity and reliability of the Assessment of Quality of Life (AQoL-8D) multi attribute utility instrument Patient. 2014;7(1):85-96.
Timepoint [1] 321540 0
Time 1 (T1, baseline, within 4 days of discharge of the care recipient), T2 (3 months post-discharge), T3 (6 months post discharge - primary timepoint), T4 (12 months post-discharge).
Primary outcome [2] 321541 0
Costs will be determined using linked health service administrative data (carers and care recipients), PBS and MBS data (carers and care recipients), and information collected from carers about use of residential aged care for care recipients (using costs available from government reports), We will use the AQOL-8D questionaire. Cost-effectiveness for carers, defined as having an incremental cost-effectiveness ratio of less than AUD$50,000/QALY gained.
Timepoint [2] 321541 0
Discharge date for the patient's index admission until at least 12 months after this date.
Secondary outcome [1] 375296 0
Change in carers' preparedness for caregiving expressed as a change in the Preparedness for Caregiving (PCS) score*

*Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Res Nurs Health. 1990;13(6):375-84.
Timepoint [1] 375296 0
T2 (3 months post-discharge), T3 (6 months post discharge), T4 (12 months post-discharge).
Secondary outcome [2] 375297 0
Change in carers' caregiving strain expressed as a change in the strain scores from the Family Appraisal of Caregiving Questinnaire - Palliative Care (FACQ).*

*Cooper B, Kinsella GJ, Picton C. Development and initial validation of a family appraisal of caregiving questionnaire for palliative care. Psychooncology. 2006;15(7):613-22.
Timepoint [2] 375297 0
T2 (3 months post-discharge), T3 (6 months post discharge), T4 (12 months post-discharge).
Secondary outcome [3] 375298 0
Change in carers' caregiving distress expressed as a change in the distress scores from the Family Appraisal of Caregiving Questinnaire - Palliative Care (FACQ).*

*Cooper B, Kinsella GJ, Picton C. Development and initial validation of a family appraisal of caregiving questionnaire for palliative care. Psychooncology. 2006;15(7):613-22.
Timepoint [3] 375298 0
T2 (3 months post-discharge), T3 (6 months post discharge), T4 (12 months post-discharge).
Secondary outcome [4] 375299 0
Change in carers' caregiving self-efficacy scores expressed as a change scores from the Caregiver Inventory*

Merluzzi T, Philip E, Vachon D, Heitzmann C. Assessment of self-efficacy for caregiving: The critical role of self-care in caregiver stress and burden. Palliat Support Care. 2011;9(1):15-24.
Timepoint [4] 375299 0
T3 (6 months post discharge), T4 (12 months post-discharge).
Secondary outcome [5] 375300 0
Change in carers' emergency presentations to hospital (from routinely collected [linked] administrative data).
Timepoint [5] 375300 0
From the 12 months before until the 12 months after the patient's index separation,
Secondary outcome [6] 375301 0
Change in patients' emergency presentations to hospital (from routinely collected [linked] administrative data).
Timepoint [6] 375301 0
From the 12 months before until the 12 months after the patient's (ie, the care recipient's) index separation.
Secondary outcome [7] 375302 0
Change in the number of days spent in hospital for carers (from routinely collected [linked] administrative data).
Timepoint [7] 375302 0
From the 12 months before until the 12 months after the patient's index separation.
Secondary outcome [8] 375303 0
Change in the number of days spent in hospital for patients (ie, care recipients) (from routinely collected [linked] administrative data). .
Timepoint [8] 375303 0
From the 12 months before until the 12 months after the patient's index separation.
Secondary outcome [9] 375304 0
Change in the number of ambulance trips for the carer (from routinely collected [linked] administrative data).
Timepoint [9] 375304 0
From the 12 months before until the 12 months after the patient's index separation.
Secondary outcome [10] 375305 0
Change in the number of ambulance trips for the patient (from routinely collected [linked] administrative data).
Timepoint [10] 375305 0
From the 12 months before until the 12 months after the patient's index separation.
Secondary outcome [11] 375306 0
Change in the use of primary health services for the carer (from routinely collected [linked] administrative data, Medicare Benefits Schedule) .
Timepoint [11] 375306 0
From the 12 months before until the 12 months after the patient's index separation.
Secondary outcome [12] 375307 0
Change in the use of primary health services for the patient (from routinely collected [linked] administrative data, Medicare Benefits Schedule).
Timepoint [12] 375307 0
From the 12 months before until the 12 months after the patient's index separation.
Secondary outcome [13] 375308 0
Change in the use of medications for the carer (from routinely collected [linked] administrative data, Pharmaceutical Benefits Scheme).
Timepoint [13] 375308 0
From the 12 months before until the 12 months after the patient's index separation.
Secondary outcome [14] 375309 0
Change in the use of medications for the patient (from routinely collected [linked] administrative data, Pharmaceutical Benefits Scheme).
Timepoint [14] 375309 0
From the 12 months before until the 12 months after the patient's index separation.
Secondary outcome [15] 375310 0
Changes in patient symptom distress scores expressed using the Symptom Assessment Scale* (patient reports or carer proxy reports if patient reports cannot be accessed).

*Aoun S, Monterosso L, Kristjanson L, McConigley R. Measuring symptom distress in palliative care: Psychometric properties of the Symptom Assessment Scale. J Palliat Med. 2011;14(3):315-21.
Timepoint [15] 375310 0
T2 (3 months post-discharge), T3 (6 months post discharge), T4 (12 months post-discharge).
Secondary outcome [16] 375311 0
Changes in patient independence expressed using the Barthel Activities of Daily Living Index* (carer reports).

*Yeo D, Faleiro R, Lincoln NB. Barthel ADL index: A comparison of administration methods. Clin Rehabil. 1995;9(1):34-9.
Timepoint [16] 375311 0
T2 (3 months post-discharge), T3 (6 months post discharge), T4 (12 months post-discharge).
Secondary outcome [17] 375312 0
Difference in time to permanent admission into residential aged care for the patient, from carer reports.
Timepoint [17] 375312 0
From T1 to T4 (12 months post-discharge).
Secondary outcome [18] 375313 0
Difference in service use (home care services or residential respite care) for the patient, from carer reports.
Timepoint [18] 375313 0

From T1 to T4 (12 months post-discharge).

Eligibility
Key inclusion criteria
Included dyads will comprise:
(a) one adult (aged 18+) carer who provides regular , ongoing , home-based physical and/or emotional care to a person aged 70 or older, when this person is returning home (discharged) from an included ward after a medical (as opposed to surgical) admission and
(b) that older person (the care recipient).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude dyads when patients do not return directly home from hospital (eg, they return home via a rehabilitation setting or an aged care facility); when the carer cannot speak, read, or understand English; or when the carer’s hearing prohibits their ability to hold telephone conversations.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list of treatment allocations will be prepared before the study; it 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 computer-generated random numbers, organised so that recruitment to the two study arms occurs at an approximately equal rate. This will be done using a blocking strategy, with half of the numbers within each block allocated to each treatment. Block length will be randomly selected and comprise an even number (from 6-12). This means that, at the end of each block, there will be an even number of dyads allocated to each group (control/intervention).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We anticipated 30% attrition during the 12 month post-discharge period so our recruitment target to address the primary outcome variable was 925 dyads for a final sample size of 648.. Based upon preliminary work, this sample size will also allow 80% power to detect meaningful differences for carer preparedness, carer strain and distress, and hospitalisation costs for patients.

Recruitment target originally 925 allowing for final sample of 648 dyads. Recruitment not possible to acheive at Queensland sites due to COVID pandemic restrictions. Enrolment point at 500 dyads indicated that drop out was less than expected hence 925 dyads would no longer be required to achieve the final sample. However COVID restrictions meant it was uncertain when recruitment would need to cease. Hence the sample size was recalculated to determine what would be required. The sample of 506 was determined with a drop out rate of approximately 10% based on recruitment to date ,meaning that 551 participants were required. To allow for uncertainty around COVID 588 dyads ( allowing for approximately 13% drop out) were recruited. Re calculation of power indicates that a sample size of n=506 will have power to detect an effect size of 0.25 with 80% power - we change from an ES=0.22 to ES=0.25. Final sample size of n=588 dyads at end of recruitment, allows for drop out post recruitment.

Statistical analysis for effectiveness.
We will use Multiple Imputation methods informed by a sensitivity analysis to manage missing data, Two analyses will be performed,analysis using only the observed data and analysis after missing value substitution (where necessary). Data will be analysed using an ‘intention-to-treat’ (ITT) approach. Secondary outcomes will be analysed in a similar manner to the primary outcome. Descriptive statistics will summarise the profile of study participants. Differences in demographic and baseline health status variables between groups at baseline will be compared using Chi-square, t-tests or non-parametric Wilcoxon 2-sample tests as appropriate. Changes from baseline in the AQoL-8D score for the carer will be calculated to each time point and tested for normality using the Shapiro-Wilk statistic; if not normally distributed, a Box-Cox transformation will be applied to the measure before further analysis. Comparison of the changes in AQoL-8D scores between control and intervention groups will be performed using a mixed model (regression model with the carer group identified as a random effect). An interaction term between time and group will be introduced into the model to test whether rates of change in the outcome differ between groups. If differences between the groups are evident at baseline, these will be included in the model as covariates so that adjustment can be made before examining differences between groups in outcomes.

Preparation for economic analyses.
Carer health state utilities will be captured at baseline and for the previous 12 months for all carer participants who meet the inclusion criteria, and at 3, 6, and 12 months post recruitment. The AQoL-8D utility algorithm weighted for the Australian population will be used to derive an overall index of the health state utility at each time point. The QALY profile for each carer will be calculated using area under the curve methods.

Cost utility and cost effectiveness analyses.
Cost effectiveness of the intervention will be measured using the framework of a within trial cost utility analysis. An incremental cost-utility analysis will be undertaken to compare the mean incremental cost and quality adjusted life year profiles for each group according to intervention status. We will also estimate cost effectiveness utilising measurement of the change in other secondary outcomes where a significant difference is observed between the intervention and control groups. Confidence intervals will be presented around the incremental cost effectiveness ratios, and cost effectiveness acceptability curves for varying threshold values of cost effectiveness will be presented. A 12-month time horizon will be used and a health system perspective using within trial probabilities and costs will be undertaken. Assessment of the sensitivity of the results obtained to variation in measured effectiveness, health care resource use, intervention and usual care unit costs and participant subgroups will be undertaken using one-way and probabilistic sensitivity analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/03/2020
Actual
26/08/2020
Date of last participant enrolment
Anticipated
2/04/2022
Actual
16/07/2022
Date of last data collection
Anticipated
30/08/2023
Actual
7/07/2023
Sample size
Target
1176
Accrual to date
Final
1190
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 14888 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 14889 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 14890 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 28156 0
6009 - Nedlands
Recruitment postcode(s) [2] 28157 0
4215 - Southport
Recruitment postcode(s) [3] 28158 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 302815 0
Government body
Name [1] 302815 0
National Health and Medical Research Council
Country [1] 302815 0
Australia
Funding source category [2] 303941 0
University
Name [2] 303941 0
Curtin University
Country [2] 303941 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 302764 0
University
Name [1] 302764 0
Griffith University
Address [1] 302764 0
Parklands Drive
Southport, Qld
4215
Country [1] 302764 0
Australia
Other collaborator category [1] 280977 0
Hospital
Name [1] 280977 0
Sir Charles Gairdner Hospital
Address [1] 280977 0
Hospital Ave, Nedlands WA 6009
Country [1] 280977 0
Australia
Other collaborator category [2] 280978 0
Hospital
Name [2] 280978 0
Gold Coast University Hospital
Address [2] 280978 0
1 Hospital Blvd, Southport, QLD, 4215
Country [2] 280978 0
Australia
Other collaborator category [3] 280979 0
Hospital
Name [3] 280979 0
Robina Hospital
Address [3] 280979 0
2 Bayberry Lane, Robina, QLD, 4226
Country [3] 280979 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303398 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 303398 0
Ethics committee country [1] 303398 0
Australia
Date submitted for ethics approval [1] 303398 0
23/08/2019
Approval date [1] 303398 0
27/09/2019
Ethics approval number [1] 303398 0
RGS3156
Ethics committee name [2] 304437 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [2] 304437 0
Ethics committee country [2] 304437 0
Australia
Date submitted for ethics approval [2] 304437 0
18/10/2019
Approval date [2] 304437 0
28/11/2019
Ethics approval number [2] 304437 0
RGS3156
Ethics committee name [3] 304440 0
Griffith University Human Research Ethics Committee
Ethics committee address [3] 304440 0
Ethics committee country [3] 304440 0
Australia
Date submitted for ethics approval [3] 304440 0
Approval date [3] 304440 0
08/11/2019
Ethics approval number [3] 304440 0
2019/888
Ethics committee name [4] 304441 0
Curtin University Human Research Ethics Committee
Ethics committee address [4] 304441 0
Ethics committee country [4] 304441 0
Australia
Date submitted for ethics approval [4] 304441 0
06/12/2019
Approval date [4] 304441 0
Ethics approval number [4] 304441 0
Ethics committee name [5] 314563 0
University of Western Australia HREC
Ethics committee address [5] 314563 0
Ethics committee country [5] 314563 0
Australia
Date submitted for ethics approval [5] 314563 0
23/11/2021
Approval date [5] 314563 0
10/12/2021
Ethics approval number [5] 314563 0
2021/ET001120

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93538 0
Prof Anne-Marie Hill
Address 93538 0
School of Allied Health, The University of Western Australia, 36 Stirling Highway Perth WA 6009
Country 93538 0
Australia
Phone 93538 0
+61400737570
Fax 93538 0
Email 93538 0
[email protected]
Contact person for public queries
Name 93539 0
Anne-Marie Hill
Address 93539 0
School of Allied Health, The University of Western Australia, 36 Stirling Highway Perth WA 6009
Country 93539 0
Australia
Phone 93539 0
+61400737570
Fax 93539 0
Email 93539 0
[email protected]
Contact person for scientific queries
Name 93540 0
Anne-Marie Hill
Address 93540 0
School of Allied Health, The University of Western Australia, 36 Stirling Highway Perth WA 6009
Country 93540 0
Australia
Phone 93540 0
+61400737570
Fax 93540 0
Email 93540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The secondary (administrative) data cannot be shared. Consideration will be given to sharing questionnaire (primary data) when future testing of the FECH program is undertaken.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5117Study protocolThe study protocol is planned to be published as a paper in a journal  
5120Ethical approval  [email protected] Evidence of ethical approval will be provided upon... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: Protocol for a multicentre randomised controlled trial.2021https://dx.doi.org/10.1136/bmjopen-2020-046600
N.B. These documents automatically identified may not have been verified by the study sponsor.