Protocol for a randomised controlled trial of an outreach support program for family carers of older people discharged from hospital

This is a mixed methods study addressing objectives and testing hypotheses in a single blind Randomised Controlled Trial (RCT) (concealed allocation), adhering to CONSORT guidelines for transparent reporting [16], during which Qualitative Evaluation and FECH program Process Evaluation will also be undertaken. The study will also be supported by an expert reference group. The RCT will compare outcomes between the control condition (usual care) and the experimental condition (usual care plus family carer inclusion on the new FECH program). Approval has been received from the Sir Charles Gairdner Group Human Research Ethics Committee (HREC) (2014–133), the Department of Health WA HREC (2014/78), and from the Curtin University HREC (HR14/2015).

The MAU is a 36-bed unit providing intensive assessment and treatment for patients with acute medical conditions, most of whom are over 70 years of age. MAUs are widely implemented in the UK, Australia and New Zealand in response to the need to increase patient through-put [17] and sustained health system pressures suggest that their use will continue to expand. Care is provided by physician-led multidisciplinary teams for up to 72 h, after which patients are discharged or transferred to inpatient units for ongoing management. A key component of the MAU model is that ongoing management for discharged patients is provided through prompt general practitioner follow-up [9].

Included participants will comprise dyads of older people (aged 70+) discharged home from the MAU during the recruitment period and their adult (aged 18+), English speaking, family carers (one per patient). The definition of a family carer is that used in a recent Australian study investigating the care of frail older people: “a family member or friend who provides unpaid personal care, support and assistance” [18]. Dyads already recruited into the study will be excluded from further recruitment upon any subsequent readmissions to the MAU.

Carer participants in the intervention group will receive standard care plus the FECH program implemented by the FECH nurse who will be appropriately skilled and trained. Currently there is no nurse involved in providing the FECH or any similar program to patients or carers.

Contacts will be made by telephone, after discharge (Fig. 1). The FECH Nurse will make initial contact with the family carer within one week of the discharge (Contact 1). This contact will include the FECH nurse introducing him/herself, explaining the intervention, and scheduling ‘Contact 2’. Contact 2 is likely to comprise a series of brief telephone interviews, if this is the arrangement that suits the family carer best, within the subsequent few days to (a) determine and respond to the extent to which the family carer understands the copy of the discharge letter to the general practitioner that has been provided to them; (b) administer the CSNAT [14] to the family carer, resulting in the carer’s self-identified and highest 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 Contact 2 is finalised (within 14 days of the discharge), the FECH nurse will check to determine if access to support has been achieved as planned, advising as appropriate (Contact 3). This contact will include asking if the services have been sourced (eg, an appointment made) and/or if the service has been accessed. These three contact points will be coordinated with the three data collection time points (T1, T2, and T3) also shown in Fig. 1.

Standard discharge ‘care’ includes the provision of a letter from the MAU’s physician to the patient’s general practitioner, with a copy provided to the patient. Medications are provided/organised by the MAU pharmacist. The MAU information booklet provides information about post-discharge support options and is intended to be taken home. Carers regarded as ‘at particular risk’ by the social work team 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 the hospital rooms. Any one or more of these options considered by treating ward staff to be relevant to the patient and their carer will be provided as usual care.

Quantitative patient outcome data will address Western Australian health care system utilisation and will be obtained through linked administrative health data provided via the WA Data Linkage System (WADLS) [28]. These Data Linkage Unit (DLU) data will capture reason for service and mode of transport plus: date of service, symptom/presenting problem, and triage code (ED presentation); admission and separation dates, primary diagnosis code, co-diagnosis code, and diagnosis related group (hospitalisation data). In addition, to account for time at risk, and to capture deaths resulting from acute events during the study follow-up period, date and cause of death will be collected.

The data retrieved from data linkage will cover the time period from the date of the index separation of the patient whose carer is the first to be recruited to the study until 3 months after the index separation of the patient whose carer is the last to be recruited. Since recruitment is planned to last approximately 6 months, this time period will cover approximately 9 months.

The primary outcome is the total score on the Preparedness for Caregiving Scale [19]. An improvement of two points in the total score is regarded as clinically relevant, given that this would mean a change such as progressing to ‘very well prepared’ from ‘well prepared’ in 25 % of items. To detect a change of this magnitude with 80 % power (assuming that the standard deviation of the change in mean score is approximately 0.5, as in previous work) [19, 29] a sample size of 63 per group will be required. Based upon previous studies by the research team, attrition of approximately 30 % is expected so a sample of 180 carers in total will be recruited.

Figure 2 shows the proposed study flow. There were more than eight MAU discharges of patients aged 70+ each day in 2013, approximately half returning home (estimated 120 per month). Therefore, recruitment of 180 participants is considered achievable within the 6 month recruitment period (30 per month).

Although the primary study outcome relates to carers of patients discharged from the MAU, other outcomes relate to the former patients themselves so carer/patient dyads will be recruited. Whenever a patient aged 70 years or older is admitted to the MAU during the recruitment period, family carers - and, when appropriate, patients - will be provided with information about the project and asked to provide written consent to participate in the study by RO1. However, many patients are likely to be too unwell to be approached with information about the study during their hospitalisation and are likely to experience ongoing poor health that may also fluctuate [9]. Others will lack (cognitive) capacity to consider consenting. In these instances, data about patients’ use of health care services will be sought via a waiver of consent. An opt out form will be provided for such patients in case there is a later opportunity – if and when the patient’s health has improved – for them to withhold consent for inclusion of their data in the study, should this be their wish.

To facilitate the assignment to group (control or intervention) of participants, a list of treatment allocations will be prepared before the study commences; it will contain a study number (whole number, starting from one), and a code to indicate the group (intervention or control). The list of codes will be obtained using a sequence of computer-generated random numbers, and organised so that recruitment to the two study arms occurs at an approximately equal rate (using a permuted random block strategy). Allocation of participants to their treatment group will occur as follows: as each new dyad is recruited to the study, the next study number will be allocated to them (next in sequence on the list), and the treatment allocation for that study number will be read from the list.

An ‘exit’ telephone interview will be conducted with an estimated 30 carers in the intervention group and, when possible, the older people receiving care from them (estimated 20). These participants will be purposively sampled on the basis of questionnaire data to cover a wide variety of carer profiles (eg, carer sex, age [older versus younger carers], duration of caregiving [new carers versus those who are more experienced], relationship to patient [husbands, wives, sons, daughters, others], and location of care). The sample will be extended if issues need further exploration and until data saturation is reached.

Interviews will occur within two weeks following administration of the final measures, to: investigate how the FECH model affected the participants, assess the support provided, identify factors influencing feasibility/usefulness, and assess how the FECH model could be improved. Written informed consent for participation will be obtained separately for this step and will involve mailing the information sheet and consent forms (for the carer and for the patient); then following up with a phone call during which questions can be answered, before requesting the return of the completed consent form in a prepaid study envelope. It is anticipated that the interviews will take approximately 30 min. A second telephone call will be offered if the interview takes longer than 30 min and the carer wishes to provide further relevant information.

A focus group interview will be convened with the MAU staff as soon as carer recruitment for the trial has been completed. The staff working on the unit during the trial will be invited to take part and will be asked to comment on any impact from the FECH program on the Unit and to suggest: program refinements that would minimise negative outcomes and maximise those that are positive, how the program could be integrated into practice, and how its sustainability could be addressed. The staff members will be invited to take part by mail, and will also be sent an information sheet and consent form.

Evaluation of FECH program processes will involve the FECH nurse documenting, during the trial: (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; (d) the contextual factors that were barriers to, or facilitators of, resource and service access and engagement; and (e) costs issues – primarily time taken to implement processes. This documentation will be achieved using an electronic database developed at the same time as the process manual and completed by the FECH nurse as the process is implemented.

Group assignment will be concealed from RO1. When RO1 conducts the T1-T3 data collection telephone questionnaire administration, he or she will commence the conversation with a request to the participant (the carer) not to mention any phone calls from other study personnel. This reminder will not always be sufficient to prevent disclosure, and instances when it occurs will be documented to inform study reports. In a previous study, quantification of any ‘unblinding’ involved asking the hospital staff to identify to which group they thought patient participants had been assigned [30]. In this study, a similar question will be asked of the research staff collecting outcome data. The person conducting the qualitative interviews will be a Research Officer employed for this purpose alone (RO2), so that blinding to group allocation will be maintained for RO1. Investigator blinding will also be maintained by allocating responsibility for this (qualitative) component of the study to one of the research team, an experienced qualitative researcher who will not be involved in quantitative data collection or analyses.

Data analyses will be performed using the IBM SPSS statistical software package [31]. A p-value of <0.05 will be taken to indicate a statistically significant result in all tests.

Since a randomised controlled trial is being undertaken to determine the efficacy of the new support program for older patients’ carers, the economic evaluation reflects a service substitution model without cost sharing or transfer. 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 Western Australian health system perspective.

All interviews will be audio-recorded and transcribed verbatim. Analysis will be aided by the use of the NVivo software program [34]. Responses will be coded on a question-by-question basis, codes will be collapsed into themes across questions, and quotes from participants will illustrate each theme. This qualitative analysis will be undertaken independently by the investigator responsible for overseeing qualitative evaluations and the interviewer to ensure consideration of the non-verbal context. These analysts will compare themes and sub-themes until agreement is reached.

Findings from the process evaluation will be summarised to support recommendations. In addition, a feasible ‘caseload’ for a full-time FECH nurse will be determined.