Study protocol: translating and implementing psychosocial interventions in aged home care the lifestyle engagement activity program (LEAP) for life

Background Tailored psychosocial activity-based interventions have been shown to improve mood, behaviour and quality of life for nursing home residents. Occupational therapist delivered activity programs have shown benefits when delivered in home care settings for people with dementia. The primary aim of this study is to evaluate the effect of LEAP (Lifestyle Engagement Activity Program) for Life, a training and practice change program on the engagement of home care clients by care workers. Secondary aims are to evaluate the impact of the program on changes in client mood and behaviour. Methods/design The 12 month LEAP program has three components: 1) engaging site management and care staff in the program; 2) employing a LEAP champion one day a week to support program activities; 3) delivering an evidence-based training program to care staff. Specifically, case managers will be trained and supported to set meaningful social or recreational goals with clients and incorporate these into care plans. Care workers will be trained in and encouraged to practise good communication, promote client independence and choice, and tailor meaningful activities using Montessori principles, reminiscence, music, physical activity and play. LEAP Champions will be given information about theories of organisational change and trained in interpersonal skills required for their role. LEAP will be evaluated in five home care sites including two that service ethnic minority groups. A quasi experimental design will be used with evaluation data collected four times: 6-months prior to program commencement; at the start of the program; and then after 6 and 12 months. Mixed effect models will enable comparison of change in outcomes for the periods before and during the program. The primary outcome measure is client engagement. Secondary outcomes for clients are satisfaction with care, dysphoria/depression, loneliness, apathy and agitation; and work satisfaction for care workers. A process evaluation will also be undertaken. Discussion LEAP for Life may prove a cost-effective way to improve client engagement and other outcomes in the community setting. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612001064897.


Background
Aged care will increasingly be provided at home rather than in institutions [1,2]. This trend is driven by the wishes of older people to stay at home [3][4][5][6], and changing social structures reducing the availability of informal family care. Although desirable, there are negative aspects to living at home as an older person. A third of community dwelling older persons have reported being lonely, most of these (80%) did not receive home visitation or telephone contact services, and 40% did not attend any group activities [7]. Community dwelling older persons have also reported having limited access to meaningful activities [8]. Older people who receive home care (also known as community or domiciliary care) services want personalised activities and opportunities for socialisation [3]. The most frequent unmet needs of persons with dementia living alone were daytime activities (54%), company (52%), and care for psychological distress (44%) [9,10]. Home care recipients' ratings of their opportunities for activities were significantly lower than residents in nursing homes [11]. Forty-two per cent of Australians referred to home care screened positive for depression [12], and similarly 43% of American home care clients met DSM-IV criteria for depression [13]. Sixty per cent of community dwelling persons with dementia have behavioural disturbances [14]. These behaviours such as agitation, aggression, psychosis, anxiety and depression are stressful and increase the burden of carers, and increase the likelihood of institutionalisation [15].
Psychosocial activity-based interventions, particularly tailored activities, have been shown to improve outcomes for residents in aged care facilities and are recommended in many dementia management guidelines [16,17]. For instance, music and diversional therapy decrease depression, anxiety and social withdrawal for persons with dementia [18]. Aromatherapy, preferred music, muscle relaxation training, Montessori activities and humour therapy have been shown to reduce behavioural disturbances in agitation, aggression and verbal disruption [19][20][21]. Individualised activity programs tailored to older person's cognitive, physical, and sensory abilities, and their lifelong habits and roles have been particularly effective in decreasing agitation, depression and improving quality of life of persons with dementia [22]. Common to these interventions is engagement of clients, which may fulfil unmet needs for company or meaningful activity and stimulation [23]. We believe that engagement of residents through activity is the critical ingredient for these interventions.
Only a few tailored psychosocial activity programs have been trialled in community settings for people with dementia [24,25]. All involved use of experienced therapists in addition to existing care. A 10 session in-home program conducted by occupational therapists included environmental modification, and training for patients and carers on how to optimise functional performance. This program reported improving the mood and quality of life of persons with dementia [25]. The Tailored Activity Program (TAP) showed that assessment informing tailored activity prescription by an occupational therapist coupled with caregiver training over eight sessions at home reduced problem behaviours and increased pleasure and engagement of persons with dementia [24]. TAP costs $961.63 per caregiver-client dyad and sustainability of effects is not known as there was no follow-up beyond four months [25].
The aim of this study is to evaluate the effects of LEAP for life on increasing home care client engagement by aged care staff. The effects of the program on client mood, behaviour and satisfaction with care, and care worker satisfaction with work will also be measured.

Methods/design
The design of the program was informed by Greenhalgh's framework for diffusion of innovations in service organisations [26] and the literature on implementation and culture change in health and aged care [27][28][29][30][31][32][33][34][35]. Cost, scalability and sustainability were also considerations of the program design. We did not specifically base the program design on a theory, as there was no published theory that appeared suitable with a sound evidence base in predicting good implementation outcomes [36]. The three components of the program are: 1) Engaging site management and care staff with the LEAP for Life program 2) Employing a LEAP champion one day a week at each site 3) A training program (detailed below) The program logic model of the implementation is outlined in Figure 1. LEAP will encourage case managers to include social and recreational goals in client care plans; and care workers to increase behaviours which engage clients socially and recreationally. Behavioural change of care workers and case managers is to be driven by a LEAP champion within each site. By increasing client engagement, we hypothesise that client depression, loneliness, apathy and/or agitation will improve for those with symptoms in these areas, and that satisfaction with care will also increase. We also hypothesise that relationships between care staff and clients, and care staff work satisfaction will increase.
A position description has been written for the LEAP champion and champions will be selected after discussion with site managers. The role of the LEAP champion is to: support care workers in ways to meaningfully engage clients; assist case managers in including social or recreational goals within clients' care plans; develop personalised resources for client engagement; develop an activities library; accompany care workers on buddy shifts; and to liaise with the research team.

Development of the training sessions
The training sessions have been developed based on literature reviews and consultation with experts as detailed under each training component below. We also reviewed the literature on how to best deliver training for aged care workers [37][38][39], and drew on the experience of the Advisory and Steering committee. The training program was designed around the principles that it was to be interactive, practical and skills based; allow care staff to experience the impact of the psychosocial strategy; include self-reflection and discussion; acknowledge care staffs' expertise and experiences; take a problem solving approach; inspire; and be fun. The training program was also developed to cater for staff with different levels of education, English language proficiency and cultural backgrounds [40].
Barriers to implementing lifestyle activities in home care were identified through the advisory and steering groups and from −6 month interviews with case managers at participating sites. Barriers identified were: lack of time, lack of knowledge, lack of resources, and attitudes of families and clients that the remit of the care worker is to just provide practical or physical assistance. These have been explicitly addressed in the training and practice change program.
The training program structure is outlined in Table 1. Each training session was refined using feedback from the advisory group, steering committee, and following a pilot session at a non-participating service.

LEAP champion training
One five-hour champion training session informed by the literature [41][42][43][44], will be delivered three months prior to the start of the program. The training will clarify the LEAP champion role including specific tasks to be performed, educate LEAP champions in the process of change and responses to change; develop interpersonal skills for person persuasion; identify potential difficulties and brainstorm solutions within their sites; and encourage networking between the LEAP champions.

Case manager training
One three-hour training session program informed by the literature and consultation with experts [45][46][47][48], will be delivered at the beginning of the program. The training introduces case managers to the aim and importance or need for LEAP and trains them in setting SMART (Specific; Measurable; Achievable; Relevant: Timely) goals [49]. The training will conclude with a brain storming session on specific strategies that could be used to fully implement LEAP within their organisation. Strategies will be fed back to each site to review, collectively finalise and action.

Care worker training
Care workers will participate in four two or three hour training sessions, held every three months. The staggered sessions will allow time to apply and consolidate sessions and act as boosters to continue using the principles of engagement taught in LEAP. Training has been designed to be delivered on-site to small groups of between 6-10 case managers or 10-20 care workers.
Care worker training was developed based on the following principles and psychosocial strategies for which there was an evidence base in improving outcomes:    taking a person-centred individualised approach [50], dementia and the unmet needs model of challenging behaviours [23], communication skills [51], autonomy and control [52,53], reminiscence [54,55], music [56], physical activity [57], Montessori activities [58] humour [59] and reciprocity [60]. Over the course of the training program, the LEAP Champion will also accompany each care worker on a buddy visit to a client in order to support care workers in practising client engagement techniques. Training materials will be translated into Chinese and delivered by a trilingual trainer (English, Mandarin, and Cantonese) in a Chinese speaking site.

Inducting new staff members
Staff turnover in home care is high [40]. LEAP champions will review and discuss LEAP for Life with care workers who missed training sessions, using a provided script and handout of key points. New case managers will also attend a brief training session.

Evaluation
The study has been approved by the University of New South Wales Human Research Ethics Committee (HC12383) and registered on the Australian New Zealand Clinical Trials Registry (ACTRN12612001064897).

Setting
The project will be evaluated with five aged care community service providers in regional and metropolitan New South Wales, Australia. The providers were approached to participate by the chief investigator. Two of the sites specifically provide services for clients from ethnic minority, non-English speaking backgrounds. These services deliver case managed home care packages. The types of services provided by these packages include personal care, domestic assistance, social support, travel to appointments, in-home respite and nursing care.
Eligibility criteria for participating services are: Government accredited, providing home care packages to older people in the community; Not enrolled in another intervention study relating to engagement and activities; Willing to sign a legal contract with regards to program terms.

1) Case managers and care workers
Site managers or their nominees will invite all staff members working on home care packages to participate in the study and provide them with a study flyer, information sheet and consent form. Care workers will either be paid for their time participating in the evaluation or receive a small inducement to complete questionnaires. Based on discussions with site managers, we anticipate that all of the 20 case managers and 90% of the 183 care workers (i.e. 165) will consent to participate.

2) Community aged care clients
All eligible clients (n = approximately 422) being cared for by the service under a home care package will be invited to participate. A 50% participation • To define how LEAP will work in each individual's own schedule and organisation. 10. Brainstorm as a group how UNSW will support the LEAP champions in their role 11. Self-reflection activity on what each person will put into practice from the session rate and 25% attrition is anticipated, thus about 211 clients will be recruited, and 158 clients will provide complete client data over 18 months. Clients will be ineligible if they are; foreshadowed to stop accessing the service, acutely unwell, or under public guardianship with no person responsible to consent on their behalf. Case managers or their nominee will invite all eligible clients to participate in the evaluation by briefly introducing the study and giving them and/or their families a study flyer. Clients and their families will give verbal assent to case managers to have their details passed onto the research team who will explain the study and provide a written information and consent form. Cognitively intact clients and families will each provide written consent for their own participation. When the client may be cognitively impaired, verbal assent will be obtained from the client, and family written consent will be obtained for both family and client participation.

Brainstorm as a group what characteristics and
Design LEAP is being evaluated using a quasi-experimental design with measurements taken at −6, 0 (baseline immediately pre-intervention), 6 and 12 months. The time period from −6 to 0 months will act as non-intervention comparison for the period between 0, 6 and 12 months. Clients will be clustered under their case managers (n = 20).

Assessment tools
Primary outcome measure: client engagement Client engagement will be assessed from both the care worker and client perspective. A six-item purpose-specific care worker questionnaire will measure the five dimensions of engagement conceptualised in Cohen-Mansfield's Observational Measure of Engagement (OME) -for which there has been demonstrated sound inter-rater reliability and construct validity [61]. The five dimensions are: client rate of refusal of offers of interaction; proportion of time during care worker visits that the client is involved with an activity or conversation; client attention level; client attitude towards any interaction; and the appropriateness of client interaction. In order to ascertain test-retest reliability of the measure, 20 care workers will be asked to complete the questionnaire twice, two weeks apart. Client perspectives on engagement with care staff will be rated by researchers after conducting semi-structured interviews with the clients and families. Researchers will rate four engagement items pertaining to frequency of and feelings towards social conversation or recreational activities during care worker visits. A random selection of 10 interviews shall be scored by a two researchers, in order to establish inter-rater reliability.
Secondary outcome measures Secondary outcome assessment tools for both client and care worker are detailed in Table 2.
Translations Assessments will be conducted in English, Cantonese, Mandarin, Vietnamese, Arabic or Spanish according to the preferred language of participants. Validated translated versions of scales will be used where available (see Table 2). Where they are not available (See Table 2), scales will be translated by accredited translators, then checked for meaning by bilingual research staff with experience in the area.

Process evaluation
The process evaluation will assess five components [72,73].

Context
Aspects of the environment or organisation that may influence intervention implementation or study outcomes (such as perceived or real barriers, enablers, organisational culture, management support, and attitudes of care staff, clients and families towards LEAP), will be established through interviews with case managers at each evaluation time-point; monthly phone meetings with the LEAP Champions; and bi-annual steering committee meetings.

Reach
Care staff attendance at each LEAP training session, and the number of LEAP inductions conducted with new care staff, shall be recorded.

Dose delivered
LEAP is a semi-scripted manualised program with set learning objectives, activity aims, activities, handouts and timings. Information about whether each component of the manual is delivered will be recorded. Number of buddy shifts conducted shall also be recorded.

Dose received
The extent to which the care staff actively engage with the LEAP program and implement the strategies and activities learnt in training shall be documented by way of case manager interviews, and phone meetings with the LEAP Champion.
A care plan audit will identify whether a SMART social or recreational goal, a vague social or recreational goal, or no goal, has been included in the care plan for each client. The audit will also identify whether or not a personal history sheet documenting clients' past and present interests, preferences, relationships, roles and so forth is included in the client's file. Case manager interviews and the care plan audit will collectively inform: 1) how well the goal was (or is being) implemented for each client (0not started; 1planned; 2in progress; 3achieved); 2) whether other engagement strategies are being implemented with each client (ranging from 0none at all, to 4 -a lot); and 3) reasons if no social or recreational goal has been identified for a client.
Care workers will complete a one week activity diary recording frequency and type of social and recreational activities undertaken with clients.

Fidelity
The extent to which LEAP is implemented as planned, shall be established by way of case manager interviews, phone meetings with LEAP Champions, and a review at 12 months of the success of each site-specific implementation plan. In regards to the behaviour of the facilitators, care staff will complete a short written evaluation after each training session.

Power
The target sample of 211 clients clustered within 20 case managers will give at least 80% power to detect a small effect size (Cohen's d = 0.2) at a significance level of two sided 0.05, assuming a median intraclass correlation (rho = 0.5) between pre and post intervention measures [74,75]. This power analysis is based on one group comparing pre-and post-measures for the primary outcome measure [75]. As the engagement score is a new measure, we do not know what the correlation structure among the repeated assessments using the instrument will be. Post hoc power analysis will be conducted upon study completion.

Data analysis
Piecewise linear mixed effect models will be used as the primary analysis method, with correlations between repeated measurements taken into account. The mean and standard deviation of the pre-intervention slope (−6 to 0 months) and post intervention slope (0 to 12 months) as well as the mean outcome measure at time 0 with 95% Confidence Interval will be estimated. The difference of the two slopes will be tested based on the Z score at the significance level of two-sided 0.05. The model will be fitted with and without covariates. Piecewise least squares analysis will be conducted as supportive analysis. The primary analysis will be performed on the qualified intention to treat (ITT) population of all the clients enrolled in this study. Missing outcome data will be handled by the mixed effect model approach, providing the missing at random (MAR) assumption is met. If appropriate, multiple imputation will be used to generate missing covariate data. Quantitative process evaluation data shall be described. Qualitative process evaluation data shall be described and where appropriate, thematically analysed. Where possible, analyses will also be conducted using process evaluation data as predictors of outcomes. An estimate of LEAP program costs will be made. This will be based on the costs of both delivering and staff attending the training, time for the LEAP champion, and the cost of any materials or resources required for activities.

Discussion
LEAP for Life is a pragmatic program with the aim of increasing engagement of aged care clients by aged care staff. The program is designed to be economical to deliver and self-sustaining after the implementation period, and is being evaluated in the real world setting.
The non-controlled design means that we cannot with certainty attribute any observed changes to the LEAP program. However it is unlikely that care worker behaviour with relation to clients would systematically be affected by external factors. The detailed process evaluation will also add confidence in attributing the change to the implementation processes, as well as in understanding the mechanisms and processes involved in changing home care staff behaviour.