3. Resultados de la investigación
4.2 Protección nacional e internacional del Inversionista Extranjero
4.2.4 Estándares de protección del inversionista extranjero en el contexto jurídico
4.3.1.10 Caso Pac Rim Cayman Llc y La República de El Salvador: (2016)
T
his element of our work related to stage 2c in our proposal: scoping the potential effects and costs of using LSW in specialist inpatient and long-term care settings (objective 3) and exploring the feasibility of formal evaluation (objective 4).Medical Research Council guidance18confirms that assessment of feasibility and piloting of methods is vital
preparatory work in developing and evaluating complex interventions. In this stage of our work we were interested, first, to see whether or not we could observe any effects from and costs of using LSW and, second, to test the feasibility of large-scale formal evaluation of LSW. We piloted two different study designs in two different settings to address our objectives:
1. a stepped-wedge trial design in independently provided care homes
2. a pre-test post-test design, with controls, in NHS mental health assessment units that specialised in the care of people with dementia.
In this chapter, we present the findings of the assessment of feasibility in both settings. The measured outcomes and costs are reported inChapters 7and8.
The aims of the feasibility elements of the work were to:
l establish the likely rates of recruitment and retention
l identify any problems service providers experienced in delivering the intervention
l assess the feasibility of measuring the outcomes of LSW in these settings
l assess the feasibility of collecting data on the costs of LSW in these settings.
Methods
Study 1: a stepped-wedge trial design in independently provided care homes
Design
We chose a stepped-wedge design to allow us to test the feasibility of not only evaluation but also rolling out the LSW approach to these new care settings. In this design, each setting receives the intervention at some point during the period of the study (ensuring equity), but roll-out is staggered, rendering implementation across multiple sites more straightforward than attempting a simultaneous start.134
We worked with a single, not-for-profit care home provider that was keen to introduce LSW across its services. The provider selected a purposive sample of six care homes. None of the homes currently practised LSW but all had managers who were disposed to introduce it.
The project was designed so that one care home introduced LSW each month for 6 months, with baseline data collected immediately before implementation and follow-up data collected 1 month, 2 months and 6 months after LSW was due to begin. The first care home entered the study in January 2014 (with training taking place in the previous month) and the following care homes entered at monthly intervals; thus, care home 6 entered the study in June 2014.
Intervention
A training package was designed, informed by the findings on good practice from the development stage of the project (seeChapters 2and3). This consisted of:
l a 2-hour training session for care home staff (delivered by the care provider’s dementia care consultant)
l printed guidance and hand-outs on good practice in LSW
l a template,‘some important things’, to help staff get started (it was emphasised in the training that the template need not be followed–the form LSW takes should be led by the needs and desires of the individual–but it could be used as a starting point).
Sample
Ten residents with dementia or dementia-like symptoms (and their family carer, if they had one) in each of the six care homes were randomly selected and invited to join the study. All staff who undertook the LSW training were also invited to take part.
Study 2: a pre-test post-test design, with controls, in NHS mental health assessment units that specialised in the care of people with dementia
Design
The stepped-wedge approach was not appropriate in the acute settings, as we were working with three mental health assessment units in which LSW was reported to be a routine part of care for all patients with dementia already. We instead opted for a pre-test post-test design in the acute settings, with a comparison setting providing a control, and collecting data over a 6-month period from baseline. All three wards in the intervention site joined the study in February 2014 and the comparison site joined in
April 2014. Intervention
In the intervention site, a group that included the NHS trust’s clinical lead for psychological therapies for older people had initiated LSW some years previously. In October 2013, we attended the trust’s Service Line Planning Group meeting for older people’s services and agreed with service managers to focus on three short-stay assessment units for older people with mental health problems where LSW (usually in book form) was routinely practised.
In the comparison site, LSW was not practised but the ward manager was keen to introduce it. We agreed that, once the 6-month participant recruitment period was over, the project team would support the ward to access LSW training.
Sample
Ten people with dementia (and their family carer, if they had one) were to be recruited sequentially from each of three inpatient assessment units that practised LSW as or soon after they were admitted and 10 were to be recruited sequentially from each of three comparison sites as or soon after they were admitted. In addition, data were to be collected from a cross-section of staff on the wards at three time points over the 6-month period.
Process (both studies)
Quantitative data collection
We planned to measure selected outcomes for all participants with dementia and family carers at baseline (for those in the LSW groups, before any LSW had commenced) and then follow them up at 1 month, 2 months and 6 months after baseline, wherever they were then living. We had originally considered training staff on site to use some of the outcome measures, but it soon became clear that this would not be workable without additional funds to backfill staff time. Two researchers in the project team (KG and JB),
supported by a research assistant employed on a casual basis (LC) for the care homes study, collected data at all time points.
Innovations in Dementia provided advice on consent and data collection processes with people with dementia, and observed the researchers in action at one care home to ensure that ethical practices were in operation.
We also planned to collect data from participants’care records about dementia diagnosis and severity at baseline, and on relevant drug use and adverse events for the 3 months prior to entering the study and the final 3 months of follow-up.
Levels of staff burnout, staff assessments of personhood and staff approaches to working with people with dementia were assessed using existing measures. In care homes, consenting staff provided baseline data and were followed up after 1 month, 2 months and 6 months. In the hospitals, cross-sectional data were collected at three time points over the 6-month study period.
Qualitative data collection
We gathered in-depth, qualitative information about experiences of LSW and the processes involved in its evaluation from carers, staff and (where possible) participants with dementia. The aims here were to:
l develop a qualitative understanding of causal links between LSW and the outcomes measured in the quantitative element of the study
l explore the acceptability of the processes involved in evaluation
l understand any implementation issues, including barriers and facilitators to LSW, and any unanticipated consequences (including how these could be managed in future).
We conducted a mix of face-to-face and telephone interviews with family carers (guided by their stated preferences) and guided conversations with participants with dementia who were able to communicate verbally (and were happy to do so). We also conducted focus groups with staff, covering both their views on the use of LSW and their experiences of taking part in the study.
Ethical approach
Research ethics approval for the feasibility study stage of the project (including the qualitative work discussed inChapter 9) was obtained from the NIHR SCREC on 28 November 2013 for people with the capacity to consent to take part, and on 2 December 2013 for those without the capacity to consent.