Reflections on using realist methodology to explore and explain costs and cost-effectiveness - the

FEMuR Feasibility Trial

Dr. Joanna Charles

Centre for Health Economics and Medicines Evaluation

Bangor University

CARES Conference, Liverpool 28th October 2014

Background FEMuR - Fracture in the Elderly Multidisciplinary Rehabilitation, a feasibility trial funded

by the HTA

Proximal femoral fracture, more commonly referred to as hip fracture, is a common, major health problem in old age.

As our aging population increases the number of elderly people falling and fracturing their hips is projected to rise further.

Many people who were living independently before their fracture lose their independence afterwards, so it imposes a large health and social care cost burden on society amounting to £2.3 billion a year in the UK.

Tian et al 2013 explored Torbay’s (Devon) patient-level linked NHS and social care costs for older people in the 12 months before and after being admitted to hospital as a result of a fall.

- Hospital, community and social care service costs for each patient were almost four times as costly in the 12 months after admission, compared to the costs of the admission itself.

- The majority of costs occurred outside of the acute hospital setting. Reference: Parker, M., Johansen, A (2006) Hip fracture BMJ;333:27 doi: http://dx.doi.org/10.1136/bmj.333.7557.27

Aim Study Aim: to develop the intervention (phase 1) and then test the feasibility and acceptability of the intervention and RCT methodology in the feasibility study (phase 2).

Development of intervention (phase 1) includes a review with both systematic and realist methodology, a national U.K. survey of current rehabilitation practice and focus groups of patients, carers and the multidisciplinary rehabilitation teams.

Realist Review Aim: to identify the important components of a multi-disciplinary rehabilitation programme following surgical treatment for hip fracture in older people.

In particular, to understand the mechanism of how successful interventions work in which setting and context, for which outcome and in which group of patients.

Conversely to understand which components do not work, under which circumstances, on which patient groups and for what outcomes.

Realist Review Adapted literature search strategy based on the NICE

guideline review for hip fracture. All study types considered: randomised and non-randomised

controlled trials, observational studies, economic studies, and qualitative studies.

Participants of interest: elderly adults with proximal hip fracture.

The intervention of interest: multidisciplinary rehabilitation. Outcomes of interest: mortality, pain, functional status,

quality of life, health utility, health service use, costs, and patients’ experience.

Databases searched MEDLINE, EMBASE, AMED, CINAHL, Cochrane Library (CDSR, Trials, Methods Studies, NHS EED, HTA, other reviews), PEDro, grey literature searching   

Economic evidence inclusion criteria All study types considered including cost-analyses, partial and full economic

evaluations.

Service users must belong to our service user group of interest - elderly adults with proximal hip fracture.

Intervention was multidisciplinary rehabilitation defined below by the FEMuR TeamPurpose Supports re-enablement of the frail elderly following proximal hip fracture to

achieve their functional potential and maintain independent living where possible.

Functions A bridge between a) the hospital and the community; b) different health care sectors and

personal social care

Views people holistically

Time limited

Structure Teams based in hospitals, the community or across both sectors

Content Treatment and therapy (to increase strength, confidence, activities of daily living and

functional abilities)

Psychological, practical and social support

Support/training to develop skills and strategies

Delivery Care delivered by a multidisciplinary team or teams

Theory Development Initial immersion in this rehabilitation literature, using Cochrane, other systematic

reviews, associated primary studies and other linked studies with a strong theoretical content.

Next mind maps of research and potential gaps under the categories of; receivers (patients), deliverers (health care and rehabilitation teams ), programmes (rehabilitation) and settings or systems (hospital, community etc) being used to deliver rehabilitation programmes.

The categories within the mind maps developed into levels;

1. Individual patient

2. Team delivering the intervention

3. The rehabilitation intervention

4. The setting for the intervention

These levels became our starting point to formulate intermediate programme theories.

Economic Theories Theory level 1- Individual patient

Behavioural economic theories affecting patients’ choices concerning rehabilitation (rational/irrational choices; automatic/reflective thinking; sure short-term gains versus uncertain long-term losses; expected utility gains; welfare judgements)

Theory level 2 – Team delivering the intervention

What combinations of practitioners generate additional costs compared with usual practice?

Theory level 3 - The rehabilitation intervention

What comprising elements of a rehabilitation programme generate additional costs compared with usual practice?

Theory level 4 – The setting for the intervention

Contextual factors - How can we implement “choice architecture” to help individuals make better decisions about rehabilitation care packages?

Setting - How do certain settings increase intervention costs?

Results of Search Strategy

Flowchart for Databases searched for theories areas from inception until 16/10/14

Classifying studies for the realist review Using similar strategy to Pearson et al (2013) in their review of

intermediate care, included studies will be classified as thus

Rich – theoretical concepts are explicit, relationships between and among concepts are clear, concepts are grounded strongly in a cited body of literature.

Thick – description of programme theory or enough information provided so that the theory is implicit, typified by models, process, function, investigate, describes, explains or experiences.

Thin – Insufficient information to enable identification of programme theory, typified by mentioning only association between variables.

Middle Range Theories Tailoring of intervention - Proximal hip fracture patients present

with a range of pre-fracture physical and mental functioning and a variety of co-morbidities affecting their ability to achieve rehabilitation goals (C) need a rehabilitation programme that is tailored to individual needs (M) in order to achieve appropriate outcomes such as improved physical functioning, greater mobility, reduced disability and independent living (O).

Practice of physical activity, exercise and ADLs - Proximal hip fracture patients with poor physical functioning, who fear falling, have low mood or who lack self-efficacy (C) require interventions that improve the quality and amount of practice of physical exercises, activities of daily living and psychological tasks (M) in order to improve self-efficacy, reduce the fear of falling, improve confidence, increase mobility and physical functioning to promote independence (O).

Middle Range Theories continued Fear of falling, loss of confidence and/or lack of self-efficacy - Hip

fracture patients who fear falling, have low mood or who lack self-efficacy (C) require interventions that improve psychological tasks, provide motivation and sense of ownership to engage in exercises (M) in order to improve self-efficacy, reduce the fear of falling, improve confidence, quicker progression through a programme of recovery, increased functional outcomes, and increased mobility (O).

Co-ordination of services and sectors delivering intervention - The diversity of services provided by different disciplines, across sectors from a variety of funders (C) requires a co-ordinated provision of the multidisciplinary rehabilitation programme (M) in order to deliver appropriate physical, functional and psychological interventions to patients in a timely manner (O).

Under these Middle Range Theories – Economics findings will be included in the co-ordination of services, once the theories have been tested

Challenges Most economic evidence included in the review would be described as ‘Thin’ –

with little detail of programme theory or explanations of relationships between concepts.

We are currently exploring the literature to support or contradict the intermediate theories developed – though initial findings suggest studies do not discuss behavioural economic theory explicitly.

The evidence suggests implications for costs with regards to setting, configuration of the healthcare team and patient characteristics such as frailty or co-morbidities.

Write-up of economic studies provides very little information to synthesise findings. Studies tend to report outcomes without detailed discussion of the potential causes for these findings.

In certain cases the cost implications can be viewed as logical and ‘common sense’ e.g., impatient rehabilitation has higher costs compared with outpatient rehabilitation.

Personal Reflections Is there a reason for the ‘Thin’ categorisation of economic studies? How do we

address this in the future?

When looking at the common sense argument do we as health economists explore deeper asking ourselves, what does this mean for outcomes? Does the higher cost of inpatient rehabilitation result in better outcomes for the patient? - therefore, making it worth the added cost.

Is the consideration of behavioural economic theories something that lends itself to particular interventions or disciplines? For example, interventions to increase physical activity by encouraging the use of stairs in office buildings rather than lifts (Nudge Theory).

How does the realist quality appraisal of ‘relevance’ and ‘rigour’ and other guidelines compare with economic appraisal tools and checklists? Should the inclusion criteria be kept as broad as possible when conducting a realist review with economic evidence.

Acknowledgments

Thank you to Dr. Nefyn Williams, the Principal Investigator, Dr. Claire Hawkes, Trial Manager and the FEMuR Realist Review Team, Dr. Nafess Din and Prof Jo Rycroft-Malone.

This project was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (funder reference: 11/33-03) and will be published in full in Health Technology Assessment. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, the National Health Service, or the Department of Health.

Thank you for listening/ Diolch

am wrandoj.charles@bangor.ac.uk