Cost effectiveness of a manual based coping strategy programme in promoting the mental health of family carers of people with dementia (the START (STrAtegies for RelaTives) study): a pragmatic randomised controlled trialBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6342 (Published 25 October 2013) Cite this as: BMJ 2013;347:f6342
- Martin Knapp, professor of social policy; professor of health economics12,
- Derek King, research fellow1,
- Renee Romeo, lecturer in health economics2,
- Barbara Schehl, visiting student1,
- Julie Barber, lecturer in medical statistics3,
- Mark Griffin, lecturer4,
- Penny Rapaport, principal clinical psychologist5,
- Debbie Livingston, trial manager6,
- Cath Mummery, consultant neurologist6,
- Zuzana Walker, reader in psychiatry of the elderly6,
- Juanita Hoe, senior clinical research associate6,
- Elizabeth L Sampson, clinical senior lecturer6,
- Claudia Cooper, clinical senior lecturer6,
- Gill Livingston, professor of older people’s mental health6
- 1Personal Social Services Research Unit, London School of Economics and Political Science, London WC2A 2AE, UK
- 2Centre for the Economics of Mental and Physical Health, King’s College London, Institute of Psychiatry, London SE5 8AF
- 3Department of Statistical Science and PRIMENT Clinical Trials Unit, University College London, London WC1E 6BT
- 4Primary Care & Population Health, Institute of Epidemiology & Health, Royal Free Hospital, London NW3 2PF
- 5Camden and Islington NHS Foundation Trust, London N19 4PJ
- 6Mental Health Sciences Unit, University College London, Charles Bell House, London W1W 7EJ
- Correspondence to: M Knapp
- Accepted 30 September 2013
Objective To assess whether the START (STrAtegies for RelatTives) intervention added to treatment as usual is cost effective compared with usual treatment alone.
Design Cost effectiveness analysis nested within a pragmatic randomised controlled trial.
Setting Three mental health and one neurological outpatient dementia service in London and Essex, UK.
Participants Family carers of people with dementia.
Intervention Eight session, manual based, coping intervention delivered by supervised psychology graduates to family carers of people with dementia added to usual treatment, compared with usual treatment alone.
Primary outcome measures Costs measured from a health and social care perspective were analysed alongside the Hospital Anxiety and Depression Scale total score (HADS-T) of affective symptoms and quality adjusted life years (QALYs) in cost effectiveness analyses over eight months from baseline.
Results Of the 260 participants recruited to the study, 173 were randomised to the START intervention, and 87 to usual treatment alone. Mean HADS-T scores were lower in the intervention group than the usual treatment group over the 8 month evaluation period (mean difference −1.79 (95% CI −3.32 to −0.33)), indicating better outcomes associated with the START intervention. There was a small improvement in health related quality of life as measured by QALYs (0.03 (−0.01 to 0.08)). Costs were no different between the intervention and usual treatment groups (£252 (−28 to 565) higher for START group). The cost effectiveness calculations suggested that START had a greater than 99% chance of being cost effective compared with usual treatment alone at a willingness to pay threshold of £30 000 per QALY gained, and a high probability of cost effectiveness on the HADS-T measure.
Conclusions The manual based coping intervention START, when added to treatment as usual, was cost effective compared with treatment as usual alone by reference to both outcome measures (affective symptoms for family carers, and carer based QALYs).
Trial Registration ISCTRN 70017938
We thank Dolores Gallagher Thompson for her original manual and allowing us to change it. We thank the participating carers, and the Camden and Islington NHS Foundation Trust, University College London Hospital, the North East London Foundation Trust, and the North Essex Partnership Foundation, and in particular Vincent Kirchner and Lisa Gee for referring many patients. We thank the members of the steering committee (Joanna Murray (chair), Thana Balamurali, Kate Maxmin, Lynne Ramsay, Mabel Saili, Lynis Lewis) and the data monitoring committee (Cornelius Katona (chair) and U Hla Htay). We thank Linda Pickard and Alistair McGuire (London School of Economics) and Paul McCrone (King’s College London) for advice on aspects of the paper. The START research team acknowledges the support of the National Institute for Health Research, through the Dementia and Neurodegenerative Research Network (DeNDRoN).
Contributors: GL, CC, JH, ZW, DL, SN [QtoA: Is this Shirley Nurock?], CM, MK, ELS, and PR contributed to the conception and design of the overall START study, which was led by GL. MK, RR, and DK developed the analytic plan for the economic evaluation. JB and MG analysed the clinical data. BS and MK calculated the costs of services. MK, RR, DK, and BS analysed the economic data. MK, RR, and DK led on preparation of the manuscript. GL, CC, ZW, JH, and CM led recruitment from their trusts. DL was the trial manager. All authors revised the article critically for important intellectual content and gave final approval of the version to be published. The researchers/therapists Monica Manela, Ryan Li, Elanor Lewis-Holmes, Ruth Shanley, Amy Waugh, Lynsey Kelly, Allana Austin, Peter Keohane, Shilpa Bavishi, Amanda Shulman, and Jonathan Bradley collected and entered the data and implemented the manual. Shirley Nurock gave advice throughout as an expert family carer. MK acts as guarantor.
Funding: The project was funded by the National Institute of Health Research (NIHR), HTA Programme (project No 08/14/06) and will be published in full in Health Technology Assessment (see HTA Programme website for further information). The authors analysed results and prepared this manuscript independently of the funding body. Views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA Programme, NIHR, National Health Service, or the Department of Health. The study was sponsored by University College London. Neither funders nor sponsors had a role in: study design; collection, analysis, and interpretation of data; writing of the article; or the decision to submit it for publication. The researchers were independent from funders and sponsors. All researchers could access all the data.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: support from the Health Technology Assessment (HTA) for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Obtained from East London and the City Research Ethics Committee 1 for the trial and Research and Development permission from the local trusts. All participants gave written informed consent.
Declaration of transparency: The lead author (MK) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Data sharing: No additional data available
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