The clinical and cost-effectiveness of rehabilitation of memory in brain injury: the ReMemBrIn RCT

das Nair, Roshan and Bradshaw, Lucy E. and Carpenter, Hannah and Clarke, Sara and Day, Florence and Drummond, Avril and Fitzsimmons, Deborah and Harris, Shaun and Montgomery, Alan A. and Newby, Gavin and Sackley, Catherine and Lincoln, Nadina B. (2017) The clinical and cost-effectiveness of rehabilitation of memory in brain injury: the ReMemBrIn RCT. Project Report. National Institute for Health Research, Health Technology Assessment. (In Press)

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Abstract

Background

People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating, and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital.

Objectives

To assess the clinical and cost-effectiveness of a group memory rehabilitation programme for people with TBI.

Design

Multi-centre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken.

Setting

Community settings in nine sites in England.

Participants

Participants were aged 18-69 years, with TBI more than 3 months prior to recruitment, reported memory problems, who were able to travel to a site to attend group sessions, communicate in English, and gave informed consent.

Randomisation and blinding

Clusters of 4 to 6 participants were randomised to intervention or control on a 1:1 ratio. Randomisation was based on a computer generated pseudo-random code using random permuted blocks of randomly varying size, stratified by study site.

Participants and therapists were aware of the treatment allocation; outcome assessors were blinded.

Interventions

Ten weekly sessions of a manualised memory rehabilitation programme were provided in addition to usual care. Participants were taught restitution strategies to retrain impaired memory functions and compensation strategies to enable them to cope with memory problems. The control arm received usual care only.

Outcomes

Outcomes were assessed at 6 and 12 months after randomisation. Primary: Patient-completed Everyday Memory Questionnaire (EMQ-p) at 6-month follow-up. Secondary: Rivermead Behavioural Memory Test-3, General Health Questionnaire-30, European Brain Injury Questionnaire, Everyday Memory Questionnaire-relative version, individual goal attainment. Costs (based on a UK NHS and PSS perspective) were collected using a service use questionnaire, with the EQ-5D 5L used to derive Quality Adjusted Life Years. A Markov model was developed to explore cost-effectiveness at 5 and 10 years, with 3.5% discount applied.

Results

We randomised 328 participants (intervention: n=171; control: n=157), with 129 in the intervention arm and 122 in the control arm included in the primary analysis. We found no clinically important difference on the EMQ-p between the two arms at 6-month follow-up (adjusted difference in means -2.1, 95% CI -6.7 to 2.5, p=0.37). For secondary outcomes, differences favouring the intervention arm were observed at 6-month follow-up for RBMT and goal attainment, but remained only for goal attainment at 12-month follow-up. There were no differences between arms in mood or quality of life. Qualitative results suggested positive experiences of participating in the trial and of attending the groups. Participants reported that memory rehabilitation was not routinely accessible in usual care. The primary health economics outcome at 12-months found memory rehabilitation to be £26.89 cheaper than usual care but less effective with an incremental QALY loss of 0.007. Differences in costs and effects were not statistically significant and non-parametric bootstrapping demonstrated considerable uncertainty in these findings. No safety concerns were raised and no deaths reported.

Limitations

As a pragmatic trial, we had broad inclusion criteria, therefore there was considerable heterogeneity within the sample. The study was not powered to perform further sub-group analyses. Participants and therapists could not be blinded to treatment allocation.

Conclusions

The group memory rehabilitation delivered in this trial is very unlikely to lead to clinical benefits or to be a cost-effective treatment for people with TBI in the community.

Future work

Future studies should examine the inclusion and selection of participants who may benefit most from memory rehabilitation.

Registration

ISRCTN65792154

Funding

National Institute for Health Research, Health Technology Assessment

Item Type: Monograph (Project Report)
Additional Information: Authors on behalf of the ReMemBrIn Trial Collaborative Group.
Keywords: Brain Injuries; Brain Injuries, Traumatic; Cost Benefit Analysis; Memory Traumatic brain injury, memory problems, memory rehabilitation, cognitive rehabilitation
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Psychiatry and Applied Psychology
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Rehabilitation and Ageing
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Health Sciences
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Units > Clinical Trials Unit
Related URLs:
URLURL Type
https://www.nihr.ac.uk/UNSPECIFIED
Depositing User: day, Florence
Date Deposited: 09 Mar 2018 13:30
Last Modified: 03 May 2018 10:59
URI: http://eprints.nottingham.ac.uk/id/eprint/50068

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