
I specialize in the design, conduct and evaluation of clinical trials, as well as providing experience in epidemiology, clinical risk modeling and quantitative health research methodology.
With a career that encompasses both the NHS and academia, I have played a major role in a large number of national and international evaluations across a variety of clinical areas that have changed the way healthcare is delivered.
My particular interest is in the area of mental health and psychosocial interventions to elicit behavior change with a focus on alcohol and substance use. My current studies involve a number of large scale randomized controlled trials of interventions for alcohol use across a variety of populations such as adolescents, adults, older people and settings, primary care, emergency departments, community services, schools and criminal justice. My research is funded from a variety of sources including the National Institute of Health Research, Medical Research Council and European Union.
In addition I have developed and evaluated interventions in other clinical areas including self-management of heart failure, pharmacological management in dementia, management of back pain in primary care and the development of risk stratification models for the early diagnosis and management of inpatients.
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Can singing groups for older people improve their physical and mental health compared with usual group activities? What effect does singing have on anxiety levels and depression? And could such activities prove more cost effective in terms of health care than usual group activities? A new project, evaluating the ‘silver song clubs’ is being undertaken by CHSS in collaboration with Eastern and Coastal Kent Primary Care Trust and Canterbury Christ Church University under the NIHR Research for Patient Benefit scheme, with the aim of answering these questions. Start date: 07/12/2010 Funder: East Kent Coastal Primary Care Trust Funding: £60,677 Publication: An evaluation of community singing for people with Chronic Obstructive Pulmonary Disease (COPD) (pdf) The effectiveness and cost-effectiveness of a participative community singing programme as a health promotion initiative for older people: protocol for a randomised controlled trial Effectiveness and cost-effectiveness of community singing on mental health-related quality of life of older people: randomised controlled trial -
A pragmatic randomised control trial to evaluate the effectiveness and cost effectiveness of Collaborative cARE for people with DEMentia in primary care (CARE-DEM Trial)
Health Secretary Jeremy Hunt recently placed dementia care at the forefront of Government plans for the NHS, calling for improved care and announcing £50m in targeted funding. There are 670,000 people in the UK diagnosed with dementia and numbers are predicted to rise by 150% over the next four decades. As part of a policy-driven health research portfolio, CHSS has been involved in several dementia studies, and Professor of Health Services Research Simon Coulton is currently leading a Kent team on statistical design for a randomised controlled trial of a new model of collaborative dementia care. The CARE-DEM trial is under way at several primary care sites between London and Kent in the South East, and Newcastle in the North East; testing how effective and cost effective it is compared with usual care. The project involves people with dementia of all ages who live independently in the community and have regular contact with an informal carer. Start date: 01/03/2011 End date: 28/02/2013 Funder: NIHR via UCL Funding: £9688 -
AESOPS: The effectiveness and cost-effectiveness of opportunistic screening stepped care interventions for older hazardous alcohol users in primary care
Do stepped care interventions for older hazardous alcohol users reduce alcohol consumption, compared with a minimal intervention at 12 months post randomisation? A wealth of evidence documents the detrimental impact of excessive alcohol consumption. In older populations it is associated with increased risk of coronary heart disease, hypertension, stroke, a range of cancers, as well as falls, early onset of dementia and other cognitive deficits. Physiological changes occurring as part of the ageing process mean older people experience alcohol related problems at lower consumption levels. There is a strong evidence base for the effectiveness of brief psychosocial interventions in reducing alcohol intake in populations identified opportunistically in primary care settings. ‘Stepped’ care interventions involve delivery of more intensive and invasive interventions only to those in the population who fail to respond to less intensive treatment and provide a potentially resource-efficient means of meeting the needs of this population. 500 eligible, consenting participants attending primary care appointments are screened. Those with alcohol use disorders are randomised with equal probability to either a minimal ‘treatment as usual’ intervention or a more invasive stepped care programme – successive steps of increasing intensity incorporating: Step 1 – behavioural practice nurse delivered counselling Step 2 – three sessions of intensive motivational enhancement with a trained therapist Progression to successive steps depends on outcomes of the previous step. Both approaches have seen reduced alcohol consumption in other studies, but where neither is beneficial, participants move to Step 3 – referral to specialist alcohol services Outcomes are measured and compared at baseline and various stages of the trial to evaluate effectiveness of the stepped care programme. The primary outcome is measured using average standard drinks per day and secondary outcome measures include health related quality of life and health utility. The study incorporates a comprehensive economic analysis, including use of social and health care resources, to assess relative cost-effectiveness of the interventions. Start date: 01/01/2008 End date: 30/09/2012 Funder: Health Technology Assessment Programmes via the Univeristy of York Funding: £15,1944 Publication: The effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care (AESOPS) – A randomised control trial protocol -
Development and outcome focussed evaluation of a multi-component programme
Start date: 17/04/2009 Funder: Kent County Council Funding: £3360 -
Does repeated vestibular stimulation induce lasting recovery from hemi-spatial neglect?
This collaborative project between CHSS, Kent University’s School of Psychology, School of Biosciences and clinicians from East Kent’s hospitals pilots a new treatment for stroke sufferers diagnosed with hemi-spatial neglect. This is a disabling, visual-spatial neuropsychological impairment frequently associated with a lesion to the right hemisphere which causes sufferers to act as if one half of their visual world is missing - bumping into objects, leaving food on one side of a plate and failure to notice people at the affected side. Effects can be over-shadowed by more observable impairments of movement or communication, yet the disorder is far more strongly predictive of general functional recovery from stroke. So far it has proved very difficult to remediate, and many showing hemi-spatial neglect at hospital admission still struggle with daily routine years later. This new treatment seeks to restore lost function to damaged visual brain areas via trans-cranial electrical stimulation, a procedure which injects sub-sensory levels of electrical current though electrodes placed on the scalp just behind the ears to stimulate nerve pathways from the inner ear to the damaged parts of the brain. Current treatment requires specialist staff and space but this new stimulation method can be administered by a nurse at bedside. This is the first MRC-funded stroke study to directly involve East Kent Hospitals University NHS Foundation Trust personnel. Start date: 01/04/2011 End date: 31/03/2013 Funder: Medical Research Council Funding: £49,835 Publications: Does Repeated Vestibular Stimulation Induce Lasting Recovery From Hemi-Spatial Neglect? (web page) Galvanic vestibular stimulation in hemi-spatial neglect -
Improving concordance in older people with type-2 diabetes
The evaluation utilizes a within-subjects design to evaluate: glycaemic control (HbA1c), cholesterol, depression, self-efficacy, health-related quality of life and illness perceptions before and after therapy. The aim is to test a psychosocial intervention (‘concordance therapy’) for people aged 65 or over with a diagnosis of type 2 diabetes. ‘Concordance therapy’ draws on both cognitive-behavioural therapy and motivational interviewing (see Higgins et al., 2005). The therapy focuses on a specific area of behavioural change (ie. concordance behaviour) and takes the patient through a structured program, first identifying the patient’s perceptions of their condition and attitudes towards self-management, then highlighting and addressing maladaptive cognitions in order to align patient conceptualisations with medical models of disease management. Improving patient self-efficacy is an important goal alongside improving adherence. Concordance therapy was originally developed for treatment of older people with depression and has been demonstrated to improve health outcomes (Higgins et al., 2005). We anticipate that this brief, inexpensive intervention could improve concordance with diet and lifestyle changes in diabetes patients, thus further reducing the risk of diabetic complications such as blindness, renal failure, loss of limbs, heart disease and stroke (DOH, 2001; ONS, 2003) and reducing costs to the NHS. If intervention effects are supported, a manual will be produced so that concordance therapy can be implemented across a range of NHS settings. Start date: 07/01/2008 End date: 06/12/2009 Funder: NIHR Research for Patient Benefit Funding: £23,146 Publication: A concordance therapy to help older people self-manage type 2 diabetes -
Preliminary data analysis and literature review for research proposal development into hospital readmission in EKHUFT
Start date: 11/11/2009 Funder: East Kent Hospitals University NHS Foundation Trust Funding: £5791 -
Screening and Brief Intervention Pilots
A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However, although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlled trial with Offender Managers (OMs) as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients. Start date: 01/01/2008 End date: 31/08/2010 Funder: King's College London Funding: £104,087 Publications: Screening and brief intervention for hazardous and harmful alcohol use in probation services: a cluster randomised control trial protocol Screening and brief interventions for hazardous alcohol use in accident and emergency departments: a randomised controlled trial protocol Screening and brief interventions for hazardous and harmful alcohol use in primary care: a cluster randomised controlled trial protocol The Effectiveness of Alcohol Screening and Brief Intervention in Emergency Departments: A Multicentre Pragmatic Cluster Randomized Controlled Trial.
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A feasibility trial of screening and brief alcohol intervention to prevent hazradous drinking in young people ages 14-15 in a high school setting (SIPS JR-HIGH)
The SIPS Junior High project, funded by the NIHR Public Health Research Programme, aims to test the feasibility of conducting a research project in a high school setting with year 10 pupils (14-15 years old) and their parents, which aims to prevent and reduce hazardous drinking in youth. After completing a questionnaire about their drinking, pupils with positive scores are invited to join the study, a cluster randomisation of seven schools in North East England, involving them in different intensities of intervention. Start date: 01/10/2011 End date: 31/07/2013 Funder: NIHR (via University of Newcastle Upon Tyne) Funding £5,755 Publications: Brief intervention to prevent hazardous drinking in young people aged 14–15 in a high school setting (SIPS JR-HIGH): study protocol for a randomized controlled trial (web page) A pilot feasiblity c-rct of screening and brief alcohol intervention in young people aged 14-15 in a high school setting: SIPS jr-high -
A randomised, double-blind placebo-controlled trial of Memantine in the treatment of the agitation in Alzeimer's dementia
Agitation in Alzheimer’s disease (AD) is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary hypothesis, memantine is superior to placebo for clinically significant agitation, in patients with moderate-to-severe AD. Start date: 01/05/2006 End date: 31/07/2010 Funder: Lundbeck Ltd Funding: £29,6707 Publication: Efficacy of Memantine for Agitation in Alzheimer’s Dementia: A Randomised Double-Blind Placebo Controlled Trial -
Alcohol Dependence and Adherence to Medicine (ADAM)
A three-arm, Randomised Controlled Trial of the effectiveness and cost-effectiveness of adjunctive medication management and contingency management to enhance adherence to medications for relapse prevention in alcohol dependence. Alcohol dependence relapse is common following conventional psychosocial interventions. Routine NHS prescription of acamprosate to maintain abstinence from alcohol is now recommended by NICE and its effectiveness in conjunction with psychosocial therapies for relapse prevention is well documented. Limited evidence exists to guide clinical practice on effective interventions and NICE have prioritised clinical trials of strategies to increase relapse prevention medication adherence. Supporting and educating patients about the role of acamprosate in relapse prevention through medication management (MM) may improve adherence and increase clinical effectiveness. Pharmacists are ideally placed to deliver MM in this context, though the effectiveness of local pharmacy delivery is currently not known. Following a simple behavioural reinforcement schedule, contingency management (CM) can be delivered at relatively low cost compared to other psycho/behavioural interventions and with greater clinical effectiveness in substance misuse. If shown to be effective CM has potential to be adopted within NHS services and the pharmacy to enhance alcohol dependence treatment. Aim of the trial: To evaluate the acceptability, effectiveness and cost-effectiveness of adjunctive MM with/without CM in improving acamprosate adherence in alcohol dependence. Objectives: To conduct an internal pilot study to assess the feasibility, recruitment and acceptability of the MM and CM interventions for pharmacists and service users. To conduct a definitive three-arm, randomised controlled trial of the effectiveness of MM with and without CM compared to standard support alone (SS) in enhancing adherence to acamprosate To estimate the cost effectiveness of MM with and without CM compared to SS alone in enhancing adherence To assess the impact of adherence to acamprosate for alcohol dependence relapse prevention on abstinence and reduced alcohol consumption. Start date: 01/12/2014 End date: 30/11/2018 Funder: NIHR Health Technology Assessment via Kings Funding: £24,112 -
Development of a risk assessment model for the prediction of new or worsening acute kidney injury (AKI)
Aim: The aim of this project is to develop and externally validate a contracting model blueprint for long-term conditions that is: • Focused on integrated care; • Collaborative and based on achievable joint outcomes; • System focused and; • Based on evidence of effectiveness. The overall aim of the contracting model will be to ensure high quality integrated care for patients with long-term conditions to support self-management, and end of life care. A key objective will be to promote innovative care pathway transformation through embedding and accelerating the use of assisted technologies in the NHS in line with the 3 million lives initiative. Approach: A mixed method approach for the development of the contracting model will be used: • The developing model will be underpinned by theoretical approaches and international research drawn from a wide literature review, and will build on the LTC model of care; • An important feature will be to capitalise on learning from agencies and industries external to the NHS and transpose key messages into the developing model. This will enable innovative ‘blueprints’ for effective LTC contracting approaches to emerge; • There will be strong stakeholder involvement of representatives from for example CCGs, acute and community providers, users, and the Advanced Assistive Technology (AAT) industry. • The model will be validated through consultation with a small panel of national and international external experts and CCG representatives from across the country. The project has been funded by Kent and Medway Commissioning Support and through the successful application of an Innovation Voucher. Start date: 01/12/2012 End date: 31/07/2014 Funder: NIHR via EKHUFT Funding: £34,790 Publications: Development of risk models for the prediction of new or worsening acute kidney injury on or during hospital admission: a cohort and nested study. -
Evaluation of Pilgrims Hospices Rapid Response Community End of Life Service in East Kent
The evaluation, funded by the NIHR, will be conducted over 29 months in collaboration with Pilgrims Hospice, CHSS, EKHUFT and the University of Sussex. It will compare outcomes for patients in areas where the new Rapid Response Community End of Life Service has been introduced with those where the service is not yet in operation. This is the first type of trial of its kind in the field of palliative care services provided at home.The primary aim of this project is to evaluate whether the new service enables more patients to die in their preferred place of death, especially for those wishing to die at home. Though death in the preferred place is a key aim in the DH’s End of Life Care Strategy, identifying reliable and useful methods for recording patient preferences is not easy. Improving the recording practices of patient preferences was the subject of a project undertaken in CHSS in preparation for this evaluation. The questionnaire that was developed is currently being used by hospice staff to good effect. The evaluation will also determine the cost of providing the new rapid response service versus the cost of usual services. The needs of carers are also being considered and the impact of the service on them will be evaluated using postal questionnaires and through interviews with bereaved carers. This design is both rigorous in allowing for comparison groups and pragmatic as it gives Pilgrims Hospice time to recruit and train new staff and implement the new service in each area. Start date: 01/12/2009 End date: 30/04/2012 Funder: Department of Health Funding: £178,202 Publications: Evaluation of a hospice rapid response community service: a controlled evaluation Results of a controlled evaluation of a hospice rapid response community service for end of life care Evaluation Of Pilgrims Hospices Rapid Response Hospice At Home Service: Summary of findings March 2015 A quasi-experimental controlled evaluation of the impact of a hospice rapid response community service for end-of-life care on achievement of preferred place of death -
Pilot study of assertive community treatment in alcohol dependence
This pilot study aims to develop and refine ACT for use in alcohol dependence, including optimal delivery and target population; to conduct a preliminary randomised controlled trial (RCT) to establish the effect size of ACT versus standard treatment and establish potential recruitment across 6 sites, to advise a definitive RCT. Alcohol dependence causes significant harm to individuals, their families and communities, contributing to morbidity, mortality and health and wider societal costs. Assertive Community Treatment (ACT) is effective in reducing the impact of severe mental illness on symptomatology, hospital bed use and quality of life, and treatment engagement but evidence for ACT for severe alcohol dependence is lacking. The RCT recruits a sample of 90 male and female alcohol dependent adults with one or more previous episodes of treatment within the past five years in community drug and alcohol services. Start date: 12/12/2009 End date: 11/01/2012 Funder: Medical Research Council (via King's College London) Funding: £8344 Publication: Assertive community treatment in alcohol dependence -
RISKIT-CJS evaluation of a multi-component intervention to reduce substance use and risk-behaviour in adolescents engaged with the criminal justice system
Adolescence is a critical developmental stage when young people make behavioural and lifestyle choices that have the potential to impact on their health and wellbeing into adulthood. While risk-taking is important for healthy psychological development, for many, inappropriate risk-taking is significantly associated with health and social harm during adolescence and these harms persist well into adulthood. Young people involved in the criminal justice system are a particularly vulnerable group with a greater propensity to take risks that are likely to have long term impact on their future health and wellbeing. The RISKIT-CJS programme is a multi-component intervention encompassing both individual and group work and includes elements of motivational enhancement, psycho-education, psychosocial approaches, cognitive behavioural therapy and mindfulness. The study is a major multi-centre evaluation of RISKIT-CJS. The methodological approach is a mixed method, prospective, pragmatic randomized controlled trial with individual allocation, combining both quantitative and qualitative evidence. The study will be conducted across three geographical areas; South East England, South London, North East England, covering a diverse socio-economic and ethnic population. Start date: 01/09/2016 End date: 31/08/2019 Funder: NIHR Public Health Research Funding £892,675