Tag Archives: randomised controlled trial

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Qualitative study of perceptions of older people with COPD and chronic heart disease on home telemonitoring in long term conditions published

chromedThe latest study from researchers at CaHRU was published this month (July 2017) in BMC Medical Infromatics and Decision Making. Entitled ‘Perceptions on use of home telemonitoring in patients with long term conditions – concordance with the Health Information Technology Acceptance Model: a qualitative collective case study‘, and co-authored by Dr Jo Middlemass (visiting fellow), Jolien Vos (doctoral student) and Prof Niro Siriwardena (director), the study formed part of the process evaluation of a large multicentre, multinational trial funded through the European Framework 7 programme, Clinical tRials fOr elderly patients with MultiplE Disease (CHROMED: clinicalTrials.gov Identifier: NCT01960907).

Figure 2This was a qualitative interview study of patients aged between 60 years and over together with their partners or relatives where applicable on implementation of a telemonitoring system in their homes for chronic obstructive pulmonary disease (COPD) combined with heart disease. Patients and their relatives were largely positive about telemonitoring but they expressed concerns regarding health professional access and attachment; heightened illness anxiety and desire to avoid continuation of the ‘sick-role’; the need for good organisational processes and informal support. Ease of use was connected to equipment design being suitable for older people. Participants felt it was important to establish trends in health status, to enable detection of early signs of infection and increase the potential for patients to self-manage.

CaHRU_logotypeThe main trial results have been previously presented at the European Respiratory Society conference and these are currently being prepared for publication. The overall conclusion of this sub-study was that to increase home telemonitoring acceptance among older people, consideration of equipment design and organisational factors was important.

By Niro Siriwardena

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CaHRU team attends CHROMED European trial meeting in Uppsala, Sweden

Dr Jo Middlemass, trial nurse, and Prof Niro Siriwardena who are members of the Clinical Trials for Elderly Patients with Multiple Diseases (CHROMED) (Funding by the European Commission’s 7th Framework Programme) attended the final investigator team meeting in Uppsala earlier this month (March 2016).

IMG_4175The study includes a consortium of seven European countries led by TESAN (Italy), Restech and including Del Politcnico Di Milano (Italy), University of Liverpool (UK), Tallina Tehnikaulikool (Estonia), Universitat De Barcelona (Spain), Uppsala Universitet (Sweden), Universitetssykehuset Nord-Norge (Norway), Bolnisnica Sezana Zavod (Slovenia), University of Lincoln, Lincolnshire Community Health Services NHS Trust.

The CHROMED study has been investigating the effectiveness and cost-effectiveness of a telemonitoring system for people with multiple chronic disease, specifically Chronic Obstructive Pulmonary Disease (COPD) and heart disease. The trial in Lincoln involved a feasibility study of five patients and a randomisation cohort of 32 patients aged 65 years and above in Lincolnshire. The monitoring equipment included a novel device for measuring lung function (using a technique called forced oscillation) and a wrist clinic measuring pulse, blood pressure, oxygen saturation, and temperature.

chromedThe study has already shown evidence that monitoring can detect patients’ worsening condition, even before symptoms are apparent. The study data have now been collected and are being analysed to see whether the monitoring system has improved patients’ outcomes, quality of life and healthcare costs.

 

 

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Study on service user involvement in a prehospital clinical trial of falls published in Trials

EMAS - PTS 2_750One of the few studies of service user involvement in a clinical trials was published this month in the journal Trials: ‘Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model‘. The study was part of the SAFER2 (Support and Assessment for Fall Emergency Referrals) trial led by the University of Swansea with Ambulance Services in the East Midlands, London and Wales and involving CaHRU at the University of Lincoln. The study was led by Bridie Evans and the trial lead was Prof Helen Snooks, both from Swansea University.

EMAS - A&E 5The study describes how it was planned for service users to be involved in the trial and how involvement actually occurred. The study team planned for service users to be involved at strategic level, at each study site and locally and this did take place. For example at strategic level, service users were involved in the trial management, EMAS - PTS 7trial steering, and data monitoring and ethics committees In addition, service users were also involved in study writing days and task and finish groups. Service users were also involved at study sites. Finally, service user reference groups were consulted at various points during the study.

Overall, the study showed how service users could be integrated into the activities of a clinical trial, the processes involved and facilitators and barriers to involvement at various levels.

 

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Paramedics’ views on their role in an ambulance based trial of ultra-acute stroke

N0013781 Cerebral infarctNovel treatments for stroke are increasingly being tested and delivered in the ultra-acute period during initial presentation to ambulance services. In the first feasibility trial of nitroglycerin (glyceryl trinitrate) in ultra-acute stroke (RIGHT) there were early indications of improvements in outcomes and disability at three months. The research team was led by Prof Philip Bath and his team at Nottingham University, together with Sandeep Ankolekar, Prof Niro Siriwardena from CaHRU and researchers at East Midlands Ambulance Service NHS Trust.

N0029297 Young man using a nicotine patchA nested qualitative study entitled ‘Views of paramedics on their role in an out-of-hospital ambulance-based trial in ultra-acute stroke: qualitative data from the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT)‘ explored facilitators and barriers to paramedic involvement in clinical trials. The fieldwork was conducted by Dr Sandeep Ankolekar and the team. Barriers to participation included the pressure of the emergency setting, difficulties  obtaining informed consent, institutional support for research, the steep learning curve for research naive staff and relative rarity for individual paramedics of clinical conditions seen, and difficulty in attending training sessions.

N0030773 Paramedic driving an ambulanceSuggestions for improvement included a simple diagnostic tool for stroke, use of assent and proxy consent on behalf of patients (as in the trial), and simpler trial processes.Recruitment became easier with each new randomisation attempt. Paramedics in the study were motivated to participate in research. Treatment of acute stroke in the out-of-hospital environment was feasible, but important barriers needed to be addressed.

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SAFER 2 (Support and Assessment for Fall Emergency Referrals) trial protocol published

The SAFER 2 study is a randomised controlled trial of the clinical and cost effectiveness of new protocols for emergency ambulance personnel to assess and refer older people who fall to appropriate community based care.  The protocol for the study, led by Prof Helen Snooks at Swansea University and including Prof. Niro Siriwardena of the CaHRU and East Midlands Ambulance Service NHS Trust as a collaborator, has recently been published in BMJ Open:

Snooks H, Anthony R, Chatters R, Cheung WY, Dale J, Donohoe R, Gaze S, Halter M, Koniotou M, Logan L, Lyons R, Mason S,  Nicholl J, Phillips C, Phillips J, Russell I, Siriwardena AN, Wani M, Watkins A, Whitfield R, Wilson L. Support and assessment for fall emergency referrals (SAFER 2) research protocol: cluster randomised trial of the clinical and cost effectiveness of new protocols for emergency ambulance paramedics to assess and refer to appropriate community-based care. BMJ Open 2012;2: e002169. doi:10.1136/bmjopen-2012-002169

The study measured the costs and benefits of a novel protocol implemented by emergency ambulance paramedics caring for older people who had fallen, allowing the paramedic to assess and refer appropriate patients to a community based falls service. The study involved ambulance services in London,Wales,East Midlands. Stations were randomly allocated to implement the new protocol (intervention) or continue to provide care according to their standard practice (control).

Paramedics based at the stations selected for the intervention group received additional training, protocols and clinical support to enable them to assess older people and decide whether they need to be taken to the Emergency Department (ED) immediately, or whether they could benefit from being left at home, with a referral to a community falls service. The study compared costs, processes and outcomes of care (particularly subsequent 999 calls and ED attendances for falls) at 1 and 6 months for patients aged 65 or over who had fallen together with other quantitative and qualitative data.

The study was recently been completed and, currently in the final data collection phase, is due to be published next year.