Case studies

A psychological intervention for suicide applied to patents with psychosis: the CARMS trial (Cognitive AppRoaches to coMbatting Suicidality)

A psychological intervention for suicide applied to patents with psychosis: the CARMS trial (Cognitive AppRoaches to coMbatting Suicidality)

The CARMS project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership, 13/161/25.

*The EME Programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland.

The Research Design Service (RDS) provides free research design and methodological advice to people intending to apply for national peer reviewed funding competitions in applied health and social care research. Many of these funding programmes have a two stage application process, whereby the applicant completes an outline of their application for stage one. This is then reviewed by the funding panel and if accepted the applicant is invited to apply to stage two, the full proposal stage. The RDS is able to provide advice on either stage one applications or stage two or both if required. One funding programme that has a two stage application process is the EME Programme.

The NIHR Research Design Service North West (RDS NW) was approached by Dr Patricia Gooding, University of Manchester, regarding the CARMS project. Dr Gooding had already submitted and been successful at stage one of EME and had been invited to submit a stage two application. She had not thought of involving RDS before, at stage one, and was initially a little sceptical about what the RDS could offer, but she was encouraged to contact RDS NW by a senior RDS NW adviser, who was a colleague at the same organisation.

The RDS NW arranged an initial face-to-face meeting with the client. The meeting was arranged by the Dr Gooding’s RDS NW case manager, an RDS NW adviser who ensures that the clients receive all the possible advice that is required to improve the chances of success. Advice may be provided directly by the case manager or they may arrange for a number of other RDS NW advisers to provide advice based on the specific areas of expertise required. In the case of this application, the case manager provided the advice that was required with an additional critical read from another RDS NW adviser.

At the initial face-to-face meeting, the case manager and the Dr Gooding looked closely at the stage one reviews, which are carried out by the funding programmes peer reviewers. They looked at the funding panel’s feed-back. This enabled discussion to address specific points raised in the reviews and panel’s feedback which needed to be considered for the stage two application. Some specific points that came about as a result of this discussion include:

• For an EME application the applicant needs to make it clear that the primary outcome, in this case suicide ideation, is an efficacy rather than an effectiveness outcome.

• EME is very interested in exploration of mechanism so it is better to model the influence of the mechanisms on the outcome, It was suggested to the client that they think about whether it is possible to power the study for mechanism evaluation, as well as for the effect on the primary outcome.

• A clear description of what the intervention is, and its rationale was needed.

• The client needed to state clearly what the population size is, and how that translates in to the study recruitment.

• EME likes to see a partnership of at least two of NHS, university and industry organisations, so it would be good to strengthen this for this application.

As part of the RDS NW advice process continuous review is offered of draft proposals.

In this instance the case manager reviewed and commented on the proposal but prior to submission of the application, the RDS NW case manager arranged for another RDS NW adviser to provide a critical read. This was carried out by an RDS NW adviser with qualitative methods expertise, to provide an alternative viewpoint of the application, particularly its qualitative aspects.

This critical read of the application, shortly before submission, showed that following RDS NW advice the proposal was very readable and much clearer than the stage one application. Overall the proposal conveyed the rationale for the study very strongly and it was thought that the model and treatment was really interesting but it was also thought that the proposal needed to be more explicit about the relevance to EME. There was a need to emphasise, in this case, where better understanding of the mechanisms responsible is necessary and valuable for treatment effectiveness. There was also a need to make clearer how the qualitative work contributes.

Comments were passed to Dr Gooding and the proposal was submitted for the stage two deadline enabling Dr Gooding to receive a conditional offer of funding. The conditional offer asked questions relating to the collection of health economics data on the project. These questions needed to be addressed before funding would formally be offered.

Dr Gooding again approached the RDS NW asking for advice on how to address this issue. The case manager reviewed the conditional offer letter from EME with the Dr Gooding, enabling them to interpret what was required and address the issues raised by the EME funding panel. As a result the client successfully received funding for the project.

Here are a few words from Dr Gooding on her experience of working with the RDS NW:

“So many thanks for all your help with it. It really improved hugely as a result of your input”

“As we had two experienced advisers, the service was absolutely brilliant.”

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Funding programme:
Efficacy and Mechanism Evaluation (EME) Programme
Professor Andrew Weeks: The post partum haemorrhage (PPH) Butterfly – clinical testing and commercial development

Professor Andrew Weeks: The post partum haemorrhage (PPH) Butterfly – clinical testing and commercial development

Post Partum Haemorrhage (PPH), loss of blood after childbirth, is a common maternity emergency affecting 40,000 women across the UK each year. The incidence and severity of PPH is increasing and novel treatments are urgently needed.

The most common cause is failure of the womb to contract, and drugs are first administered to stimulate the womb to contract. If these fail, then the woman is taken into an operating theatre to find the source of the bleeding, and physical methods used to stop the bleeding under anaesthetic. A device that could simply ‘turn off the tap’, without the need for surgical intervention, would be a major advance in PPH management.

The PPH Butterfly is a completely new device. It is placed into the birth canal when bleeding starts and allows the doctor or midwife to stop the bleeding by squeezing the womb against it. It also detects whether the bleeding is coming from the womb or vaginal tears.

The National Institute for Health Research (NIHR) Inventions for Innovation (i4i) programme has funded the design and initial human testing of the device.

The study is being led by Andrew Weeks, Professor of International Maternal Health Care at the University of Liverpool, and Director of the Sanyu Research Unit.

The design will first be optimised for commercial production with assistance from our commercial partner. Simultaneously, a training package will be developed for staff at the recruiting hospital, and its effectiveness assessed in an observational study of 118 women with PPH at Liverpool Women’s Hospital. Interviews will be conducted with staff and recruited women to assess the device’s acceptability and usability. A health economics analysis will look at the costs of a PPH when managed traditionally, and when treated by the PPH Butterfly. Cost and clinical outcome data from recruited women will be compared with that of a historical cohort.

Following successful completion of the study, the device will be submitted for CE marking and a commercial review undertaken to assess the market potential of the device.

During the development of the stage 2 funding application, Professor Weeks and his team sought advice from the NIHR Research Design Service North West (RDS NW). On approaching the RDS NW the proposal was well worked up and as such the RDS NW provided a critical read of the proposal. Following the critical read, advice was provided on the statistical aspects of the proposal. The RDS NW also helped respond to reviewer’s comments following the project being offered conditional funding.

The RDS NW provides an advice service that covers all aspects of developing a research funding application in applied health and social care. From advice on formulating a research question, structuring and designing the proposal, research methods, public involvement to a critical reads of the proposal. For full details of the advice offered by the RDS NW visit the RDS NW website here.

This study was funded by the NIHR Invention for Innovation (i4i) programme.

The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

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Funding programme:
NIHR Invention for Innovation (i4i) programme
Prof Fiona Lobban: IMPlementation of A Relatives’ Toolkit: Examining the critical success factors, barriers and facilitators to implementation of an online supported self-management intervention in the NHS (IMPART study)

Prof Fiona Lobban: IMPlementation of A Relatives’ Toolkit: Examining the critical success factors, barriers and facilitators to implementation of an online supported self-management intervention in the NHS (IMPART study)

The IMPART study, funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research (HS&DR) Programme (project number 14/04/16), successfully received funding following expert advice from the NIHR Research Design Service North West (RDS NW).

The study uses an iterative case series design in six NHS Trusts and examines the implementation process of an online support self-management intervention for relatives of people with psychosis / bipolar disorder in Early Intervention Services. This is an important study that aims to help reduce the evidence-practice gap and will have broad implications for digital development across healthcare settings.

See www.nets.nihr.ac.uk/projects/hsdr/140416 for more information on the study.

Led by Professor Fiona Lobban, Spectrum Centre for Mental Health Research, Lancaster University, the study was developed and is delivered in collaboration with a range of clinical academics, clinical health professionals, methodological experts and service users across UK Universities and NHS Trusts.

During the development of the funding application an RDS NW case manager led an advising team of three RDS NW advisers, including the case manager, in providing advice on the development of the funding application.

When the RDS NW was first approached, it was not clear which funding programme this project would be best suited to. The RDS NW enabled the identification of the appropriate funding programme, HS&DR, but also facilitated communication with other successful HS&DR applicants, enabling the application to fit the requirement of the programme. Through the RDS NW case manager, expert RDS NW methodologists were identified in key areas. These advisers enabled the project team to think through the most appropriate design. Advisers also provided support on the funding submission process including detailed feedback on draft submissions. The RDS NW also provided advice on user involvement in developing the application. Service users and relatives were involved in developing the study and are also involved in the delivery of the study.

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HS&DR Programme, NIHR, NHS or the Department of Health.

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Funding programme:
NIHR Health Services and Delivery Research
Dr Elizabeth Tyler: Developing and evaluating a psychological  therapy for older adults with bipolar disorder

Dr Elizabeth Tyler: Developing and evaluating a psychological therapy for older adults with bipolar disorder

Dr Elizabeth Tyler, a clinical psychologist based at the Spectrum Centre for Mental Health at Lancaster University has recently been awarded a NIHR Doctoral Fellowship.

The research will focus on developing and testing out a recovery focused cognitive behavioural therapy (CBT) intervention for older adults with bipolar disorder (BD).

BD is a severe and chronic mental health problem that persists into older adulthood. Current estimates suggest around 0.5 per cent of people over 65 years of age are living with BD (Depp and Jeste, 2004). However this figure is set to rise as the UK experiences a rapid ageing of its population (United Nations, 2002). The National Institute for Clinical Excellence (NICE) guidelines for BD, 2006, highlight the absence of evidence for older adults with regards to psychosocial interventions and there are currently no published randomised controlled trials (RCT) studies evaluating psychosocial interventions for later life bipolar disorder.

The aim of the research is to adapt a recovery focused CBT intervention (RfCBT: Jones et al, 2013) developed by the Spectrum Centre for working age adults, for an older adult population. A recent RCT has found RfCBT to be effective on both functional and symptomatic outcomes (Jones et al, 2014) and recovery informed interventions of this type are now recommended by the UK government (Department of Health, 2011). Adaptation will be achieved through both literature searches and a series of focus groups with older adults with lived experience of bipolar disorder and an ‘expert’ academic/clinician group. Once adapted, RfCBT for older adults will be tested out using an RCT design.

The RDS NW were able to help Elizabeth in a number of areas including: trial design, mental health advice, structuring and writing the proposal and helping to review the application form.

RDS NW also carried out a mock interview which was found to be incredibly useful. It provided the opportunity to review the project with a number of academics who did not specialise in the area.

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Funding programme:
NIHR Doctoral Research Fellowship
Dr Angharad Care: Three arm Pilot Randomised Controlled Trial  to investigate the impact of progesterone  vs. Arabin pessary vs. cerclage in high risk  women with a short cervix to prevent pre-term  birth

Dr Angharad Care: Three arm Pilot Randomised Controlled Trial to investigate the impact of progesterone vs. Arabin pessary vs. cerclage in high risk women with a short cervix to prevent pre-term birth

Dr Angharad Care and team from the Liverpool Womens NHS Foundation Trust were successful in obtaining NIHR Research for Patient Benefit(RfPB) of nearly £195000 following advice from RDS NW.

The study was a three arm controlled trial using three different treatments to control and prevent early pre-term labour in pregnancy.

Dr Care approached the RDS NW requesting advice on formulating her research question, structuring the proposal, qualitative aspects of the proposal and trial design.

The RDS NW provided advice on these areas but also identified other areas in which the proposal could be strengthened.

RDS NW identified that there was also very little patient and public involvement (PPI) in early drafts of the application and to overcome this Dr Care was advised to apply for an RDS NW PPI bursary to help develop a strong partnership with lay people who can help with elements of trial design, recruitment strategies and input to the design of patient information sheets and consent forms. Dr Care was advised to contact the Research User Group at her Trust and arrange to present her work to them and get their feedback.

Dr Care needed to strengthen her team and RDS NW advised her to include clinicians, a
statistician, a health economist, a lay applicant, research midwives and a Clinical Trials Unit (CTU). There was also a need to involve the Trust R&D department and the Clinical Research Network (CRN) to help with staff support costs and general administration of the application.

Dr Care was advised to strengthen the ‘need for the research’ element of the proposal, giving an idea of national incidence and prevalence rates, an outline of NHS and maternal/neonatal costs and how much the work could benefit both NHS and women themselves. A high patient benefit trajectory also needed to be underlined, which is
particularly important for a RfPB application.

Dr Care was asked what she found useful about the service, she responded,

“My RDS NW adviser, Dr Anne Rannard, was helpful from the start. In addition to critiquing the application she helped plan my timeline up to the deadline for the application and gave me realistic expectations of how long it would take me to get e.g. clinical trials unit involvement for my project and additionally helped me develop the PPI aspect of the project.”

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Funding programme:
Research for Patient Benefit
Funding amount:
£195000