Case studies

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
Dr Anton Krige: A randomised controlled trial of thoracic  epidural analgesia versus rectus sheath  catheters for open midline incisions in major  abdominal surgery within an Enhanced  Recovery Program (TERSC)

Dr Anton Krige: A randomised controlled trial of thoracic epidural analgesia versus rectus sheath catheters for open midline incisions in major abdominal surgery within an Enhanced Recovery Program (TERSC)

Dr Anton Krige, a Consultant in Intensive Care Medicine and Anaesthesia as well as the Clinical lead for the Enhanced Recovery Programs at East Lancashire Hospitals NHS Trust, has a particular interest in providing good pain relief to patients after major surgery so that patients can recover quickly and avoid post-operative complications.

Dr Krige approached the RDS NW for advice on how to develop his research idea of comparing the most common approach of pain relief – epidural, and another approach – Rectus Sheath Catheters (RSCs). Epidurals, which use a fine tube being placed in the spine through which local anaesthetic is given, numbing the nerve supply to the abdomen and controlling the pain, can be very effective but they do have a number of possible side effects including common side effects such as headaches and low blood pressure as well as very rare side effects such as nerve injury.

The Rectus Sheath Catheters can be used when surgery involves a midline (vertical) incision of the abdomen. In this technique, local anaesthetic is infused directly into the abdominal wall, blocking the nerves around the wound site. An old technique, RSCs are now in use again as ultrasound allows doctors to site the catheters accurately between the muscle layers of the abdomen.

Many of the side effects associated with epidurals do not apply to rectus sheath catheters and this may confer an advantage. However, no formal research had been conducted and so it is not known for sure which technique results in the best pain relief with the least side effects. This is the question that the TERSC research study aims to answer.

Dr Krige approached the RDS NW for general advice on how to apply for the RfPB programme and was allocated an adviser who initially explored the options for the appropriate research study design to develop to answer Dr Krige’s research questions. The adviser brought on board other methodological advisers as required in clinical trial design, qualitative methods and health economics.

Dr Krige and his team attended a dedicated advice support programme organised by the RDS NW for applicants to the RfPB programme.

The RDS NW also provided advice on how to develop the proposal further with PPI and these activities were supported by the RDS NW PPI bursary to facilitate the bringing together of past patients who had undergone such surgery in the past to advise on the most appropriate design and study materials ahead of a submission for RfPB funding.

Some of these patients have since agreed to stay with the project by being involved in managing and delivering the study now that patients are being recruited into the TERSC study.

This is the first research grant that Dr Krige has been awarded in his role as a hospital consultant.

The RDS NW were able to recommend other research methodologists who may be interested in supporting the application for funding and becoming co-applicants.

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Funding programme:
Research for Patient Benefit
Funding amount:
Over £249,000
Prof Martin Tickle: A randomised controlled trial comparing  the quality of life (QoL) and masticatory  efficiency of patients with implant-retained  (IRMO) compared with mini-implant-retained  mandibular overdentures (MIRMO).

Prof Martin Tickle: A randomised controlled trial comparing the quality of life (QoL) and masticatory efficiency of patients with implant-retained (IRMO) compared with mini-implant-retained mandibular overdentures (MIRMO).

It is estimated that there are over three million people in the UK who have no teeth at all. There is national and international evidence that these patients should be provided with dental implants in the lower jaw to help to retain their lower denture. However, this treatment is costly and considered invasive by potential patients.

A team at the University of Manchester Dental Hospital, led by Professor Martin Tickle and Dr Craig Barclay, have secured a NIHR Research for Patient Benefit (RfPB) award of £250,000 to fund a pilot randomised controlled trial comparing standard dental implants to smaller diameter ‘mini’ implants, which are cheaper and simpler to place.

This project was propelled into action when a member of the research team attended an RDS NW RfPB development series in the autumn of 2011.

The project was also awarded a PPI bursary from RDS NW to help with the inclusion of PPI in the proposal development.

Mark Harrison and Tanya Walsh from the RDS NW Greater Manchester team provided advice in areas including: evaluation design, health economics, statistics, trial design and they also critically read the proposal.

Warm thanks to all those who helped facilitate

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Funding programme:
Research for Patient Benefit
Funding amount:
£250,000