About the research
When a patient moves between care settings (e.g. from hospital to home) medicine problems are common and planned changes are not always followed through. Patients particularly at risk are those with long-term illnesses taking several medicines – especially when medicines have been started or changed in hospital.
Patients with heart failure are the focus of our study as they are a public health and NHS priority, are frequent service users (including readmission to hospital), and susceptible to poorly managed medicines. Heart failure is responsible for approximately 5% of medical admissions and the hospital readmission rate within 3 months of discharge has been estimated as being as high as 50%.
ISCOMAT aims to help the way patients are supported with their medicines. This may contribute to improving their health through helping them better understand their medicines. It also aims to improve the way medical professionals work together to offer good standards of care to patients when they leave hospital.
The programme will design and test a complex intervention (a Medicines at Transitions Toolkit) – co-designed with patients and clinicians – to make best use of medicines and reduce harm through effective medicines management for heart failure patients from hospital discharge and into primary care.
ISCOMAT is funded by the National Institute for Health Research Programme Grant for Applied Research (NIHR PGfAR). It is a series of interlinked work packages delivered by a multidisciplinary research collaboration between the BTHT (as NHS lead and sponsor), the University of Bradford and University of Leeds. Each work package has designated lead(s) and is supported by researchers and collaborators from each of the organisations. BTHT has overall responsibility for the delivery of the programme and delegates responsibilities to the University of Bradford and the University of Leeds.
Objectives
- To map and evaluate current medicines management pathways for patients with heart failure being discharged from hospital (Work package 1a)
- Using an experience-based co-design process, to develop a complex intervention, referred to as a Medicines at Transitions Toolkit (MaTT) (Work Package 2a and 2b)
- To devise an underlying data linkage and data collection exercise to measure the effect of the proposed intervention (Work package 1b)
- Assess the intervention for usability and acceptability, establish an effective implementation process, and determine the feasibility of data collection for economic evaluation (Work package 3)
- Evaluate the effect and cost effectiveness of the intervention in a multi-centre cluster randomised trial, in conjunction with a rigorous process evaluation (Work package 4)
Work package 1 - Systems Analysis and Data Linkage
ISCOMAT is being delivered in four different work packages, each of which is briefly described below:
Work Package 1 undertook a systems analysis using mixed methods to map and evaluate the cardiology medicines pathway from discharge to primary care in four healthcare areas. This comprised observations and documentary analysis in hospitals, interviews with staff in hospital and in primary care and interviews with patients at discharge and then at two later time points.
We have also undertaken a data linkage exercise in an attempt to join up data from different routine data sets, including nationally collected heart failure outcomes data, hospital data and primary care data. Data will be obtained from each of the data providers and transferred to the CTRU at the University of Leeds for analysis.
Lead
- Professor Peter Gardner
Team
- Dr Beth Fylan
- Dr Hanif Ismail
- Dr Liz Breen
- Robert Turner
- Suzanne Hartley
- Jan Speechley
Work packages 2a and 2b - Intervention Design
In Work Packages 2a and 2b we designed and developed the complex intervention for our cluster randomised clinical trial. Drawing on the findings of Work Package 1, we created a ‘trigger film’ to summarise important aspects of the care pathway for heart failure patients. Showing a trigger film to patients and professionals is an important step in the process of experience based co-design (EBCD).
Normally, EBCD is used to guide service improvement in a single healthcare organisation. In collaboration with NHS partners, we adapted EBCD to (a) design a research intervention and (b) work across multiple organisations and geographical areas. In EBCD, groups of patients and professionals work together to agree priorities for service improvement and design solutions to problems.
Our work in Work Package 2a and adaptations of EBCD are fully described at Experience-based co-design-Adapting the method for a researcher-initiated study in a multi-site setting.
In Work Package 2b, we brought together the solutions designed by different groups to look for common themes and compare suggestions with the existing research evidence. This allowed us to create an intervention for feasibility testing (in Work Package 3) with several elements:
• Staff training for everyone supporting patients with medicines use
• Information for patients about the bundle of medicines they take
• Better communication between healthcare professionals
• Checks on medicines and patient understanding after hospital discharge
When preparing new information, we were informed by existing materials published by the British Heart Foundation and Pumping Marvellous (charities that supports people with heart failure).
The information that we designed for patients focused on medicines that are used in combination and have adjustable doses. We know that these things can make it difficult for patients to understand their medicines. Currently available information focuses only on understanding the disease or the effects of individual medicines.
Our staff training package was developed in collaboration with the Centre for Pharmacy Post-Graduate Education (CPPE). The information for staff and changes in discharge processes focused on improving communication between professionals in different sectors of care. For example, by letting community pharmacists know that a patient had been discharged and how their medicines had been changed.
Lead
- Dr Jon Silcock
Team
- Dr Beth Fylan
- Dr Hanif Ismail
- Dr Liz Breen
- Robert Turner
- Jan Speechley
Work package 3 - Feasibility study
Work package 3 took place between July and October 2017 and was a mixed-methods feasibility study with 30 patients across three healthcare areas to: establish the optimum implementation process for the intervention, assess usability and acceptability, identify key facilitators and barriers to implementation, and test data collection methods.
The intervention was deemed to be acceptable and feasible to implement and the progression criteria to trial were met.
Leads
- Professor David Alldred
Team
- Dr Jon Silcock
- Dr Beth Fylan
- Dr Hanif Ismail
- Dr Liz Breen
- Dr Sarah Alderson
- Robert Turner
- Jan Speechley
Work package 4a - Trial
Work package 4 is a randomised cluster control trial, economic evaluation and process evaluation in 42 NHS trusts in three regions (n=2100 patients.
The mixed-methods process evaluation will examine the effect of organisational context and setting and optimal ways of implementing the intervention.
You can find out more about the Trials Unit on the University of Leeds ISCOMAT page.
WP4b Process Evaluation
Work package 4b commenced October 2018. It involves a mixed method process evaluation conducted across six purposively selected sites. The key aims of the evaluation are to inform interpretation of the trial findings, inform implementation of the intervention on a wider scale and aid potential future implementation of the intervention.
The original plan of interviews with up to 30 hospital staff and 10 community pharmacists, and surveys with secondary and primary care staff was amended due to Covid-19. Hospital observations at six sites, interviews with 20 patients and 11 hospital staff were conducted. Data will be synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research where appropriate.
The process evaluation will determine the degree to which the intervention is delivered, explore and explain the relationships between intervention implementation and trial outcomes and identify barriers and facilitators to successful implementation and roll out of the intervention (if successful).
Leads
- Professor Chris Gale
- Professor Amanda Farrin
- Professor David Alldred
Team
- Professor Peter Gardner
- Dr Jon Silcock
- Dr Liz Breen
- Dr Beth Fylan
- Dr Hanif Ismail
- Dr Sarah Alderson
- Jan Speechley
- Dr Lauren Moreau
- Dr Catherine Powell
- Prof C Bojke
- Suzanne Hartley
- Dr Bonnie Cundell
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