Coproducing a Randomised Controlled Trial
Lucy Goldsmith
St George's, University of London
Background: ENRICH is the world’s first coproduced randomised controlled trial. In coproduction, the knowledge of people with lived experience of mental health problems is used throughout to inform key decisions and power is shared. Current literature covers the principles of coproduction and describes coproduction in qualitative research projects in which there’s typically more methodological flexibility than in quantitative research. This presentation explores the challenges and solutions adopted to design and deliver a coproduced randomised controlled trial in mental health.
Methods: Two methods were used. Data from minutes of meetings of the groups that collectively manage the trial were used to identify how, when and why the decisions which shaped the scope and focus of the research were reached and the potential impact of those decisions on the research process and outputs. Second, members of the team contributed reflections about implementing those decisions.
Results: Establishing and communicating clearly, with a clear framework regarding all the relevant factors for a decision, which methodological and practical decisions and processes can be coproduced, when, by whom, and how, has been vital.
Implications: With contributions from experts with different skills (statistical, methodological, clinical and lived experience), RCTs can be conducted in a way which incorporates and values service user perspectives, delivering research with greater social accountability which is also of higher quality and more relevant to service users and their journeys through mental health.
Q Improvement Lab: working collaboratively and creatively to improve care across mental and physical health services
Jo Scott
The Health Foundation
Background: An increasing number of people live with long-term mental and physical health problems, but the UK’s fragmented healthcare system struggles to provide effective joined-up care. Using an approach based on learning from design, social innovation and improvement, the Health Foundation and Mind collaborated through the Q Improvement Lab to better understand this challenge. Between September 2018 and September 2019 they considered how to improve care for people living with both mental health problems and persistent pain.
The Q Improvement Lab is part of the Q Community, delivered by the Health Foundation and supported by NHS England and NHS Improvement.
Method: The Lab works experimentally to support healthcare services to make progress on complex problems. The research and evaluation methods were embedded in its approach.
Over a six-month period, the Lab worked collaboratively with over 100 health professionals and people with lived experience. Activities included an online survey with 140 responses; six participatory workshops; 35 telephone interviews; six in-depth interviews conducted by peer researchers; and desk research of existing evidence.
The insights generated from this research were used to support five frontline teams to develop and test ideas in practice. The Lab’s approach to testing draws heavily on the Design Council’s double diamond approach to design, adapted to be a triple diamond to give greater focus on the work needed for setting up a team. For a six-month testing phase, the Lab provided tailored support and coaching in design methods to enable the teams to collaborate with different service users and health professional teams to diagnose their local problems, think about them in new ways, and creatively design and iterate solutions.
Developmental evaluation, using a learning loop methodology, was embedded to enable the team to iterate the approach.
Results: The Lab’s learning highlights that, while action is needed at a national level to enable widespread changes to improve care across mental and physical healthcare services, there is a lot that is within the gift of an individual service or team that can make a big difference to people.
A learning resource has been produced to draw out highly practical learning for frontline teams when seeking to do this work, in order to build capability and understand of how improvements can be made in practice. Additionally, a set of service principles were created to describe what good quality care looks like.
Implications: The Lab’s approach enabled teams to take a step back to understand the problem fully before moving to solutions. This requires a different mode of working: as the teams acknowledged, there is a tendency in health care services to rush to solutions and action.
The Lab’s learning highlights the importance of supporting people to develop a different mindset to do this type of work, which is different from what is normally expected of people in leadership positions or specialist roles in health and care. The work with testing teams draws attention to the fact that, while some of the improvement ideas in themselves might be simple, the teams are trying to change entrenched behaviours and cultures, and this is what is complex. By focusing our learning on *how* to implement solutions, and working closely to equip people with skills and competence to do this work in practice, the Lab is seeking to increase capacity for improvement in complex environments.
The Lab has developed a skills map to describe these skills and attitudes needed for collaborative and creative problem solving, to be published in Feb 2020, and we will continue to work with frontline teams to learn more about how to support people to implement these in practice.
Co-design and implementation of an intervention to facilitate patient information sharing upon admission to an acute mental health ward
Natasha Tyler(1), Nicola Wright(2), Justin Waring(3), Andrew Grundy(2), Kyri Gregoriou(4)
(1)Greater Manchester Patient Safety Translational Research Centre, (2)University of Nottingham, (3)University of Birmingham, (4)Derbyshire Foundation Healthcare Trust
Background: Many interventions have been developed that aim to improve the transition from ward to community at the time of discharge, with varying success. Yet, guidelines suggest that discharge planning should begin from admission, but in reality this is ideal rather than standard practice. This research aims to develop a novel intervention that improves mental health care transitions by providing a framework for capturing relevant information at admission that facilitates and accelerates discharge.
Methods:
Phase one: Co-design
A novel tool was developed during two workshop based on the principles of co-design, within a single NHS trust. The 23 attendees (various professional cadres) agreed on core information categories that should be captured at admission, the developed tool was critiqued throughout.
Phase two: Implementation
During implementation the tool was piloted on three wards within one campus. Evaluation involved observation of conversations that happen with external agencies upon admission, within 140 hours of ethnographic style research. 45 interviews were conducted with 40 staff across the campus. Thematic analysis was used.
Results:
Phase one: Co-design
The tool developed considerably as the process evolved. The finished product is a list of 10 relevant information categories that should be captured from external agencies upon admission to facilitate discharge planning.
Phase two: Implementation
There were three thematic benefits of the tool reported during the implementation phase: 1) facilitating confidence in junior staff to legitimately question the suitability of a patient for an acute ward 2) collecting and storing essential information in a single accessible place that can be used throughout the care pathway and 3) collecting information from the services/agencies that patients will eventually be discharged to. Barriers to implementation included lack of knowledge about other services, fears of duplication and concerns over the definition of an ‘admission’.
Implications: The results suggest that improving the quality of information captured upon admission has the potential to facilitate and accelerate discharge. The novel tool provides a framework for capturing this information that can be incorporated into existing information systems. Reducing the barriers to implementation, such as increasing knowledge of other health and social care services may help improve implementation.
Co-creation of a patient decision aid for coronary heart disease treatment options
Emma Harris(1), Angel Jimenez-Aranda(2), Philippa Hedley-Takhar(2), Dwayne Conway(3), Jeremy Butts(4), Richard Thomson(5), Luke Watson(1), Felicity Astin(6)
(1)University of Huddersfield, (2)NIHR Devices for Dignity MedTech Co-operative, (3)The Mid Yorkshire Hospitals NHS Trust, (4)Calderdale and Huddersfield NHS Foundation Trust, (5)Newcastle University, (6)University of Huddersfield and Calderdale and Huddersfield NHS Foundation Trust
Background: Shared decision-making is a two-way process in which healthcare professionals support patients to make important healthcare choices. Research shows that patients treated with one of the commonest interventions in cardiology, coronary angioplasty, do not always make informed treatment decisions. They often overestimate the benefits, underestimate risks and are unaware of less hazardous treatment options. Patient decision aids are evidence-based interventions that improve understanding, reduce decisional conflict and promote informed consent. No interactive decision aids for coronary heart disease are available for use in the UK. The aim of this study was to prototype the first digital decision aid for UK patients with stable coronary heart disease (CONNECT: COroNary aNgioplasty dECision Tool).
Method: The stages of the International Patient Decision Aid Standards Framework guided a robust development process. First, a multidisciplinary steering group was convened comprised of cardiologists, cardiology nurses, service users, digital device experts and academics. Preliminary ideas for the purpose, content and format of the decision aid were discussed. Second, three workshops with patients (n=9) and healthcare professionals (n=13) were arranged to explore end-users’ preferences for content, along with their information and decision support needs. Patient participants who had previously experienced coronary angiography or angioplasty were invited from regional heart support groups. Healthcare professionals (cardiologists and cardiology specialist nurses) from two NHS Trusts in Northern England also participated. A draft digital prototype of CONNECT was developed in the third stage, which incorporated workshop feedback. The draft underwent several iterations following steering group discussions. In the final stage, alpha testing was conducted with end-users. Following ethical approval, a purposive sample of patients and healthcare professionals (cardiologists and cardiology specialist nurses) were recruited from two NHS Trusts in Northern England. The comprehensibility, acceptability and usability of CONNECT were assessed through individual face-to-face cognitive interviews and a questionnaire (5-point Likert scale). The Brief Health Literacy Screening Tool (BHLST) was used to measure the health literacy levels of patient participants. Interviews were audio recorded and observations of participants using the decision aid documented. Data from interviews and questionnaires were analysed using content analysis and descriptive statistics, respectively.
Results: Feedback from the steering group and workshops confirmed that a patient decision aid was required for heart disease patients deciding between two treatment options; coronary angioplasty plus medications or continuing with medications alone. The draft prototype of CONNECT presented information about heart disease, treatment options (risks, benefits, side-effects), and ‘things to consider’. Interactive elements enabled patients to consider their treatment goals, preferences and concerns. Ten participants (5 patients; 5 healthcare professionals) completed alpha testing. Patient participants had either marginal or adequate health literacy levels. Preliminary analysis of the data from cognitive interviews confirmed that CONNECT was comprehensible, usable and acceptable to end-users. Ease of use, usefulness and satisfaction scored highly (median: 4 out of 5). Areas for further development included additional simplification of terminology, the use of multi-media with specific suggestions regarding improvements in the navigation and login process. Access for users with low digital literacy levels was identified as a potential barrier to use. All participants agreed that CONNECT could potentially enhance patient participation in the decision-making process, highlight patients values and concerns about treatment options and serve to individualise consultations.
Implications: Alpha testing of CONNECT confirms the potential of the decision aid as a tool to improve shared decision-making for patients with stable coronary heart disease. Patients require a clear understanding of their treatment options to give informed consent for treatment. The next stage of development (beta testing) will integrate end-user feedback to co-create a final CONNECT prototype and evaluate the feasibility of its integration into clinical practice.
Funders: Grow MedTech (POF000103)
Co-design of a logic model describing components, mechanisms of change and potential impacts of case management for people who frequently call ambulance services
Rabeea'h Aslam(1), Robert Cole(2), Bernie Diethart(1), Adrian Edwards(3), Bridie A Evans(1), Theresa Foster(4), Rachael Fothergill(5), Penny Gripper(6), Ann John(1), Ashrafunnesa Khanom(1), Valentina Pendolino(5), Andy Rosser(2), Ceri Philips(1), Alison Porter(1), Jason Scott(7), Helen Snooks(1), Gladys Makuta(1)
(1)Swansea University Medical School, (2)West Midlands Ambulance Service, (3)Cardiff University, (4)East of England Ambulance Trust, (5)London Ambulance Service, (6)Lay member, (7)Northumbria University
Background: A small minority of people make a high number of calls to the emergency ambulance service. Repeated presentations may be indicative of gaps elsewhere in the health care system, which could perhaps be more effectively addressed by pro-active care. Multi-agency case management is being introduced by ambulance services and their partners in the UK to try to identify and address the needs of those who call 999 ambulance services frequently. However, there is a lack of evidence about what works well in this setting and how. Based on current nationally agreed definitions, calling frequently is defined as 5 or more times in a month or 12 or more times in a three-month period.
The STRETCHED study (STRategies to manage Emergency ambulance Telephone Callers with sustained High needs – an Evaluation using linked Data) study seeks to evaluate clinical and cost-effectiveness, safety, and efficiency of case management for people who frequently call the emergency ambulance service; and gain an understanding of barriers and facilitators to implementation.
As an initial stage, we developed a logic model to describe key components, mechanisms of change and expected impacts of multi-disciplinary, cross-sectoral case management approaches to the management of people who call 999 frequently over a sustained period.
Method: We conducted a stakeholder event with 37 people from Wales, England and Northern Ireland including patient representatives and professional staff involved in commissioning, planning and delivering case management for people who call 999 services frequently. We formed 5 discussion groups to address the following questions,
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What does case management look like?
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How do you think case management works?
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How does it affect the person, family, providers, and ambulance service/NHS?
Responses were recorded, aggregated, and discussed in a plenary session at the workshop. We used the responses as the basis for developing a logic model.
Results:
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Key components: dedicated staff time for case management, availability and knowledge of relevant services for referral, multidisciplinary collaboration, organisational support, and clear information-sharing protocols.
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Mechanisms: provision of space for a clear understanding of reasons for calling, tailoring of multi-sectoral management to individual needs, offering therapeutic support and assistance in the development of self-efficacy.
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Potential impacts of case management: improvement in access to appropriate and timely care, increase in efficiency and accessibility of the healthcare system, reduction in emergency calls, costs and
Implications: Case management is a developing area of provision in prehospital emergency care for people who call ambulance services frequently. Some uncertainty about the risks, benefits and costs of case management. Our logic model provides a firm foundation for evaluation to build the urgently needed evidence base for case management of people who call ambulance services frequently.
Using creative co-design to mobilise knowledge in healthcare: A qualitative study
Cheryl Grindell(1), Angela Tod(2), Tom Sanders(3), Remi Bec(4), Daniel Wolstenholme(5)
(1)ScHARR The University of Sheffield/Sheffield Teaching Hospitals, (2)University of Sheffield, (3)Northumbria University, (4)Sheffield Hallam University, (5)Royal college of obstetricians and gynaecologists
A Qualitative study of the use of creative co-design to mobilise knowledge in healthcare
Background: It is increasingly recognised that those on the giving and receiving end of healthcare interventions should be involved in their development. Co-production and co-design have been suggested as key ways of ensuring that the right knowledge is generated, shared and acted upon (i.e knowledge mobilisation) to improve healthcare practice and the experience thereof. As a result co-production and co-design have been increasing in popularity in healthcare research and service improvement with a broad range of approaches being used, often without formal evaluation.
The translating knowledge into Action (TK2A) theme of the NIHR Collaborations for Leadership in Applied Health research and Care (CLAHRC) Yorkshire and Humber (YH), a team of clinical and design researchers, have been using and developing the ‘creative co-design’ approach over the past 10 years exploring its role in knowledge mobilisation.
This paper presents the qualitative evaluation of these methods.
Methods: Semi-structured interviews were carried out with 20 of the projects leads (a mixture of academics, clinical academics and clinicians) from 14 TK2A projects (a mixture of research and service improvement projects).
Data was analysed using the Framework approach as described by Ritchie and Lewis (2003). In keeping with the participatory nature of the TK2A methods and to validate the early framework a workshop involving participants from the first 10 interviews was held prior to the subsequent 10 interviews taking place and then the charting phase of the Framework approach.
Results: The findings from the data suggest that creative co-design adds value to knowledge mobilisation in healthcare in 2 main ways represented by the 2 main inter-connected themes and associated sub themes described below:
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By being a design led creative and visual approach. The methods are fun and informal and encourage and support engagement to broaden and question participants way of thinking. They support ideation and can generate novel ideas. The design input results in the creation of visible and tangible outputs that reinforce the engagement of participants so they feel a sense of ownership of the co-designed solution(s).
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By breaking down barriers. The methods create a safe space for open and honest knowledge sharing in an inclusive non-hierarchical environment. Giving voice to those who often aren’t heard or often don’t engage.
In addition further themes around the practice of creative co-design were co-constructed from the data and include:
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The challenges of undertaking the approach particularly to academics who had not used it before.
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How expert facilitation and having a designer in the room aided its success.
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How it achieved impact by promoting actual change in services and in practice, bringing people together to develop new partnerships and recognising how the power of the patient (and staff) voice can influence implementation.
The main two themes resonate with key elements of the collective making process model for knowledge mobilisation (Langley et al 2018), whereas the last three themes are an original contribution to the understanding of the practice of co-production.
Implications: This study is the first to formally evaluate the creative co-design approach to knowledge mobilisation in a healthcare setting. Despite the challenges identified from this study and also from the wider literature on co-production, the results are positive and warrant its use to improve knowledge mobilisation and healthcare practice. Further use and evaluation of the creative co-design approach will help this and similar approaches develop into recognised and effective methods to be used in healthcare research and service improvement.