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Background: Do not attempt cardiopulmonary resuscitation decisions have been widely criticised. The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) process was developed to facilitate shared decisions between patients and clinicians in relation to emergency treatments, including cardiopulmonary resuscitation. Objective: To explore how, when and why ReSPECT plans are made and what effects the plans have on patient outcomes. Design: A mixed-methods evaluation, comprising (1) a qualitative study of ReSPECT decision-making processes, (2) an interrupted time series examining process and survival outcomes following in-hospital cardiac arrest and (3) a retrospective observational study examining factors associated with ReSPECT recommendations and patient outcomes. Setting: NHS acute hospitals and primary care and community services in England (2017–2020). Participants: Hospital doctors, general practitioners, nurses, patients and families. Data sources: The following sources were used: (1) observations of ReSPECT conversations at six hospitals and conversations with clinicians, patient, families and general practitioners, (2) survey and freedom of information data from hospitals participating in the National Cardiac Arrest Audit and (3) a review of inpatient medical records, ReSPECT forms and NHS Safety Thermometer data. Results: By December 2019, the ReSPECT process was being used in 40 of 186 (22%) acute hospitals. In total, 792 of 3439 (23%) inpatients, usually those identified at risk of deterioration, had a ReSPECT form. Involvement of the patient and/or family was recorded on 513 of 706 (73%) ReSPECT forms reviewed. Clinicians said that lack of time prevented more conversations. Observed conversations focused on resuscitation, but also included other treatments and the patient’s values and preferences. Conversation types included open-ended conversations, with clinicians actively eliciting the patients’ wishes and preferences, a persuasive approach, swaying the conversation towards a decision aligned with medical opinion, and simply informing the patient/relative about a medical decision that had already been made. The frequency of harms reported on the NHS Safety Thermometer was similar among patients with or without a ReSPECT form. Hospital doctors and general practitioners gave different views on the purpose of the ReSPECT process and the type of recommendations they would record. Limitations: The research was undertaken within the first 2 years following the implementation of ReSPECT. Local policies meant that doctors led these conversations. Most patients were seriously ill, which limited opportunities for interviews. Incomplete adoption of the ReSPECT process and problems associated with the NHS Safety Thermometer tool affected the evaluation on clinical outcomes. Conclusions: Patients and families were involved in most ReSPECT conversations. Conversations focused on resuscitation, but also included other emergency treatments. Respect for patient autonomy and duty to protect from harm informed clinicians’ approach to varying degrees, depending on the clinical situation and their views of ReSPECT as a shared decision-making process. The complexity of these conversations and the clinical, emotional and organisational barriers observed suggest that a nuanced and multifaceted approach will be necessary to support good ReSPECT processes. Future work: Further research is needed to understand the advantages and disadvantages to the adoption of a national emergency care and treatment plan system, the most effective national and local implementation approaches, and whether or not shared decision-making approaches in the context of emergency care and treatment plans could further enhance patient and family engagement. Study registration: This study is registered as ISRCTN11112933. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 40. See the NIHR Journals Library website for further project information.

Rationale Clinical trials are the gold standard for testing interventions. COVID-19 has further raised their public profile and emphasised the need to deliver better, faster, more efficient trials for patient benefit. Considerable overlap exists between data required for trials and data already collected routinely in electronic healthcare records (EHRs). Opportunities exist to use these in innovative ways to decrease duplication of effort and speed trial recruitment, conduct and follow-up.Approach The National Institute of Health Research (NIHR), Health Data Research UK and Clinical Practice Research Datalink co-organised a national workshop to accelerate the agenda for ‘data-enabled clinical trials’. Showcasing successful examples and imagining future possibilities, the plenary talks, panel discussions, group discussions and case studies covered: design/feasibility; recruitment; conduct/follow-up; collecting benefits/harms; and analysis/interpretation.Reflection Some notable studies have successfully accessed and used EHR to identify potential recruits, support randomised trials, deliver interventions and supplement/replace trial-specific follow-up. Some outcome measures are already reliably collected; others, like safety, need detailed work to meet regulatory reporting requirements. There is a clear need for system interoperability and a ‘route map’ to identify and access the necessary datasets. Researchers running regulatory-facing trials must carefully consider how data quality and integrity would be assessed. An experience-sharing forum could stimulate wider adoption of EHR-based methods in trial design and execution.Discussion EHR offer opportunities to better plan clinical trials, assess patients and capture data more efficiently, reducing research waste and increasing focus on each trial’s specific challenges. The short-term emphasis should be on facilitating patient recruitment and for postmarketing authorisation trials where research-relevant outcome measures are readily collectable. Sharing of case studies is encouraged. The workshop directly informed NIHR’s funding call for ambitious data-enabled trials at scale. There is the opportunity for the UK to build upon existing data science capabilities to identify, recruit and monitor patients in trials at scale.