Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments.

BACKGROUND: The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses) is the UK national platform investigating repurposed therapies for COVID-19 treatment of older people in the community at high risk of complications. Standard methods of patient recruitment were failing to meet the required pace and scale of enrolment. This paper describes the development and appraisal of a near real-time, data-driven, ethical approach for enhancing recruitment in community care by contacting people with a recent COVID-19 positive test result from the central NHS Test and Trace service within approximately 24-48 h of their test result. METHODS: A multi-disciplinary team was formed to solve the technical, ethical, public perception, logistical and information governance issues required to provide a near-real time (approximately within 24-48 h of receiving a positive test) feed of potential trial participants from test result data to the research team. PRINCIPLE was also given unique access to the Summary Care Record (SCR) to ensure safe prescribing, and to enable the trial team to quickly and safely bring consented patients into the trial. A survey of the public was used to understand public perceptions of the use of test data for this proposed methodology. RESULTS: Prior to establishing the data service, PRINCIPLE registered on average 87 participants per week. This increased by up to 87 additional people registered per week from the test data, contributing to an increase from 1013 recruits to PRINCIPLE at the start of October 2020 to 2802 recruits by 20 December 2020. Whilst procedural caveats were identified by the public consultation, out of 2639 people contacted by PRINCIPLE following a positive test result, no one raised a concern about being approached. CONCLUSIONS: This paper describes a novel approach to using near-real time NHS operational data to recruit community-based patients within a few days of presentation with acute illness. This approach increased recruitment and reduced time between positive test and randomisation, allowing more rapid evaluation of treatments and increased safety for participants. End-to-end public and patient involvement in the design of the approach provided evidence to inform information governance decisions. TRIAL REGISTRATION: PRINCIPLE is funded by UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research. EudraCT number: 2020-001209-22 . 26/03/2020 ISRCTN registry: ISRCTN86534580 . 20/03/2020 REC number: 20/SC/058 IRAS number: 281958.

Achieving and sustaining profound institutional change in healthcare: case study using neo-institutional theory.

Change efforts in healthcare sometimes have an ambitious, whole-system remit and seek to achieve fundamental changes in norms and organisational culture rather than (or as well as) restructuring the service. Long-term evaluation of such initiatives is rarely undertaken. We report a secondary analysis of data from an evaluation of a profound institutional change effort in London, England, using a mixed-method longitudinal case study design. The service had received £15 million modernisation funding in 2004, covering multiple organisations and sectors and overseen by a bespoke management and governance infrastructure that was dismantled in 2008. In 2010-11, we gathered data (activity statistics, documents, interviews, questionnaires, site visits) and compared these with data from 2003 to 2008. Data analysis was informed by neo-institutional theory, which considers organisational change as resulting from the material-resource environment and three 'institutional pillars' (regulative, normative and cultural-cognitive), enacted and reproduced via the identities, values and activities of human actors. Explaining the long-term fortunes of the different components of the original programme and their continuing adaptation to a changing context required attention to all three of Scott's pillars and to the interplay between macro institutional structures and embedded human agency. The paper illustrates how neo-institutional theory (which is typically used by academics to theorise macro-level changes in institutional structures over time) can also be applied at a more meso level to inform an empirical analysis of how healthcare organisations achieve change and what helps or hinders efforts to sustain those changes.

"If we build it, will it stay?" A case study of the sustainability of whole-system change in London.

CONTEXT: The long-term sustainability of whole-system change programs is rarely studied, and when it is, it is inevitably undertaken in a shifting context, thereby raising epistemological and methodological questions. This article describes a transferable methodology that was developed to guide the evaluation of a three-year follow-up of a large health care change program in London, which took place during a period of economic turbulence and rapid policy change. METHOD: Using a mixed-method organizational case study design, we studied three services (stroke, kidney, and sexual health) across primary and secondary care. Each had received £5 million (US$7.8 million) in modernization funding in 2004. In 2010/2011, we gathered data on the services and compared them with data from 2004 to 2008. The new data set contained quantitative statistics (access, process, and outcome metrics), qualitative interviews with staff and patients, documents, and field notes. Our data analysis was informed by two complementary models of sustainability: intervention-focused (guided by the question, What, if anything, of the original program has been sustained?) and system-dynamic (guided by the question, How and why did change unfold as it did in this complex system?). FINDINGS: Some but not all services introduced in the original transformation effort of 2004-2008 were still running; others had ceased or been altered substantially to accommodate contextual changes (e.g., in case mix, commissioning priorities, or national policies). Key cultural changes (e.g., quality improvement, patient centeredness) largely persisted, and innovative ideas and practices had spread elsewhere. To draw causal links between the original program and current activities and outcomes, it was necessary to weave a narrative thread with multiple intervening influences. In particular, against a background of continuous change in the local health system, the sustainability of the original vision and capacity for quality improvement was strongly influenced by (1) stakeholders' conflicting and changing interpretations of the targeted health need; (2) changes in how the quality cycle was implemented and monitored; and (3) conflicts in stakeholders' values and what each stood to gain or lose. CONCLUSIONS: The sustainability of whole-system change embodies a tension between the persistence of past practice and the adaptation to a changing context. Although the intervention-focused question, What has persisted from the original program? (addressed via a conventional logic model), may be appropriate, evaluators should qualify their findings by also considering the system-dynamic question, What has changed, and why? (addressed by producing a meaningful narrative).