What is the impact of large-scale implementation of stroke Early Supported Discharge? A mixed methods realist evaluation study protocol

Abstract

Background Stroke Early Supported Discharge (ESD) is a service innovation that facilitates discharge from hospital and delivery of specialist rehabilitation in patients’ homes. There is currently widespread implementation of ESD services in many countries, driven by robust clinical trial evidence. In England, the type of ESD service patients receive on the ground is variable, and in some regions, ESD is still not offered at all. This protocol presents a study designed to investigate the mechanisms and outcomes of implementing ESD at scale in real-world conditions. This will help to establish which models of ESD are most effective and in what context. Methods A realist evaluation approach composed of two interlinking work packages will be adopted to investigate how and why ESD works, for whom and in what circumstances. Work package 1 (WP1) will begin with a rapid evidence synthesis to formulate preliminary realist hypotheses. Quantitative analyses of historical prospective Sentinel Stroke National Audit Programme (SSNAP) data will be performed to evaluate service outcomes based on the degree to which evidence-based ESD has been implemented. Work package 2 (WP2) will involve the qualitative investigation of purposively selected case study sites featuring in WP1 and covering different regions in England. The perspectives of clinicians, managers, commissioners, and service users will be explored qualitatively. Cost implications of ESD models will be examined using a cost-consequence analysis. Cross-case comparisons and triangulation of the data sources from both work packages will be performed to test, revise, and refine initial programme theories and address research aims. Discussion This study will investigate whether and how current large-scale implementation of ESD is achieving the outcomes suggested by the evidence base. The theory-driven evaluation approach will highlight key mechanisms and contextual conditions necessary to optimise outcomes and allow us to draw transferable lessons to inform the effective implementation and sustainability of ESD in clinical practice. In addition, the methodological framework will progress the theoretical understanding of implementation and evaluation of complex rehabilitation interventions in stroke care. Trial registration ISRCTN: 15568163, registration date: 26 October 2018.

Effectiveness of Stroke Early Supported Discharge

“…Although we acknowledge that more in depth investigation of ESD model features is required to make definitive conclusions, this approach offered a useful way to quantify adoption of core components for quantitative analytical purposes. 16 It provided a simple means by which to evaluate services based on international consensus and clinical guidelines relating to ESD. 4 , 5 , 13 We attempted to control for several confounders; however, we cannot rule out the possible influence of unobserved variables.…”

“…It should also be noted that previous studies have suggested ESD reduces length of hospital stay; investigation of this, using hospital SSNAP data, will be reported in a further paper. 16 …”

“…We present results from an observational cohort study (Figure), conducted as part of an overall mixed-method study. 16 The study protocol was approved by a University of Nottingham Ethics Committee and the United Kingdom Healthcare Quality Improvement Partnership Data Access Request Group. Data access requests should be directed to the Healthcare Quality Improvement Partnership as the joint data controller and SSNAP as the data provider.…”

“…The study protocol including statistical analysis plan is available online. 16 We determined a priori, a sample size of 4750 patients for a study power of 80% to detect standardized effect sizes of 0.25 for each outcome.…”

“…The sampling strategy was devised in accordance with the overall mixed-method study design and included all ESD services in specific regions of England. 16 Here, we report findings from quantitative investigation of ESD effectiveness across West and East Midlands and East of England (across which a specific initiative to promote ESD was initiated in 2010) and the North of England, a region with a defined lack of ESD. 10 , 17…”