Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care): Protocol for a Nationwide Observational Study
Authors: Ranta Annemarei , Thompson Stephanie , Harwood Matire Louise Ngarongoa , Cadilhac Dominique Ann-Michele , Barber Peter Alan , Davis Alan John , Gommans John Henry , Fink John Newton , McNaughton Harry Karel , Denison Hayley , Corbin Marine , Feigin Valery , Abernethy Virginia , Levack William , Douwes Jeroen , Girvan Jacqueline , Wilson Andrew 
Published: November 2020

Background
Stroke systems of care differ between larger urban and smaller rural settings and it is unclear to what extent this may impact on patient outcomes. Ethnicity influences stroke risk factors and care delivery as well as patient outcomes in nonstroke settings. Little is known about the impact of ethnicity on poststroke care, especially in Māori and Pacific populations.

Objective
Our goal is to describe the protocol for the Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care) study.

Methods
This large, nationwide observational study assesses the impact of rurality and ethnicity on best practice stroke care access and outcomes involving all 28 New Zealand hospitals caring for stroke patients, by capturing every stroke patient admitted to hospital during the 2017-2018 study period. In addition, it explores current access barriers through consumer focus groups and consumer, carer, clinician, manager, and policy-maker surveys. It also assesses the economic impact of care provided at different types of hospitals and to patients of different ethnicities and explores the cost-efficacy of individual interventions and care bundles. Finally, it compares manual data collection to routine health administrative data and explores the feasibility of developing outcome models using only administrative data and the cost-efficacy of using additional manually collected registry data. Regarding sample size estimates, in Part 1, Study A, 2400 participants are needed to identify a 10% difference between up to four geographic subgroups at 90% power with an α value of .05 and 10% to 20% loss to follow-up. In Part 1, Study B, a sample of 7645 participants was expected to include an estimated 850 Māori and 419 Pacific patients and to provide over 90% and over 80% power, respectively. Regarding Part 2, 50% of the patient or carer surveys, 40 provider surveys, and 10 focus groups were needed to achieve saturation of themes. The main outcome is the modified Rankin Scale (mRS) score at 3 months. Secondary outcomes include mRS scores; EQ-5D-3L (5-dimension, 3-level EuroQol questionnaire) scores; stroke recurrence; vascular events; death; readmission at 3, 6, and 12 months; cost of care; and themes around access barriers.

Results
The study is underway, with national and institutional ethics approvals in place. A total of 2379 patients have been recruited for Part 1, Study A; 6837 patients have been recruited for Part 1, Study B; 10 focus groups have been conducted and 70 surveys have been completed in Part 2. Data collection has essentially been completed, including follow-up assessment; however, primary and secondary analyses, data linkage, data validation, and health economics analysis are still underway.

Conclusions
The methods of this study may provide the basis for future epidemiological studies that will guide care improvements in other countries and populations.

International Registered Report Identifier (IRRID)
DERR1-10.2196/25374