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 and patient outcomes in non-stroke settings. Little is known about the impact of ethnicity on post-stroke care especially in Māori and Pacific populations.
OBJECTIVE
To describe the study 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 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 economic impact of care provided at different types of hospitals and to different ethnicities, as well as exploring cost-efficacy of individual interventions and care bundles. Finally it compares manual study 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.
Sample size estimates: Part 1a - 2,400 participants to identify a 10% difference between up to four geographic sub-groups at 90% power with alpha 0.05 and 10-20% loss to follow-up. Part 1b - 7,645 to include an estimated 850 Māori and 419 Pacific patients to provide >90% and >80% power respectively. Part 2 – fifty patient/carer surveys, forty provider surveys, and ten focus groups to achieve saturation of themes.
Study outcome(s): Main outcome is modified Rankin Score at 3 months (mRS). Secondary outcomes include mRS, EQ-5D-3L, stroke recurrence, vascular events, death, and readmission at 3, 6, and 12 months as well as cost of care and themes around access barriers.
RESULTS
The study is underway with national and institutional ethics approval in place, 2,379 patients recruited for part 1a, 6,837 for part 1b, ten focus groups conducted, and 70 surveys completed. Data collection is essentially completed including follow-up assessment, however, primary and secondary analyses, data linkage, data validation, and health economics analysis still underway.
CONCLUSIONS
The methods of this study may provide the basis for future epidemiological studies to guide care improvements in other countries and populations.
Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care): A Nationwide Observational Study Protocol (Preprint)
