Does the Diabetes Alliance Program Improve Longer-term Health Outcomes of Patients with Type 2 Diabetes Attending Primary Care Practices? A Target Trial Protocol for Emulating a Cluster Trial Using Linked General practice and Tertiary Health Data
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Background
Effective management of type 2 diabetes remain a challenge for health services in Australia. Rural and remote communities in particular are at a higher risk of diabetes-related complications due to reduced access to specialist services, making the role of general practices all the more important in the provision of diabetes care. Integrated care targeted around increasing capacity to rural general practices in the treatment of type 2 diabetes may reduce the disparity in health outcomes among rural and remote patients suffering from type-2 diabetes. This protocol aims to describe a causal approach for the evaluation of a specialist-led integrated model of care delivered to general practices using large administrative health data.
Methods and analysis
This will be an observational cohort study using linked general practice and hospital data from the Lumos program. This protocol adopts the target trial framework approach described by Hernan et al and the estimands framework proposed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). We describe the data structure and statistical analysis plan that would be required for causal inferences. The target causal estimand is the effect of the Diabetes Alliance Program Plus integrated care intervention, among general practice active-attending adult patients with current and new diagnoses of type 2 diabetes, on three-year hospitalisation rates wherein type 2 diabetes is the principal diagnosis. Causal effect estimates and the precision in these estimates will be quantified.
Ethics and dissemination
The Diabetes Alliance Program Plus has ethics approval from the Hunter New England Human Research Ethics Committee (2024/ETH01649), with approval registered with the University of Newcastle (R-2024-0073). The Lumos data asset is also ethically approved by the Population Health Services Research Ethics Committee (PHSREC; 2019/ETH00660), and DAP+ has received approval by their Governance Committee for the evaluation in this protocol. The analysis and interpretation of the results will be contingent of the quality of the observational data. Findings will be disseminated to local stake holders and submitted to scientific peer-reviewed journals.
Data statement
The data will not be made publicly available due to privacy, ethical, and data governance restrictions.
ARTICLE SUMMARY
Strengths and limitations of this study
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This protocol incorporates design principles from randomised trials to the analysis plan of a large health-service data asset, which allowed us to construct a clear target causal estimand.
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This approach describes a novel two-step propensity matching approach to account for cluster-level confounding in observational analyses in order to create a statistical analogue of cluster randomisation.
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The statistical methods described in this protocol describes an appropriate method comparing individual-level effects across clusters, in cases where an intervention results in clusters of all-treated and all-not-treated individuals.
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The implementation of this protocol will be limited by the availability and quality of data collection in the proposed data asset.
