Experimental Research

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Experimental Research MITE6025 Methods of Research and Enquiry

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Research Objective: The SAFTINet project was funded by the AHRQ to build a distributed network of existing clinical and claims data that would support comparative effectiveness research (CER), with a focus on underserved populations and healthcare delivery system (HDS) characteristics. Observational research methods are appropriate, but require detailed protocols with a priori hypotheses and analytic plans. SAFTINet research specifically concerns the effects of a discrete set of HDS features (those often included in Patient-Centered Medical Home (PCMH) models) on health outcomes for primary care patients with asthma, hypertension, and hypercholesterolemia. Our objective is to present a description of this study’s measurement challenges, and to specify a priori hypotheses, analytic strategies, and plans for addressing bias and confounding for our asthma cohorts. Study Design: An observational, longitudinal cohort study of primary care patients with asthma, with both secondary use of existing clinical and claims data and primary data collection for HDS features and patient- reported outcomes. Population Studied: Our sample consists of 59 primary care practices in 5 healthcare organizations in Colorado, Utah and Tennessee; all practices serve underserved populations. These practices care for about 275,000 patients per year, of whom an estimated 22,000 have a diagnosis of asthma. Principal Findings: We will present the processes used to define and measure the HDS features, covariates and asthma outcomes, along with planned analysis. Challenges include valid measurement of a multi-faceted HDS “exposure” variable, the inability to identify exposure onset, and the non-dichotomous nature of HDS characteristics. To measure HDS characteristics, we created a practice-level survey assessing 9 PCMH domains, including care coordination, specialty care and mental health integration, and patient-centeredness, as well as asthma-specific HDS characteristics (e.g., the use of asthma registries). Asthma outcomes included (1) those available as a result of routine electronic documentation of clinical care and claims administration (utilization indicative of an exacerbation), and (2) patient reported outcomes tools (Asthma Control Test). We used directed acyclic graphs to identify potential confounders of the relationship between HDS characteristics and asthma control, as well as other potential biases. The analytic plan is based on linear mixed effects models. Perspectives of the CER team, the technology team and the community engagement group were considered in the operationalization of all variables. Conclusions: The design of rigorous observational CER observational CER should recognize the need for an intense planning phase. In accordance with good practice guidance for observational studies, an important component of the planning phase is to disseminate and obtain feedback on the research design in advance of its conduct.

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