29 research outputs found

    The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial

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    Background. Shared decision making contributes to high quality healthcare by promoting a patientcentered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient's values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice. Methods. We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms. Discussion. Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices

    Effectiveness of Transcatheter Closure of Patent Foramen Ovale in Clinical Practice

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    Background Transcatheter closure of patent foramen ovale (PFO) has reduced the risk of recurrent stroke in patients with cryptogenic strokes in randomized clinical trials. Whether PFO closure in clinical practice is associated with similar benefit remains unknown. Methods and Results We identified patients with PFO and a history of ischemic stroke or transient ischemic attack who were treated with PFO closure or medical therapy in the OptumLabs database. The primary end point was recurrent ischemic stroke or systemic embolization. Secondary outcomes included mortality, all stroke, transient ischemic attack, and major bleeding. A total of 6668 propensity‐matched patients were included (PFO closure n=4111; medical therapy n=2557). The incidence of stroke or systemic embolization per 100 person‐years was 2.38 after PFO cohort and 2.99 with medical therapy (hazard ratio [HR], 0.85 [95% CI, 0.68–1.05], P=0.13). Mortality was lower in the PFO closure cohort (1.78 versus 2.59 per 100 person‐years: HR, 0.69 [95% CI, 0.55–0.87], P=0.002). Falsification end points showed that this difference is unlikely to be completely explained by residual confounders. There were no significant differences between the groups in secondary end points including intracranial hemorrhage and major bleeding except for an increase in nonintracranial hemorrhage bleeding among patients treated with oral anticoagulation (1.42 versus 2.16 per 100 person‐years: HR, 0.69 [95% CI, 0.48–0.99], P=0.043). The main end point was consistent in subanalyses including patients <60 years of age, patients with prior stroke, and those treated after the publication of the positive PFO trials in 2017. Conclusions In contemporary US practice, PFO closure is not associated with lower rates of recurrent ischemic stroke or systemic embolization compared with medical therapy. Potential reasons for this discrepancy warrant further investigation

    Cardiovascular Events Among Survivors of Sepsis Hospitalization: A Retrospective Cohort Analysis

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    Background Sepsis is associated with an elevated risk of late cardiovascular events among hospital survivors. Methods and Results We included OptumLabs Data Warehouse patients from 2009 to 2019 who survived a medical/nonsurgical hospitalization lasting at least 2 nights. The association between sepsis during hospitalization, based on explicit and implicit discharge International Classification of Diseases, Ninth Revision (ICD‐9)/Tenth Revision (ICD‐10) diagnosis codes, with subsequent death and rehospitalization was analyzed using Kaplan–Meier survival analysis and multivariable Cox proportional‐hazards models. The study population included 2 258 464 survivors of nonsurgical hospitalization (5 396 051 total patient‐years of follow‐up). A total of 808 673 (35.8%) patients had a sepsis hospitalization, including implicit sepsis only in 448 644, explicit sepsis only in 124 841, and both in 235 188. Patients with sepsis during hospitalization had an elevated risk of all‐cause mortality (adjusted hazard ratio [HR], 1.27 [95% CI, 1.25–1.28]; P<0.001), all‐cause rehospitalization (adjusted HR, 1.38 [95% CI, 1.37–1.39]; P<0.001), and cardiovascular hospitalization (adjusted HR, 1.43 [95% CI, 1.41–1.44]; P<0.001), especially heart failure hospitalization (adjusted HR, 1.51 [95% CI, 1.49–1.53]). Patients with implicit sepsis had higher risk than those with explicit sepsis. A sensitivity analysis using the first hospitalization yielded concordant results for cardiovascular hospitalization (adjusted HR, 1.78 [95% CI, 1.76–1.78]; P<0.001), as did a propensity‐weighted analysis (adjusted HR, 1.52 [95% CI, 1.50–1.54]; P<0.001). Conclusions Survivors of sepsis hospitalization are at elevated risk of early and late post‐discharge death as well as cardiovascular and non‐cardiovascular rehospitalization. This hazard spans the spectrum of cardiovascular events and may suggest that sepsis is an important cardiovascular risk factor
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