ABSTRACT
BACKGROUND: Diabetes care has been traditionally focused on targeting certain levels of glycemic control. This narrow emphasis may impose burdens on patients, including high treatment costs, illness-related work, or side effects from medications, while leaving other patient needs and goals under-addressed. The authors aim to shift the paradigm of care for people with diabetes, to focus on quality of life, burden of treatment, safety, and avoidance of future events: the QBSAfe domains. METHODS: We describe a single-arm pilot study to assess the feasibility and acceptability of using the QBSAfe agenda setting kit (ASK) during routine clinical visits. The set of 14 conversation aid cards was co-developed with patients, family caregivers, and clinicians. The ASK will be used in the context of a clinic visit, which will be recorded by members of the study team to identify patterns of clinician-patient conversations. Feasibility will be measured by the number of participants recruited, time to goal accrual, and completeness of data collection; acceptability will be assessed using post-visit surveys of patients and clinicians. A subgroup of patients will be invited to participate in post-visit qualitative semi-structured interviews for additional feedback. This study will be conducted across three medical centers in the Midwest and East Coast of the USA. DISCUSSION: Current healthcare infrastructure and associated demands and pressures on clinicians make changes in care difficult. However, this intervention has the potential to shift conversations during clinical encounters so they can address and directly respond to patient needs, symptoms, and capacity. As part of the QBSAfe ASK, the authors are also actively collaborating with a variety of stakeholders to create tools to help clinicians respond more effectively to patient concerns as they are raised during the clinical encounters. Additional insights about the use of the QBSAfe approach in the virtual space will be gathered during the process of our study due to restrictions imposed upon face to face visit during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04514523 . Registered 17 August 2020-retrospectively registered.
ABSTRACT
We sought to determine the associations between hemoglobin A1c (A1c) and admission glucose with in-hospital mortality among patients with diabetes mellitus (DM) hospitalized with COVID-19. Adults hospitalized between 3/5/20 and 12/1/20 in a Connecticut health care system were included if they had prior DM diagnosis, an in-hospital A1c, and a positive RT-PCR nasopharyngeal swab for SARS-CoV-2. A1c was stratified into <7%, 7-<9%, and ≥9%. Both bivariate and multi-variable adjusted logistic regression analyses were performed to determine the association of A1c categories and admission glucose >200 mg/dL with mortality (in-hospital death or transition to hospice) and with intensive care unit (ICU) use. Models were adjusted for demographics and 8 relevant comorbidities. Among 733 patients (median age 67 years [interquartile range, 56-77], 48.3% female, 43.11% White, 35.47% Black, 24.97% Hispanic, 1.64% Asian), 31.7% had A1c <7%, 40.5% 7-<9%, 27.8% ≥9%, and 38.1% admission glucose >200 mg/dL. During hospitalization, 111 (15.1%) patients died or transitioned to hospice and 230 (31.4%) required ICU care. In 2 multi-variable adjusted analyses, neither A1c category nor high admission glucose were significantly associated with mortality (A1c 7-<9%: OR 0.89, 95% CI 0.53-1.49;A1c >9% OR 1.3, CI 0.72-2.35 compared with A1c <7%;glucose >200 OR 1.34, CI 0.72-2.35) or ICU care (A1c 7-<9% OR 1.30, 95% CI 0.88-1.93;A1c ≥9% OR 1.35, CI 0.86-2.1 compared with A1c <7%;glucose >200 OR 1.26, CI 0.9-1.78). Age (per year OR 1.06, CI 1.04-1.08), male sex (OR 1.78, CI 1.14-2.81), obesity (OR 1.85, CI 1.16-2.96) and CKD (OR 1.90, CI 1.19-3.03) were significantly associated with mortality. Only female sex (OR 0.67, CI 0.48-0.93) was significantly associated with ICU care. In our retrospective study of hospitalized patients with DM, neither A1c nor admission glucose were prognostic of COVID-19 mortality or ICU care. In those with DM, male sex, obesity and CKD predicted worse outcomes.