One in five Americans over the age of 75 (~4 million people) has type 2 diabetes and this population is expected to double over the next 25 years. About half of these oldest patients have multiple comorbidities and functional impairments, and the vast majority has one or more geriatric conditions. As a result, glycemic management in this population is challenging. Multiple chronic conditions and impairments make it challenging to self-manage complex tasks (such as insulin administration and dosing), leave patients overwhelmed and overburdened by the work required to manage their conditions, and increase the risk of adverse events (such as hypoglycemia). To shift the paradigm of care for this population ? from the narrow focus on reaching hemoglobin A1c targets to prioritizing patient-centered goals ? we propose to develop and test the QBSafe protocol. QBSafe will focus on maximizing Quality of life (reducing the burden of symptoms), optimizing the Burden of treatment (medication administration, costs, and monitoring), and improving treatment Safety (reducing adverse effects, such as hypoglycemia). Utilizing our experience with stakeholder engagement in research, we propose to assemble a working group of patients, caregivers, and clinicians to co-develop the QBSafe protocol of care. Next, we propose to pilot test QBSafe in a single-arm feasibility two-site study and examine the extent to which QBSafe (a) can be embedded within clinical practice routines (using Normalization Process Theory and its Toolkit); (b) affects quality of life, treatment burden, and hypoglycemia risk 6 months after implementation (using validated measures); (c) affects clinician satisfaction with diabetes care; and (d) is ready for testing in a large multicenter randomized trial. To maximize chances of success, our team brings together experience and expertise in diabetes and aging, minimally disruptive medicine, prevention of hypoglycemia, stakeholder engagement in research, design and testing of interventions in randomized trials, and evaluation of factors that promote or hinder the adoption of innovations in routine clinical care. If successful, QBSafe will offer a novel alternative diabetes care strategy for patients with type 2 diabetes since the demonstration of the glycemic hypothesis and the institutionalization of hemoglobin A1c-based care 25 years ago. This work will set the stage for a randomized trial to compare the impact of the intervention on quality of life, treatment burden, and adverse events when compared with usual clinical guideline-directed care, i.e., targeting hemoglobin A1c level <8% for older, complex adults with type 2 diabetes. A larger, longer clinical trial will examine tradeoffs associated with QBSafe approach that may emerge over a longer time-frame.
PROJECTS NARRATIVE Older, complex adults with type 2 diabetes experience challenges in self-management, high treatment burden, and frequent adverse events, such as hypoglycemia. To address these challenges, we propose to build a stakeholder working-group to co-develop the QBSafe protocol of care, focused on maximizing Quality of life, optimizing the Burden of treatment, and improving treatment Safety. We then propose to test QBSafe in a single-arm two-site feasibility study to estimate the acceptability and efficacy of this intervention in clinical practice.
