QBSafe: a randomized trial of a novel intervention to improve care for people living with type 2 diabetes.

PROJECT ABSTRACT: Clinical guidelines, performance measures, and clinical trials for patients with type 2 diabetes mellitus (DM2) have traditionally focused on achieving certain levels of glycemic control. Yet, when glycemic control is the main focus of diabetes care, important aspects of patients’ health and wellbeing may be

overlooked or undervalued. For patients with poor glycemic control, clinicians typically respond by intensifying the regimen, all too often without attention to the workload this imposes on patients, their capacity to carry out the treatment plan, or the contextual factors involved. As a result, diabetes and its treatment may disrupt and

interfere with valued activities and interests (i.e., cause worsening “illness intrusiveness”), and actually worsen how a person feels or functions. The goal of our program is to promote a paradigm shift in DM2 care: from reaching HbA1c targets to a whole-person approach that responds to the situation of each patient and reduces

illness intrusiveness. Here, we propose to test a novel intervention to treat DM2 focused on Quality of life, Burden of treatment (medication administration, costs, and monitoring), Safety (reducing adverse effects), and Avoidance of Future Events (acute and chronic diabetes complications) – the QBSafe approach. We have

previously developed an Agenda Setting Kit (ASK) for patients to use during their routine office visits. The ASK is comprised of (a) a set of conversation cards designed to enable patients to identify aspects of QBSafe that are pertinent to their situation and to share them with their clinician to obtain their input; and (b) materials that

help clinicians respond to patient concerns. We propose to conduct a clustered randomized trial at a federally qualified healthcare center in New Haven, CT, and to randomize 10 primary care clinicians and 144 of their patients with DM2 and HbA1c >8% to receive usual care with or without QBSafe ASK in order to achieve

the following: Aim 1: To determine the feasibility of the research procedures necessary to conduct a practice- based randomized trial to determine the clinical effectiveness of QBSafe ASK in the care of patients with DM2. Aim 2: Since a definitive trial will require some mechanistic evidence of efficacy, we will power this trial to also

estimate the extent to which usual care with and without QBSAFE ASK can improve: Aim 2A: Patient-reported outcomes, principally illness intrusiveness (Illness Intrusiveness Rating Scale), as well as diabetes distress (Diabetes Distress Scale), treatment burden (Treatment Burden Questionnaire), hypoglycemia, and global

quality of life (1-item analogue scale) at 6 months after the intervention. Aim 2B: Clinical outcomes measured as change in HbA1c between baseline and 6 months. Aim 2C: Patient-centered diabetes judged by (a) rating the audiovisual recordings of clinical encounters (including the time spent total and in discussing QBSafe

domains), and (b) patient satisfaction (using the ambulatory CAHPS survey) and clinician satisfaction (using post-encounter survey) with how the encounter went. This work will provide necessary preliminary data for a multicenter randomized trial to determine the clinical effectiveness of QBSafe ASK in diabetes care.