Quality of life, burden of treatment, safety, and avoidance of future events (QBSAfe) protocol: a pilot study testing an intervention to shift the paradigm of diabetes care

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.

Financial Toxicity in the Clinical Encounter: A Paired Survey of Patient and Clinician Perceptions

“…This can be done through education or interventional nudges to go beyond discussing just financial burden, but situating such discussion in the context of quality of life, safety, lifestyle, and other burdens of alternative treatments. 13 In particular, clinicians need guidance and resources to identify financial burdens and improve the quality of cost conversations. 14 , 15 Patient affordability is typically a delicate issue that is brushed aside in medical encounters owing to its sensitive nature and time constraints.…”

Feasibility and Acceptability of an Agenda-Setting Kit in the Care of People With Type 2 Diabetes: The QBSAFE ASK Feasibility Study

“…The full pilot protocol was published previously ( 6 ). Once enrolled in the study and before a scheduled appointment, people with diabetes were approached by study personnel in person, by telephone, or via e-mail to review the QBSAFE ASK in a paper ( Supplementary Figure S1 ) or electronic ( https://patientrevolution.org/qbsafe ) format.…”

“…We previously developed a set of conversation cards as an agenda-setting kit (ASK) to improve person-centered care for people with type 2 diabetes ( 6 ). Our specific goals were to promote conversations between people with diabetes and their clinicians, facilitating collaborative problem-solving while addressing issues related to diabetes care, including quality of life, the burden of treatment, safety, and avoidance of future events (QBSAFE).…”

<b>Feasibility and Acceptability of an Agenda-Setting Kit in the Care of People With Type 2 Diabetes: The QBSAFE ASK Feasibility Study</b>

“…The full pilot protocol was published previously (6). Once enrolled in the study and before a scheduled appointment, people with diabetes were approached by study personnel either in person, by telephone, or via e-mail to review the QBSAFE ASK in a paper (Supplementary Figure S1) or electronic (https://patientrevolution.org/qbsafe) format.…”