QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
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Details and patient eligibility
About
Glycemic control is often the main indicator of successful diabetes care, but a singular focus on glycemic control may lead to patients' overall health and wellbeing being overlooked or undervalued. The investigators have previously developed an intervention comprised of (a) a set of conversation cards designed to enable patients to identify aspects of life with diabetes important to them and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns. The investigators will now conduct a randomized clinical trial to test the feasibility of the research procedures and efficacy of the intervention with respect to patient reported outcome measures.
Full description
The goal of this study is to assess the feasibility and efficacy of usual care with the QBSafe intervention compared to usual care alone within a cluster randomized clinical trial among patients with type 2 diabetes.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Clinicians
- any physicians, residents, nurse practitioners, and physician assistants who participate in the care of patients with type 2 diabetes (DM2) management (DM2) and prescribe medications for them
Participants
- diagnosed with DM2
- able to sign informed consent
- fluent in either English or Spanish
- HbA1c >8%
Exclusion criteria
- Participants for whom an HbA1c target >8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences
Trial design
Primary purpose
Allocation
Interventional model
Masking
164 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Victor Montori, MD; Kasia Lipska, MD MHS
Data sourced from clinicaltrials.gov
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