Clinical trial NCT05553912: QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
Official title: QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2Diabetes
Diabetes
Keywords: A1c
HbA1c
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-09-26
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster randomized clinical trial of usual care with a behavioral intervention (use of conversation cards during routine clinical encounters) compared with usual care alone. The study will randomize 10-15 clinicians and 72 of their patients with type 2 diabetes to each arm. Data collected includes medical record data, patient and clinician surveys, and audio-visual recordings of clinical encounters.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Illness intrusiveness measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6
timeFrame: Month 6
measure: HbA1c at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Diabetes distress will be measured using the Diabetes Distress Scale (DDS-17) at Month 6
timeFrame: Month 6
measure: Treatment burden will be assessed using the Treatment Burden Questionnaire (TBQ) at Month 6
timeFrame: Month 6
measure: Quality of life was assessed using the Visual Analogue Scale (VAS) at Month 6.
timeFrame: Month 6
measure: Hypoglycemia measured at month 6
timeFrame: Month 6
measure: Quality of communication assessed using 3 questions from the CAHPS Clinician and Group survey
timeFrame: up to 6 months
Other outcomes:
measure: Patient satisfaction survey
timeFrame: up to 6 months
measure: Clinician satisfaction survey
timeFrame: up to 6 months
Locations:
city: New Haven
country: United States
facility: Fair Haven Community Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Kasia Lipska, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: