Trial Outcomes & Findings for QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes. (NCT NCT05553912)

Not collected for Clinicians

The change in illness intrusiveness measured by the validated Illness Intrusiveness Ratings Scale (IIRS). IIRS is comprised of 13 items that ask participants to rate the degree to which their "illness and/or its treatment" interfere with life domains central to quality of life. Overall score is calculated by summing the 13 items creating a value between 13 to 91, where higher scores indicate increased illness intrusiveness. Analysis will assess the 6 months response as the outcome adjusting for arm and the initial score. Subscales are scored 1-7 with higher scores indicating more disruption or intrusiveness.

HbA1c value at month 6. Analysis will model the 6 month HbA1c assessment adjusting for arm and the initial score.

The DDS is a validated 17-item self-report instrument where each item is rated on a 6-point Likert scale from (0) "not a problem" to (6) "a serious problem." The scale yields a total DDS score, plus scores for 4 subscales: emotional burden, regimen distress, physician distress, and interpersonal distress. Total and subscale scores are calculated using mean item scores, which are then categorized as little or no distress (0- 2.0), moderate distress (greater than or equal to 2.0 and less than or equal to 2.9) and high distress (3.0-6.0). Moderate and high distress are considered 'clinically significant.'

The TBQ is a self-reported questionnaire assessing the burden of treatment without restricting its scope to a single condition or treatment context. It is composed of 15 items rated on a Likert scale ranging from 0 (no impact) to 10 (considerable impact) related to the burden associated with taking medicine, self-monitoring, laboratory tests, physician visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment. Item scores can be summed into a global score, ranging from 0 to 150. Higher scores reflect higher treatment burden.

The quality of communication will be assessed with a modified version of 3 questions from the CAHPS Clinician and Group survey. These questions indicate the extent to which the communication is patient-centered, covering technical (explain things in a way you could understand) and affective (show respect for what you have to say) communication.

Hypoglycemia will be measured by asking participants about the frequency of any hypoglycemia (defined by a glucose level below 70 mg/dl \[Level 1 hypoglycemia\] or symptoms consistent with hypoglycemia), any blood glucose level below 54 mg/dl (Level 2 severe hypoglycemia), or any hypoglycemia requiring assistance from another person to treat.

To assess global quality of life, a single-item VAS survey will be used with scale ranging from 0 (worst possible)-to-100 (best possible).

Patients will rate their satisfaction with the approach used during the encounter on a 5-point Likert scale, which could have been usual care alone or usual care with the QBSafe ASK.

Clinicians will rate their satisfaction with the approach used during the encounter on a 5-point Likert scale, which could have been usual care alone or usual care with the QBSafe ASK.