QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.

Study Overview
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Brief Summary
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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
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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.

Official Title
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QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.

Conditions
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Type2Diabetes, Diabetes

Intervention / Treatment
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* Behavioral: QBSafe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QBSafe intervention<br> | Behavioral: QBSafe<br>* an intervention comprised of (a) a set of conversation cards (QBSafe ASK) 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.<br>|
| No Intervention: usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illness intrusiveness measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6 | 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. the 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 | Month 6 | 
| HbA1c at Month 6 | HbA1c value at month 6. Analysis will model the 6 month HbA1c assessment adjusting for arm and the initial score. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes distress will be measured using the Diabetes Distress Scale (DDS-17) at Month 6 | 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 (< 2.0), moderate distress (greater than or equal to 2.0 and less than or equal to 2.9) and high distress (greater than equal to 3.0). Moderate and high distress are considered 'clinically significant.' | Month 6 | 
| Treatment burden will be assessed using the Treatment Burden Questionnaire (TBQ) at Month 6 | 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. | Month 6 | 
| Quality of life was assessed using the Visual Analogue Scale (VAS) at Month 6. | 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). | Month 6 | 
| Hypoglycemia measured at month 6 | 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. | Month 6 | 
| Quality of communication assessed using 3 questions from the CAHPS Clinician and Group survey | 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. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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A1c, HbA1c