Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care
Brief Summary: Mounting evidence documents the positive impact of using patient decision aids (PtDA) to facilitate shared decision-making (SDM) between patients and physicians in preference sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains low. More compelling evidence is needed to make the case for policies that would accelerate adoption of PtDAs in routine clinical practice in primary care settings that serve diverse and economically disadvantaged populations. The investigators believe that it is now time to move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials of PtDAs, to evaluate whether these tools can also change health behavior and improve health outcomes. Therefore, the investigators will build on their expertise in working with community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a mixed-methods approach. The investigators patient sample will be drawn from primary care practices serving African American, Latino and Caucasian patients. The investigators will conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA, combined with telephone coaching, in increasing patient self-care and self-efficacy, increasing diabetes knowledge and improving clinical measures including glycosylated hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in effects of the patient decision aid, comparing African American, Latino and Caucasian patients and conduct in-depth interviews with a randomly selected subset of trial participants to explore patient perceptions of the decision aid and variation across racial/ethnic groups. The investigators hypothesize that, compared to the control condition, participants assigned to receiving the video PtDA program and telephone coaching will report: greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood pressure levels. The conceptual model guiding the investigators trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:

1. attitudes toward performing the behavior
2. perceived social norms about performing the behavior
3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these constructs directly or indirectly.


Options:
A: Arm Label: 1; Type: OTHER; Interventions: Drug: Insulin glulisine, Drug: Insulin glargine, Drug: Metformin | Arm Label: 2; Type: OTHER; Interventions: Drug: Insulin glulisine, Drug: Insulin glargine, Drug: Metformin | Intervention Type: DRUG; Name: Insulin glulisine; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Insulin glargine; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): 1, 2
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Expanded Chronic Care Model | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Expanded Chronic Care Model; Assigned to Arm(s): 1
C: Intervention Type: BEHAVIORAL; Name: Multidisciplinary team care; Assigned to Arm(s): N/A
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Patient video decision aid & telephone coaching | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Printed educational brochure | Intervention Type: BEHAVIORAL; Name: Patient video decision aid & telephone coaching; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Printed educational brochure; Assigned to Arm(s): 2

Answer: D