HSR&D Home » Research » IIR 12-050 – HSR&D Study
A randomized trial of an educational intervention in type 2 diabetes patients
Howard S. Gordon, MD BS
Jesse Brown VA Medical Center, Chicago, IL
Funding Period: June 2013 - May 2017
Diabetes is estimated to affect up to 1 in 5 VA patients overall and up to 1 in 4 racial/ethnic minority patients. Patients with low health literacy and minority groups have more difficulty communicating with physicians, report lower adherence to physicians' recommendations, and have higher rates of poor diabetes outcomes. Activating patients to use more effective communication with physicians' can lead to better adherence to treatment and to better biomedical outcomes. In this project we build upon our prior work from two HSRD funded pilot projects to improve doctor patient communication in patients with type 2 diabetes mellitus (T2DM). In a previously funded short-term project, SHP-08-182, we conducted focus groups with patients with T2DM to elicit and understand from the patient perspective, barriers to communicating with their physician. This qualitative work was used in a subsequent pilot project, PPO-08-402 to refine and pilot test an educational video to encourage patients to use active participatory communication in their visits to physicians. This work was successfully completed and the product is a 10 minute video titled "Speak Up!" that in testing was found to be acceptable to patients and feasible for patients to view immediately preceding their medical encounter.
In this project (ACTIVet) we tested the effectiveness of the video (Speak Up!) as an intervention to improve patients' communication. Our primary aim is to conduct a randomized controlled trial of an intervention testing whether the intervention increases patients' active participatory communication behaviors, patients' post-visit ratings of self efficacy to communicate, medication adherence, and diabetic control (HgbA1c). There are four secondary aims which include assessments of the (1) mediators, and (2) moderators of the relationship of the intervention condition to outcomes, (3) costs of the intervention, and (4) an evaluation of the feasibility of using the video for pre-visit preparation.
We conducted a two group, pre-post, randomized controlled, single-site trial of the Speak Up! intervention video in patients with T2DM. We screened 794 patients and consented 176 patients (excluding 7 who moved to another facility or to a non-participating PCP. We randomly assigned 169 patients with 77 allocated to and 64 received the intervention and 92 allocated to and 83 received the allocated control. Two patients were lost to follow-up. Patients were seen at pre and post-intervention visit by one of 21 Primary care providers. Patients were randomized to view a 10 minute intervention or control video prior to their second visit. Visits were audio recorded. Analysis of the audio-recordings is ongoing. Audio-recordings are analyzed for patients' and physicians' communication behaviors. Self-efficacy to communicate was collected by self report. Adherence was collected by self-report and by medication possession ratio. Diabetic control was collected by chart review. Analyses examined the relationship of the intervention condition to outcomes, mediators and moderators of that relationship, and will estimate costs of the intervention and feasibility of using the video in a busy clinic.
There were no statistically significant differences in age, race, gender, education, marital status, income, health literacy, quality of life, trust in physician, or the other co-variates measured between the control and intervention groups (P>0.10). In bivariate analysis (n=147), self-efficacy at visit 1 among intervention and control was not statistically different (P=0.94), but at visit 2 self-efficacy was somewhat higher (P=0.07) in the intervention compared with the controls. After adjusting for baseline self-efficacy score using multiple regression, patients in the intervention group had higher self-efficacy compared with the control group [Beta 0.71 (SE 0.32); P=0.03]. Mean A1c was 9.7% before visit 1 and 9.1% after visit 2. In mixed regression analyses using A1c values from 4 weeks to one year after visit 2, the A1c decreased 0.6% more in the intervention than the control group P=0.02.
VA transformation efforts including interprofessional Patient Aligned Care Teams (PACT) are focusing attention on patient-centered care. Improved communication is a central feature of patient centered care. Communication in medical interactions is critical and plays an important, but often overlooked role in health-care decision making and quality of care. Patients who have difficulty communicating are less involved in consultations with their physician, receive less information and support, and are less satisfied with their care. In turn, these patients may not understand their treatment options, may have less knowledge, less positive beliefs about treatment and less trust in physician, and may experience poorer health outcomes. Teaching patients to communicate more effectively is patient-centered because it inherently supports a patient-driven approach to delivering healthcare. Our intervention is designed to encourage patients' active communication. Improving patients' communication is a unique focus that may supplement and add to the VA efforts in areas such as the Patient Aligned Care Team. In addition, the methodology is not disease specific and may be a paradigm for improvement in other conditions.
The "Speak Up" (intervention) video developed for this study was mentioned in an article by Dr. Gordon in the May 2015 issue of VA HSRD FORUM.
The "Speak Up" video developed for this study is being used as part of new patient orientation at the CBOC in Crown Point, Indiana. An informal survey indicated that this use was well received by the Veterans.
The "Speak Up" video developed for this study is now incorporated into the intervention of another VA project ("Point-of-care Health Literacy and Activation Information to improve diabetes care" HSRD Project #12-426 PI-Woodard). "Speak Up" is used to assist patients communicate with their physician/provider about their personalized goal setting.
Preliminary results suggest that the brief pre-visit video intervention (Speak Up!) improved diabetes patients' self-efficacy in interacting with their physicians and led to improvement in diabetic control.
External Links for this Project
NIH ReporterGrant Number: I01HX000919-01
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DRA: Aging, Older Veterans' Health and Care, Health Systems, Diabetes and Other Endocrine Disorders
DRE: Treatment - Observational, Prognosis, Treatment - Efficacy/Effectiveness Clinical Trial
MeSH Terms: none