The Partnership to Improve Diabetes Education Trial: a Cluster Randomized Trial Addressing Health Communication in Diabetes Care.

BACKGROUND: Effective type 2 diabetes care remains a challenge for patients including those receiving primary care in safety net settings. OBJECTIVE: The Partnership to Improve Diabetes Education (PRIDE) trial team and leaders from a regional department of health evaluated approaches to improve care for vulnerable patients. DESIGN: Cluster randomized controlled trial. PATIENTS: Adults with uncontrolled type 2 diabetes seeking care across 10 unblinded, randomly assigned safety net clinics in Middle TN. INTERVENTIONS: A literacy-sensitive, provider-focused, health communication intervention (PRIDE; 5 clinics) vs. standard diabetes education (5 clinics). MAIN MEASURES: Participant-level primary outcome was glycemic control [A1c] at 12 months. Secondary outcomes included select health behaviors and psychosocial aspects of care at 12 and 24 months. Adjusted mixed effects regression models were used to examine the comparative effectiveness of each approach to care. KEY RESULTS: Of 410 patients enrolled, 364 (89%) were included in analyses. Median age was 51 years; Black and Hispanic patients represented 18% and 25%; 96% were uninsured, and 82% had low annual income level (< $20,000); adequate health literacy was seen in 83%, but numeracy deficits were common. At 12 months, significant within-group treatment effects occurred from baseline for both PRIDE and control sites: adjusted A1c (- 0.76 [95% CI, - 1.08 to - 0.44]; P < .001 vs - 0.54 [95% CI, - 0.86 to - 0.21]; P = .001), odds of poor eating (0.53 [95% CI, 0.33-0.83]; P = .01 vs 0.42 [95% CI, 0.26-0.68]; P < .001), treatment satisfaction (3.93 [95% CI, 2.48-6.21]; P < .001 vs 3.04 [95% CI, 1.93-4.77]; P < .001), and self-efficacy (2.97 [95% CI, 1.89-4.67]; P < .001 vs 1.81 [95% CI, 1.1-2.84]; P = .01). No significant difference was observed between study arms in adjusted analyses. CONCLUSIONS: Both interventions improved the participant's A1c and behavioral outcomes. PRIDE was not more effective than standard education. Further research may elucidate the added value of a focused health communication program in this setting.

An Integrative Medicine Educational Program for Radiation Oncology Patients: Patient-Reported Outcomes.

Purpose: Complementary health approaches (CHAs) equip patients to self-manage radiation therapy (RT)-related symptoms and fulfill unmet needs, but few disclose CHA use to their radiation oncologist. An integrative medicine educational program (IMEP) was developed to assess its ability to improve patient self-efficacy for symptom management and CHA use disclosure. Methods and Materials: The IMEP included 4 1-hour sessions covering topics of (1) meditation, (2) yoga, (3) massage therapy, and (4) nutrition. Individuals over age 18 years and actively receiving RT were administered presession and postsession surveys. The primary outcomes were intention to disclose CHA use and self-efficacy. Qualitative data were assessed with a thematic approach. Results: Overall, 23 patients attended 1 or more sessions, yielding 43 completed surveys. Compared with 35.9% of participants who had disclosed CHA use before the session, 67.4% intended to disclose after the session. Of the 5 self-efficacy statements, there were significant improvements in "I have ownership over my health" (increase of 0.42; 95% CI, 0.07-0.77; P = .01), "I have tools to manage my disease on my own" (1.14; 95% CI, 0.42-1.87; P = .001), and "I have control over my cancer" (0.96; 95% CI, 0.39-1.53; P < .001). Barriers to involvement included transportation, timing relative to RT appointment, and poor performance status. Conclusions: A radiation-specific IMEP resulted in a high rate of intention to disclose CHA use and improvements in patients' reported self-efficacy to manage radiation-related symptoms. However, substantial resources were needed to deliver the IMEP. Future work must focus on increasing accessibility through telehealth and flexible timing.

The Diabetes Literacy and Numeracy Education Toolkit (DLNET): materials to facilitate diabetes education and management in patients with low literacy and numeracy skills.

PURPOSE: Diabetes self-management education is an important component of comprehensive diabetes care. Patients with low health literacy and numeracy may have difficulty translating information from traditional diabetes educational programs and materials into effective self-care. METHODS: To address this potential barrier to successful diabetes teaching and counseling, the authors developed the Diabetes Literacy and Numeracy Education Toolkit (DLNET). CONCLUSION: The DLNET is composed of 24 interactive modules covering standard diabetes care topics that can be customized to individual patient needs and used by all members of the multidisciplinary diabetes care team. The material's content and formatting aims to improve the ease of use for diabetes patients with low literacy and numeracy by adhering to a lower text reading level, using illustrations for key concepts, and color-coding and other accommodations to guide patients through instructions for self-care. Individual sections of the DLNET may be provided to patients for initial teaching, as well as for reinforcement. Although designed for lower literacy and numeracy skills, the DLNET provides unique materials to facilitate diabetes education for all patients.

Glycemic relapse in type 2 diabetes.

OBJECTIVE: To characterize the occurrence of glycemic relapse after initial improvement in blood glucose levels and to describe predictors of relapse in patients with type 2 diabetes. METHODS: Occurrence of glycemic relapse was analyzed in 393 consecutive patients with type 2 diabetes after participation in a 3-month intensive outpatient intervention. All patients had hemoglobin A1c (A1C) values (3)7% before the intervention and had achieved adequate glycemic control (nadir A1C<7%) afterward. The median follow-up time was 26.5 months. Relapse was defined as a subsequent increase in A1C to (3)7%. RESULTS: The probability of glycemic relapse was 45% at 1 year after the intervention and was 76% at 3 years. The median time to relapse was 15.2 months. Cox multivariate regression analysis indicated that treatment with insulin was associated with a greater risk of relapse-- hazard ratio=1.5 (95% confidence interval, 1.1 to 2.2), after controlling for the patient's age, sex, race, body mass index, duration of diabetes, weight change during the intervention, and nadir A1C value. Among those patients not treated with insulin at the end of the intervention, a shorter duration of diabetes and weight loss during the intervention period were significantly associated with decreased risk of relapse. CONCLUSION: The majority of study patients with type 2 diabetes who attained satisfactory glycemic control after intensive outpatient intervention had a relapse after the end of the intervention period. Patients receiving insulin therapy were at particular risk of glycemic relapse. Therefore, such patients should receive high priority for continuation of intensive care or for other relapse prevention measures.

The PRIDE (Partnership to Improve Diabetes Education) Toolkit: Development and Evaluation of Novel Literacy and Culturally Sensitive Diabetes Education Materials.

PURPOSE: Patients with low literacy, low numeracy, and/or linguistic needs can experience challenges understanding diabetes information and applying concepts to their self-management. The authors designed a toolkit of education materials that are sensitive to patients' literacy and numeracy levels, language preferences, and cultural norms and that encourage shared goal setting to improve diabetes self-management and health outcomes. The Partnership to Improve Diabetes Education (PRIDE) toolkit was developed to facilitate diabetes self-management education and support. METHODS: The PRIDE toolkit includes a comprehensive set of 30 interactive education modules in English and Spanish to support diabetes self-management activities. The toolkit builds upon the authors' previously validated Diabetes Literacy and Numeracy Education Toolkit (DLNET) by adding a focus on shared goal setting, addressing the needs of Spanish-speaking patients, and including a broader range of diabetes management topics. Each PRIDE module was evaluated using the Suitability Assessment of Materials (SAM) instrument to determine the material's cultural appropriateness and its sensitivity to the needs of patients with low literacy and low numeracy. Reading grade level was also assessed using the Automated Readability Index (ARI), Coleman-Liau, Flesch-Kincaid, Fry, and SMOG formulas. CONCLUSIONS: The average reading grade level of the materials was 5.3 (SD 1.0), with a mean SAM of 91.2 (SD 5.4). All of the 30 modules received a "superior" score (SAM >70%) when evaluated by 2 independent raters. The PRIDE toolkit modules can be used by all members of a multidisciplinary team to assist patients with low literacy and low numeracy in managing their diabetes.

The diabetes nutrition education study randomized controlled trial: A comparative effectiveness study of approaches to nutrition in diabetes self-management education.

OBJECTIVE: To compare the effectiveness of different approaches to nutrition education in diabetes self-management education and support (DSME/S). METHODS: We randomized 150 adults with type 2 diabetes to either certified diabetes educator (CDE)-delivered DSME/S with carbohydrate gram counting or the modified plate method versus general health education. The primary outcome was change in HbA1C over 6 months. RESULTS: At 6 months, HbA1C improved within the plate method [-0.83% (-1.29, -0.33), P<0.001] and carbohydrate counting [-0.63% (-1.03, -0.18), P=0.04] groups but not the control group [P=0.34]. Change in HbA1C from baseline between the control and intervention groups was not significant at 6 months (carbohydrate counting, P=0.36; modified plate method, P=0.08). In a pre-specified subgroup analysis of patients with a baseline HbA1C 7-10%, change in HbA1C from baseline improved in the carbohydrate counting [-0.86% (-1.47, -0.26), P=0.006] and plate method groups [-0.76% (-1.33, -0.19), P=0.01] compared to controls. CONCLUSION: CDE-delivered DSME/S focused on carbohydrate counting or the modified plate method improved glycemic control in patients with an initial HbA1C between 7 and 10%. PRACTICE IMPLICATIONS: Both carbohydrate counting and the modified plate method improve glycemic control as part of DSME/S.

Personality characteristics as a function of frequency and type of substance use.

Problematic and unhealthy personality characteristics have typically been the focus of researchers interested in the possible causes of substance use/abuse. Recent research has begun to identify differences between individuals based upon frequency of use, with indications that moderate users may have "healthier" characteristics than either abstainers or regular users. The present study was conducted in a rural setting and compared personality structure (based on the California Psychological Inventory) among three groups of college students: abstainers, experimenters, and regular users. The comparisons were conducted as a function of all illicit substance use (excluding alcohol) and for alcohol use only. Minimal support was obtained for the above hypothesis when comparing the three groups on illicit substance use. When comparing the three groups on alcohol use only, support for the theory was identified, with fewer differences found between the experimenters and the abstainers than between the experimenters and the regular users. It is suggested that rural use of psychoactive substances may be more limited to alcohol due to easier availability and less stigma. Data supporting the "healthier" personality structure of moderate users of alcohol would thus be more likely in rural settings even though such use would still be "risky" behavior given its illegality for individuals under age 21. The need for adaptations to current treatment approaches is suggested.

Numeracy and dietary intake in patients with type 2 diabetes.

PURPOSE: The purpose of this study is to describe the association between numeracy and self-reported dietary intake in patients with type 2 diabetes. METHODS: Numeracy and dietary intake were assessed with the validated Diabetes Numeracy Test and a validated food frequency questionnaire in a cross-sectional study of 150 primary care patients enrolled in a randomized clinical trial at an academic medical center between April 2008 and October 2009. Associations between numeracy and caloric and macronutrient intakes were examined with linear regression models. RESULTS: Patients with lower numeracy consumed a higher percentage of calories from carbohydrates and lower percentages from protein and fat. However, no differences in energy consumption or the percentage of energy intake owing to carbohydrates, fat, or protein were observed in adjusted analyses. Patients with lower numeracy were significantly more likely to report extremely high or low energy intake inconsistent with standard dietary intake. CONCLUSIONS: Numeracy was not associated with dietary intake in adjusted analyses. Low numeracy was associated with inaccurate dietary reporting. Providers who take dietary histories in patients with diabetes may need to consider numeracy in their assessment of dietary intake.

Extending nurse practitioner care using the virtual reality world of second life.

The growth of Internet applications has substantially broadened the potential for its use in global telehealth. This pilot project used the virtual reality world of Second Life for diabetic patients to meet with their nurse practitioners for their maintenance visits. Using avatars and the online patient portal, these scheduled visits were designed to meet the needs of the patients as determined by the results from a questionnaire completed by patients prior to the visit. The virtual visits took place in the replicated building where patients typically receive their care, the Eskind Diabetes Clinic. Orientation sessions to Second Life were made available prior to the actual visit, and additional online resources were made available after the visit was over. Although only seven pilot patients have currently completed visits, data illustrate the positive potential use of this treatment modality for future study.

A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: study protocol (NCT00362193).

BACKGROUND: Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. OBJECTIVE: This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. METHODS: The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive), routine care with phone contact every three months (moderate intensity) or routine care with phone contact every month (most intensive). CONCLUSION: The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.

Improving glycemic control in adults with diabetes mellitus: shared responsibility in primary care practices.

BACKGROUND: Primary care physicians provide care for most patients with diabetes mellitus, but few have the resources to achieve the level of glycemic control needed to avert complications METHODS: Primary care physicians referred patients with unsatisfactory glycemic control, frequent hypoglycemia, or inadequate self-management to an endocrinologist-directed team of nurse and dietitian educators for a 3-month program of intensive diabetes care. Patients had at least weekly contact with a diabetes educator and received changes in insulin and/or other medication, coupled with extensive individualized instruction. The main outcome measurement was change in glycosylated hemoglobin (HbA1c) level at 3 months. RESULTS: The first 350 patients who completed the program had overall mean decrease in HbA1c level of 1.7% (95% CI 1.4%-1.9%). CONCLUSIONS: Barriers to improving glycemic control may be overcome by establishment of a system of collaboration between primary care providers and endocrinologist-directed diabetes educators.