Preventing glycaemic relapse in recently controlled type 2 diabetes patients: a randomised controlled trial.

AIMS/HYPOTHESIS: After achieving glycaemic control, many type 2 diabetic patients relapse to clinically significant levels of hyperglycaemia. We sought to determine the optimal frequency of telephone contact by nurse practitioners that was necessary to prevent glycaemic relapse. METHODS: This parallel, randomised controlled trial ran from June 2002 to February 2006 at an academic medical centre, studying 164 type 2 diabetic patients who had recently achieved glycaemic control. Participants were randomly assigned by sequential, concealed, computer-generated allocation to a 2 year maintenance strategy consisting of: (1) routine follow-up (n = 54); (2) routine follow-up and quarterly telephone contact (n = 55); or (3) routine follow-up and monthly telephone contact (n = 55). Blinding was not possible. The primary outcome was cumulative incidence of glycaemic relapse, defined as an increase in HbA(1c) of > or =1%; all participants were analysed. Cumulative incidence and prevalent proportions were compared. Weight change and hypoglycaemia were also assessed. RESULTS: All participants randomised were included in the analyses. The study was completed by 90% of participants and intervention fidelity was high. At 24 months, the cumulative incidence of relapse was 41%. At 12 months, prevalent proportions of relapse were 20%, 14% and 15% for control, quarterly contact and monthly contact, respectively. At 24 months, they were 25%, 21% and 29%, respectively. There was no statistically significant difference in cumulative incidence or prevalent proportions of relapse among the study arms. Adverse events did not differ between study arms. CONCLUSIONS/INTERPRETATION: This first randomised controlled trial to test an intervention to prevent glycaemic relapse found that regularly scheduled telephone contact by a nurse practitioner was no more effective than routine follow-up care in preventing glycaemic relapse.

Using real time process measurements to reduce catheter related bloodstream infections in the intensive care unit.

PROBLEM: Measuring a process of care in real time is essential for continuous quality improvement (CQI). Our inability to measure the process of central venous catheter (CVC) care in real time prevented CQI efforts aimed at reducing catheter related bloodstream infections (CR-BSIs) from these devices. DESIGN: A system was developed for measuring the process of CVC care in real time. We used these new process measurements to continuously monitor the system, guide CQI activities, and deliver performance feedback to providers. SETTING: Adult medical intensive care unit (MICU). KEY MEASURES FOR IMPROVEMENT: Measured process of CVC care in real time; CR-BSI rate and time between CR-BSI events; and performance feedback to staff. STRATEGIES FOR CHANGE: An interdisciplinary team developed a standardized, user friendly nursing checklist for CVC insertion. Infection control practitioners scanned the completed checklists into a computerized database, thereby generating real time measurements for the process of CVC insertion. Armed with these new process measurements, the team optimized the impact of a multifaceted intervention aimed at reducing CR-BSIs. EFFECTS OF CHANGE: The new checklist immediately provided real time measurements for the process of CVC insertion. These process measures allowed the team to directly monitor adherence to evidence-based guidelines. Through continuous process measurement, the team successfully overcame barriers to change, reduced the CR-BSI rate, and improved patient safety. Two years after the introduction of the checklist the CR-BSI rate remained at a historic low. LESSONS LEARNT: Measuring the process of CVC care in real time is feasible in the ICU. When trying to improve care, real time process measurements are an excellent tool for overcoming barriers to change and enhancing the sustainability of efforts. To continually improve patient safety, healthcare organizations should continually measure their key clinical processes in real time.

Body fat distribution and risk of diabetes among Chinese women.

OBJECTIVE: To assess the relationship between measures of central and overall obesity and risk of diabetes. DESIGN: Nested case-control study. SETTING: Shanghai, China. PARTICIPANTS: A total of 57 130 women were screened for diabetes at enrollment for the Shanghai Women's Health Study (SWHS), a population-based cohort study of Chinese women aged 40-70 y. In this study, 345 women diagnosed with diabetes and 2760 age-matched controls (eight controls per case), randomly selected from women who tested negative for urine glucose, were included. RESULTS: Risk of diabetes increased significantly with increasing levels of obesity, particularly with measures of central obesity. Compared to those in the lowest quartile, women in the highest quartile of body mass index (BMI) (>/=26.57) and waist to hip ratio (WHR) (>/=0.855) had a 2.57-fold (95% CI 1.75-3.77) and a 6.05-fold (95% CI 4.05-9.04) increased risk of diabetes, respectively. The risk of diabetes was elevated with increasing WHR at all levels of BMI, while the positive association between BMI and diabetes was observed primarily among women with a low WHR. However, test for multiplicative interaction was not statistically significant. CONCLUSIONS: Our data indicated that central obesity is a stronger risk factor for diabetes than overall obesity, suggesting that WHR may be a better indicator of risk of diabetes than BMI among Chinese women.

Overcoming turf battles: developing a pragmatic, collaborative model to improve glycemic control in patients with diabetes.

BACKGROUND: Collaboration between primary care physicians (PCPs) and endocrinologists should be the first step in improving care of patients with diabetes. However, the coordination of care between specialists and PCPs often does not work well. At Vanderbilt University Medical Center, a collaborative model between PCPs and endocrinology was used in an effort to improve glycemic control for patients with diabetes. METHODS: In 1998 a project team was formed; the team members attempted to find ways to improve the care of patients with diabetes, specifically patients with poor glycemic control. The team proceeded through ten iterations of the model before reaching one accepted by all-one with clear responsibilities and referral criteria. RESULTS: Survey results indicated a high level of satisfaction with the collaborative model among patients and PCPs. Appropriate referrals to the diabetes improvement program--a 12-week outpatient program consisting of instruction and support in diabetes self-management coupled with adjustment of insulin and oral hypoglycemic medications-increased during the team effort, and a control chart indicated a change in the process that was significant and sustained. The patients enrolled in the program experienced a reduction of mean glycated hemoglobin levels from 9.2% at entry to 7.5% after 3 months (p < 0.05). DISCUSSION: An initial first step to improving care is to create an environment of trust and collaboration between the PCPs and specialists who assist in that care. After this collaboration has been established, many of the improvements identified in other studies can more easily be implemented.

A taxonomy for diabetes educational interventions.

Diabetes education is a cornerstone of diabetes self-care management. Despite terrific progress in refining educational interventions, the diabetes literature continues to contain substantial inconsistencies in reporting the elements of educational interventions. This unnecessary variation in the quality of reporting has led to difficulties in understanding the results of educational research in diabetes. We provide a taxonomy that should prove helpful, both in the conceptual design of diabetes educational interventions and in the reporting of those interventions. An application of this taxonomy to 30 diabetes educational randomized controlled trials is presented to highlight the extent of variation in diabetes educational interventions.

Influences on day-to-day self-management of type 2 diabetes among African-American women: spirituality, the multi-caregiver role, and other social context factors.

OBJECTIVE: Many African-American women are affected by diabetes and its complications, and culturally appropriate lifestyle interventions that lead to improvements in glycemic control are urgently needed. The aim of this qualitative study was to identify culturally relevant psychosocial issues and social context variables influencing lifestyle behaviors--specifically diet and physical activity--of southern African-American women with diabetes. RESEARCH DESIGN AND METHODS: We conducted 10 focus group interviews with 70 southern African-American women with type 2 diabetes. Group interviews were audiotaped and transcripts were coded using qualitative data analysis software. A panel of reviewers analyzed the coded responses for emerging themes and trends. RESULTS: The dominant and most consistent themes that emerged from these focus groups were 1) spirituality as an important factor in general health, disease adjustment, and coping; 2) general life stress and multi-caregiving responsibilities interfering with daily disease management; and 3) the impact of diabetes manifested in feelings of dietary deprivation, physical and emotional "tiredness," "worry," and fear of diabetes complications. CONCLUSIONS: Our findings suggest that influences on diabetes self-management behaviors of African-American women may be best understood from a sociocultural and family context. Interventions to improve self-management for this population should recognize the influences of spirituality, general life stress, multi-caregiving responsibilities, and the psychological impact of diabetes. These findings suggest that family-centered and church-based approaches to diabetes care interventions are appropriate.

Development of a health status measure for older African-American women with type 2 diabetes.

OBJECTIVE: To develop a health status measure in older African-American women with type 2 diabetes. RESEARCH DESIGN AND METHODS: African-American women, age > or =40 years with type 2 diabetes, were recruited from central North Carolina to participate in three sequential phases: 1) Seven focus groups were convened and transcripts evaluated to generate questions and identify plausible domains; 2) Ten one-on-one cognitive response interviews were performed to ensure clarity and cultural appropriateness of the questions; and 3) 217 women participated in psychometric evaluation to establish the internal consistency and validity of the instrument. RESULTS: Three broad categories--mental, physical, and social well-being--captured important issues generated during the focus groups. "My diabetes" was added during the cognitive response interviews as a way of separating the impact of diabetes from coexisting issues that affect health status. The response option was changed from a six- to a four-point Likert scale to accommodate subject preference. Using principal components and subsequent promax rotation, we identified two hierarchical domains (mental and social well-being) and a physical symptom index. The internal consistency (Cronbach's alpha) of the mental and social well-being subscales are 0.83 and 0.93, respectively. A priori hypothesized correlations between subscales along with each subscale and glycated hemoglobin, diabetes duration, physical activity, and a perceived health competence scale helped establish the construct validity of the instrument. CONCLUSIONS: A culturally appropriate disease-specific health status measure for older African-American women with type 2 diabetes has been developed. We have established the internal consistency, construct validity, and factor analytic properties of the measure. This measure should prove useful for investigators who seek a health status instrument that addresses issues germane to African-American women with type 2 diabetes.

A diabetes management program for African American women with type 2 diabetes.

PURPOSE: This paper describes a clinic- and community-based diabetes intervention program designed to improve dietary, physical activity, and self-care behaviors of older African American women with type 2 diabetes. It also describes the study to evaluate this program and baseline characteristics of participants. METHODS: The New Leaf ... Choices for Healthy Living With Diabetes program consists of 4 clinic-based health counselor visits, a community intervention with 12 monthly phone calls from peer counselors, and 3 group sessions. A randomized, controlled trial to evaluate the effectiveness of this intervention is described. RESULTS: Seventeen focus groups of African American women were used to assessed the cultural relevance/acceptability of the intervention and measurement instruments. For the randomized trial, 200 African American women with type 2 diabetes were recruited from 7 practices in central North Carolina. Mean age was 59, mean diabetes duration was 10 years, and participants were markedly overweight and physically inactive. CONCLUSIONS: Participants found this program to be culturally relevant and acceptable. Its effects on diet, physical activity, and self-care behaviors will be assessed in a randomized trial.

Measuring subjective outcomes: rethinking reliability and validity.

Reliability and validity are criteria used to assess metric adequacy and are typically quantified by correlation coefficients. Reliability is described as the extent to which repeated measurements yield consistent results. Validity is described as the extent to which a measure actually measures what it purports to measure. These conceptualizations are less useful when applied to measures of subjective outcomes because they do not convey other influences that "drive" correlation coefficients. Consistency is a manifestation of a reliable instrument but does not ensure that an instrument is reliable. Establishing the validity of an instrument is a complex process that is heavily dependent on an investigator's hypothesis. Hence, validity coefficients may be more a reflection of hypothesis adequacy than of the extent to which instruments measure what they purport to measure. Appreciating how coefficients are influenced will better enable clinicians to assess the adequacy of subjective outcome measures.

Secondary prevention practices after acute myocardial infarction in a large city hospital.

Novel approaches to treat cholesterol are needed to effectively manage post-myocardial infarction patients in a public hospital setting. Although cardiologists were more likely to prescribe cholesterol-lowering agents than primary care practitioners, their impact on cholesterol reduction was still negligible.