Context Little is known about the effects of quality-of-care improvement programs on the process of care and outcomes of diabetes. Contribution The study involved 8661 patients with diabetes, 63 provider groups, and 3 disease management strategies (provider feedback, reminders, and structured care). The quality measures included 8 processes of care, 3 intermediate diabetes outcomes, and medication management of these outcomes. More intense disease management strategies predicted higher measures of many processes of care but only 1 intermediate outcome and 1 medication management outcome. Implications The disease management strategies improved processes of care but not outcomes. Experts in quality improvement may need to refocus their efforts. The Editors Persons with diabetes continue to receive suboptimal care (16). To improve quality, many health systems have implemented disease management programs for diabetes and other chronic conditions (79). These programs typically incorporate population-based strategies, such as disease registries, clinical guidelines, performance feedback, physician reminders, self-management support for patients, and targeted case management for high-risk patients (10). Evidence for the effectiveness of disease management comes primarily from small efficacy trials (1020). Such studies consistently found improved processes of diabetes care; however, improvements in outcomes (such as control of cardiovascular disease risk factors) were less consistent (12, 17, 18, 2022). Furthermore, most studies evaluated only 1 or 2 strategies (instead of multicomponent programs) in selected clinical settings. It is unclear how well findings from these smaller studies apply to entire patient populations. Many components of disease management focus on improving processes of care. Early performance measurement projects, such as the Health Plan Employer Data Information System (23) and the Diabetes Quality Improvement Program (5), emphasized the importance of such processes as annual retinal screening or hemoglobin A1c determination. Particularly for health plans, process measures are more readily available than are outcomes data. However, if disease management is to improve patient outcomes, it must also improve intermediate outcomes, such as hemoglobin A1c levels, systolic blood pressure, and serum low-density lipoprotein (LDL) cholesterol levels. Translating Research into Action for Diabetes (TRIAD) (24) is a multicenter study of diabetes care in managed care. The TRIAD study's central hypothesis is that health care systems features can affect quality of care. Here, we examine how 3 disease management strategies vary in intensity across physician groups and whether physician groups with more intensive disease management have higher quality of diabetes care. We assess quality by processes of care, by levels of intermediate outcomes, and by current clinical management of these outcomes. Methods Overview of the TRIAD Study and Sample The TRIAD study's sampling frame, methods, key hypotheses, and power calculations are detailed elsewhere (24). The study comprised 6 collaborating translational research centers that were partnered with 10 managed care health plans in 7 states. Of the 10 plans, 7 contracted with 1 to 26 physician groups (total, 68 groups), whereas 4 plans directly contracted with individual physicians. A standard algorithm was applied to automated pharmacy, laboratory utilization, and inpatient and outpatient diagnostic data (25) to identify all community-dwelling patients with diabetes who were 18 years of age and older and who had been continuously enrolled in the TRIAD health plan for at least 18 months. The study cohort was randomly sampled from this population. Sampled patients were recruited between July 2000 and October 2001 by using computer-assisted telephone interviews or written surveys that were conducted in English or Spanish. Eligibility was confirmed if patients verified that they had had diabetes for at least 12 months and had received most of their diabetes care through the TRIAD health plan. Permission was sought from all respondents to request copies of their outpatient medical records for the previous 18 months. All health plan and physician group directors received mailed surveys (Appendix Figure) during the same interval. Face-to-face or telephone interviews were used to complete and clarify responses. Each director was offered $100 for completing the survey. Appendix Figure. Translating Research into Action for Diabetes (TRIAD) Physician Group Survey. The TRIAD study was reviewed and approved by the institutional review boards of each research center and by the Centers for Disease Control and Prevention (CDC). Informed consent was obtained from all survey respondents. Data Sources Patient surveys included questions on health status, diabetes duration, current diabetes treatment, and demographic characteristics. Of 13086 contacted and eligible persons, 11927 (91%) completed the survey (56.6% by computer-assisted telephone interview and 43.4% by written survey) (Figure). We were unable to contact many individuals. Using a practice that is endorsed by the Council of American Survey Research Organizations (26), we assumed that persons whom we could not contact or for whom we could not confirm eligibility had the same eligibility rate as those contacted. Under that assumption, the response rate was 69%. Figure. Description of sampling and response rate. xx Of 11927 patients who completed a survey, 8661 (73%) consented to medical record review and subsequently had charts available for review. Centrally trained reviewers used standardized data collection software to abstract process measures, most recent levels of hemoglobin A1c, upper limits of normal for hemoglobin A1c measurements that were recorded, serum LDL cholesterol levels, systolic blood pressure, current medications, and comorbid conditions. Interrater reliability () for the main quality measures ranged from 0.86 to 0.94. All 10 health plan directors and 52 of 68 physician group directors completed surveys. Surveys assessed organizational age, size, structure, profit status, insurance products, contracting arrangements, history of involvement with managed care, and detailed information on the organization's use of diabetes disease management strategies. Of the physician groups that did not respond (443 participants), 11 existed solely for the purpose of contracting with plans and had no diabetes disease management. These physician groups were assumed to have no care management strategies and were included in the analyses, as were patient groups (1150 participants) from the 4 health plans that contracted directly with physicians. The remaining 5 groups (159 participants) did not respond and were excluded from analyses (Figure). Consequently, the resulting sample included a total of 8661 survey respondents with charts available for review and data from 63 physician groups and 4 additional health plans (Figure). Mean duration of diabetes, body mass index, and health status did not meaningfully differ between persons whose medical records and physician group variables were available to the study team and those whose records were unavailable. Predictors, End Points, and Covariates The primary predictors were 3 measures of the intensity of disease management strategies: physician reminders, performance feedback, and structured care. These were calculated for physician groups and health plans from multiple survey items. A detailed description of the methods used to calculate composite intensity scores is provided in Appendix 2. Selected item-level responses for physician groups in the most intense versus least intense tercile of each strategy are displayed in Table 1. Table 1. Selected Item-Level Responses for Provider Groups for Each Disease Management Strategy* The physician reminders intensity score was derived from 2 questions, which detailed the types and content of the reminders physicians received. Groups whose use of reminders represented the upper tercile of intensity were found to have reminded physicians about 4 care processes on average. Most groups in the upper tercile delivered reminders electronically at the point of care. Performance feedback intensity was obtained by tallying responses to a checklist of possible diabetes process and outcome feedback items. A total of 86% and 82% of groups in the upper tercile included levels of hemoglobin A1c and serum LDL cholesterol, respectively, in feedback to physicians (Table 1). Physician feedback focused on many of the same elements of care as reminders. The use of formal case management, diabetes guidelines, patient reminders, and diabetes education correlated highly in physician groups (Pearson correlation coefficients ranged from 0.63 to 0.88); therefore, we could not look at these approaches independently. Consequently, we combined the 4 approaches into a single composite score for structured diabetes care management. Use of formal case management was assessed by the proportion of patients with diabetes who were enrolled, the number of case managers per 10000 patients, the extent to which the program targeted high-risk patients, and a checklist of case management activities. The clinical guidelines were scored to reflect the extent of implementation. The highest score was assigned to physician groups that incorporated guidelines into automated physician or patient reminders. Patient reminder intensity incorporated the number, type, and frequency of reminders sent. On average, physician groups in the upper tercile had diabetes education as a covered benefit, whereas those in the lowest tercile generally did not have these programs. Because of the differing numbers of questions and wide range of possible values within each intensity score, each question was z-transformed to a mean of 0.0 and standard deviation near or equal to 1.0 to facilitate comparison. Sco
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