BACKGROUND/RATIONALE:
Despite a growing array of therapeutic options and efficacious treatment strategies to prevent or delay some of the most severe complications of type 2 diabetes, there continue to be many individuals with outcomes that are far from optimal. Interventions to improve diabetes care by educating providers and patients have been disappointing. In the past several years, case management has been widely advocated as a cost-effective approach to coordinate diabetes care and improve outcomes, although there is little rigorous evidence demonstrating the benefits of this type of intervention.

OBJECTIVE(S):
This study had the following specific aims: 1) to evaluate the effect of a targeted, proactive case management intervention for high risk veterans with type 2 diabetes on: a) glycemic control, b) intermediate cardiovascular outcomes, c) satisfaction, d) adherence to specific care standards, and e) short-term resource utilization; and 2) using Monte Carlo simulation models, to estimate the expected impact of changes in key processes of care and intermediate outcomes on end-stage outcomes.

METHODS:
This study was conducted as a prospective randomized controlled trial. Participating veterans with diabetes (N = 246) receiving care at two VAMCs were randomly assigned, stratified by site and baseline hemoglobin A1c (A1c), to the intervention or control group. The intervention consisted of two nurse practitioners who actively monitored and coordinated patient care, guided by approved treatment algorithms. Data for the study were collected through a baseline and exit examination, a baseline and exit survey, and the VA medical information system. The primary outcome measure was the change in glycemic control, as measured by A1c. Secondary outcomes included serum LDL, blood pressure, satisfaction, and resource utilization. The data were analyzed using univariate and bi-variate (t-test, Wilcoxon rank-sum, chi-square) methods as well as multivariable regression.

FINDINGS/RESULTS:
18-month follow up data were obtained for 94 percent of the study participants. Mean A1c values in the intervention and the control groups at both baseline and follow up were over nine percent (SD ± 2, p = .69), indicating persistent poor glycemic control. The mean change in LDL cholesterol was -18 mg/dL (SD ± 39) for the intervention group and -13 mg/dL (SD ± 38) for the controls (p = .37). For both groups, mean diastolic blood pressure decreased slightly (-2.5 mmHg ± 13 versus -3.3 mmHg ± 11, p = .61), while systolic blood pressure increased slightly (2.5 mmHg ± 24 versus 0.6 mmHg ± 20, p = .53). Intervention patients were generally more satisfied with their diabetes care and 78 percent rated their health care providers as better than average compared with 67 percent of those in the control group (p = .04). There were no substantial differences in resource use, including number of hospitalizations, outpatient primary care visits and medication costs, between study groups.

IMPACT:
These findings suggest that a collaborative case management model may not be an effective mechanism for improving key physiologic outcomes for some high-risk patients with type 2 diabetes or in certain clinical settings. Both the characteristics of patients targeted for intervention and how the intervention is administered are likely critical factors in determining the effectiveness of case management. Therefore, health systems and medical centers must recognize the potential limitations of this approach before expending substantial resources, time and effort on case management programs, as the expected improvements in outcomes and down-stream cost-savings may not be realized.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Krein SL, Klamerus ML, Vijan S, Lee JL, Fitzgerald JT, Pawlow A, Reeves P, Hayward RA. Case management for patients with poorly controlled diabetes: a randomized trial. The American journal of medicine. 2004 Jun 1; 116(11):732-9. [view]
2. Krein SL, Hofer TP, Kerr EA, Hayward RA. Whom should we profile? Examining diabetes care practice variation among primary care providers, provider groups, and health care facilities. Health services research. 2002 Oct 1; 37(5):1159-80. [view]

Journal Other

1. Krein SL, Vijan S, Choe HM, Hayward RA. Quality improvement strategies for type 2 diabetes. [Letter to the Editor]. JAMA : the journal of the American Medical Association. 2006 Dec 13; 296(22):2680; author reply 2681. [view]

DRA: none
DRE: Epidemiology, Treatment - Observational
Keywords: Clinical practice guidelines, Diabetes, Managed care
MeSH Terms: Diabetes Mellitus, Managed Care Programs, Guidelines