Treatment adjustment and medication adherence for complex patients with diabetes, heart disease, and depression: a randomized controlled trial.

PURPOSE: Medication nonadherence, inconsistent patient self-monitoring, and inadequate treatment adjustment exacerbate poor disease control. In a collaborative, team-based, care management program for complex patients (TEAMcare), we assessed patient and physician behaviors (medication adherence, self-monitoring, and treatment adjustment) in achieving better outcomes for diabetes, coronary heart disease, and depression. METHODS: A randomized controlled trial was conducted (2007-2009) in 14 primary care clinics among 214 patients with poorly controlled diabetes (glycated hemoglobin [HbA(1c)] ≥8.5%) or coronary heart disease (blood pressure >140/90 mm Hg or low-density lipoprotein cholesterol >130 mg/dL) with coexisting depression (Patient Health Questionnaire-9 score ≥10). In the TEAMcare program, a nurse care manager collaborated closely with primary care physicians, patients, and consultants to deliver a treat-to-target approach across multiple conditions. Measures included medication initiation, adjustment, adherence, and disease self-monitoring. RESULTS: Pharmacotherapy initiation and adjustment rates were sixfold higher for antidepressants (relative rate [RR] = 6.20; P <.001), threefold higher for insulin (RR = 2.97; P <.001), and nearly twofold higher for antihypertensive medications (RR = 1.86, P <.001) among TEAMcare relative to usual care patients. Medication adherence did not differ between the 2 groups in any of the 5 therapeutic classes examined at 12 months. TEAMcare patients monitored blood pressure (RR = 3.20; P <.001) and glucose more frequently (RR = 1.28; P = .006). CONCLUSIONS: Frequent and timely treatment adjustment by primary care physicians, along with increased patient self-monitoring, improved control of diabetes, depression, and heart disease, with no change in medication adherence rates. High baseline adherence rates may have exerted a ceiling effect on potential improvements in medication adherence.

Depression and increased mortality in diabetes: unexpected causes of death.

PURPOSE: Recent evidence suggests that depression is linked to increased mortality among patients with diabetes. This study examines the association of depression with all-cause and cause-specific mortality in diabetes. METHODS: We conducted a prospective cohort study of primary care patients with type 2 diabetes at Group Health Cooperative in Washington state. We used the Patient Health Questionnaire (PHQ-9) to assess depression at baseline and reviewed medical records supplemented by the Washington state mortality registry to ascertain the causes of death. RESULTS: Among a cohort of 4,184 patients, 581 patients died during the follow-up period. Deaths occurred among 428 (12.9%) patients with no depression, among 88 (17.8%) patients with major depression, and among 65 (18.2%) patients with minor depression. Causes of death were grouped as cardiovascular disease, 42.7%; cancer, 26.9%; and deaths that were not due to cardiovascular disease or cancer, 30.5%. Infections, dementia, renal failure, and chronic obstructive pulmonary disease were the most frequent causes in the latter group. Adjusting for demographic characteristics, baseline major depression (relative to no depression) was significantly associated with all-cause mortality (hazard ratio [HR]=2.26, 95% confidence interval [CI], 1.79-2.85), with cardiovascular mortality (HR = 2.00; 95% CI, 1.37-2.94), and with noncardiovascular, noncancer mortality (HR = 3.35; 95% CI, 2.30-4.89). After additional adjustment for baseline clinical characteristics and health habits, major depression was significantly associated only with all-cause mortality (HR = 1.52; 95% CI, 1.19-1.95) and with death not caused by cancer or atherosclerotic cardiovascular disease (HR = 2.15; 95% CI, 1.43-3.24). Minor depression showed similar but nonsignificant associations. CONCLUSIONS: Patients with diabetes and coexisting depression face substantially elevated mortality risks beyond cardiovascular deaths.

Lipid screening in children and adolescents.

Despite enormous advances in research supporting lipid screening among adults, there are critical research gaps in our understanding of the potential benefit and harm of routine screening of young children and adults. Although clear clinical opportunities exist to test and treat individual children from high risk backgrounds, building the case for systematically screening all children as part of a comprehensive cardiovascular disease prevention program requires more convincing evidence that this type of screening will yield true net positive clinical and public health outcomes. This should not prevent the pediatric community from aggressive promotion of healthy lifestyles, both in the office and through effective public policy.

One-Step Approach to Identifying Gestational Diabetes Mellitus: Association With Perinatal Outcomes.

OBJECTIVE: To compare perinatal outcomes before and after a clinical guideline change from a two-step to a one-step approach to screening for gestational diabetes mellitus (GDM). METHODS: We conducted a before-after cohort study of women with singleton live birth deliveries within Kaiser Permanente Washington, a mixed-model health plan in Washington state. We used Kaiser Permanente Washington electronic health data and linked birth certificates. We compared outcomes before (January 2009-March 2011) and after (April 2012-December 2014) the guideline change among women who received prenatal care from health care providers internal to Kaiser Permanente Washington (n=4,977 before, n=6,337 after). We made the same comparison among women who received prenatal care from external health care providers (not exposed to the guideline change; n=3,386 before, n=4,454 after) to control for time trends unrelated to the guideline change. Adjusted relative risks and 95% CIs were estimated using Poisson generalized estimating equations. RESULTS: After the guideline change, receipt of the one-step approach became widespread among women cared for by Kaiser Permanente Washington internal providers (87%), and use of insulin increased 3.7-fold from 1.2% to 4.4%. Among women cared for by Kaiser Permanente Washington internal providers, GDM increased from 6.9% to 11.4%, induction of labor from 25.2% to 28.6%, neonatal hypoglycemia from 1.3% to 2.0%, and outpatient nonstress testing from 134.6 to 157.0 test days per 100 women. After accounting for background trends in outcomes (based on the women cared for by external providers), the guideline change was associated with increased incidence of GDM (relative risk [RR] 1.41, 95% CI 1.17-1.69), labor induction (RR 1.20, 95% CI 1.09-1.32), neonatal hypoglycemia (RR 1.77, 95% CI 1.14-2.75), and nonstress testing (RR 1.12, 95% CI 1.02-1.24% per 100 women). There was no association with other outcomes including cesarean delivery or macrosomia. CONCLUSION: Adopting the one-step approach was associated with a 41% increase in the diagnosis of GDM without improved maternal or neonatal outcomes.

Successful prospective prediction of type 1 diabetes in schoolchildren through multiple defined autoantibodies: an 8-year follow-up of the Washington State Diabetes Prediction Study.

OBJECTIVE: Almost 90% of type 1 diabetes appears in individuals without a close family history. We sought to evaluate the best current predictive strategy, multiple defined autoantibodies, in a long-term prospective study in the general population. RESEARCH DESIGN AND METHODS: Autoantibodies to pancreatic islets (islet cell antibodies [ICAs]) and defined autoantibodies (d-aab) to human GAD, IA2/ICA512, and insulin were tested in 4,505 Washington schoolchildren. Eight years later, 3,000 (67%) subjects were recontacted, including 97% of subjects with any test >99th percentile. RESULTS: Six subjects developed diabetes (median interval 2.8 years), all from among the 12 individuals with multiple d-aab, representing 50% positive predictive value (95% CI 25-75%) and 100% sensitivity (58-100%). Among the others, diabetes occurred in 0 of 6 with one d-aab plus ICA, 0 of 26 with ICA only, 0 of 7 with one d-aab equaling the 99th percentile and another d-aab equaling the 97.5th percentile, 0 of 86 with one d-aab, and 0 of 2,863 with no d-aab or ICA. Adjusted for verification bias, multiple d-aab were 99.9% specific (99.86-99.93%). At this age, new d-aab seldom appeared. Once present, d-aab usually persisted regardless of disease progression, although less so for insulin autoantibodies. Insulin secretion by sequential glucose tolerance testing remained normal in four multiple d-aab subjects not developing diabetes. Of children developing diabetes, five of six (83%) would be included if HLA-DQ genotyping preceded antibody testing, but HLA-DQ did not explain outcomes among high-risk subjects, even when considered along with other genetic markers. CONCLUSIONS: Multiple d-aab were established by age 14 years and prospectively identified all schoolchildren who developed type 1 diabetes within 8 years.

Depression and advanced complications of diabetes: a prospective cohort study.

OBJECTIVE: To prospectively examine the association of depression with risks for advanced macrovascular and microvascular complications among patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: A longitudinal cohort of 4,623 primary care patients with type 2 diabetes was enrolled in 2000-2002 and followed through 2005-2007. Advanced microvascular complications included blindness, end-stage renal disease, amputations, and renal failure deaths. Advanced macrovascular complications included myocardial infarction, stroke, cardiovascular procedures, and deaths. Medical record review, ICD-9 diagnostic and procedural codes, and death certificate data were used to ascertain outcomes in the 5-year follow-up. Proportional hazard models analyzed the association between baseline depression and risks of adverse outcomes. RESULTS: After adjustment for prior complications and demographic, clinical, and diabetes self-care variables, major depression was associated with significantly higher risks of adverse microvascular outcomes (hazard ratio 1.36 [95% CI 1.05-1.75]) and adverse macrovascular outcomes (1.24 [1.0-1.54]). CONCLUSIONS: Among people with type 2 diabetes, major depression is associated with an increased risk of clinically significant microvascular and macrovascular complications over the ensuing 5 years, even after adjusting for diabetes severity and self-care activities. Clinical and public health significance of these findings rises as the incidence of type 2 diabetes soars. Further research is needed to clarify the underlying mechanisms for this association and to test interventions to reduce the risk of diabetes complications among patients with comorbid depression.

A state-level application of the chronic illness breakthrough series: results from two collaboratives on diabetes in Washington State.

BACKGROUND: Breakthrough Series Collaboratives addressing chronic conditions have been conducted at the national level and in single health care delivery systems but not at the state level. Two state-level collaboratives were conducted: Diabetes Collaborative I (October 1999-November 2000) included 17 clinic teams from across the state, and Diabetes Collaborative II (February 2001-March 2002) included 30 teams and 6 health plans. METHODS: Both collaboratives took place in Washington State, where a diverse group of primary care practices participated, and health insurance plans partnered with the clinic teams. Teams individually tested and implement changes in their systems of care to address all components of the Chronic Care Model. RESULTS: All 47 teams completed the collaboratives, and all but one maintained a registry throughout the 13 months. Most teams demonstrated some amount of improvement on process and outcome measures that addressed blood sugar testing and control, blood pressure control, lipid testing and control, foot exams, dilated eye exams, and self-management goals. CONCLUSION: The benefits of holding collaboratives more locally include increased technical support and increased participation, translating into wider implementation of prevention-focused, patient-centered care.

Case studies from two collaboratives on diabetes in Washington State.

Two individual teams, one from a small, rural clinic and one from a larger urban health system, were able to introduce innovations in care and realize improvement in patient outcomes.