Medical clinics versus usual care for patients with both diabetes and hypertension: a randomized trial.

BACKGROUND: Group medical clinics (GMCs) are widely used in the management of diabetes and hypertension, but data on their effectiveness are limited. OBJECTIVE: To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00286741) SETTING: 2 Veterans Affairs Medical Centers in North Carolina and Virginia. PATIENTS: 239 patients with poorly controlled diabetes (hemoglobin A(1c) [HbA(1c)] level > or =7.5%) and hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg). INTERVENTION: Patients were randomly assigned within each center to either attend a GMC or receive usual care. Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist, a pharmacist, and a nurse or other certified diabetes educator. Each session included structured group interactions moderated by the educator. The pharmacist and physician adjusted medication to manage each patient's HbA(1c) level and blood pressure. MEASUREMENTS: Hemoglobin A(1c) level and systolic blood pressure, measured by blinded research personnel at baseline, study midpoint (median, 6.8 months), and study completion (median follow-up, 12.8 months). Linear mixed models, adjusted for clustering within GMCs, were used to compare HbA(1c) levels and systolic blood pressure between the intervention and control groups. RESULTS: Mean baseline systolic blood pressure and HbA(1c) level were 152.9 mm Hg (SD, 14.2) and 9.2% (SD, 1.4), respectively. At the end of the study, mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group (P = 0.011 by linear mixed model), whereas mean HbA(1c) level improved by 0.8% in the GMC group and 0.5% in the usual care group (P = 0.159). LIMITATION: Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention. CONCLUSION: Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c) level in diabetic patients. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs Health Services Research and Development Service.

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.

Cognitive dysfunction and poor health literacy are common in veterans presenting with acute coronary syndrome: insights from the MEDICATION study.

BACKGROUND: Patient nonadherence to cardiac medications following acute coronary syndrome (ACS) is associated with increased risk of recurrent events. However, the prevalence of cognitive dysfunction and poor health literacy among ACS patients and their association with medication nonadherence are poorly understood. METHODS: We assessed rates of cognitive dysfunction and poor health literacy among participants of a clinical trial that tested the effectiveness of an intervention to improve medication adherence in patients hospitalized with ACS. Of 254 patients, 249 completed the Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) survey, an assessment of risk for poor literacy, and the St Louis University Mental Status (SLUMS) exam, a tool assessing for neurocognitive deficits, during ACS hospitalization. We assessed if SLUMS or REALM-R scores were associated with medication adherence. RESULTS: Based on SLUMS score, 14% of patients were categorized as having dementia, and 52% with mild neurocognitive disorder (MNCD). Based on REALM-R score of ≤6, 34% of patients were categorized as at risk for poor health literacy. There was no association between poor health literacy and medication nonadherence. Of those with MNCD, 35.5% were nonadherent, compared to 17.5% with normal cognitive function and 6.7% with dementia. In multivariable analysis, cognitive dysfunction was associated with medication nonadherence (P=0.007), mainly due to an association between MNCD and nonadherence (odds ratio =12.2, 95% confidence interval =1.9 to 243; P=0.007). Cognitive status was not associated with adherence in patients randomized to the intervention. CONCLUSION: Cognitive dysfunction and risk for poor health literacy are common in patients hospitalized with ACS. We found an association between MNCD and medication nonadherence in the usual care group but not in the intervention group. These findings suggest efforts to screen for MNCD are needed during ACS hospitalization to identify patients at risk for nonadherence and who may benefit from an adherence intervention.

Can group medical clinics improve lipid management in diabetes?

BACKGROUND: Group medical clinics may improve diabetes and hypertension control, but data about dyslipidemia are limited. We examined the impact of group medical clinics on lipids among patients with uncontrolled diabetes and hypertension. METHODS: Prespecified secondary analysis of 239 veterans randomized to group medical clinics or usual care. Lipids were assessed at study baseline, midpoint, and end. We used linear mixed models to compare lipid levels between arms and generalized estimating equation models to compare low-density lipoprotein cholesterol (LDL-C) goal attainment. An additional post hoc analysis examined intensification of cholesterol-lowering medications in both arms. RESULTS: At baseline, mean total cholesterol was 169.7 mg/dL (SD 47.8), LDL-C 98.2 mg/dL (SD 41.7), and high-density lipoprotein cholesterol (HDL-C) 39.3 mg/dL (SD 13.0). Median baseline triglycerides were 131 mg/dL (interquartile range 122). By study end, mean total cholesterol and LDL-C in group medical clinics were 14.2 mg/dL (P = .01) and 9.2 mg/dL (P = .02) lower than usual care, respectively; 76% of group medical clinic patients met goals for LDL-C, versus 61% of usual care patients (P = .02). Triglycerides and HDL-C remained similar between study arms. Treatment intensification occurred in 52% of group medical clinic patients, versus 37% of usual care patients between study baseline and end (P = .04). The mean statin dose was higher in group medical clinic patients at study midpoint and end. CONCLUSIONS: Group medical clinics appear to enhance lipid management among patients with diabetes and hypertension. This may be a result of greater intensification of cholesterol-lowering medications in group medical clinics relative to usual care.

Impact of baseline insulin regimen on glycemic response to a group medical clinic intervention.

OBJECTIVE: Group medical clinics (GMC) combine medication management and self-management training, and may improve diabetes outcomes. It remains unclear which patients benefit most from GMC. This secondary analysis examined the impact of baseline insulin regimen on GMC response. RESEARCH DESIGN AND METHODS: We analyzed a trial of 239 veterans with type 2 diabetes randomized to GMC or usual care (UC). We categorized baseline insulin regimen as the following: no insulin; basal insulin only; or complex insulin (basal-prandial or mixed regimens). Using linear mixed models adjusted for clustering within GMC, we evaluated the differential impact of GMC relative to UC on hemoglobin A1c (HbA1c) and self-efficacy among patients on different baseline insulin regimens. RESULTS: From linear mixed models, the effect of GMC on HbA1c differed by baseline insulin regimen versus UC (P = 0.05); there was no differential effect on self-efficacy (P = 0.29). Among those using complex insulin regimens at baseline, GMC reduced HbA1c by study end compared with UC (-1.0%; 95% CI -1.8 to -0.2; P = 0.01). We found no such HbA1c difference between GMC and UC patients using no insulin (P = 0.65) or basal insulin only (P = 0.71). There were no clinically significant differences in hypoglycemia by baseline insulin regimen and intervention group. CONCLUSIONS: We found that compared with UC, GMC lowered HbA1c specifically among patients using complex insulin regimens at study baseline, which may relate to this group's demanding medication and self-management requirements. Implementing GMC among patients using complex insulin regimens may maximize this care delivery strategy's potential.

Overcoming inertia: improvement in achieving target low-density lipoprotein cholesterol.

OBJECTIVE: To improve lipid management of high-risk patients in a large academic primary care practice. STUDY DESIGN: Educational intervention with historical controls. METHODS: We determined the likelihood of providers within an academic Veterans Affairs primary care practice to adjust simvastatin doses before and after a low-cost educational intervention. Study patients were enrolled during a 2-year preintervention period, had an indication to achieve a low-density lipoprotein cholesterol (LDL-C) level of <100 mg/dL, and were taking simvastatin but not at the maximum dose. We explored factors that might affect dose changing, including patient demographics, diabetes, coronary disease, patient medication adherence, and a threshold effect where LDL-C values just above the target might lead to provider inaction. RESULTS: Initially, 49% of 4048 patients met their LDL-C target. Before the intervention, the simvastatin dose was changed at only 16% of 2103 patient visits where the patient was not at treatment target and was on less than the maximum dose. Providers were more likely to adjust the dose for patients with high LDL-C and those who were compliant, and less likely to adjust it for older or diabetic patients. After the intervention, 62% of 1414 patients met their treatment target. Compared with the preintervention period, providers were more likely to increase the simvastatin dose for patients not yet at their target (P = .023). CONCLUSION: Following a low-cost intervention, providers more aggressively treated high LDL-C in high-risk patients, and more patients reached their treatment target goal.