Table 4:

Summary of articles focused on Health and Health Care

Author/Year	Study Design	Objective	Number of Participants	Sample population	Setting	Impact on Outcome
Bains, 2011 (29)	Cross-sectional	Assess association among health literacy, diabetes knowledge, self-care, and glycemic control	125	Low-income, predominantly minority adults diagnosed with T2DM	Internal Medicine clinic in southeastern US (SC)	Health literacy was not associated with glycemic control; however, diabetes knowledge (β=0.12; 95% CI 0.01, .23) and perceived health status (β=1.14, 95% CI 0.13, 2.16) were significantly associated with glycemic control.
Banister, 2004 (30)	Quasi-experimental (diabetes self-management program, DSMT)	Assess clinical outcomes (HbA1c, BMI, and prescribed medication regimen) and cost-effectiveness of a DSMT	70	Adult patients with T2DM living at or below the US federal poverty level	Community clinic-based DSMT in the south (TX)	Statistical improvement in mean HbA1c (9.7±2.4% to 8.2±2.0%, p<.001) (n=70). Cost of the program was $280 pp/yr; $185 for each point reduction in HbA1c (n=127).
Bradley, 2009 (32)	Retrospective, observational	Describe changes in clinical risk factors (HbA1c, LDL, HDL, TG, SBP, DBP) while using naturopathic complementary and alternative medicine	37	Adult patients with T2DM who received naturopathic care for at least 6 months over a 5-year period	Abstracted medical charts from patients seen at a natural health center in Seattle, WA	Significant mean changes in HbA1c (−0.65%, p=0.046), SBP (−7mmHg, p=0.02), DBP (−5mmHg, p=0.003), and TG (−45mg/dL, p=0.037). No significant mean changes in LDL or HDL. Clinically significant risk factor improvements in HbA1c (42%), SBP (51%), DBP (54%), LDL (28%), HDL (25%), and TG (38%).
Cavanaugh, 2009 (35)	Two RCTs	Assess the impact of literacy and numeracy on diabetes care using an enhanced multidisciplinary program vs. usual delivery of the same program (baseline vs. 3 months vs. 6 months)	198	Adult patients with T1DM or T2DM with most recent HbA1c ≥7%	Two academic medical centers (Vanderbilt University Medical Center in TN and the University of NC Chapel Hill) from April 2006 to June 2008	Both groups had significant improvements in HbA1c at 3months (intervention: −1.50, 95% CI −1.80, −1.02; control: −0.80, 95% CI −1.10, −0.30; p=0.005). After adjustments, intervention group had greater improvement in HbA1c vs. control group (p=0.03). There were no statistical differences in HbA1c between groups at 6 months (p=1.0).
Fernandez, 2012 (41)	Cross-sectional	Assess the association between aspects of cultural competence (doctor communication-positive behaviors, trust, and doctor communication-health promotion) and diabetes clinical outcomes (HbA1c, LDL, SBP)	600	Ethnically diverse, low-income patients with T2DM	Data from the Immigration, Culture, and Health Care (ICHC) Study conducted within 9 free-standing or hospital-based safety net clinics in San Francisco and Chicago in 2008-2009	Patients with high trust were less likely to have poor glycemic control than those with low trust (41.2% vs. 53%, p=0.005); this persisted after adjusting for sociodemographic and clinical factors (OR 0.59, CI 0.41, 0.84). Patients reporting high health promotion communication with their physician were more likely to have poor glycemic control (54.3% vs. 44%, p=0.03); this remained true after adjustments (OR 1.49, 95% CI 1.02-2.19). Patients reporting high doctor communication about positive behaviors were more likely to have poor SBP control (39.7% vs. 29.1%, p=0.007); this did not persist after adjusting. No domains of cultural competence were associated with LDL in unadjusted or adjusted analyses.
Jakicic, 2013 (50)	RCT	Examine the impact of an intensive lifestyle intervention (ILI) vs. diabetes support and education (DSE) on the four-year change in fitness and physical activity (PA) and the effect of change in fitness and PA on glycemic control	3,942	Overweight/obese adults with T2DM with available fitness data at 4 years	Several large, randomized, multicenter trials	Fitness change at 4 years was inversely related to change in HbA1c after adjustments overall (p<0.0001) and for both DSE (p<0.0001) and ILI (p<0.001). Change in PA was not associated with change in HbA1c.
Littenberg, 2006 (64)	Cross-sectional	Describe the use of medication adherence aids and evaluate their impact on clinical outcomes (HbA1c, HTN, hypercholesterolemia)	289	Random selection of adults with T2DM	The Vermont Diabetes Information System (125 primary care providers from 69 practices across VT, NH, and upstate NY)	Patients who placed adherence aid in special place had better glycemic (−0.36%, p=.04) and blood pressure (−5.9, p=.05) control after adjusting. Associating adherence with a daily event improved glycemic control (−0.56, p=.01) vs. those without aids. The use of adherence aids was not associated with cholesterol control.
Miller, 2003 (66)	Prospective RCT	Determine whether rapid-turnaround HbA1c availability improves intensification of DM therapy and reduces HbA1c levels in T2DM (baseline vs. 1 follow-up visit vs. 2 follow-up visits)	597	Adult patients with T2DM of at least 6 months	Neighborhood primary care clinic affiliated with an academic health system (Atlanta, GA)	No significant changes in HbA1c at the first follow-up visit between groups (p=0.56); however, for those whose therapy was intensified and whose HbA1c was ≥7%, glycemic control improved in both groups (rapid, p<0.001; routine, p=0.02). In patients with 2 follow-up visits, HbA1c improved significantly in the rapid group (8.4 to 8.1%, p=0.04), but not in the routine group (8.1 to 8.0, p=0.31).
Otero-Sabogal, 2010 (71)	Pilot Study	Assess changes in self-management among patients with T2DM when using community health workers in clinical team	114	Predominantly low-income Latino adult patients with T2DM (from ethnically diverse neighborhood)	“Safety-net” clinics in San Francisco, CA serving low income (underinsured and underserved) Spanish-speaking patients	For (20) patients with poor glycemic control (≥9%) at baseline, the HbA1c improved significantly (p<0.001) at follow-up. LDL decreased significantly from baseline to follow-up for (88) patients (p<0.005). No significant changes in SBP or DBP.
Polonsky, 2011 (72)	Cluster-randomized, multicenter trial	Evaluate the impact of a structured patient/physician self-monitoring program (STG) on glycemic control and treatment modification recommendations (TMR) over 12 months (vs. active control group, ACG)	483	Ethnically diverse sample of adults with T2DM	34 primary care practice sites across the southeastern US	Significant reduction in HbA1c in STG vs. ACG with at least one TMR (−1.2% vs. −0.8%, p<0.03). Patients with baseline HbA1c≥8.5% who received a TMR at 1-month visit had greater reduction in HbA1c (−1.8% vs. −1.3%, p=0.002). No significant association between total number of visits with TMR and glycemic control over time.
Rothman, 2003 (76)	Quasi-experimental	Evaluate a pharmacist-led, primary care-based diabetes disease management program	159	Patients with uncontrolled T2Dm	Academic general internal medicine practice at Vanderbilt University Medical Center from September 1999 to May 2000	The mean reduction in HbA1c was 1.9% (95% CI 1.5, 2.3) after 6 months. Baseline HbA1c and new onset diabetes were associated with significant improvements in HbA1c.
Ruggiero, 2010 (78)	Randomized pilot study	Evaluate the impact of an intervention using coaching by certified medical assistants (MAC) to provide DM education and self-care support vs. treatment as usual (TAU) and compared to matched no contact controls (NCC)	100	Low-income minority patients with T2DM	Primary care clinic at a federally qualified health center in Chicago	No significant differences between groups on HbA1c (ANCOVA, F [2, 88]=0,888, ns); however, HbA1c decreased from baseline to follow-up for the MAC patients and increased over time for patients in the TAU group and the NCCs.
Smith, 2008 (82)	Observational	Understand clinical differences and associated risk factors in patients diagnosed with T2DM early vs. later in life	1385	Medically indigent patients with T2DM in a large urban setting	Outpatient clinic in the Chicago metropolitan area between October 2000 and December 2003	Early onset patients had higher HbA1c (p≤0.001), were more likely to smoke (p≤0.01) and be depressed (p≤0.01), and had more emergency department visits (p≤0.001).
Wendel, 2006 (87)	Prospective, cross-sectional (observational) study	Examine the association between race/ethnicity and control of CVD risk factors	338	Insulin-treated veterans with T2DM	Consortium of 3 Veteran Affairs Medical Centers in the southwest	Mean HbA1c differed significantly by race/ethnicity (NHW 7.86 vs. H 8.16 vs. AA 8.84, p=0.05). Adjusted HbA1c significantly higher in AA (+0.93%, p=0.002) vs. NHW. Higher depression scores (p=0.049), greater work hours per week (p=0.002), greater number of household dependents (p=0.023), being employed (p=0.004), and age (p=0.0001) were significantly associated with higher baseline HbA1c. Statistically significant differences in insulin doses for patients with HbA1c≥8% (p<0.01)
Bray, 2013 (33)	Quasi experimental	To determine the effectiveness of a redesigned primary care model on glycemic control, blood pressure and lipid levels	727	Rural African American adults with T2DM	8 Rural fee for service primary care practices	Intervention patients showed reduction in A1c at intermediate follow-up (p<.05) as well as long term follow-up (p<.005). Intervention patients also showed greater reduction blood pressure levels (p<.01)
de Rekeneire, 2003 (38)	Cross-sectional	To evaluate racial differences and factors associated with poor glycemic control in older adults with T2DM	468	Older adults age 70-79 with T2DM enrolled in the Health, Aging and Body Composition Study	The Health ABC Study	Control was poor in all diabetic patients and blacks had worse glycemic control than whites (p<0.01)
Gold, 2008 (46)	Quasi experimental	Evaluate the efficacy of a multidisciplinary diabetes self-management program with a focus on improving diabetes control by synchronizing regularly scheduled provider visits with a multidisciplinary diabetes education program.	44	Predominately Hispanic patients with T2DM with average A1c ≥9.5	Olive View-UCLA Medical Center	Synchronous management approach significantly improved A1c level for Hispanic patients with long standing poorly controlled T2DM (p<.001)
Grant, 2003 (48)	Cross-sectional	To determine medication adherence and predictors of suboptimal adherence in a community cohort of patients with diabetes. To test the hypothesis that adherence decreases as medicines prescribed increases.	128	Adults with T2DM from single community health center	Massachusetts General Hospital Revere HealthCare Center	High medication adherence rates were reported regardless of number of prescriptions. Patients with suboptimal adherence were found to be adherent to all medication except one. Side effects and lack of confidence were predictors of suboptimal adherence.
Johnson, 2010 (55)	Retrospective observational	To evaluate the clinical outcomes of uninsured or underinsured patients with T2DM who received care from pharmacists in local medical homes	484	Adults with T2DM	The University of Southern California School of Pharmacy-local safety net clinic	Patients receiving care from pharmacists showed a reduction in A1c by 1.38%, p<0.001), compared to usual care. Integrating “safety net” medical homes with clinical pharmacy services showed improvement in clinical outcomes in patients with T2DM.
McPherson, 2008 (65)	Cross-sectional	To determine the relationship between patient’s knowledge about their diabetes medications and their blood glucose control	44	Predominantly African American adults with T2DM	University of Maryland Medical System	A1c and knowledge scores were inversely related (p<.001).
Rhee, 2005 (74)	Observational Cross-sectional	To examine whether differences in health care access affected A1c levels in patients with T2DM.	605	Adults with T2DM, predominately African American	Outpatient diabetes program affiliated with a large public health system with hospital and community primary care sites.	Patients with difficulty obtaining care had higher A1c levels (p=0.001) as well patients who used acute care facilities (p<0.001) or who no usual source of care (p<0.001).
Spencer, 2011 (83)	RCT	To test the effectiveness of a culturally tailored, behavioral theory based community health worker intervention for improving glycemic control	164	African American and Latino adults with T2DM	Federally qualified community health center in southwest Detroit and major local health system from eastside Detroit	Intervention patients showed a significant drop in A1c level compared to control group (p<.01). Also showed significant improvements in self-report diabetes understanding compared to control group.
Strum, 2005 (84)	Retrospective analysis	To evaluate the effects of a clinical based medication assistance program (MAP) on the health outcomes and medication use of patients with T2DM	52	Adults with T2DM enrolled in MAP	University of Arkansas for Medical Sciences pharmacy managed MAP and outpatient pharmacy database	Mean A1c and LDL levels decreased significantly after enrollment in the program (p<0.001 for both)
Welch, 2011 (88)	RCT	Evaluate the clinical usefulness of the CDMP care model	67	Adults age 30-85 with T2DM	Urban community healthcare center in Springfield, Massachusetts	Intervention patients had significant improvements in A1c from baseline to 12months compared to control (p=.01). Treatment satisfaction and DM distress also improved significantly for intervention patients.
Miller, 2012 (67)	Randomized controlled trial with parallel interventions Smart Choices compared to Mindfulness Based Eating Awareness Training Duration: 3 months	To evaluate the impact of a diabetes self-management education intervention compared to the Mindfulness-Based Eating Awareness Training	120	Individuals between the ages of 35-65 years with type 2 diabetes for at least 1 year, body mass index ≥ 27, HbA1c ≥ 7%, and not insulin dependent	N/A	Reduction in HbA1c in the Smart Choices (−0.67±0.24%) and Mindfulness Based Eating Awareness Training (−0.83±0.24%) groups
Quandt, 2005 (73)	Cross-sectional	To describe the level of glycemic control by ethnic control by ethnicity and gender and to consider whether health and healthcare characteristics account for ethnic differences in glycemic control.	693	Adults ≥ 65 years old with type 2 diabetes in rural North Carolina	Home interviews	In older adults, having an HbA1c ≥ 7% was associated with ethnicity (p=0.019), living arrangements (p=0.041), use of medications for diabetes (p<0.0001), and having had a diabetes-related healthcare visit in he previous year (p=0.0006); this population is at an increase risk for diabetes complications
Harris, 2001(49)	Cross-sectional	Evaluate health care access and utilization and health status and outcomes according to race and ethnicity and determine whether health status is influenced by access and utilization	1,480	Adults studied in NHANES III that reported being diagnosed with diabetes, excluding pregnant women and those defined at at<30 at diagnosis	National US sample	With few exceptions outcomes in each racial and ethnic group were not significantly associated with having a primary source of ambulatory care, number of physician visits per year, any type of health insurance or having private health insurance.
Ruelas, 2009 (77)	Randomized, prospective, observational study	Evaluate which factors are associated with reaching program goals in a disease-management program for underserved Latino area	162	Adults with type 2 diabetes	Health center serving low-income Latino patients in east Los Angeles	HbA1c decreased by 1%, with medication adherence being strongest predictor (p=0.01). Knowledge scores increased for those reaching target, but measures of self-efficacy and empowerment did not.