***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND African Americans suffer disproportionately from diabetes complications , but little research has focused on how to improve diabetic control in this population . There are also few or no data on a combined primary care and community-based intervention approach . METHODS We r and omly assigned 186 urban African Americans with type 2 diabetes ( 76 % female , mean A SD age 59 A 9 years ) to 1 of 4 parallel arms : ( 1 ) usual care only ; ( 2 ) usual care + nurse case manager ( NCM ) ; ( 3 ) usual care + community health worker ( CHW ) ; ( 4 ) usual care + nurse case manager/community health worker team . Using the framework of the Precede-Proceed behavioral model , interventions included patient counseling regarding self-care practice s and physician reminders . RESULTS The 2-year follow-up visit was completed by 149 individuals ( 84 % ) . Compared to the Usual care group , the NCM group and the CHW group had modest declines in HbA(1c ) over 2 years ( 0.3 and 0.3 % , respectively ) , and the combined NCM/CHW group had a greater decline in HbA(1c ) ( 0.8 % . P = 0.137 ) . After adjustment for baseline differences and /or follow-up time , the combined NCM/CHW group showed improvements in triglycerides ( -35.5 mg/dl ; P = 0.041 ) and diastolic blood pressure , compared to the usual care group ( -5.6 mmHg ; P = 0.042 ) . CONCLUSIONS Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes . Although results were clinical ly important , they did not reach statistical significance . This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans Background : Lack of concordance between medications listed in the medical record and taken by the patient contributes to poor outcomes . We sought to determine whether patients who received health coaching by medical assistants improved their medication concordance and adherence . Methods : This was a nonblinded , r and omized , controlled , pragmatic intervention trial . English- or Spanish-speaking patients , age 18 to 75 years , with poorly controlled type 2 diabetes , hypertension , and /or hyperlipidemia were enrolled from 2 urban safety net clinics and r and omized to receive 12 months of health coaching versus usual care . Results : Outcomes included concordance between medications documented in the medical record and those reported by the patient and adherence based on the patient-reported number of days ( of the last 7 ) on which patient took all prescribed medications . The proportion of medications completely concordant increased in the coached group versus the usual care group ( difference in change , 10 % ; P = .05 ) . The proportion of medications listed in the chart but not taken significantly decreased in the coached group compared with the usual care group ( difference in change , 17 % ; P = .013 ) . The mean number of adherent days increased in the coached but not in the usual care group ( difference in change , 1.08 ; P < .001 ) . Conclusions : Health coaching by medical assistants significantly increases medication concordance and adherence Patient navigation ( PN ) programs are being widely implemented to reduce disparities in cancer care for racial/ethnic minorities and the poor . However , few systematic studies cogently describe the processes of PN . We qualitatively analyzed 21 transcripts of semistructured exit interviews with three navigators about their experiences with patients who completed a r and omized trial of PN .  We iteratively discussed codes/categories , reflective remarks , and ways to focus/organize data and developed rules for summarizing data . We followed a three-stage analysis model : reduction , display , and conclusion drawing/verification . We used ATLAS.ti_5.2 for text segmentation , coding , and retrieval . Four categories of factors affecting cancer care outcomes emerged : patients , navigators , navigation processes , and external factors . These categories formed a preliminary conceptual framework describing ways in which PN processes influenced outcomes . Relationships between processes and outcomes were influenced by patient , navigator , and external factors . The process of PN has at its core relationship-building and instrumental assistance . An enhanced underst and ing of the process of PN derived from our analyses will facilitate improvement in navigators ’ training and rational design of new PN programs to reduce disparities in cancer-related care OBJECTIVE To assess the impact of health coaching on patients ' in their primary care provider . METHODS R and omized controlled trial comparing health coaching with usual care . PARTICIPANTS Low-income English or Spanish speaking patients age 18 - 75 with poorly controlled type 2 diabetes , hypertension and /or hyperlipidemia . MAIN OUTCOME MEASURE Patient trust in their primary care provider measured by the 11-item Trust in Physician Scale , converted to a 0 - 100 scale . ANALYSIS Linear mixed modeling . RESULTS A total of 441 patients were r and omized to receive 12 months of health coaching ( n=224 ) vs. usual care ( n=217 ) . At baseline , the two groups were similar to those in the usual care group with respect to demographic characteristics and levels of trust in their provider . After 12 months , the mean trust level had increased more in patients receiving health coaching ( 3.9 vs. 1.5 , p=0.47 ) , this difference remained significant after adjustment for number of visits to primary care providers ( adjusted p=.03 ) . CONCLUSIONS Health coaching appears to increase patients trust in their primary care providers . PRACTICE IMPLICATION S Primary care providers should consider adding health coaches to their team as a way to enhance their relationship with their patients Debates over the degree to which st and ards of evidence and methods from traditional clinical research can or should apply to quality improvement ( QI ) have recurred over the past 10 years.1–4 When , if ever , do we need a r and omised controlled trial ( RCT ) demonstrating benefit to decide that an intervention has worked ? Can we recommend QI interventions for widespread adoption even without supportive RCTs ? On one side of the debate , some have argued that QI and the RCT are like oil and water — never the twain shall mix . Certainly , many have argued , we should not presume that RCTs represent the gold st and ard for evidence in QI . On the face of it , the report by Mate et al 5 supports this oil and water view of RCTs and QI interventions . The authors report their struggles conducting a pragmatic , multisite RCT of a complex intervention to reduce  perinatal transmission of HIV in KwaZulu-Natal Province , South Africa . The intervention included socioadaptive strategies,6 , 7 such as engaging local health system leaders , securing a commitment to the aims of the project , and providing participating health centres with the tools to perform data -driven improvement cycles . It also promoted specific best practice s for key steps in the prevention of perinatal transmission of HIV ( eg , increasing the proportion of women receiving early antenatal care that includes HIV counselling and testing , increasing the proportion of mothers with low CD4 counts who receive treatment , and so on ) . The authors initially planned to evaluate this complex intervention using an equally complex study design —a step-wedge , cluster RCT involving 48 clusters of clinics ( for a total of 222 individual clinics ) in three waves of intervention and control sites ; hence , the ‘ step-wedge ’ label . It will come as no surprise to most readers that this double dose of complexity — from the intervention itself and the trial design —overwhelmed OBJECTIVES We tested the effectiveness of a culturally tailored , behavioral theory-based community health worker intervention for improving glycemic control . METHODS We used a r and omized , 6-month delayed control group design among 164 African American and Latino adult participants recruited from 2 health systems in Detroit , Michigan . Our study was guided by the principles of community-based participatory research . Hemoglobin A1c ( HbA1c ) level was the primary outcome measure . Using an empowerment-based approach , community health workers provided participants with diabetes self-management education and regular home visits , and accompanied them to a clinic visit during the 6-month intervention period . RESULTS Participants in the intervention group had a mean HbA1c value of 8.6 % at baseline , which improved to a value of 7.8 % at 6 months , for an adjusted change of -0.8 percentage points ( P < .01 ) . There was no change in mean HbA1c among the control group ( 8.5 % ) . Intervention participants also had significantly greater improvements in self-reported diabetes underst and ing compared with the control group . CONCLUSIONS This study contributes to the growing evidence for the effectiveness of community health workers and their role in multidisciplinary teams engaged in culturally appropriate health care delivery Objectives . Although people with HIV experience significant oral health problems , many consistently identify oral health as an unmet health care need . We conducted a r and omized controlled trial to evaluate the impact of a dental case management intervention on dental care use . Methods . We evaluated the intervention according to self-reported dental care use at 6- , 12- , and 18-month follow-ups . Multivariable logistic models with generalized estimating equations were used to assess the effects of the intervention over time . Results . The odds of having a dental care visit were about twice as high in the intervention group as in the st and ard care group at 6 months ( adjusted odds ratio [ OR ] = 2.52 ; 95 % confidence interval [ CI ] = 1.58 , 4.08 ) and 12 months ( adjusted OR = 1.98 ; 95 % CI = 1.17 , 3.35 ) , but the odds were comparable in the 2 groups by 18 months ( adjusted OR = 1.07 ; 95 % CI = 0.62 , 1.86 ) . Factors significantly associated with having a dental care visit included frequent physician visits and dental care referrals . Conclusions . We demonstrated that a dental case management intervention targeting people with HIV was efficacious but not sustainable over time . Barriers not addressed in the intervention must be considered to sustain its use over time Background : There is limited high- quality evidence about the impact of patient navigation ( PN ) on outcomes for patients with diagnosed cancer . Methods : We pooled data from two sites from the national Patient Navigation Research Program . Patients ( n = 438 ) with newly diagnosed breast ( n = 353 ) or colorectal cancer ( n = 85 ) were r and omized to PN or usual care .  Trained lay navigators met with patients r and omized to PN to help them assess treatment barriers and identify re sources to overcome barriers . We used intent-to-treat analysis to assess time to completion of primary treatment , psychologic distress ( impact of events scale ) , and satisfaction ( patient satisfaction with cancer-related care ) within 3 months after initiation of cancer treatment . Results : The sample was predominantly middle-aged ( mean age = 57 ) and female ( 90 % ) ; 44 % were race-ethnic minorities ( 44 % ) , 46 % reported lower education levels , 18 % were uninsured , and 9 % reported a non-English primary language . The r and omized groups were comparable in baseline characteristics . Primary analysis showed no statistically significant group differences in time to completion of primary cancer treatment , satisfaction with cancer-related care , or psychologic distress . Subgroup analysis showed that socially disadvantaged patients ( i.e. , uninsured , low English proficiency , and non-English primary language ) who received PN reported higher satisfaction than those receiving usual care ( all P < 0.05 ) . Navigated patients living alone reported greater distress than those receiving usual care . Conclusions : Although the primary analysis showed no overall benefit , the subgroup analysis suggests that PN may improve satisfaction with care for certain disadvantaged individuals . Impact : PN for cancer patients may not necessarily reduce treatment time nor distress . Cancer Epidemiol Biomarkers Prev ; 21(10 ) ; 1673–81 . © 2012 AACR BACKGROUND AND OBJECTIVES Many patients with ESRD , particularly minorities and women , face barriers in completing the steps required to obtain a transplant . These eight sequential steps are as follows : medical suitability , interest in transplant , referral to a transplant center , first visit to center , transplant workup , successful c and i date , waiting list or identify living donor , and receive transplant . This study sought to determine the effect of navigators on completion of steps . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Cluster r and omized , controlled trial at 23 Ohio hemodialysis facilities . One hundred sixty-seven patients were recruited between January 2009 and August 2009 and were followed for up to 24 months or until study end in February 2011 . Trained kidney transplant recipients met monthly with intervention participants  ( n=92 ) , determined their step in the transplant process , and provided tailored information and assistance in completing the step . Control participants  ( n=75 ) continued to receive usual care . The primary outcome was the number of transplant process steps completed . RESULTS Starting step did not significantly differ between the two groups . By the end of the trial , intervention participants completed more than twice as many steps as control participants ( 3.5 versus 1.6 steps ; difference , 1.9 steps ; 95 % confidence interval , 1.3 - 2.5 steps ) . The effect of the intervention on step completion was similar across race and sex subgroups . CONCLUSIONS Use of trained transplant recipients as navigators result ed in increased completion of transplant process steps BACKGROUND A r and omized , controlled trial was conducted to evaluate the impact of a directly administered antiretroviral therapy program ( DAART ) and intensive adherence case management ( IACM ) intervention on virologic and immunologic response to highly active antiretroviral therapy ( HAART ) among patients 
    Output:
    
Conclusions There is considerable heterogeneity in intervention content across  patient navigator interventions .
Our results provide a schema from which to develop PN interventions and illustrate how an evidence -based model was used to develop a real-world PN intervention .