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Improving Diabetes Care in Practice: findings from the TRANSLATE trial.

ABSTRACT: OBJECTIVE:The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practices. RESEARCH DESIGN AND METHODS:This was a group-randomized, controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention (TRANSLATE) in 24 practices. The intervention included implementation of an electronic diabetes registry, visit reminders, and patient-specific physician alerts. A site coordinator facilitated previsit planning and a monthly review of performance with a local physician champion. The principle outcomes were the percentage of patients achieving target values for the composite of systolic blood pressure (SBP) <130 mmHg, LDL cholesterol <100 mg/dl, and A1C <7.0% at baseline and 12 months. Six process measures were also followed. RESULTS:Over 24 months, 69,965 visits from 8,405 adult patients with type 2 diabetes were recorded from 238 health care providers in 24 practices from 17 health systems. Diabetes process measures increased significantly more in intervention than in control practices, giving net increases as follows: foot examinations 35.0% (P < 0.0.001); annual eye examinations 25.9% (P < 0.001); renal testing 28.5% (P < 0.001); A1C testing 8.1%(P < 0.001); blood pressure monitoring 3.5% (P = 0.05); and LDL testing 8.6% (P < 0.001). Mean A1C adjusted for age, sex, and comorbidity decreased significantly in intervention practices (P < 0.02). At 12 months, intervention practices had significantly greater improvement in achieving recommended clinical values for SBP, A1C, and LDL than control clinics (P = 0.002). CONCLUSIONS:Introduction of a multicomponent organizational intervention in the primary care setting significantly increases the percentage of type 2 diabetic patients achieving recommended clinical outcomes.

SUBMITTER: Peterson KA

PROVIDER: S-EPMC2584171 | biostudies-literature | 2008 Dec

REPOSITORIES: biostudies-literature

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Improving Diabetes Care in Practice: findings from the TRANSLATE trial.

Peterson Kevin A KA Radosevich David M DM O'Connor Patrick J PJ Nyman John A JA Prineas Ronald J RJ Smith Steven A SA Arneson Thomas J TJ Corbett Victor A VA Weinhandl Joyce C JC Lange Carol J CJ Hannan Peter J PJ

Diabetes care 20080922 12

<h4>Objective</h4>The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practices.<h4>Research design and methods</h4>This was a group-randomized, controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention (TRANSLATE) in 24 practices. The intervention included implementation of an electronic diabetes registry, vi ...[more]

PMID: 18809622

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Project description:Chronic kidney disease (CKD) and end stage renal disease (ESRD) are steadily increasing in prevalence in the United States. While there is reasonable evidence that specific activities can be implemented by primary care physicians (PCPs) to delay CKD progression and reduce mortality, CKD is under-recognized and undertreated in primary care offices, and PCPs are generally not familiar with treatment guidelines. The current study addresses the question of whether the facilitated TRANSLATE model compared to computer decision support (CDS) alone will lead to improved evidence-based care for CKD in primary care offices.This protocol consists of a cluster randomized controlled trial (CRCT) followed by a process and cost analysis. Only practices providing ambulatory primary care as their principal function, located in non-hospital settings, employing at least one primary care physician, with a minimum of 2,000 patients seen in the prior year, are eligible. The intervention will occur at the cluster level and consists of providing CKD-specific CDS versus CKD-specific CDS plus practice facilitation for all elements of the TRANSLATE model. Patient-level data will be collected from each participating practice to examine adherence to guideline-concordant care, progression of CKD and all-cause mortality. Patients are considered to meet stage three CKD criteria if at least two consecutive estimated glomerular filtration rate (eGFR) measurements at least three months apart fall below 60 ml/min. The process evaluation (cluster level) will determine through qualitative methods the fidelity of the facilitated TRANSLATE program and find the challenges and enablers of the implementation process. The cost-effectiveness analysis will compare the benefit of the intervention of CDS alone against the intervention of CDS plus TRANSLATE (practice facilitation) in relationship to overall cost per quality adjusted years of life.This study has three major innovations. First, this study adapts the TRANSLATE method, proven effective in diabetes care, to CKD. Second, we are creating a generalizable CDS specific to the Kidney Disease Outcome Quality Initiative (KDOQI) guidelines for CKD. Additionally, this study will evaluate the effects of CDS versus CDS with facilitation and answer key questions regarding the cost-effectiveness of a facilitated model for improving CKD outcomes. The study is testing virtual facilitation and Academic detailing making the findings generalizable to any area of the country.Registered as NCT01767883 on clinicaltrials.gov

Project description:BackgroundEfforts to improve primary care diabetes management have assessed strategies across heterogeneous groups of patients and practices. However, there is substantial variability in how well practices implement interventions and achieve desired outcomes.ObjectiveTo examine practice contextual features that moderate intervention effectiveness.DesignSecondary analysis of data from a cluster randomized trial of three approaches for implementing the Chronic Care Model to improve diabetes care.ParticipantsForty small to mid-sized primary care practices participated, with 522 clinician and staff member surveys. Outcomes were assessed for 822 established patients with a diagnosis of type 2 diabetes who had at least one visit to the practice in the 18 months following enrollment.Main measuresThe primary outcome was a composite measure of diabetes process of care, ascertained by chart audit, regarding nine quality measures from the American Diabetes Association Physician Recognition Program: HgA1c, foot exam, blood pressure, dilated eye exam, cholesterol, nephropathy screen, flu shot, nutrition counseling, and self-management support. Data from practices included structural and demographic characteristics and Practice Culture Assessment survey subscales (Change Culture, Work Culture, Chaos).Key resultsAcross the three implementation approaches, demographic/structural characteristics (rural vs. urban + .70(p = .006), +2.44(p < .001), -.75(p = .004)); Medicaid: < 20 % vs. ≥ 20 % (-.20(p = .48), +.75 (p = .08), +.60(p = .02)); practice size: < 4 clinicians vs. ≥ 4 clinicians (+.56(p = .02), +1.96(p < .001), +.02(p = .91)); practice Change Culture (high vs. low: -.86(p = .048), +1.71(p = .005), +.34(p = .22)), Work Culture (high vs. low: -.67(p = .18), +2.41(p < .001), +.67(p = .005)) and variability in practice Change Culture (high vs. low: -.24(p = .006), -.20(p = .0771), -.44(p = .0019) and Work Culture (high vs. low: +.56(p = .3160), -1.0(p = .008), -.25 (p = .0216) were associated with trajectories of change in diabetes process of care, either directly or differentially by study arm.ConclusionsThis study supports the need for broader use of methodological approaches to better examine contextual effects on implementation and effectiveness of quality improvement interventions in primary care settings.

Project description:BackgroundThe literature reports long time lags between the several processes involved in the translation of drug research and development into clinical application. To expedite these processes, translational research has emerged as a process that can be applied to reduce the lag between scientific discoveries and their practical application. Thus, the objective of this study was to estimate the time lag in translational research of biological drugs for the treatment of rheumatoid arthritis included in the Brazilian Unified Health System [Sistema Único de Saúde (SUS)].MethodsA descriptive retrospective study was conducted based on secondary data loaded by SUS users in public sources and systems to estimate the time lag between the publication of phase I clinical trial results to drug use in clinical settings. The dates of translational research activities were identified from markers and steps. Structured searches were conducted in the literature and reports from the National Commission for the Incorporation of Technologies in the SUS (Conitec) as well as from health authorities, and analyzed.ResultsBetween 2012 and 2019, SUS included five biological agents for the treatment of rheumatoid arthritis. The mean time lag from clinical development to use of these agents was 11.13 years (range, 8.57 to 12.90 years). The mean time lag for the stages of translational research were 5.30 (T1-basic research to clinical research), 5.08 (T2-clinical research to research synthesis), and 0.75 (T3-research synthesis to evidence-based practice) years. A shorter time lag was observed in the Brazilian case when it was possible to compare with other studies.ConclusionsThe estimated time lag of biological drugs used in the treatment of rheumatoid arthritis was determined based on the translational research steps model adapted to the Brazilian context. Brazil has instituted legal frameworks that set deadlines for sanitary registration, health technology assessment (HTA), and the availability of drugs in the SUS, thus, allowing for a reduced stage T2 time lag. Nevertheless, improvements are still required in stages T1 and T2, especially in publishing the results of clinical trials.

Project description:The global epidemic of type 2 diabetes has prompted numerous studies and public health efforts to reduce its development. A variety of interventions, including lifestyle modifications and pharmacological agents directed at ameliorating the major risk factors for type 2 diabetes, are of proven efficacy in reducing the development of type 2 diabetes in people with impaired glucose tolerance. While prevention of the hyperglycaemia characteristic of diabetes is arguably an important, clinically relevant outcome, a more compelling outcome with greater clinical significance is the prevention or reduction of the relatively diabetes-specific microvascular and less-specific cardiovascular disease (CVD) complications associated with diabetes. These complications cause the majority of morbidity and excess mortality associated with diabetes. Any reduction in diabetes should, logically, also reduce the occurrence of its long-term complications; however, most diabetes prevention trials have not been of sufficient duration to allow such an evaluation. The limited long-term data, largely from the Da Qing Diabetes Prevention Study (DQDPS) and the Diabetes Prevention Program (DPP) and their respective follow-up studies (DQDPOS and DPPOS), suggest a reduction in microvascular complications and amelioration of CVD risk factors. Only the DQDPOS and Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) studies have shown a reduction in CVD events and only DQDPOS has demonstrated a decrease in CVD and overall mortality. While these limited data are promising, whether diabetes prevention directly reduces complication-related morbidity and mortality remains unclear. Longer follow-up of prevention studies is needed to supplement the limited current clinical trial data, to help differentiate the effects of diabetes prevention itself from the means used to reduce diabetes development and to understand the balance among benefits, risks and costs of prevention.

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Improving Diabetes Care in Practice: findings from the TRANSLATE trial.

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Improving Diabetes Care in Practice: findings from the TRANSLATE trial.

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