Abstract
BackgroundChronic 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.Methods/DesignThis 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.DiscussionThis 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.Trial registration Registered as NCT01767883 on clinicaltrials.gov NCT01767883
Highlights
Chronic kidney disease (CKD) and end stage renal disease (ESRD) are steadily increasing in prevalence in the United States
This study will evaluate the effects of computer decision support (CDS) versus CDS with facilitation and answer key questions regarding the cost-effectiveness of a facilitated model for improving CKD outcomes
The current study addresses the question of whether an adaptation of the facilitated TRANSLATE model with CDS, compared to CDS alone, will lead to improved evidence-based care for CKD in primary care offices, thereby slowing the progression to ESRD and improving patient health outcomes
Summary
Limitations Some data elements like nephrology referral may be difficult to collect if they are entered as free text and not as order entry. Our TRANSLATE framework incorporates an implementation team that includes a clinician champion, site coordinator, and an administrator to allocate resources and guide and oversee implementation progress It utilizes information technology systems such as EMR or middleware programs to produce registries to facilitate the identification of high-risk patients and generate performance reports to provide data for ongoing feedback. In future projects, this framework will be used to assess the readiness of practices to participate in QI projects, and to help diagnose why a project may be failing to improve outcomes, thereby allowing for mid-course corrections. KK contributed to the design of the facilitation intervention and the process evaluation and reviewed the manuscript critically for content. Author details 1Department of Family Medicine, State University of New York – University at Buffalo, 77 Goodell St, Buffalo, NY 14203, USA. 2Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA. 3Department of Health Systems, Management, and Policy, Colorado School of Public Health, University of Colorado Denver, Denver, CO, USA. 4American Academy of Family Physicians National Research Network, Leawood, USA. 5Department of Family Medicine, University of Kansas School of Medicine, Kansas, USA. 6Division of Nephrology, Mount Sinai Medical Center, New York, USA. 7National Kidney Foundation, New York, USA. 8Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, Minnesota, USA
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