Improving Evidence-Based Primary Care for Chronic Kidney Disease

Completed · Not applicable

Conditions studied: Chronic Kidney Disease, Chronic Kidney Insufficiency, Chronic Renal Diseases, Chronic Renal Insufficiency, Kidney Insufficiency, Chronic

In brief

Background: Chronic Kidney Disease (CKD) is under-recognized and under-treated in primary care offices and primary care physicians are generally not familiar with treatment guidelines. Even when diagnosed properly, as a chronic condition CKD is frequently associated with co-morbidities that make effective treatment difficult due to complexity of care. Availability of Clinical Decision Support (CDS) for CKD may help promote effective, evidence-based care, but evidence suggests that CDS alone may not be sufficient for quality improvement and other interventions such as CDS plus practice facilitation may be needed. Purpose: The project aims to: 1) assess the viability of CDS in implementing evidence-based guidelines for Primary Care Practices (PCPs) and 2) to develop evidence-based practice guidelines that PCPs may use to enhance the care they provide to a difficult to manage segment of the healthcare population. Methods: This is a randomized controlled trial of point-of-care CDS plus full TRANSLATE model of practice change, versus CDS alone. The study aims to analyze differences in promoting evidence-based care in primary care practices. Thirty-six practices will be recruited for this study. Patient inclusion criteria: adult patients with estimated Glomerular Filtration Rate (eGFR) of \<60 and \>15ml/min/1.73m2 confirmed with repeat testing over three or more months. A process evaluation will be conducted between the CDS practices with facilitation and the CDS only practices to assess clinical outcomes of CKD progression and all-cause mortality. Lastly, a cost-effective analysis will compare the cost-to-benefit ratio of CDS alone to that of CDS plus TRANSLATE (i.e. practice facilitation) in relation to cost per quality adjusted years of life. This study is funded by NIH NIDDK under R01 mechanism starting on 07/01/2011 and ending on 06/30/2016.

Key facts

Study ID

NCT01767883

Run by

American Academy of Family Physicians

People needed

27000

Starts

2011-07-01

Expected to finish

2016-01-30

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• all individuals whose primary care provider offices participate in the study who is over the age of 18 with a diagnosis of stages 2-4 of CKD and/or diabetes and/or hypertension and/or one eGFR <60 and/or one urine albumin/creatinine ratio >30

You may not qualify if…

• individual patients whose primary care provider's practice has not signed practice and data use agreements with the AAFP NRN to participate in this practice improvement project at the practice level

Where it is running

• American Academy of Family Physicians — Leawood, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.