Improving Evidence-Based Primary Care for Chronic Kidney Disease

Summary

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.

Conditions

• Chronic Kidney Disease
• Chronic Kidney Insufficiency
• Chronic Renal Diseases
• Chronic Renal Insufficiency
• Kidney Insufficiency, Chronic

Interventions

OTHER

Facilitated Clinical Decision Support

The primary care practices in this arm will receive: * CKD decision support algorithms added to their Clinical Decision Support * System Academic detailing concerning the rationale for the algorithms * On-going mentoring and practice facilitation * Audit and feedback during quarterly reviews of practice data with the practice facilitator by videoconference.

OTHER

Clinical Decision Support Only

* CKD decision support algorithms added to their Clinical Decision Support * System Academic detailing concerning the rationale for the algorithms

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University at Buffalo

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• National Kidney Foundation, United States

  collaborator OTHER

• American Academy of Family Physicians

  lead OTHER

Principal Investigators

• Chester H Fox, MD · State University of New York at Buffalo

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-01

Primary Completion

2015-11-30

Completion

2016-01-30

Countries

• United States

Study Locations