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Sponsor study identifier
Secondary identifiers
interventional
27,000
1 country
1
Study Start
July 1, 2011
Actual (reported)Primary Completion
November 30, 2015
Actual (reported)Study Completion
January 30, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2011
Actual (reported)January 10, 2013
Actual (reported)January 15, 2013
Actual (reported)November 30, 2015
Actual (reported)January 30, 2016
Actual (reported)Degree of evidence-based guideline-concordant care for CKD
Percentage of patients at goal for: Control Blood Pressure Control LDL Control HbA1C Use ACE/ARB Eliminate NSAID/Cox-2 use Refer to Nephrologist Eliminate Smoking
up to 3 years
CKD Management Process Measures
upt to 3 years
Cost of intervention
up to 3 years
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
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
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.
American Academy of Family Physicians
Leawood, Kansas, 66211, United States
Carroll JK, Pulver G, Dickinson LM, Pace WD, Vassalotti JA, Kimminau KS, Manning BK, Staton EW, Fox CH. Effect of 2 Clinical Decision Support Strategies on Chronic Kidney Disease Outcomes in Primary Care: A Cluster Randomized Trial. JAMA Netw Open. 2018 Oct 5;1(6):e183377. doi: 10.1001/jamanetworkopen.2018.3377.
Loskutova NY, Smail C, Ajayi K, Pace WD, Fox CH. Recruiting primary care practices for practice-based research: a case study of a group-randomized study (TRANSLATE CKD) recruitment process. Fam Pract. 2018 Jan 16;35(1):111-116. doi: 10.1093/fampra/cmx064.
Chester H Fox, MD
State University of New York at Buffalo
27,000 participants (actual enrollment reported by the registry).
First Submitted
January 10, 2013
First Posted
January 15, 2013
Study Start
July 1, 2011
Actual (reported)All-cause mortality
up to 3 years
Process evaluation outcomes
Change from Baseline practice performance at 3 years
* CKD decision support algorithms added to their Clinical Decision Support * System Academic detailing concerning the rationale for the algorithms
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Cipparone CW, Withiam-Leitch M, Kimminau KS, Fox CH, Singh R, Kahn L. Inaccuracy of ICD-9 Codes for Chronic Kidney Disease: A Study from Two Practice-based Research Networks (PBRNs). J Am Board Fam Med. 2015 Sep-Oct;28(5):678-82. doi: 10.3122/jabfm.2015.05.140136.
Kahn LS, Vest BM, Madurai N, Singh R, York TR, Cipparone CW, Reilly S, Malik KS, Fox CH. Chronic kidney disease (CKD) treatment burden among low-income primary care patients. Chronic Illn. 2015 Sep;11(3):171-83. doi: 10.1177/1742395314559751. Epub 2014 Nov 21.
Fox CH, Vest BM, Kahn LS, Dickinson LM, Fang H, Pace W, Kimminau K, Vassalotti J, Loskutova N, Peterson K. Improving evidence-based primary care for chronic kidney disease: study protocol for a cluster randomized control trial for translating evidence into practice (TRANSLATE CKD). Implement Sci. 2013 Aug 8;8:88. doi: 10.1186/1748-5908-8-88.
Primary Completion
November 30, 2015
Actual (reported)Study Completion
January 30, 2016
Actual (reported)Last Updated
December 12, 2018
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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