Chronic Kidney Disease - Improving Evidence-based Primary Care
Chronic kidney disease (CKD) is steadily increasing in prevalence in the United States, causing significant morbidity and mortality. There is reasonable evidence that specific actions can be implemented by primary care physicians to delay CKD progression and reduce mortality. The availability of computer decision support (CDS) for CKD may help promote effective, evidence-based care. This group randomized controlled trial will test the extent to which CDS, plus practice facilitation, promotes evidence-based care and improves the clinical outcomes of reduced disease progression and mortality in primary care practices. This study will enroll 40 practices associated with the Distributed Ambulatory Research in Therapeutics Network (DARTNet), a federated network of organizations that use electronic health records.
- Conduct a group randomized controlled trial of point-of-care computer decision support plus the full TRANSLATE model of practice change, versus computer decision support alone in promoting evidence-based care in primary care practices for all patients with an eGFR <60 and >15 ml/min/1.73m2 confirmed with repeat testing over three or more months. (CKD stages 3 and 4)
Hypothesis 1.1: CDS practices using the TRANSLATE model will provide a greater degree of evidence-based guideline-concordant care for CKD than CDS only practices.
- Conduct an intent-to-treat and process analysis between the CDS practices with facilitation versus the CDS-only practices of the clinical outcomes of CDK progression and all-cause mortality.
Hypothesis 2.1: Patients with stage 3 and 4 CKD in facilitated practices will have slower CKD progression than patients in CDS-only practices.
Hypothesis 2.2: Patients with stage 3 and 4 CKD in facilitated practices will have significantly lower all-cause mortality than stage 3 and 4 patients in CDS-only practices.
Hypothesis 2.3: The process evaluation will determine through qualitative methods the fidelity of the facilitated TRANSLATE program; find the challenges and enablers of the implementation process, and the contextual factors that contribute to TRANSLATE decisions and strategies; and translate lessons learned into pragmatic “best practices” for future facilitation and dissemination.
- Conduct a cost-effectiveness analysis that will compare the benefit of the intervention of computer decision support alone against the intervention of computer decision support plus TRANSLATE (practice facilitation) in relationship to overall cost per quality adjusted years of life.
Hypothesis 3.1: The intervention of computer decision support plus TRANSLATE is more cost-effective than the intervention of computer decision support alone.
This project was funded from September 2011 through August 2016.
The project is in the data analysis phase.
Effect of 2 Clinical Decision Support Strategies on Chronic Kidney Disease Outcomes in Primary Care A Cluster Randomized Trial(jamanetwork.com). Carroll JK, Pulver G, Dickinson LM, Pace WD, Vassalotti JA, Kimminau KS, Manning BK, Staton EW, Fox CH,JAMA Network Open. 2018;1(6):e183377.
Recruiting primary care practices for practice-based research: a case study of a group-randomized study (TRANSLATE CKD) recruitment process(6 page PDF). Loskutova NY, Smail C, Ajayi K, Pace WD, Fox CH. Fam Pract. July 2017 (1- 6) cmx064. doi: 10.1093/fampra/cmx064
Chronic Kidney Disease Guideline Implementation in Primary Care: A Qualitative Study of Providers in the TRANSLATE CKD Study(8 page PDF).Vest BM, York TRM, Sand J, Fox CH, Kahn LS. J Am Board Fam Med. September-October 2015; 28(5):624-31.
Achieving Balanced Study Arms in Pragmatic Cluster Randomized Trials Using Covariate Constrained Randomization(13 page PDF). Dickinson LM, Beaty B, Fox CH, Pace WD, Dickinson WP, Emsermann C, Kempe A. J Am Board Fam Med. September-October 2015; 28(5):663-72.
Inaccuracy of ICD-9 Codes for Chronic Kidney Disease: A Study from Two Practice-based Research Networks (PBRNs)(5 page PDF). Cipparone CW, Withiam-Leith M, Kimminau KS, Fox CH, Singh R, Kahn L. J Am Board Fam Med. September-October 2015; 28(5):678-82.
Importance of urine albumin creatinine ratio in the diagnosis and prognosis of chronic kidney disease.(4 page PDF) Fox CH, Neuhaus K, Vassalotti JA. OA Nephrology 2013 Nov 01;1(3):21. https://www.oapublishinglondon.com/article/1027
Improving evidence-based primary care for chronic kidney disease: study protocol for a cluster randomized control trial for translating evidence into practice (TRANSLATE CKD).(9 page PDF) Fox CH, Vest BM, et al. Implementation Sci. 2013;8:88.
For additional information about this study, please contact:
Brian Manning, MPH, CHES
Associate Research Director
AAFP National Research Network
This project was funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH.