Improving Evidence-Based Primary Care for Chronic Kidney Disease
2 other identifiers
interventional
27,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 10, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2016
CompletedDecember 12, 2018
December 1, 2018
4.4 years
January 10, 2013
December 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
CKD Management Process Measures
upt to 3 years
Cost of intervention
up to 3 years
All-cause mortality
up to 3 years
Other Outcomes (1)
Process evaluation outcomes
Change from Baseline practice performance at 3 years
Study Arms (2)
Facilitated Clinical Decision Support
EXPERIMENTALThe 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
Clinical Decision Support Only
ACTIVE COMPARATORThe 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
Interventions
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.
* CKD decision support algorithms added to their Clinical Decision Support * System Academic detailing concerning the rationale for the algorithms
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Academy of Family Physicianslead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- University at Buffalocollaborator
- University of Colorado, Denvercollaborator
- National Kidney Foundation, United Statescollaborator
Study Sites (1)
American Academy of Family Physicians
Leawood, Kansas, 66211, United States
Related Publications (5)
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.
PMID: 30646261DERIVEDLoskutova 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.
PMID: 28985294DERIVEDCipparone 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.
PMID: 26355142DERIVEDKahn 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.
PMID: 25416418DERIVEDFox 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.
PMID: 23927603DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chester H Fox, MD
State University of New York at Buffalo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2013
First Posted
January 15, 2013
Study Start
July 1, 2011
Primary Completion
November 30, 2015
Study Completion
January 30, 2016
Last Updated
December 12, 2018
Record last verified: 2018-12