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Improving Evidence-Based Primary Care for Chronic Kidney Disease

NCT ID: NCT01767883

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-01

Study Completion Date

2016-01-30

Brief Summary

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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.

Detailed Description

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The proposed trial tests the extent to which CDS plus facilitation promotes evidence-based care and improves the clinical outcomes of reduced disease progression and mortality in primary care practices. We also conduct an observational comparative effectiveness analysis of data from a larger database of electronic medical records in order to identify the most successful components of evidence-based care with respect to disease progression and all-cause mortality.

Specific Aim 1: 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.

Specific Aim 2: Conduct an intent-to-treat and process analysis between the CDS practices with facilitation versus the CDS only practices of the clinical outcomes of CKD 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, the role of facilitation, and the contextual factors that contribute to TRANSLATE decisions and strategies; and translate lessons learned into pragmatic "best practices" for future facilitation and dissemination.

Specific Aim 3: 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). Hypothesis 3.1 The intervention of computer decision support plus TRANSLATE is more cost-effectiveness than the intervention of computer decision support alone.

Conditions

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

Keywords

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Chronic Kidney Disease CKD TRANSLATE Practice Facilitation Practice-based research CKD Guidelines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Facilitated Clinical Decision Support

Intervention Type OTHER

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.

Clinical Decision Support Only

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

Group Type ACTIVE_COMPARATOR

Clinical Decision Support Only

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Clinical Decision Support Only

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

Intervention Type OTHER

Other Intervention Names

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Facilitated CDS, CDS plus facilitation CDS Only "Comparator"

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University at Buffalo

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

National Kidney Foundation, United States

OTHER

Sponsor Role collaborator

American Academy of Family Physicians

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chester H Fox, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

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American Academy of Family Physicians

Leawood, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30646261 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28985294 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26355142 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25416418 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23927603 (View on PubMed)

Other Identifiers

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1R01DK090407-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAFP-CKD-102020846

Identifier Type: -

Identifier Source: org_study_id