Improving Evidence-Based Primary Care for Chronic Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by American Academy of Family Physicians
Sponsor:
Collaborators:
University at Buffalo
University of Colorado, Denver
National Kidney Foundation
Information provided by (Responsible Party):
American Academy of Family Physicians
ClinicalTrials.gov Identifier:
NCT01767883
First received: January 10, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Chronic Kidney Insufficiency
Chronic Renal Diseases
Chronic Renal Insufficiency
Kidney Insufficiency, Chronic
Other: Facilitated Clinical Decision Support
Other: Clinical Decision Support Only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Improving Evidence-Based Primary Care for Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by American Academy of Family Physicians:

Primary Outcome Measures:
  • Degree of evidence-based guideline-concordant care for CKD [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • CKD Management Process Measures [ Time Frame: upt to 3 years ] [ Designated as safety issue: No ]

    Percentage of patients who have:

    Diagnosis of CKD Annual Microalbumin/Creatinine Ratio Annual LDL Annual A1c Follow up creatinine measure Follow up ACR measure


  • Cost of intervention [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Extra costs of the "Translate CKD" intervention and the control intervention, compared to no intervention. Claims data from Centers for Medicare & Medicaid Services, additional practice and patient costs

  • All-cause mortality [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Death data from the CDC National Death Index


Other Outcome Measures:
  • Process evaluation outcomes [ Time Frame: Change from Baseline practice performance at 3 years ] [ Designated as safety issue: No ]
    Qualitative and descriptive measure of practice performance, physician and staff satisfaction and process changes as obtained through site visit observations, interviews and questionnaires.


Estimated Enrollment: 27000
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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 Names:
  • Facilitated CDS,
  • CDS plus facilitation
Active Comparator: 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
Other: Clinical Decision Support Only
  • CKD decision support algorithms added to their Clinical Decision Support
  • System Academic detailing concerning the rationale for the algorithms
Other Names:
  • CDS Only
  • "Comparator"

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767883

Contacts
Contact: Natalia Loskutova, MD, PhD 1-800-274-2237 ext 3786 nloskutova@aafp.org
Contact: Craig Smail, MA, MSc 1-800-274-2237 ext 3185 CSmail@aafp.org

Locations
United States, Kansas
American Academy of Family Physicians Recruiting
Leawood, Kansas, United States, 66211
Contact: Natalia Loskutova, MD, PhD    800-274-2237 ext 3186    nloskutova@aafop.org   
Principal Investigator: Wilson D Pase, MD         
Sponsors and Collaborators
American Academy of Family Physicians
University at Buffalo
University of Colorado, Denver
National Kidney Foundation
Investigators
Principal Investigator: Chester H Fox, MD State University of New York at Buffalo
  More Information

Additional Information:
No publications provided by American Academy of Family Physicians

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: American Academy of Family Physicians
ClinicalTrials.gov Identifier: NCT01767883     History of Changes
Other Study ID Numbers: AAFP-CKD-102020846, 1R01DK090407-01A1
Study First Received: January 10, 2013
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by American Academy of Family Physicians:
Chronic Kidney Disease
CKD
TRANSLATE
Practice Facilitation
Practice-based research
CKD Guidelines

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014