Improving Evidence-Based Primary Care for Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Improving Evidence-Based Primary Care for Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767883
• Other study ID #: AAFP-CKD-102020846
• Secondary ID: 1R01DK090407-01A
• Status: Completed
• Phase: N/A
• Start date: July 1, 2011
• Est. completion date: January 30, 2016

Study information

• Verified date: December 2018
• Source: American Academy of Family Physicians
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27000
• Est. completion date: January 30, 2016
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Kidney Insufficiency
• Chronic Renal Diseases
• Chronic Renal Insufficiency
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Insufficiency, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	American Academy of Family Physicians	Leawood	Kansas

Sponsors (5)

Lead Sponsor	Collaborator
American Academy of Family Physicians	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Kidney Foundation, University at Buffalo, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process evaluation outcomes	Qualitative and descriptive measure of practice performance, physician and staff satisfaction and process changes as obtained through site visit observations, interviews and questionnaires.	Change from Baseline practice performance at 3 years
Primary	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	CKD Management Process Measures	Percentage of patients who have: Diagnosis of CKD Annual Microalbumin/Creatinine Ratio Annual LDL Annual A1c Follow up creatinine measure Follow up ACR measure	upt to 3 years
Secondary	Cost of intervention	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	up to 3 years
Secondary	All-cause mortality	Death data from the CDC National Death Index	up to 3 years

External Links

•   study web-page on the AAFP website