Improving Evidence-Based Primary Care for Chronic Kidney Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/14/2018 |
| Start Date: | July 1, 2011 |
| End Date: | January 30, 2016 |
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.
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.
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.
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.
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
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