Improving Evidence-Based Primary Care for Chronic Kidney Disease
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| ClinicalTrials.gov Identifier: NCT01767883 |
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Recruitment Status :
Completed
First Posted : January 15, 2013
Last Update Posted : December 12, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 27000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Health Services Research |
| Official Title: | Improving Evidence-Based Primary Care for Chronic Kidney Disease |
| Actual Study Start Date : | July 1, 2011 |
| Actual Primary Completion Date : | November 30, 2015 |
| Actual Study Completion Date : | January 30, 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Facilitated Clinical Decision Support
The primary care practices in this arm will receive:
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Other: Facilitated Clinical Decision Support
The primary care practices in this arm will receive:
Other Names:
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Active Comparator: Clinical Decision Support Only
The primary care practices in this arm will receive:
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Other: Clinical Decision Support Only
Other Names:
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- Degree of evidence-based guideline-concordant care for CKD [ Time Frame: up to 3 years ]
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
- CKD Management Process Measures [ Time Frame: upt to 3 years ]
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 ]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 ]Death data from the CDC National Death Index
- Process evaluation outcomes [ Time Frame: Change from Baseline practice performance at 3 years ]Qualitative and descriptive measure of practice performance, physician and staff satisfaction and process changes as obtained through site visit observations, interviews and questionnaires.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767883
| United States, Kansas | |
| American Academy of Family Physicians | |
| Leawood, Kansas, United States, 66211 | |
| Principal Investigator: | Chester H Fox, MD | State University of New York at Buffalo |
| Responsible Party: | American Academy of Family Physicians |
| ClinicalTrials.gov Identifier: | NCT01767883 |
| Other Study ID Numbers: |
AAFP-CKD-102020846 1R01DK090407-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 15, 2013 Key Record Dates |
| Last Update Posted: | December 12, 2018 |
| Last Verified: | December 2018 |
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Chronic Kidney Disease CKD TRANSLATE |
Practice Facilitation Practice-based research CKD Guidelines |
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Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency Kidney Failure, Chronic Urologic Diseases |