Chronic Kidney DiseaseNCT01767883
Improving Evidence-Based Primary Care for Chronic Kidney Disease
A study testing Facilitated Clinical Decision Support and Clinical Decision Support Only in people with Chronic Kidney Disease and Chronic Kidney Insufficiency, run by American Academy of Family Physicians at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Chronic Kidney Insufficiency, Chronic Renal Diseases
- What is being tested?
- Facilitated Clinical Decision Support and Clinical Decision Support Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2011to 30 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
American Academy of Family Physicians
Leawood, Kansas, 66211
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Chronic Kidney Insufficiency, Chronic Renal Diseases, Chronic Renal Insufficiency, Kidney Insufficiency, Chronic
- Being tested
- Facilitated Clinical Decision Support, Clinical Decision Support Only
- Keywords
- Chronic Kidney Disease, CKD, TRANSLATE, Practice Facilitation, Practice-based research, CKD Guidelines
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated Clinical Decision SupportOther
Also called Facilitated CDS,, CDS plus facilitation
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 OnlyOther
Also called CDS Only, "Comparator"
- CKD decision support algorithms added to their Clinical Decision Support
- System Academic detailing concerning the rationale for the algorithms
| Study group | Role | What they receive |
|---|---|---|
| Facilitated Clinical Decision Support | Experimental | 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 Receives: Other: Facilitated Clinical Decision Support |
| Clinical Decision Support Only | Active comparator | 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 Receives: Other: Clinical Decision Support Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 years
Secondary outcomes (3)
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
Measured: upt to 3 years
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
Measured: up to 3 years
All-cause mortality
Death data from the CDC National Death Index
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study start1 Jul 2011
- Primary completion30 Nov 2015
- Study completion30 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Academy of Family Physicians
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University at Buffalo, University of Colorado, Denver, National Kidney Foundation, United States
- Responsible party
- Sponsor
- Investigators
- Chester H Fox, MD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767883
- Sponsor's protocol ID
- AAFP-CKD-102020846
- Other IDs
- 1R01DK090407-01A1
- Status last verified
- Dec 2018
- First submitted
- 10 Jan 2013
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30646261Loskutova 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.
PubMed 28985294Cipparone 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.
PubMed 26355142Kahn 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.
PubMed 25416418Fox 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.
PubMed 23927603
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Evidence-Based Primary Care for Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01767883
- Acronym / sponsor ID
- AAFP-CKD-102020846
- Conditions
- Chronic Kidney Disease, Chronic Kidney Insufficiency, Chronic Renal Diseases, Chronic Renal Insufficiency, Kidney Insufficiency, Chronic
- Keywords
- Chronic Kidney Disease, CKD, TRANSLATE, Practice Facilitation, Practice-based research, CKD Guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,000 participants (actual)
- Lead sponsor
- American Academy of Family PhysiciansUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University at Buffalo, University of Colorado, Denver, National Kidney Foundation, United States
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Jan 2016 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facilitated Clinical Decision Support | Experimental | Other: Facilitated Clinical Decision SupportThe 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 |
| Clinical Decision Support Only | Active comparator | Other: Clinical Decision Support OnlyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitated Clinical Decision SupportAlso: Facilitated CDS,, CDS plus facilitationThe 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 | Facilitated Clinical Decision Support |
| Clinical Decision Support OnlyAlso: CDS Only, "Comparator"* CKD decision support algorithms added to their Clinical Decision Support * System Academic detailing concerning the rationale for the algorithms | Other | Clinical Decision Support Only |
Primary outcome
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
3 secondary outcomes
CKD Management Process Measures
Time frame: upt to 3 years
Cost of intervention
Time frame: up to 3 years
All-cause mortality
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Derived from this study: PubMed 30646261Carroll 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.
- Derived from this study: PubMed 28985294Loskutova 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.
- Derived from this study: PubMed 26355142Cipparone 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.
- Derived from this study: PubMed 25416418Kahn 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.
- Derived from this study: PubMed 23927603Fox 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.
- study web-page on the AAFP websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chester H Fox, MD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Clinical Decision Support and Clinical Decision Support Only in people with Chronic Kidney Disease and Chronic Kidney Insufficiency, run by American Academy of Family Physicians at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of evidence-based guideline-concordant care for CKD (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767883, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.