Chronic Renal InsufficiencyNCT00921687
Chronic Kidney Disease (CKD) Guideline Adherence - A Quality Improvement Study
A study testing Education only and Multifactorial intervention in people with Chronic Renal Insufficiency, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial summary
Chronic kidney disease (CKD) is defined as kidney damage for greater than 3 months or a glomerular filtration rate less than 60 mL/min per 1.73m2 for greater than 3 months. Patients with CKD are at high risk for development of cardiovascular disease and metabolic complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Insufficiency
- What is being tested?
- Education only and Multifactorial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 781 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 primary care providers at the Wade Park Veterans Affairs Medical Center (VAMC) will be eligible for the study
- Patients:
- Receive primary care from a provider at the Wade Park VAMC
- Have:
- CKD as defined by an estimated glomerular filtration rate (eGFR) less than 60 on two separate occasions 90 to 730 days apart,
- diabetes, OR
- hypertension
Who cannot join
- End-stage renal disease
- Renal transplant recipients
- Less than 18 years of age on July 1, 2009
- No primary care visit between Jan 1, 2008 and July 1, 2009
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio
About this study
Official title: Chronic Kidney Disease Guideline Adherence - a Cluster Randomized Controlled Quality Improvement Study
Chronic kidney disease (CKD) is defined as kidney damage for greater than 3 months or a glomerular filtration rate less than 60 mL/min per 1.73m2 for greater than 3 months. Patients with CKD are at high risk for development of cardiovascular disease and metabolic complications. Guidelines for the care of patients with CKD have been developed by the National Kidney Foundation. Despite the wide availability of these guidelines, adherence is low. The goal of the current study is to evaluate whether a multifactorial intervention, including a CKD registry, will improve CKD guideline adherence. The hypothesis is that providers exposed to a multifactorial clinical intervention including education, academic detailing, and a CKD registry will be more likely to adhere to CKD guidelines than those only exposed to education.
- Conditions
- Chronic Renal Insufficiency
- Being tested
- Education only, Multifactorial intervention
- 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.
Education onlyBehavioural
The education will consist of a lecture and distribution of a CKD reference card.
Multifactorial interventionBehavioural
Providers in the intervention group will receive a lecture on CKD, a CKD reference card, academic detailing (residents only), and access to the CKD registry.
| Study group | Role | What they receive |
|---|---|---|
| Multifactorial intervention | Experimental | The multifactorial intervention will consist of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry. Receives: Behavioral: Multifactorial intervention |
| Education only | Active comparator | Providers in the education only arm will receive a CKD lecture and be given a CKD reference card. Receives: Behavioral: Education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTH (Parathyroid Hormone) Adherence
Probability for having a PTH measured during the study period comparing intervention vs control clinic during the study period as estimated by Generalized Estimating Equation (determines probability, not proportion). Participants assigned 1 if PTH was measured and 0 if PTH was not measured during the study period.
Measured: One year
Secondary outcomes (1)
Last Clinic BP <130/80 mmHg
Probability of last Clinic BP <130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal InsufficiencyStudies 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
- Outcomes assessor
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Drawz, Louis Stokes VA Medical Center
- Investigators
- Paul E Drawz, MD, MHS, MS, Principal investigator, Louis Stokes VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921687
- Sponsor's protocol ID
- LSCVAMCCKD1
- Status last verified
- May 2013
- First submitted
- 15 Jun 2009
- Last updated
- 27 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PubMed 11904577Hoy T, Fisher M, Barber B, Borker R, Stolshek B, Goodman W. Adherence to K/DOQI practice guidelines for bone metabolism and disease. Am J Manag Care. 2007 Nov;13(11):620-5.
PubMed 17988187Philipneri MD, Rocca Rey LA, Schnitzler MA, Abbott KC, Brennan DC, Takemoto SK, Buchanan PM, Burroughs TE, Willoughby LM, Lentine KL. Delivery patterns of recommended chronic kidney disease care in clinical practice: administrative claims-based analysis and systematic literature review. Clin Exp Nephrol. 2008 Feb;12(1):41-52. doi: 10.1007/s10157-007-0016-3. Epub 2008 Jan 5.
PubMed 18175059Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. doi: 10.1001/jama.282.15.1458.
PubMed 10535437Drawz PE, Miller RT, Singh S, Watts B, Kern E. Impact of a chronic kidney disease registry and provider education on guideline adherence--a cluster randomized controlled trial. BMC Med Inform Decis Mak. 2012 Jul 5;12:62. doi: 10.1186/1472-6947-12-62.
PubMed 22765882
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease Guideline Adherence - a Cluster Randomized Controlled Quality Improvement Study
- ClinicalTrials.gov ID
- NCT00921687
- Acronym / sponsor ID
- LSCVAMCCKD1
- Conditions
- Chronic Renal Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Posted 23 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic kidney disease (CKD) is defined as kidney damage for greater than 3 months or a glomerular filtration rate less than 60 mL/min per 1.73m2 for greater than 3 months. Patients with CKD are at high risk for development of cardiovascular disease and metabolic complications. Guidelines for the care of patients with CKD have been developed by the National Kidney Foundation. Despite the wide availability of these guidelines, adherence is low. The goal of the current study is to evaluate whether a multifactorial intervention, including a CKD registry, will improve CKD guideline adherence. The hypothesis is that providers exposed to a multifactorial clinical intervention including education, academic detailing, and a CKD registry will be more likely to adhere to CKD guidelines than those only exposed to education.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifactorial intervention | Experimental | Behavioral: Multifactorial interventionThe multifactorial intervention will consist of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry. |
| Education only | Active comparator | Behavioral: Education onlyProviders in the education only arm will receive a CKD lecture and be given a CKD reference card. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All primary care providers at the Wade Park Veterans Affairs Medical Center (VAMC) will be eligible for the study
- Receive primary care from a provider at the Wade Park VAMC
- Have:
Key exclusion criteria (4 listed)
- End-stage renal disease
- Renal transplant recipients
- Less than 18 years of age on July 1, 2009
- No primary care visit between Jan 1, 2008 and July 1, 2009
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 |
|---|---|---|
| Education onlyThe education will consist of a lecture and distribution of a CKD reference card. | Behavioural | Education only |
| Multifactorial interventionProviders in the intervention group will receive a lecture on CKD, a CKD reference card, academic detailing (residents only), and access to the CKD registry. | Behavioural | Multifactorial intervention |
Primary outcome
PTH (Parathyroid Hormone) Adherence
Time frame: One year
Probability for having a PTH measured during the study period comparing intervention vs control clinic during the study period as estimated by Generalized Estimating Equation (determines probability, not proportion). Participants assigned 1 if PTH was measured and 0 if PTH was not measured during the study period.
1 secondary outcome
Last Clinic BP <130/80 mmHg
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11904577National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
- Background: PubMed 17988187Hoy T, Fisher M, Barber B, Borker R, Stolshek B, Goodman W. Adherence to K/DOQI practice guidelines for bone metabolism and disease. Am J Manag Care. 2007 Nov;13(11):620-5.
- Background: PubMed 18175059Philipneri MD, Rocca Rey LA, Schnitzler MA, Abbott KC, Brennan DC, Takemoto SK, Buchanan PM, Burroughs TE, Willoughby LM, Lentine KL. Delivery patterns of recommended chronic kidney disease care in clinical practice: administrative claims-based analysis and systematic literature review. Clin Exp Nephrol. 2008 Feb;12(1):41-52. doi: 10.1007/s10157-007-0016-3. Epub 2008 Jan 5.
- Background: PubMed 10535437Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. doi: 10.1001/jama.282.15.1458.
- Derived from this study: PubMed 22765882Drawz PE, Miller RT, Singh S, Watts B, Kern E. Impact of a chronic kidney disease registry and provider education on guideline adherence--a cluster randomized controlled trial. BMC Med Inform Decis Mak. 2012 Jul 5;12:62. doi: 10.1186/1472-6947-12-62.
- abstract - BMC Medical Informatics and Decision MakingLink 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.
Paul E Drawz, MD, MHS, MS principal investigator
Louis Stokes VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education only and Multifactorial intervention in people with Chronic Renal Insufficiency, run by Louis Stokes VA Medical Center 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 7 inclusion and 4 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 27 May 2013. 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?
Yes. Results are posted in the registry (first posted 23 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PTH (Parathyroid Hormone) Adherence (time frame: One year). 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 NCT00921687, 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 27 May 2013.