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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifactorial intervention | Experimental | The multifactorial intervention will consist of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry. |
|
| Education only | Active Comparator | Providers in the education only arm will receive a CKD lecture and be given a CKD reference card. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education only | Behavioral | The education will consist of a lecture and distribution of a CKD reference card. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
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Providers:
Inclusion Criteria:
Patients:
Inclusion Criteria:
Receive primary care from a provider at the Wade Park VAMC
Have:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul E Drawz, MD, MHS, MS | Louis Stokes VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes Cleveland Veterans Affairs Medical Center | Cleveland | Ohio | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11904577 | Background | 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. | |
| 17988187 | Background | Hoy 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. |
| Label | URL |
|---|---|
| abstract - BMC Medical Informatics and Decision Making | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Providers in the control group received education only (CKD lecture and a CKD reference card). |
| FG001 | Intervention | The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Clinic | Providers in the control group received education only (chronic kidney disease (CKD) lecture and a CKD reference card). |
| BG001 | Intervention Clinic | The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | probability of having a PTH measured | One year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Clinic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Drawz, MD, MHS, MS | Louis Stokes Cleveland VA Medical Center | 6126255423 | draw0003@umn.edu |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Multifactorial intervention | Behavioral | 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. |
|
| 18175059 | Background | Philipneri 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. |
| 10535437 | Background | Cabana 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. |
| 22765882 | Derived | Drawz 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diabetes | Number | participants |
|
| Hypertension | Number | participants |
|
| Stage of chronic kidney disease | Stage III - estimated glomerular filtration rate (eGFR) <60 and >=30 Stage IV - eGFR <30 and >=15 Stage V - eGFR <15 Stage V is the worst clinical stage (lower eGFR indicates worse kidney function). | Number | participants |
|
| Participants |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | probability of controlled clinic BP | One year |
|
|
|
|
| 0 |
| 418 |
| 0 |
| 418 |
| EG001 | Intervention Clinic | 0 | 363 | 0 | 363 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |