Chronic Renal Insufficiency
Conditions
Brief 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. 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.
Interventions
BEHAVIORALEducation only
The education will consist of a lecture and distribution of a CKD reference card.
BEHAVIORALMultifactorial intervention
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.
Sponsors
Louis Stokes VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Providers: Inclusion Criteria: * All primary care providers at the Wade Park Veterans Affairs Medical Center (VAMC) will be eligible for the study Patients: Inclusion Criteria: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTH (Parathyroid Hormone) Adherence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Last Clinic BP <130/80 mmHg | One year | Probability of last Clinic BP \<130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Clinic Providers in the control group received education only (chronic kidney disease (CKD) lecture and a CKD reference card). | 418 |
| Intervention Clinic The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry. | 363 |
| Total | 781 |
Baseline characteristics
| Characteristic | Control Clinic | Intervention Clinic | Total |
|---|---|---|---|
| Age Continuous | 71 years STANDARD_DEVIATION 10.3 | 71 years STANDARD_DEVIATION 10.7 | 71 years STANDARD_DEVIATION 10 |
| Diabetes No | 208 participants | 200 participants | 408 participants |
| Diabetes Yes | 210 participants | 163 participants | 373 participants |
| Hypertension No | 29 participants | 11 participants | 40 participants |
| Hypertension Yes | 389 participants | 352 participants | 741 participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 37 Participants |
| Sex: Female, Male Male | 401 Participants | 343 Participants | 744 Participants |
| Stage of chronic kidney disease Stage III | 383 participants | 325 participants | 708 participants |
| Stage of chronic kidney disease Stage IV | 32 participants | 36 participants | 68 participants |
| Stage of chronic kidney disease Stage V | 3 participants | 2 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 418 | 0 / 363 |
| serious Total, serious adverse events | 0 / 418 | 0 / 363 |
Outcome results
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.
Time frame: One year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Clinic | PTH (Parathyroid Hormone) Adherence | 0.23 probability of having a PTH measured |
| Intervention Clinic | PTH (Parathyroid Hormone) Adherence | 0.28 probability of having a PTH measured |
p-value: 0.0495% CI: [1.01, 2.3]Generalized Estimating Equation
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.
Time frame: One year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Clinic | Last Clinic BP <130/80 mmHg | 0.41 probability of controlled clinic BP |
| Intervention Clinic | Last Clinic BP <130/80 mmHg | 0.44 probability of controlled clinic BP |
p-value: 0.4495% CI: [0.84, 1.49]Generalized Estimating Equation