Chronic Kidney Disease
Conditions
Brief summary
The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect. Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.
Detailed description
Research Plan: The experimental design is a prospective, randomized controlled trial evaluating the impact of a Chronic Care Model (CCM) based quality improvement program on CKD guideline adherence. The intervention will focus on three main goals: 1) reduction of BP to target levels, 2) appropriate monitoring of patients for metabolic complications of CKD, and 3) reduced use of dialysis catheters in patients initiating dialysis. The CKD CCM QI program will include a lecture on CKD guidelines and hypertension to all CBOC providers and a centrally located pharmacist with access to the CKD registry. Methodology: Veterans receive primary care at Community Based Outpatient Centers (CBOCs) throughout Northeast Ohio. Patients with CKD who receive their primary care at a Northeast Ohio CBOC will be eligible for the study. The hypothesis was formulated before data collection.
Interventions
OTHERPharmacist based QI program
Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR \<30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
OTHERUsual Care
Patients in the control arm will continue to receive usual care from their VA providers.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* receipt of primary care at a VISN 10 Northeast Ohio CBOC * GFR (calculated according to the 4 variable Modification of Diet in Renal Disease study equation) less than 45 mL/min per 1.73m2 with a second GFR less than 60 at least 90 to 730 days prior to the index GFR (26); and * at least one primary care visit in the year prior to study initiation.
Exclusion criteria
* ESRD as defined by chronic renal replacement therapy, * receipt of a renal transplant, * hospice care, and * age greater than 85 years or less than 18 years at the time of study initiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) | one year | Average SBP for those with a baseline BP \> 130/80 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With PTH Measurement During the Study Period | one year | The primary process outcome was measurement of PTH during the study period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pharmacist Intervention Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR \<30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy. | 1,070 |
| Control - Usual Care Patients assigned to control will continue to receive care from their VA provider.
Usual Care: Patients in the control arm will continue to receive usual care from their VA providers. | 1,129 |
| Total | 2,199 |
Baseline characteristics
| Characteristic | Pharmacist Intervention | Control - Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 75.6 years STANDARD_DEVIATION 8.2 | 75.7 years STANDARD_DEVIATION 8.2 | 75.6 years STANDARD_DEVIATION 8.2 |
| Race/Ethnicity, Customized Black | 62 participants | 56 participants | 118 participants |
| Race/Ethnicity, Customized Not Black | 1008 participants | 1073 participants | 2081 participants |
| Region of Enrollment United States | 1070 participants | 1129 participants | 2199 participants |
| Sex: Female, Male Female | 16 Participants | 23 Participants | 39 Participants |
| Sex: Female, Male Male | 1054 Participants | 1106 Participants | 2160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,070 | 0 / 1,129 |
| serious Total, serious adverse events | 0 / 1,070 | 0 / 1,129 |
Outcome results
Primary
Systolic Blood Pressure (SBP)
Average SBP for those with a baseline BP \> 130/80
Time frame: one year
Population: Baseline blood pressure \>130/80 mmHg
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist Intervention | Systolic Blood Pressure (SBP) | 135.1 mmHg | Standard Deviation 17.4 |
| Control - Usual Care | Systolic Blood Pressure (SBP) | 134.4 mmHg | Standard Deviation 17.6 |
p-value: 0.57t-test, 2 sided
Secondary
Number of Participants With PTH Measurement During the Study Period
The primary process outcome was measurement of PTH during the study period.
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pharmacist Intervention | Number of Participants With PTH Measurement During the Study Period | 502 participants |
| Control - Usual Care | Number of Participants With PTH Measurement During the Study Period | 182 participants |
p-value: <0.001Chi-squared