There are an estimated 20 million Americans with chronic kidney disease (CKD). Independent of age, sex, and other comorbid conditions, patients with CKD are at increased risk of a premature cardiovascular event or death compared with the general population. Patients with lower income and those in racial/ethnic minorities are more likely to have kidney failure, creating a burden on healthcare systems that disproportionately provide for their care.
Previous studies have demonstrated that CKD decline and progression to end-stage renal disease can be delayed with interventions to control blood pressure and to reduce proteinuria with angiotensin receptor blockers (ARB) or angiotensin-converting enzyme (ACE) inhibitors; these treatments also decrease morbidity and mortality associated with CKD. Factors involved in failure to implement these best practices in primary care may include poor awareness of CKD-related findings and limited confidence among primary care providers (PCPs) in delivering renal care, particularly in the context of healthcare systems that rely on overburdened providers to deliver care to patients with chronic and complex diseases.
Management of chronic disease can be enhanced with the use of disease registries, information platforms that capture and track patient-level data allowing healthcare teams to manage patients through in-reach at the point of care or via out-reach programs outside of scheduled appointment times. Studies of CKD registries in the United States utilizing computer-assisted prompts/alerts have not resulted in improved outcomes related to management of CKD or in clinical outcomes.
Researchers, led by Delphine S. Tuot, MDCM, MAS, conducted a randomized, pragmatic trial of a CKD registry versus a usual-care registry for 1 year to test the hypothesis that prior negative results in the United States were not due to unique refractoriness of CKD to the registry approach, but because prior US CKD registries did not focus on behavior change among individual physicians rather than among healthcare teams and care systems. The researchers created an electronic CKD registry to identify patients with CKD and provide data relating to CKD management to the entire healthcare team. The approach was tested in safety-net primary care clinics with a high burden of hypertension and CKD. Results were reported in the American Journal of Kidney Diseases [2018;72(2):168-177].
The trial was conducted in two primary care clinics in San Francisco’s public healthcare delivery system from 2013 to 2015. The prevalence of CKD in the two clinics was high; one clinic was an academic training facility and the other was a community clinic with no trainees. Practice teams that included several physicians (with or without trainees), one nurse, nurse practitioners, medical assistants, and behaviorists were randomly assigned in a 1 to 1 ratio to one of two arms: access to an electronic CKD registry or to a usual-care registry for 12 months.
The CKD registry alerted practice teams of a patient’s CKD-relevant information to enhance delivery of care in accordance with recommended guidelines. The registry provided point-of-care data regarding patient-specific status such as estimated glomerular filtration rate (eGFR), recent ambulatory clinic blood pressure readings, status of ACE/ARB prescription, and quantification of albuminuria (complete vs not complete). Data on diabetes care, immunization status, and information pertinent to age-appropriate cancer screening were also included in the CKD registry. Quarterly feedback relative to the metrics was provided to practice teams and individual PCPs to promote outreach to the patients.
Usual care included an electronic registry that was in use prior to implementation of the trial. The registry provided practice teams with point-of-care data on diabetes care, age-appropriate cancer screening, and immunization status. There were no CKD-related data included in the usual care registry, and there was no quarterly feedback provided to practice teams in the usual-care registry group.
The primary outcome of interest was change in ambulatory clinic systolic blood pressure from baseline to 12 months. Secondary outcomes included changes in the proportion of patients with blood pressure control defined as blood pressure <140/<90 mm Hg, proportion of patients whose albuminuria was quantified among those who had not received quantification at trial initiation, albuminuria severity, and proportion of patients prescribed an ACE inhibitor/ARB or who had a documented reason for no prescription. Change in eGFR was not a prespecified outcome, however, it was included in a post hoc analysis.
Mean age of the overall patient population was 56.7 years, 53% were women, and the cohort was racially/ethnically diverse (8% non-Hispanic white, 35.7% black, 24.5% Hispanic, and 24.4% Asian). Nearly 30% of the patients with CKD had a non-English language preference; all either had public insurance or were unemployed. With the exception of age, race/ethnicity, and language preference, baseline characteristics were similar between the two study groups.
CKD stage was distributed as follows: 41.6% had CKD stage 1 or 2, 38.6% had stage 3a, 1.5% had stage 3b, and 4.8% had CKD stage 4. Overall, 38% had albuminuria quantified at baseline; average albumin-creatinine ratio was 421 mg/g. Approximately 20% had a glycated hemoglobin level >6.5% and 36% of patients had uncontrolled blood pressure. Average baseline systolic blood pressure was 133.6 mm Hg and average baseline diastolic blood pressures was 79.6 mm Hg.
In the CKD registry group, there were 285 patients among 30 PCPs; 461 patients among 49 PCPs were randomly assigned to the usual-care registry group. In comparison between the two groups, there was no association between the CKD registry and the usual-care registry and a change in systolic blood pressure over time. There was no association between random assignment to the CKD registry group and change in the proportion of patients with controlled blood pressure <140/90 mm Hg. There were no differences by PCP type, CKD stage, or baseline blood pressure control. There was no association between assignment to the CKD registry group and change in eGFR overall.
There was an association between random assignment to the CKD registry group and 2-fold greater odds of ACE inhibitor/ARB prescription and albuminuria quantification during the 1-year study period compared with the usual-care registry group.
Study limitations included limiting the cohort to patients treated in a public safety-net healthcare system, potential misclassification of CKD, and missing baseline medication data.
“In conclusion, a primary care registry directed toward the entire healthcare team with point-of-care alerts and outreach lists can improve essential CKD processes of care. In the context of healthcare reform and the evolution of patient-centered medical homes with team-based chronic care delivery, this has wide public health implications. Although this study needs to be replicated in a larger delivery system with long-term outcomes, adoption of team-based CKD registries may represent an important step of translating evidence into practice for CKD management, particularly in health delivery systems that care for patient populations with a high burden of kidney disease,” the researchers said.
- Researchers conducted a randomized, pragmatic trial to test the impact of a primary care chronic kidney disease (CKD) registry in a public safety-net healthcare delivery system in the United States.
- At the end of the 12-month study period, random assignment to the CKD registry group was not associated with changes in systolic blood pressure, proportion of patients with uncontrolled blood pressure, or degree of albuminuria, compared with assignment to the usual-care registry group.
- There was an association between assignment to the CKD registry group and 2-fold greater odds of angiotensin receptor blocker or angiotensin-converting enzyme inhibitor prescription and albuminuria quantification compared with assignment to the usual-care registry group.