Medication Intervention for Chronic Kidney Disease Patients Transitioning from Hospital to Home: Study Design and Baseline Characteristics

Abstract

Background: The hospital readmission rate in the population with chronic kidney disease (CKD) is high and strategies to reduce this risk are urgently needed.

Methods: The CKD-Medication Intervention Trial (CKD-MIT; www.clinicaltrials.gov; NCTO1459770) is a single-blind (investigators), randomized, clinical trial conducted at Providence Health Care in Spokane, Washington. Study participants are hospitalized patients with CKD stages 3-5 (not treated with kidney replacement therapy) and acute illness. The study intervention is a pharmacist-led, home-based, medication management intervention delivered within 7 days after hospital discharge. The primary outcome is a composite of hospital readmissions and visits to emergency departments and urgent care centers for 90 days following hospital discharge. Secondary outcomes are achievements of guideline-based targets for CKD risk factors and complications.

Results: Enrollment began in February 2012 and ended in May 2015. At baseline, the age of participants was 69 ± 11 years (mean ± SD), 50% (77 of 155) were women, 83% (117 of 141) had hypertension and 56% (79 of 141) had diabetes. At baseline, the estimated glomerular filtration rate was 41 ± 14 ml/min/1.73 m2 and urine albumin-to-creatinine ratio was 43 mg/g (interquartile range 8-528 mg/g). The most frequent diagnosis category for the index hospital admission was cardiovascular diseases at 34% (53 of 155), but the most common single diagnosis for admission was community-acquired acute kidney injury at 10% (16 of 155).

Conclusion: Participants in CKD-MIT are typical of acutely ill hospitalized patients with CKD. A medication management intervention after hospital discharge is under study to reduce post-hospitalization acute care utilization and to improve CKD management.

Trial registration: ClinicalTrials.gov NCT01459770.

Figure 1. CONSORT Flow Diagram

Figure 2

Average number of Elixhauser comorbidities (with the 95% confidence intervals) by albuminuria category (<30 mg/g, 30-300 mg/g, >300 mg/g). The probability level refers to the linear component of the association by analysis of variance.

Figure 3

Frequency of study participants achieving goals for CKD risk factor control, complications and use of angiotensin converting enzyme inhibitors and angiotensin II receptor blocker medications at baseline. Abbreviations: angiotensin converting enzyme inhibitors and angiotensin II receptor blocker (ACE/ARB), systolic and diastolic blood pressure (SBP, DBP), hemoglobin (Hb), phosphorus (PO4), parathyroid hormone (PTH), and hemoglobin A1C (HbA1C).