Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans.

BACKGROUND: Whether screening for chronic kidney disease (CKD) can improve the care of persons at high risk for complications remains uncertain. We describe the design and early implementation experience of a pilot, cluster-randomized pragmatic trial to evaluate the feasibility, implementation, and effectiveness of a "triple marker" CKD screening program (creatinine, cystatin C and albumin to creatinine ratio) for improving care among hypertensive veterans seen in primary care at one Veterans Administration Hospital. METHODS/DESIGN: Non-diabetic hypertensive veterans age 18-80 without known CKD were randomized in clusters determined by primary care provider (unit of randomization) into three arms. Usual care will be compared with two incrementally intensified treatment strategies: (1) screen for CKD followed by patient and provider education or (2) screen-educate plus a clinical pharmacist-led CKD and BP management program. The primary clinical outcome is systolic blood pressure (BP) change from baseline. Secondary clinical outcome is BP control. The primary process outcomes is triple marker screening (across three arms), and secondary process outcomes include use of inhibitors of the renin-angiotensin system (ACE/ARB) overall and in persons with albuminuria, CKD recognition by PCP, use of non-steroidal anti-inflammatory drugs (NSAIDs) and NSAID education by PCP. The design uses the Veterans Health Administration electronic health record (EHR) to identify participants, deliver the interventions and ascertain study outcomes. Assessment of the program implementation will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Study duration is 12 months. RESULTS: A total of 1,819 patients have been randomized within 41 provider clusters. The median age (interquartile range) is 68 years (61-72), and 99% of participants are male. Approximately 16% are Black, and 5% Hispanic. In the first 6 months of the trial, 434 triple marker screening tests have been ordered, and 217(50%) have been tested. A total of 48 new CKD cases have been identified among those tested, for a preliminary yield of 22%. CONCLUSION: We have successfully implemented a pragmatic protocol that uses the EHR to identify and characterize eligible participants, deliver the intervention, and ascertain study outcomes with high rates of participation by providers and patients. Results from this study can guide design of pragmatic trials in the field of CKD. TRIAL REGISTRATION: NCT01978951 ; Date or Registration: 1/17/2014.

Implementing an opioid risk assessment telephone clinic: Outcomes from a pharmacist-led initiative in a large Veterans Health Administration primary care clinic, December 15, 2014-March 31, 2015.

BACKGROUND: In response to the national epidemic of prescription opioid misuse and related adverse outcomes, two clinical pharmacists developed a telephone risk assessment clinic to promote safe opioid prescribing through a monthly assessment of patient medication use, aberrant behaviors, and side effects. METHODS: A pilot group of five primary care providers and their patients with chronic nonmalignant pain on chronic opioid therapy, defined as having received prescription opioid medications for ≥90 days in the last 120 days, were identified. A risk assessment evaluation based on Veterans Health Administration/Department of Defense Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain was created. Factors assessed were receipt of non-San Francisco Veterans Administration Health Care System controlled substance prescriptions through California's prescription drug monitoring program, urine drug test (UDT) results, and aberrant behaviors. Pharmacist-recommended changes to regimen and provider response to recommendation were compiled. The pilot was conducted from December 15, 2014, to March 31, 2015. RESULTS: Among 608 patients on chronic opioid therapy, 148 were assigned to pilot providers and 447 assessments were completed. Twenty-five (16.8%) patients had non-VA controlled substance prescriptions, of which 14 (56.0%) patients filled a non-VA controlled substance within 3 months of the start of pilot. Seventeen UDT results inconsistent with their prescribed regimens were identified from 12 patients (8.1%). Pharmacists recommended 66 changes to chronic opioid prescriptions in 48 patients (32.4%), including decreasing quantity of opioid(s) (33.3%), discontinuing chronic opioid therapy (22.7%), and delaying a fill (19.7%). Sixty-one of 66 (92.5%) pharmacist recommendations for regimen change were implemented by providers. Chronic opioid therapy was discontinued in 14 (9.5%) patients over the course of the pilot study. CONCLUSIONS: A pharmacist-led telephone risk assessment clinic improved adherence to clinical guidelines and changed opioid prescribing practices in more than one third of assessed patients.

Screening for CKD To Improve Processes of Care among Nondiabetic Veterans with Hypertension: A Pragmatic Cluster-Randomized Trial.

BACKGROUND AND OBJECTIVES: We conducted a pilot, pragmatic, cluster-randomized trial to evaluate feasibility and preliminary effectiveness of screening for CKD using a triple-marker approach (creatinine, cystatin C, and albumin/creatinine ratio), followed by education and guidance, to improve care of hypertensive veterans in primary care. We used the electronic health record for identification, enrollment, intervention delivery, and outcome ascertainment. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We randomized 1819 veterans without diabetes but with hypertension (41 clusters) into three arms: (1) CKD screening followed by patient and provider education; (2) screening, education, plus pharmacist comanagement; or (3) usual care. The primary clinical outcome was BP change over 1 year. Implementation and process measures included proportion screened; CKD detection rate; and total and new use of renin-angiotensin system inhibitors, nonsteroidal anti-inflammatory drugs, and diuretics. RESULTS: Median age was 68 years, 55% were white, 1658 (91%) had a prior creatinine measure, but only 172 (9%) had prior urine albumin/creatinine ratio, and 83 (5%) had a prior cystatin C measure. Among those in the intervention, 527 of 1215 (43%) were identified with upcoming appointments to have CKD screening. Of these, 367 (69%) completed testing. Among those tested, 77 (21%) persons had newly diagnosed CKD. After 1 year, change in systolic BP was -1 mm Hg (interquartile range, -11 to 11) in usual care, -2 mm Hg (-11 to 11) in the screen-educate arm, and -2 mm Hg (-13 to 10) in the screen-educate plus pharmacist arm; P=0.49. There were no significant differences in secondary outcomes in intention-to-treat analyses. In as-treated analyses, higher proportions of participants in the intervention arms initiated a renin-angiotensin system inhibitor (15% and 12% versus 7% in usual care, P=0.01) or diuretic (9% and 12% versus 4%, P=0.03). CONCLUSIONS: The pragmatic design made identification, enrollment, and intervention delivery highly efficient. The limited ability to identify appointments resulted in inadequate between-arm differences in CKD testing rates to determine whether screening improves clinical outcomes.