Document text
Principal Investigator: Diana I Jalal
Organization: IOWA CITY VA MEDICAL CENTER
Fiscal Year: 2024
Funding agency: Veterans Affairs
Background. Chronic kidney disease (CKD) associates with high morbidity and mortality due to CKD
progression and cardiovascular disease (CVD). Blood pressure (BP) lowering reduces the risk of CVD and
CKD progression. In spite of the large number of BP medications available, a significant proportion of Veterans
with CKD have BP above the goal. The current practice involves licensed providers performing medication
titrations to achieve BP goals and is associated with limited patient engagement. Our preliminary data indicate
that the implementation of pharmacist-guided patient-driven titration of BP medications is effective and feasible
in CKD. In this model, Veterans self-manage their BP medications under the guidance of the clinical
pharmacist based on a pre-determined medication titration plan.
Significance. The prevalence of CKD is extremely high among Veterans, with some studies reporting a
prevalence of 47% (vs 11% in the general population). Here, we propose a novel interdisciplinary care model
that engages the Veterans as an active participant in their care with the goal of improving BP control to
improve long term outcomes. The application addresses a key HSR&D priority (management of complex
chronic disease).
Innovation and Impact. First, the proposed care model is one that has not been tested and includes the
clinical pharmacist working with the provider and the Veterans so that Veterans with CKD can self-manage
their hypertension. While self-management is exercised in CKD once patients are on dialysis (via home
dialysis modalities), the self-management approach is not utilized in the earlier stages of CKD. Second, in the
approach, we will utilize a transdisciplinary approach to evaluate the implementation of pharmacist-guided self-
management of BP medications and we will apply constructs of an implementation science framework,
Consolidated Framework for Implementation Research (CFIR), to understand Veteran and system factors that
may either facilitate or impede the implementation and sustainment of the pharmacist-guided self-management
approach.
Specific aims. Specific aim 1 will evaluate if pharmacist-guided self-management of BP medications is more
effective than self-monitoring of home BP + the standard care amongst Veterans with CKD. Specific aim 2 will
identify and understand Veteran factors that may influence the acceptability of and the adherence to the self-
management approach whereas specific aim 3 will focus on understanding system factors that may facilitate or
impede the implementation of the self-management approach.
Methods. One hundred and sixty Veterans with uncontrolled hypertension and either stage 2 CKD with
albuminuria or stage 3 and 4 CKD will be randomized to either pharmacist-guided self-management or to self-
monitoring + the standard practice for 12 months. Aim 1 will evaluate change in [standardized] office systolic
BP at 12 months as the primary outcome. Aim 2 will utilize a mixed methods approach including semi-
structured interviews to evaluate a sample of 20 Veterans in each of the study arms. We will further design
data abstraction tools to evaluate the adherence to the intervention. In aim 3, we will utilize CFIR constructs to
guide our qualitative semi-structured interviews with key organizational stakeholders including PACT clinical
pharmacists, PCPs, and CKD providers (20 key stakeholders).
Implementation. The PI will implement the pharmacist-guided self-management approach with the Pharmacy
and Ambulatory care services as operational partners. The implementation of this approach will improve the
patient experience (Survey of Healthcare Experiences of Patients) and the quality of care
(Clinical Performance Measurement Program and the Strategic Analytics for Improvement and Learning).
Terms: <Address><Adherence><Affect><Albuminuria><Ambulatory Care><Appointment><Assess implementation><BP control><BP management><BP reduction><Blood Pressure><Cardiovascular Diseases><Caring><Characteristics><Chronic Disease><Chronic Illness><Chronic Kidney Failure><Chronic Renal Disease><Chronic Renal Failure><Cities><Clinic Visits><Clinical><Clinical Pharmacists><Clinical Trials><Complex><Consolidated Framework for Implementation Research><Consolidated Framework for Implementation Science><Consolidated Framework for Implementing Change><Data><Dialysis><Dialysis procedure><Disease Progression><Drugs><ESRD><End stage renal failure><End-Stage Kidney Disease><End-Stage Renal Disease><Evaluation><Exercise><Feasibility Studies><Funding><General Population><General Public><Goals><Health Care Surveys><Health Care Systems><Healthcare Delivery><Healthcare Surveys><Healthcare Systems><Home><Home Blood Pressure Monitoring><Hypertension><Implementation assessment><Instruction><Intervention><Intervention Strategies><Interview><Investigators><Iowa><Kidney Diseases><Learning><Licensing><Measurement><Medication><Methods><Modality><Modeling><Monitor><Morbidity><Morbidity - disease rate><NIH><National Institutes of Health><Nephropathy><Out-patients><Outcome><Outpatient Care><Outpatients><Participant><Patients><Performance><Pharmaceutical Preparations><Pharmacies><Pharmacists><Pharmacy facility><Prevalence><Provider><QOC><Quality of Care><Randomized><Renal Disease><Reporting><Research><Research Personnel><Researchers><Risk><Risk Factors><Risk Reduction><Sampling><Self Blood Pressure Monitoring><Self Management><Service delivery model><Service model><Services><Standardization><Structure><System><Testing><Time><Titrations><United Kingdom><United States National Institutes of Health><Universities><Vascular Hypertensive Disease><Vascular Hypertensive Disorder><Veterans><Veterans Health Administration><Veterans Health Affairs><arm><blood pressure control><blood pressure management><blood pressure medication><blood pressure medicine><blood pressure reduction><cardiovascular disease risk><cardiovascular disorder><cardiovascular disorder risk><cardiovascular risk><cardiovascular risk factor><care delivery model><care services><care systems><chronic disorder><chronic kidney disease><death risk><design><designing><dialysis therapy><drug/agent><evaluate implementation><evaluation of implementation><experience><health and care delivery><health care delivery><health care delivery model><health care model><health delivery systems><health services delivery><healthcare delivery model><healthcare model><high blood pressure><high risk><homes><hyperpiesia><hyperpiesis><hypertension control><hypertension management><hypertensive disease><hypertensive disorder><implementation evaluation><implementation facilitation><implementation framework><implementation research framework><implementation science framework><improved><innovate><innovation><innovative><interventional strategy><kidney disorder><lower BP><lower blood pressure><lowers blood pressure><mortality><mortality risk><new approaches><novel><novel approaches><novel strategies><novel strategy><outpatient treatment><participant engagement><patient engagement><primary care provider><primary outcome><programs><providers from primary care><providers of primary care><randomisation><randomization><randomly assigned><reduce BP><reduce blood pressure><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><reduction in BP><reduction in blood pressure><renal disorder><risk-reducing><shared decision making><standard care><standard treatment><team-based care><tool><traditional care>