Patient-driven Management of BP in CKD

Chronic Kidney Disease Clinical Trial

Official title:

Pharmacist-guided, Patient-driven Management of High Blood Pressure in CKD: A Novel Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546099
• Other study ID #: IIR 21-255
• Status: Recruiting
• Phase: Phase 3
• Start date: December 15, 2022
• Est. completion date: November 20, 2026

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: Diana Jalal, MD
• Phone: (319) 338-0581
• Email: diana.jalal[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed research will evaluate if patients managing their blood pressure medications under the guidance of a clinical pharmacist works better to lower blood pressure than patients monitoring their blood pressure at home and the standard care. 60 Veterans with chronic kidney disease (CKD) will be included in the study. The study will further evaluate factors that may influence the Veteran to accept the self-management approach and what factors in the VHA healthcare system affect the implementation of the self-management approach.

Description:

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. The investigators 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.

The prevalence of CKD is extremely high among Veterans, with some studies reporting a prevalence of 47% (vs 11% in the general population). Here, the investigators 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).

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. Importantly, in the approach, the investigators will utilize a transdisciplinary approach to evaluate the implementation of pharmacist-guided self-management of BP medications and the investigators 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 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.

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. The investigators will further design data abstraction tools to evaluate the adherence to the intervention. In aim 3, the investigators will utilize CFIR constructs to guide the investigators qualitative semi-structured interviews with key organizational stakeholders including PACT clinical pharmacists, PCPs, and CKD providers (20 key stakeholders).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 20, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years,

• CKD stage 3 or 4 (estimated GFR: 15-59 mL/min/1.73m2) or

• Stage 2 CKD (estimated GFR 60-89 mL/min/1.73m2) with urinary albumin/creatinine ratio (ACR 300 mg/g if no DM and 30 mg/g if with DM), and

• Uncontrolled hypertension defined as the avg of 2 readings > 140 systolic.

Exclusion Criteria:

• Severely uncontrolled hypertension defined as systolic BP >180,

• Patients with resistant hypertension and taking 4 BP medications,

• Orthostatic hypotension defined as reduced systolic BP by 20 mmHg or diastolic BP by 10 mmHg after 3 minutes of standing,

• Severe CKD defined as estimated GFR < 20 mL/min/1.73m2,

• Life expectancy <1 year,

• Severe liver disease,

• Severe congestive heart failure,

• Severe cognitive decline due to dementia,

• Pregnant, breastfeeding, or unwilling to use adequate birth control

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Self-management of BP medications
Patients will be educated on how to manage their home BP based on a pre-determined protocol. They will then monitor home BP and adjust meds accordingly and under the guidance of the clinical pharmacist.
• Self-monitoring of home BP
Patients will be educated on how to monitor home BP and will be educated to contact their primary care provider/CKD provider if the BP is above the goal.

Locations

Country	Name	City	State
United States	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in standardized office BP	Detailed procedure for standardized office BP measurement: This will be obtained by a trained research coordinator in accordance with the ACC/AHA and KDIGO (Kidney Disease Improving Global Outcomes) guideline.	12 months
Secondary	Change in conventional office BP	BP measured during standard of care clinical visits will be included.	12 months
Secondary	Home BP readings	The average of the last 10 BP readings at home will be utilized a secondary outcome	12 months
Secondary	Change in standardized office diastolic BP	Measured same as the primary outcome	12 months