A Clinical Trial Evaluating Pharmacist-Guided Self-Management of Hypertension among Veterans with CKD, Rationale and Study Design

Abstract

Rationale & Objective:

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. Despite the large number of BP medications available, a significant proportion of patients 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. Here, we evaluate the effectiveness of pharmacist-guided patient-driven titration of BP medications in CKD.

Study Design:

Randomized clinical trial

Setting & Participants:

One hundred and sixty Veterans with uncontrolled hypertension and either stage 2 CKD with albuminuria or stage 3 or 4 CKD are recruited from the Iowa City VA Healthcare system.

Interventions:

Subjects are randomized to the pharmacist self-guided management arm or the self-monitoring arm for 12 months.

Outcomes:

This is a mixed methods study. The primary outcome is change in standardized office systolic BP at 12 months. Secondary outcomes include change in standardized office diastolic BP, change in home systolic and diastolic BPs, change in conventional office systolic and diastolic BPs, and emergency room visits for uncontrolled hypertension or hypertensive emergency. The study team will conduct semi-structured interviews to evaluate the acceptability and the adherence to the self-management approach to Veterans and to assess potential barriers and facilitators to implementation of the self-management approach.

Trial Registration:

NCT05546099

Introduction

One in 10 individuals is estimated to have chronic kidney disease (CKD) in the U.S.¹ The prevalence of CKD is even higher amongst Veterans, with some estimates indicating one third to 47% of Veterans have CKD.² In addition to the risk of end stage kidney disease (ESKD), individuals with CKD are at high risk of death from cardiovascular disease (CVD).³

Hypertension is a well-known risk factor for CVD, CKD progression, and mortality and is highly prevalent in individuals with CKD.^4–6 Several studies have shown lowering blood pressure (BP) reduces mortality and slows CKD progression.⁷ Despite this, a significant proportion of individuals with CKD do not achieve BP goals.^4–6,8 Considering the wide range of BP medications available, these data indicate a pressing need for innovative healthcare delivery models to improve BP control in individuals with CKD.

The promise of the team-based approach

Several studies have shown that intensifying treatment for hypertension improves BP control even in the absence of patient adherence.^9–11 As such, targeting inertia in the healthcare system represents a high yield target for improving BP control.

Several factors may account for provider inertia in the management of hypertension, the most important being uncertainty about the clinical diagnosis of hypertension and competing medical priorities due to complex medical problems.¹² Interventions such as provider education, provider reminders, and ambulatory BP monitoring may improve provider inertia but are, at best, moderately effective to improve BP control.¹³ The most potent strategy to reduce inertia in the healthcare system is to utilize a team-based approach to monitor and treat high BP in contrast to the standard practice of providers evaluating clinic BP readings and adjusting BP medications during clinic visits.¹⁴ In a meta-analysis by Carter et al., utilizing registered nurse (RN) or clinical pharmacist expertise in the monitoring and management of high BP significantly lowered BP. Notably, interventions that utilized the clinical pharmacist were found to be significantly more effective than interventions that utilized only the RN.¹⁴ A considerable number of studies have shown that physician-pharmacist collaboration in the management of high BP is associated with improved BP lowering, including data by our group.^15–17

A critical member of the healthcare team in the management of hypertension is the patient themselves. Self-monitoring of home BP, which consists of the patient measuring and documenting home BP, is often utilized in clinical practice as some studies suggest that self-monitoring of home BP may lead to better adherence to BP medications ¹⁸ and may improve office BP.¹⁹ In reality, however, recent data shed considerable doubt on the effectiveness of self-monitoring of home BP alone. For example, a recent meta-analysis of 22 trials evaluated whether self-monitoring lowers BP in patients with hypertension and hypertension-related comorbidities including CVD.²⁰ The reported findings suggest that self-monitoring is only effective when combined with high-intensity interventions, such as tailored support from a pharmacist or a clinician or the provision of regular educational classes.²⁰ Our group reported similar results when evaluating self-monitoring of home BP as a strategy to lower BP in patients with CKD.²¹

Some studies have taken patient engagement a step farther by pairing self-monitoring of home BP with self-titration of BP medications to improve BP control.^22,23 Specifically, studies have evaluated self-management of hypertension, defined as self-monitoring of home BP and patient self-titration of BP medications based on a pre-determined titration plan by the patient’s primary care provider (PCP).²² These studies, published by McManus et al., were conducted in the U.K. in both low and high risk patients with hypertension and indicated that protocol-based patient self-titration of BP medications can be safe, feasible, and effective.^{22,23 24}

We adapted the self-management intervention developed by McManus et al. ^22,23 to include the clinical pharmacist and piloted the intervention (pharmacist-guided self-management of BP medications) in a CKD clinic (Figure 1). ²⁴ In the pharmacist-guided self-management intervention, the clinical pharmacist evaluated the patients and provided instruction on self-monitoring of home BP, a protocol for the up-titration of home BP medications, and dietary education. Self-monitoring of home BP was delegated to the patient but also, the recognition of BP being above the goal and the need to progress to the next step of the titration protocol and the responsibility to contact the clinical pharmacist to request updated prescriptions. This allowed the clinical pharmacist to review the titration protocol and the patients’ data, to update the medication lists and prescriptions, and to order any necessary safety labs. We believe that the full reliance on the patient to comply with the self-titration protocol without the support of a member of the healthcare team represents a barrier for the implementation of the self-management approach in CKD (as reported by McManus et al.), considering the increased risk of adverse events, the reported impairment in self-management and self-efficacy, and the lower health literacy in this patient population.^25,26 Seventeen patients participated in the pilot.²⁴ We found that 12 of the 17 patients (70%) were adherent in entering their BP readings into the electronic health record (EHR) and 11 of the 17 patients had follow-up visits with the clinical pharmacist at 6 months. Significant improvements in systolic and diastolic BP were observed.

Figure 1.

Figure 1 illustrates the prevalent model of care for the management of high blood pressure (BP). In the proposed model, the patient would assume key functions in the management of their hypertension including monitoring of home BP and recognizing the need to intensify the BP-lowering medical regimen.

Based on our pilot data, we are conducting a single-center, mixed methods clinical trial where Veterans are randomized to pharmacist-guided self-titration of BP medications based on home BP readings versus self-monitoring of home BP. Here, we review this ongoing study.

Hypothesis and Aims

Our primary hypothesis is that the pharmacist-guided self-management approach is effective to improve BP control in patients with CKD vs self-monitoring of home BP. Secondarily, we hypothesize that the pharmacist-guided self-management approach will be acceptable to patients with CKD and will associate with high levels of adherence. System factors that facilitate or impede the implementation of the pharmacist-guided self-management approach will be evaluated.

One hundred and sixty Veterans with uncontrolled hypertension and either stage 2 CKD with albuminuria or stage 3 or 4 CKD will be randomized to either pharmacist-guided self-management of BP medications or to self-monitoring of home BP for 12 months (Figure 2). The following specific aims are pursued:

Figure 2.

Figure 2 summarizes the study design

Aim 1: Determine the degree of BP lowering for the pharmacist-guided self-management approach compared to self-monitoring of home BP

Aim 2: Determine the acceptability of and the adherence to the pharmacist-guided self-management approach among Veterans with CKD and evaluate Veteran factors that influence the acceptability of and the adherence to this treatment approach.

Aim 3: Determine system factors that impede or facilitate the implementation and sustainment of the core components of the pharmacist-guided self-management approach within the healthcare system.

In aims 2 and 3, to systematically identify and understand factors impeding and facilitating the implementation and enhancement of our pharmacist-guided self-management approach for the treatment of high BP in a real-world context, we are using the approach formulated in the Consolidated Framework for Implementation Research (CFIR).²⁷ CFIR allows our team to ensure that our intervention aligns with stakeholder needs and resources.²⁸

Methods

a. Design

This is a concurrent, mixed methods randomized clinical trial. The study will collect and analyze quantitative and qualitative data at the same time, but separately from one another.^29–31

One hundred and sixty Veterans with CKD and uncontrolled hypertension will be recruited from the CKD clinics and primary care setting at the Iowa City VA HCS. As shown in Figure 2, subjects are randomized to one of the 2 study arms for 12 months:

1. The control (self-monitoring):

This consists of pharmacist education regarding monitoring of home BP monitoring and target BP, followed by patient self- monitoring of home BP. Patients are instructed to contact their primary care or appropriate specialty provider if their BP is above the goal. The management of BP medications is deferred to the primary care/specialty provider along with any additional follow up.

2. The intervention (pharmacist-guided self-management):

The clinical pharmacist evaluates the patients and provides education on self-monitoring of home BP and a pre-determined protocol for the up-titration of home BP medications, in addition to dietary counseling. The following tasks are delegated to the patient: a) Self-monitoring of home BP, b) The recognition that home BP is above the goal and the need to progress to the next step of the titration protocol, and c) The responsibility to contact the clinical pharmacist to request updated prescriptions. The clinical pharmacist reviews the titration protocol and patient data and updates the medication list and prescriptions. If needed, the clinical pharmacist will order the necessary monitoring labs.

Subjects in both study arms receive educational materials on dietary salt restriction and the value of other lifestyle modifications including smoking cessation, moderate alcohol intake, and exercise. Note templates ensure proper documentation of the intervention.

b. Participating Centers

The trial is being conducted in the VA Iowa City HCS, Iowa City, Iowa including the community- based outpatient clinics in the surrounding area and capitalizes on the VA Patient-Aligned Care Team (PACT) model. The PACT model relies on a team of health care providers, including a primary care physician as well as a RN care manager, licensed practical nurse, clinical pharmacist, social worker, and others to provide whole-person, coordinated healthcare for Veterans.^32,33 Clinical pharmacists in PACT have defined scopes of practice including medical titration for chronic disease management.

c. Study population

The inclusion and exclusion criteria are detailed in Table 1. Veterans must be 18 years of age or over. Uncontrolled hypertension is defined as the average of 2 readings of systolic BP > 140 mm Hg within the last 6 months. Only ambulatory office BP values are included; we will exclude BP measurements obtained during emergency room or inpatient admissions. Veterans with stage 2 CKD (estimated glomerular filtration rate [eGFR] 60–89 mL/min/1.73 m²) and albuminuria or stages 3 or 4 CKD (defined as: eGFR 20–59 mL/min/1.73 m2) are eligible to participate. eGFR is calculated based on the CKD-EPI formula.³⁴ Albuminuria is defined as urinary albumin/creatinine ratio (ACR) ≥30 mg/g. Patients with severely uncontrolled hypertension, defined as systolic BP > 180 mm Hg or with severe CKD defined as estimated GFR <20 mL/min/1.73m² are excluded.

Table 1:

Inclusion and exclusion criteria

Inclusion Criteria	Exclusion Criteria
Age ≥ 18 years old	Severely uncontrolled hypertension defined as systolic BP >180
CKD defined as:  - estimated GFR: 20–59 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)	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 54
Uncontrolled hypertension defined as the average of 2 readings of systolic BP > 140* [within the last 6 months]	Life expectancy <1 year
Able to give informed consent	Severe liver disease
	Severe congestive heart failure
	Severe cognitive decline due to dementia
	Pregnant, breastfeeding, or unwilling to use adequate birth control

^*Uncontrolled HTN is defined as systolic BP >140 for the study purposes to ensure the opportunity for BP lowering via a BP medication titration plan. Only ambulatory office BP values will be included (we will exclude BP measurements obtained during emergency room or inpatient admissions).

d. Recruitment and consent procedures

Recruitment is conducted as per the IRB-approved protocol (ID# 202205210). A report of potential subjects who fulfill the inclusion criteria (based on age, estimated GFR, and BP values) is generated via VA Informatics Computing Infrastructure (VINCI) Corporate Data Warehouse. A study coordinator then evaluates subjects based on the inclusion and exclusion criteria available in the medical record. Veterans who may qualify for the study are then sent a letter via USPS signed by the PI (Jalal) inviting them to participate in the study.

The letter includes a statement that the potential subject will be called if the card is not returned by a specific date. If the subject does not contact the study team within the specified date, the coordinator will call the patient to discuss the study and answer any questions. Willing subjects are then scheduled for a consent/enrollment visit.

Informed consent is conducted by the study coordinator or PI in a private patient room in one of the outpatient clinics at the Iowa City VA HCS. The potential subject is provided a copy of the consent document to read and review after which the consent document is reviewed with the subject. Specifically, we review the purpose of the research study, duration of study participation, and the number of study visits required. The study procedures in each study arm are highlighted and subjects are informed that they will be randomized either to the control or intervention. Other components of the consent reviewed include: the potential risks and the voluntary nature of the study, conditions that may lead to study subject discontinuation, and the contact information for the study team. Subjects who consent to the participation in the study are considered enrolled in the study.

e. Randomization

Enrolled subjects undergo the following screening procedures: a) Standardized measurement of their BP, b) Evaluation for orthostatic hypotension, and c) The completion of the screening questionnaire. BP is measured in accordance with the American College of Cardiology (ACC)/American Heart Association (AHA) and KDIGO (Kidney Disease Improving Global Outcomes) guidelines.^35,36 This is conducted in a private patient exam room, using the right-sized cuff, and appropriate patient and arm position, in addition to patient avoidance of caffeine, exercise, and smoking for 1 hour prior to the visit.

Subjects who fulfill all the inclusion/exclusion criteria are then randomly assigned to either the control or the intervention arms. We used RANDOM.ORG’s integer generator* to assign 200 IDs into the two groups (100 each). This ID list is imported into the project database. When the subject is ready to randomize, the coordinator clicks a button that looks up the next available unused ID, and the group assigned to it, and saves that group to the patient.

f. Intervention implementation

In partnership with the Cardiovascular Risk Service (CVRS) the PACT care model is adapted to deliver the self-management intervention. CVRS is an innovative healthcare model at the University of Iowa where clinical pharmacists support primary care providers in the management of cardiovascular risk factors. CVRS has led several large NIH-funded clinical trials dedicated to improved BP control.^15,16,37,38

Prior to the initiation of the trial, clinical pharmacists assigned to the project undergo training with the study team on the indications of use for certain BP medications such as angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor 2 blockers (ARB), diuretics, β-blockers, and calcium channel blockers. The use of second line agents (e.g., hydralazine or minoxidil) will also be reviewed. Individual care plans are developed for each patient randomized to the intervention by the clinical pharmacist in collaboration with the study investigator. A list of medication classes utilized in the study is provided in Table 2.

Table 2.

List of medications to be utilized in the intervention

Prescribing order	Proteinuric* CKD
First	Angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB)
Second	Diuretic: chlorthalidone first then furosemide55
Third	Dihydropyridine calcium channel blockers (e.g., amlodipine/nifedipine)
Fourth	B-blocker (e.g. carvedilol/metoprolol)
Fifth	Direct oral vasodilators (e.g. hydralazine/minoxidil)

^*Proteinuric CKD is defined as urinary albumin/creatinine ratio (ACR) ≥ 300 mg/g if no DM and ≥ 30 mg/g if with DM.⁵⁶ Of note, the optimal first line agent for non-proteinuric CKD is less defined. We anticipate using diuretics (chlorthalidone) and/or dihydropyridine calcium channel blockers (e.g., amlodipine/nifedipine) in the absence of underlying coronary heart disease (CHD). If the patient has a history of CHD, then ACEi/ARB will be considered.

Patient Education Guides have been developed (included in the Supplemental Materials). We anticipated a large percentage of the study subjects will require the use of ACEi/ARB and diuretics. In addition to receiving education on the up-titration of BP medications, subjects in the intervention arm receive instructions to stop the use of ACEi/ARB or diuretics in the instance of illness such as diarrhea, nausea/vomiting, reduced oral intake due to common infections such as the flu, urinary tract infections or pneumonia, or other illness that results in home systolic BP <100 mmHg. For the control arm, the clinical pharmacists review Veteran education regarding self-monitoring BP, recommended BP targets for patients with CKD, and guidance for patients to contact their PCP or specialty provider (cardiology/nephrology as applicable) to relay home readings if their BP is above the target.

g. Study visits

The study duration for each subject is 12 months. The clinical pharmacist visit takes place within 2 weeks of the consent and randomization/baseline visit. In addition to the baseline visit, there are 4 research visits that take place at 3, 6, 9, and 12 months. A trained renal research coordinator conducts all the research visits. Study procedures for each session are shown in Table 3. At each research visit, standardized office BP measurement is conducted. ^35,36 A safety assessment is conducted by the research coordinator. The Safety Assessment Guide is included with the Supplemental Materials.

Table 3.

Detailed study visits and procedures

Session	Study Procedures
Visit 1, 0 months Consent and randomization/baseline	- Introduction to study activities: informed consent - Screening questionnaire to verify inclusion/exclusion criteria - Record medical history, allergies, and current medications. All women of child-bearing age will undergo a pregnancy test - Collection of baseline BP - 7-day physical activity recall - Education on collection of 24-hour urine for sodium and creatinine
Randomization Occurs
Development of Titration Plan
Visit 2, ~2 weeks from first visit Clinical pharmacist	Arm 1 (Intervention): - Patients receive BP monitor (automated Omron HEM 907-XL) - Clinical pharmacist conducts education on proper BP measurement technique - Additional education provided on frequency and timing of BP measurements, BP goal, medication changes indicated for measurements above target, information in case of acute illness - All necessary labs ordered by clinical pharmacist and written instructions provided for follow-up plan - Education on low salt diet, as well as smoking cessation, alcohol intake, and exercise as indicated - Detailed visit note will be entered into EHR and shared with PCP and appropriate specialty providers*	Arm 2 (Control): - Patients receive BP monitor (automated Omron HEM 907-XL) - Clinical pharmacist conducts education on proper BP measurement technique - Additional education provided on frequency and timing of BP measurements, BP goal, and instructions to relay home BP readings - Education on low salt diet, as well as smoking cessation, alcohol intake, and exercise as indicated - Detailed visit note will be entered into EHR and shared with PCP and appropriate specialty providers*
	Interim monitoring – Veterans will contact clinical pharmacist every 2 weeks x 2 months then monthly thereafter; clinical pharmacist will review home BP readings, ask patient if they need medication titration, update HER
Visit 3, 3 months Research visit	- Standardized office BP, orthostatic BP measurement, heart rate, weight, height measurements - Review of any adverse events (e.g. fatigue, dyspnea, dizziness or fainting, hospital admissions or emergency room visits and associated cause) - Safety assessment completion
Visit 4, 6 months Research visit	- Standardized office BP, orthostatic BP measurement, heart rate, weight, height measurements - Review of any adverse events (e.g. fatigue, dyspnea, dizziness or fainting, hospital admissions or emergency room visits and associated cause) - Safety assessment completion - Collection of the 24-hour urine
Visit 5, 9 months Research visit	- Standardized office BP, orthostatic BP measurement, heart rate, weight, height measurements - Review of any adverse events (e.g. fatigue, dyspnea, dizziness or fainting, hospital admissions or emergency room visits and associated cause) - Safety assessment completion
Visit 6, 12 months Research visit	- Standardized office BP, orthostatic BP measurement, heart rate, weight, height measurements - Review of any adverse events (e.g. fatigue, dyspnea, dizziness or fainting, hospital admissions or emergency room visits and associated cause) - Safety assessment completion - Collection of the 24-hour urine

^*Specialty providers may include cardiology or kidney specialists who manage the subjects BP

h. Power

Power and sample calculation are based on our preliminary data ²⁴ and the literature. With regards to the control group, we relied on the most recent systematic review on the topic. This included 13 randomized clinical trials that evaluated whether self-monitoring of home BP improves office BP and reported that 2 of the 13 studies showed worsening BP, 5 showed no difference, and 5 showed modest improvement.³⁹ The systematic review analysis revealed no significant improvement in BP at 12 months with self-monitoring. Using PROC POWER in SAS, we calculated the power associated with 1:1 allocation. Assuming a 9.7 mm Hg in between group difference ²⁴), with a SD of 19.2, a sample size of 80 in each group would provide 88.8% power when conducting a two-sample t-test at α = 0.05 and a two-sided alternative.

i. Study outcomes and analysis plan

Aim 1:

The primary outcome is change in standardized office systolic BP at 12 months (AIM 1). Secondary outcomes include change in home systolic BP after 12 months, change in conventional office and home diastolic BP, patient’s visits to the emergency department for uncontrolled hypertension or hypertensive emergency. 12 month- home systolic and diastolic BP will be calculated as the average of daily home BP values during the last 2 weeks of the study. For conventional office BP, we will include only ambulatory values obtained within the last month of the study. We will additionally evaluate the number of patients who achieve pre-specified BP goal and time to achieving BP goal in the intervention and control arms. Importantly, the number of BP medication titrations during the study follow up will be reported for both the intervention and control arms.

We will compare baseline characteristics of patients between randomization arms to confirm successful randomization to the intervention and control groups. Descriptive statistics will be provided for demographic characteristics, baseline measures, and outcome variables as appropriate for each of the two study arms. Continuous measures will be reported as means and SDs or medians and IQRs, and categorical measures will be reported as counts and percentages.

All analyses will be conducted via “intent-to-treat” (ITT) principle. Change in standardized office systolic BP at 12 months will be assessed using the linear mixed modeling (LMM) framework. Intervention group, time, and their interaction will be included as fixed effects in the unadjusted model, and a random effect will be specified for patient ID. Subsequent adjusted models will be fit to explore the impact of age, sex, race, baseline CKD stage, BP medication class, or change in weight, physical activity, and salt intake on between-intervention group differences at follow up. Based on our pilot study, we do not anticipate severe adverse events, but we will tabulate all observed events. We will furthermore tabulate any deviations from the outlined titration plan for the intervention group. Significance for all analyses will be defined as p value < 0.05. All analyses will be performed by using SAS 9.4, SAS Institute Inc., Cary, NC, USA.

We anticipate loss to follow-up and missing values will occur but based on our experience we estimate no more than 10% loss to follow up. We will tabulate baseline characteristics to examine any difference between those lost to follow up and those who complete the study. In the unlikely event of >10% missing data, we will perform multiple imputation under assumption of missing at random (MAR) mechanism and examine any change in conclusions.

Aim 2:

We will use a mixed methods approach to assess the intervention acceptability to Veterans and evaluate Veteran adherence to intervention protocols. Descriptive statistics will be generated using number of days Veterans submitted a blood pressure reading across 90-day intervals (90, 180, 270, 360) to ascertain percent adherence over the course of the study. In order to understand factors underlying Veteran acceptability and adherence, we will conduct semi-structured interviews with a sample of 20 subjects in each of the two arms, control (20) and intervention (20) for a total of 40 interviews. Interview guides have been developed using the updated CFIR model discussed above and refined for usability and understanding following the first five interviews (Supplemental Materials). Interviews will last 30–45 minutes and will take place after the subject has been in the study for 3 months to ensure enough time to draw on their experiences in responding to questions.

The interviews focus on Veterans’ understanding of their BP and CKD conditions, perceptions of past BP treatment, and the acceptability of the intervention arm in which they are enrolled. Interview participants are asked to describe their daily routine for blood pressure measurement in detail, with follow-up questions asked, if necessary, regarding elements such as sitting posture, number of measurements, timing of measurements, etc. We also address patient needs, preferences, and resources and perceived self-efficacy related to BP medications and control. The same interview guide is used for the control and intervention arms for comparison between arms. Interviewers experienced in qualitative interviewing methods conduct the interviews using MS Teams, allowing for immediate auto-transcription of the interviews. All files are stored directly on a VA secured server.

The auto-transcribed files are cleaned and validated for accuracy using MaxQDA qualitative data management and analysis software program. The interviews are coded for major themes by a team of qualitative analysts using a combination of deductive codes developed from the CFIR framework and research questions as well as inductive codes derived from themes that emerge across the interviews. Tests for saturation of major themes and coding reliability will be performed. After coding, the qualitative theme will analyze code reports for adherence by assessing how participants’ descriptions of blood pressure measurement aligned with procedures described in the protocol and areas where participants noted challenges to adherence, benefits of measurement, and understanding of BP titration protocols. We will also analyze data to evaluate acceptability using deductive measures, such as responses to direct questions regarding how well blood pressure monitoring and/or medication titration fits into their daily lives, and inductive measures, such as interpreting complaints about monitoring or titration of BP medications. Veteran factors will be examined using codes related to interview participants’ explicit comments on their identity as Veterans and how orientation to military or Veteran experiences affects their perceptions of study activities, other comorbid conditions including diabetes and heart disease, and rural residence.

Aim 3:

The current proposal is designed to inform the successful implementation and sustainability of the self-management approach in Veterans with CKD. We will examine system factors that impede or facilitate implementation and sustainment of the core components of the pharmacist-guided self-management approach. Implementation and sustainment are priority topics in implementation science.⁴⁰ Implementing an intervention into a clinic does not guarantee that the intervention will be sustained.

We theorize that organizational factors will influence the implementation and sustainment of the pharmacist-guided self-management approach. There is evidence that even when fidelity is shown to be important for intervention effectiveness, there are aspects of the intervention’s core components that can be adapted, while upholding desired outcomes.⁴¹

We will recruit at least 20 key stakeholders, defined as providers, PACT clinical pharmacists, and other PACT members involved in patient care. The interviews will be conducted per the interview guide (Supplemental Materials) at least 12 months after the intervention has been launched and evaluate pharmacist and provider perceptions of patient acceptability, needs, and preferences in addition to the available resources. The acceptability of the intervention to the clinical pharmacists and providers is evaluated by assessing system factors including how the implementation of the intervention would change their role and if they can identify barriers they see to the integration of the pharmacist-guided self-management approach in the PACT care model. Other system factors that will be examined include the implementation climate and compatibility of the intervention in the main campus and the community- based clinics. Importantly, we will seek to understand the adaptability of the pharmacist-guided self-management approach by inquiring about any changes that the interviewee believes are needed to adapt the intervention and whether there are core components that should not be altered.

The qualitative analysis of interviews will use thematic content analysis that parallels the analysis of Veteran data in AIM 2, which will allow us to determine key stakeholders’ perceptions. We will explore how key stakeholders perceive their roles during the intervention (providers vs. nurses vs. clinical pharmacists) and how components of the self-management intervention were adapted.⁴²

Innovation and Impact

In the currently-described study, we evaluate the effectiveness and implementation of a healthcare delivery model for high BP management in CKD that differs significantly from the current healthcare model and other studied self-management models.^22,23 Self-management of CKD before patients require dialysis is a novel concept; that is, despite the aged concept of patient self-management of dialysis therapies once ESKD ensues. Specifically, home dialysis therapies including peritoneal and hemo-dialysis have been, not only acceptable, but also desirable approaches for the delivery of ESKD care.⁴³ Studies have shown that home dialysis, compared to in-center dialysis, is associated with better or similar health outcomes,^44,45 improved quality of life,⁴⁶ and reduced cost,⁴⁷ culminating in several efforts to expand home dialysis programs.^48–50 Our study expands the concept of self-management beyond ESKD by initiating a healthcare delivery approach which engages the patient at a much earlier stage of their disease (before they develop ESKD). Importantly, improved BP control in the earlier stages of CKD stands to impact CVD, CKD progression, and mortality in patients with CKD.

To date, few qualitative studies have been conducted on patient experience of and adherence to self-monitoring of BP generally, and none in CKD.^51,52 Johnson et al. evaluated shared decision making in 5 general practices in south-west England.⁵³ They conducted 46 interviews and observed 18 patient clinic visits (n=11 patients). Their findings indicated that often, patients’ understanding of their hypertension was limited, most did not know their BP or their BP goal, and even as several patients monitored their home BP, the majority did not discuss the home readings with their provider during the visit.⁵³ Through a mixed-methods approach, the ongoing study will provide detailed information about the feasibility of self-monitoring and self-management of blood pressure for CKD patients as an acceptable strategy for managing hypertension. Not only will we be able to determine the acceptability of such an approach, but we will also be able to understand how factors such as family/caregiver support and relationship with clinical pharmacists might contribute to patient adherence.

Future directions

If the pharmacist-guided self-management approach is an effective and safe treatment approach to improve BP management in Veterans with CKD, then it is our intent to integrate this treatment approach into our clinical practice. The implementation of this approach stands to improve the patient experience and the quality of care by improving the number of patients with BP meeting the goal. Tools may be developed to facilitate the identification of patients best suited for the pharmacist-guided self-management approach based on the findings of AIM 2. For example, we might find that Veterans who still work find the self-management approach to be extremely appealing or that patients with mild CKD are the most comfortable utilizing this approach. AIM 3 will allow us to gather critical data for the implementation of the pharmacist-guided self-management approach by gathering key input from the stakeholders such as the clinical pharmacists, PCPs, and nephrology specialists. For example, we might find that the clinical pharmacist-primary care duo is best suited to manage patients with mild CKD utilizing this approach whereas for patients with advanced CKD, the clinical pharmacist might need to collaborate with the nephrology specialist. As such, by utilizing a mixed methods approach, the findings of the ongoing study are key to informing future implementation strategies.