Effects of Intensive Blood Pressure Treatment on Acute Kidney Injury Events in the Systolic Blood Pressure Intervention Trial (SPRINT).

BACKGROUND: Treating to a lower blood pressure (BP) may increase acute kidney injury (AKI) events. STUDY DESIGN: Data for AKI resulting in or during hospitalization or emergency department visits were collected as part of the serious adverse events reporting process of the Systolic Blood Pressure Intervention Trial (SPRINT). SETTING & PARTICIPANTS: 9,361 participants 50 years or older with 1 or more risk factors for cardiovascular disease. INTERVENTIONS: Participants were randomly assigned to a systolic BP target of <120 (intensive arm) or <140mmHg (standard arm). OUTCOMES & MEASUREMENTS: Primary outcome was the number of adjudicated AKI events. Secondary outcomes included severity of AKI and degree of recovery of kidney function after an AKI event. Baseline creatinine concentration was defined as the most recent SPRINT outpatient creatinine value before the date of the AKI event. RESULTS: There were 179 participants with AKI events in the intensive arm and 109 in the standard arm (3.8% vs 2.3%; HR, 1.64; 95% CI, 1.30-2.10; P<0.001). Of 288 participants with an AKI event, 248 (86.1%) had a single AKI event during the trial. Based on modified KDIGO (Kidney Disease: Improving Global Outcomes) criteria for severity of AKI, the number of AKI events in the intensive versus standard arm by KDIGO stage was 128 (58.5%) versus 81 (62.8%) for AKI stage 1, 42 (19.2%) versus 18 (14.0%) for AKI stage 2, and 42 (19.2%) versus 25 (19.4%) for AKI stage 3 (P=0.5). For participants with sufficient data, complete or partial resolution of AKI was seen for 169 (90.4%) and 9 (4.8%) of 187 AKI events in the intensive arm and 86 (86.9%) and 4 (4.0%) of 99 AKI events in the standard arm, respectively. LIMITATIONS: Trial results are not generalizable to patients with diabetes mellitus or without risk factors for cardiovascular disease. CONCLUSIONS: More intensive BP lowering resulted in more frequent episodes of AKI. Most cases were mild and most participants had complete recovery of kidney function. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT01206062.

Effects of Intensive BP Control in CKD.

The appropriate target for BP in patients with CKD and hypertension remains uncertain. We report prespecified subgroup analyses of outcomes in participants with baseline CKD in the Systolic Blood Pressure Intervention Trial. We randomly assigned participants to a systolic BP target of <120 mm Hg (intensive group; n=1330) or <140 mm Hg (standard group; n=1316). After a median follow-up of 3.3 years, the primary composite cardiovascular outcome occurred in 112 intensive group and 131 standard group CKD participants (hazard ratio [HR], 0.81; 95% confidence interval [95% CI], 0.63 to 1.05). The intensive group also had a lower rate of all-cause death (HR, 0.72; 95% CI, 0.53 to 0.99). Treatment effects did not differ between participants with and without CKD (P values for interactions ≥0.30). The prespecified main kidney outcome, defined as the composite of ≥50% decrease in eGFR from baseline or ESRD, occurred in 15 intensive group and 16 standard group participants (HR, 0.90; 95% CI, 0.44 to 1.83). After the initial 6 months, the intensive group had a slightly higher rate of change in eGFR (-0.47 versus -0.32 ml/min per 1.73 m2 per year; P<0.03). The overall rate of serious adverse events did not differ between treatment groups, although some specific adverse events occurred more often in the intensive group. Thus, among patients with CKD and hypertension without diabetes, targeting an SBP<120 mm Hg compared with <140 mm Hg reduced rates of major cardiovascular events and all-cause death without evidence of effect modifications by CKD or deleterious effect on the main kidney outcome.

The role of patients' explanatory models and daily-lived experience in hypertension self-management.

BACKGROUND: Uncontrolled hypertension remains a significant problem for many patients. Few interventions to improve patients' hypertension self-management have had lasting effects. Previous work has focused largely on patients' beliefs as predictors of behavior, but little is understood about beliefs as they are embedded in patients' social contexts. OBJECTIVE: This study aims to explore how patients' "explanatory models" of hypertension (understandings of the causes, mechanisms or pathophysiology, course of illness, symptoms and effects of treatment) and social context relate to their reported daily hypertension self-management behaviors. DESIGN: Semi-structured qualitative interviews with a diverse group of patients at two large urban Veterans Administration Medical centers. PARTICIPANTS (OR PATIENTS OR SUBJECTS): African-American, white and Latino Veterans Affairs (VA) primary care patients with uncontrolled blood pressure. APPROACH: We conducted thematic analysis using tools of grounded theory to identify key themes surrounding patients' explanatory models, social context and hypertension management behaviors. RESULTS: Patients' perceptions of the cause and course of hypertension, experiences of hypertension symptoms, and beliefs about the effectiveness of treatment were related to different hypertension self-management behaviors. Moreover, patients' daily-lived experiences, such as an isolated lifestyle, serious competing health problems, a lack of habits and routines, barriers to exercise and prioritizing lifestyle choices, also interfered with optimal hypertension self-management. CONCLUSIONS: Designing interventions to improve patients' hypertension self-management requires consideration of patients' explanatory models and their daily-lived experience. We propose a new conceptual model - the dynamic model of hypertension self-management behavior - which incorporates these key elements of patients' experiences.

Usability Testing of the Kidney Score Platform to Enhance Communication About Kidney Disease in Primary Care Settings: Qualitative Think-Aloud Study.

BACKGROUND: Patient awareness of chronic kidney disease (CKD) is low in part due to suboptimal testing for CKD among those at risk and lack of discussions about kidney disease between patients and clinicians. To bridge these gaps, the National Kidney Foundation developed the Kidney Score Platform, which is a web-based series of tools that includes resources for health care professionals as well as an interactive, dynamic patient-facing component that includes a brief questionnaire about risk factors for kidney disease, individualized assessment of risk for developing CKD, and self-management tools to manage one's kidney disease. OBJECTIVE: The aim of this study is to perform usability testing of the patient component of the Kidney Score platform among veterans with and at risk for kidney disease and among clinicians working as primary care providers in Veterans Affairs administration. METHODS: Think-aloud exercises were conducted, during which participants (veterans and clinicians) engaged with the platform while verbalizing their thoughts and making their perceptions, reasonings, and decision points explicit. A usability facilitator observed participants' behaviors and probed selectively to clarify their comprehension of the tool's instructions, content, and overall functionality. Thematic analysis on the audio-recording transcripts was performed, focusing on positive attributes, negative comments, and areas that required facilitator involvement. RESULTS: Veterans (N=18) were 78% (14/18) male with a mean age of 58.1 years. Two-thirds (12/18) were of non-White race/ethnicity, 28% (5/18) had laboratory evidence of CKD without a formal diagnosis, and 50% (9/18) carried a diagnosis of hypertension or diabetes. Clinicians (N=19) were 29% (5/17) male, 30% (5/17) of non-White race/ethnicity, and had a mean of 17 (range 4-32) years of experience. Veterans and clinicians easily navigated the online tool and appreciated the personalized results page as well as the inclusion of infographics to deliver key educational messages. Three major themes related to content and communication about risk for CKD emerged from the think-aloud exercises: (1) tension between lay and medical terminology when discussing kidney disease and diagnostic tests, (2) importance of linking general information to concrete self-management actions, and (3) usefulness of the tool as an adjunct to the office visit to prepare for patient-clinician communication. Importantly, these themes were consistent among interviews involving both veterans and clinicians. CONCLUSIONS: Veterans and clinicians both thought that the Kidney Score Platform would successfully promote communication and discussion about kidney disease in primary care settings. Tension between using medical terminology that is used regularly by clinicians versus lay terminology to promote CKD awareness was a key challenge, and knowledge of this can inform the development of future CKD educational materials.

The Kidney Score Platform for Patient and Clinician Awareness, Communication, and Management of Kidney Disease: Protocol for a Mixed Methods Study.

BACKGROUND: Patient awareness, clinician detection, and management of chronic kidney disease remain suboptimal, despite clinical practice guidelines and diverse education programs. OBJECTIVE: This protocol describes a study to develop and investigate the impact of the National Kidney Foundation Kidney Score Platform on chronic kidney disease awareness, communication, and management, by leveraging the Behavior Change Wheel, an implementation science framework that helps identify behavioral intervention targets and functions that address barriers to behavior change. METHODS: We interviewed 20 patients with chronic kidney disease and 11 clinicians to identify patient and clinician behaviors suitable for intervention and barriers to behavior change (eg, limited awareness of chronic kidney disease clinical practice guidelines within primary care settings, limited data analytics to highlight chronic kidney disease care gaps, asymptomatic nature of chronic kidney disease in conjunction with patient reliance on primary care clinicians to determine risk and order kidney testing). Leveraging the Behavior Change Wheel, the Kidney Score Platform was developed with a patient-facing online Risk Calculator and a clinician-facing Clinical Practice Toolkit. The Risk Calculator utilizes risk predictive analytics to provide interactive health information tailored to an individual's chronic kidney disease risk and health status. The Clinical Practice Toolkit assists clinicians in discussing chronic kidney disease with individuals at risk for and with kidney disease and in managing their patient population with chronic kidney disease. The Kidney Score Platform will be tested in 2 Veterans Affairs primary health care settings using a pre-post study design. Outcomes will include changes in patient self-efficacy for chronic kidney disease management (primary outcome), quality of communication with clinicians about chronic kidney disease, and practitioners' knowledge of chronic kidney disease guidelines. Process outcomes will identify usability and adoption of different elements of the Kidney Score Platform using qualitative and quantitative methods. RESULTS: As of September 2020, usability studies are underway with veterans and clinicians to refine the patient-facing components of the Kidney Score Platform before study initiation. Results and subsequent changes to the Kidney Score Platform will be published at a later date. The study is expected to be completed by December 2021. CONCLUSIONS: Results of this study will be used to inform integration of the Kidney Score Platform within primary care settings so that it can serve as a central component of the National Kidney Foundation public awareness campaign to educate, engage, and empower individuals at risk for and living with chronic kidney disease. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/22024.

Beyond Medication Adherence: The Role of Patients' Beliefs and Life Context in Blood Pressure Control.

Objective: Despite numerous interventions to address adherence to antihypertensive medications, continued high rates of uncontrolled blood pressure (BP) suggest a need to better understand patient factors beyond adherence associated with BP control. We examined how patients' BP-related beliefs, and aspects of life context affect BP control, beyond medication adherence. Methods: We conducted a cross-sectional telephone survey of primary care patients with hypertension between 2010 and 2011 (N=103; 93 had complete data on all variables and were included in the regression analyses). We assessed patient sociodemographics (including race/ethnicity), medication adherence, BP-related beliefs, aspects of life context, and used clinical BP assessments. Results: Regression models including sociodemographics, medication adherence, and either beliefs or context consistently predicted BP control. Adding context after beliefs added no predictive value while adding beliefs after context significantly predicted BP control. Practical Implications: Results suggest that when clinicians must choose a dimension on which to intervene, focusing on beliefs would be the most fruitful approach to effecting change in BP control.

National utilization of antihypertensive medications from 2000 to 2006 in the Veterans Health Administration: focus on thiazide diuretics.

The authors sought to determine the prescribing practices of clinicians treating veterans with hypertension. A descriptive analysis was performed using a national pharmacy database of patients with a diagnosis of hypertension receiving antihypertensive medication in the fiscal years 2000 to 2006. Angiotensin-converting enzyme inhibitors were the most frequently prescribed antihypertensive class, with utilization increasing from 56.0% in fiscal year 2000 to 63.2% of patients in 2006. Utilization of thiazide-type diuretics increased from 31.9% of patients in fiscal year 2000 to 42.0% in 2006. When patient comorbidities were taken into consideration, 48.1% of patients defined as having uncomplicated hypertension had at least one prescription for a thiazide diuretic in fiscal year 2006. Utilization by monotherapy and combination therapy were also evaluated. The trends in utilization allowed for identification of areas in which a change in prescribing practices may improve blood pressure control and health outcomes in the Veterans Health Administration.

Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design.

Diabetes mellitus affects not only life expectancy but also quality of life. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial's health-related quality of life (HRQOL) and cost-effectiveness components will enable the assessment of the relative importance of the various outcomes from the point of view of patients, provide an understanding of the balance between the burdens and benefits of the intervention strategies, and offer valuable insights into adherence. The HRQOL measures used include the Diabetes Symptoms Distress Checklist; the 36-Item Short Form Health Survey, Version 2 (SF-36) (RAND Corporation, Santa Monica, CA); the Patient Health Questionnaire (PHQ) depression measure (Pfizer Inc, New York, NY); the World Health Organization (WHO) Diabetes Treatment Satisfaction Questionnaire (DTSQ); and the EuroQol Feeling Thermometer (EuroQol Group, Rotterdam, Netherlands). The cost-effectiveness analysis (CEA) in ACCORD will provide information about the relative economic efficiency of the different interventions being compared in the trial. Effectiveness will be measured in terms of cardiovascular event-free years gained and quality-adjusted life-years gained (using the Health Utilities Index Mark 3 [HUI-3] [Health Utilities Inc., Dundas, Ontario, Canada] to measure health-state utility). Costs will be direct medical costs assessed from the perspective of a single-payer health system collected by means of patient and clinic cost forms and hospital discharge summaries. The primary HRQOL and CEA hypotheses mirror those in the main ACCORD trial, addressing the effects of the 3 main ACCORD interventions considered separately. There are also secondary (pairwise reference case) comparisons that do not assume independence of treatment effects on HRQOL. CEA will be done on a subsample of 4,311 ACCORD participants and HRQOL on a subsample of 2,053 nested within the CEA subsample. Most assessments will occur through questionnaires at baseline and at 12, 36, and 48 months.

The role of comorbidities in patients' hypertension self-management.

OBJECTIVE: We sought to understand barriers to hypertension self-management in patients with hypertension and comorbidities. METHODS: We conducted semi-structured, qualitative interviews with 48 patients with uncontrolled hypertension and at least one comorbidity to learn about beliefs and behaviors that might affect hypertension self-management. Using a grounded theory strategy, we analyzed interview transcripts detailing patients' hypertension self-management behaviors vis-à-vis a framework including Explanatory Models-a patient's understanding of the pathophysiology, cause, course, treatment, and severity of an illness, such as hypertension. RESULTS: We identified four factors that interfered with hypertension self-management. (1) Interdependence: Participants saw hypertension as interconnected to their comorbidities and subsequently had difficulty separating information about their illnesses. (2) Low priority: Compared to other conditions, participants assigned hypertension a lower priority. (3) Conflicts: Participants struggled with conflicts between hypertension self-management practices and those for comorbidities. (4) Managing multiple medications: Polypharmacy led to patients' confusion and concern about taking medications as prescribed. DISCUSSION: Participants did not experience hypertension as a discreet clinical condition; rather, they self-managed hypertension concurrently with other conditions, leading to a breakdown in hypertension self-management. We provide strategies to address each of the four barriers to better equip providers in addressing their clinically salient concerns.