Association of Age and Gender With Concerns About Live Donor Kidney Transplantation Among Black Individuals.

Black individuals are less likely to receive live donor kidney transplantation (LDKT) compared to others. This may be partly related to their concerns about LDKT, which can vary based on age and gender. We conducted a cross-sectional, secondary analysis of the baseline enrollment data from the Talking about Living Kidney Donation Support trial, which studied the effectiveness of social workers and financial interventions on activation towards LDKT among 300 Black individuals from a deceased donor waiting list. We assessed concerns regarding the LDKT process, including their potential need for postoperative social support, future reproductive potential, recipient and donor money matters, recipient and donor safety, and interpersonal concerns. Answers ranged from 0 ("not at all concerned") to 10 ("extremely concerned"). We described and compared participants' concerns both overall and stratified by age (≥45 years old vs <45 years old) and self-reported gender ("male" versus "female"). The participants' top concerns were donor safety (median [IQR] score 10 [5-10]), recipient safety (5 [0-10]), money matters (5 [0-9]), and guilt/indebtedness (5 [0-9]). Younger females had statistically significantly higher odds of being concerned about future reproductive potential (odds ratio [OR] 3.77, 95% CI 2.77, 4.77), and older males had statistically higher mean concern about postoperative social support (OR 1.79, 95% CI 0.19, 3.38). Interventions to improve rates of LDKT among Black individuals should include education and counseling about the safety of LDKT for both recipients and donors, reproductive counseling for female LDKT candidates of childbearing age, and addressing older males' needs for increased social support.

Characteristics Associated with Burnout among Cardiologists in an Academic Medical Setting: Baseline Survey Results from a Communication Coaching RCT.

OBJECTIVES: Clinician burnout poses risks not just to clinicians but also to patients and the health system. Cardiologists might be especially prone to burnout due to performing high-risk procedures, having to discuss serious news, and treating diseases that incur significant morbidity and mortality. Few have attempted to examine which cardiologists might be at higher risk of burnout. Knowing at-risk cardiologists can help frame resilience interventions. METHODS: We enrolled 41 cardiologists across five ambulatory cardiology clinics into a randomized controlled trial where we assessed the Maslach Burnout Inventory at baseline. We used bivariate analyses to assess associations between cardiologist demographics and burnout. RESULTS: Cardiologists reported low burnout for depersonalization and personal accomplishment and moderate levels for emotional exhaustion. Female cardiologists reported emotional exhaustion scores in the "low" range (M = 12.3; SD = 10.06), compared to male cardiologists whose score was in the "moderate" range 19.6 (SD = 9.59; p = 0.113). Cardiologists who had greater than 15 years in practice reported higher mean scores of emotional exhaustion, indicating moderate burnout (M = 20.0, SD = 10.63), compared to those with less than 15 years in practice (M = 16.6, SD = 9.10; p = 0.271). CONCLUSIONS: In this sample, unlike prior studies, male cardiologists reported more burnout. Consistent with prior work, mid-level cardiologists might be at highest risk of emotional exhaustion.

Communication Coaching in Cardiology (CCC): A study protocol and methodological challenges and solutions of a randomized controlled trial in outpatient cardiology clinics.

Given the role of effective communication in improving patient adherence and satisfaction, high quality patient-clinician communication is critical. Building on previous communication interventions in oncology and pediatrics, we developed a tailored communication coaching intervention to improve empathic communication quality and patient-centered care. In this randomized controlled trial, cardiologists record their patient encounters for review by a communication coach who provides tailored feedback. We are recruiting 40 cardiologists and 400 patients, or 4 patients per cardiologist in the Pre-intervention phase and 6 patients per cardiologists in the Post-intervention phase, from outpatient cardiology clinics within the Duke Health System. The primary goal of the trial is to determine the efficacy of the clinician communication coaching versus usual care in the post-intervention phase (240 patient encounters). In this paper, we describe the development of the communication coaching intervention. We also describe the details of the methods and outcomes of the ongoing trial. Finally, we discuss the challenges, solutions, and lessons learned during the start-up phase of the study.

Transplant social worker and donor financial assistance to increase living donor kidney transplants among African Americans: The TALKS Study, a randomized comparative effectiveness trial.

Lack of donors hinders living donor kidney transplantation (LDKT) for African Americans. We studied the effectiveness of a transplant social worker intervention (TALK SWI) alone or paired with living donor financial assistance to activate African Americans' potential living kidney donors. African Americans (N = 300) on the transplant waiting list were randomly assigned to usual care; TALK SWI; or TALK SWI plus Living Donor Financial Assistance. We quantified differences in live kidney donor activation (composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) after 12 months. Participants' mean age was 52 years, 56% were male, and 43% had annual household income less than $40,000. Most previously pursued LDKT. Participants were highly satisfied with TALK social workers, but they rarely utilized Financial Assistance. After 12 months, few (n = 39, 13%) participants had a new donor activation event (35 [12%] new donor inquiries; 17 [6%] new donor evaluations; 4 [1%] LDKT). There were no group differences in donor activation events (subdistribution hazard ratio [95% CI]: 1.09 [0.51-2.30] for TALK SWI and 0.92 [0.42-2.02] for TALK SWI plus Financial Assistance compared to Usual Care, p = 91). Alternative interventions to increase LDKT for African Americans on the waiting list may be needed. Trial registration: ClinicalTrials.gov (NCT02369354).

Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial.

BACKGROUND: Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown. DESIGN: The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures. SUMMARY: AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.

A Patient Safety Educational Tool for Patients With Chronic Kidney Disease: Development and Usability Study.

BACKGROUND: Chronic kidney disease (CKD) is a health condition that threatens patient safety; however, few interventions provide patient-centered education about kidney-specific safety hazards. OBJECTIVE: We sought to develop and test the usability of a mobile tablet-based educational tool designed to promote patient awareness of relevant safety topics in CKD. METHODS: We used plain language principles to develop content for the educational tool, targeting four patient-actionable safety objectives that are relevant for individuals with CKD. These four objectives included avoidance of nonsteroidal anti-inflammatory drugs (NSAIDs); hypoglycemia awareness (among individuals with diabetes); temporary cessation of certain medications during acute volume depletion to prevent acute kidney injury (ie, "sick day protocol"); and contrast dye risk awareness. Our teaching strategies optimized human-computer interaction and content retention using audio, animation, and clinical vignettes to reinforce themes. For example, using a vignette of a patient with CKD with pain and pictures of common NSAIDs, participants were asked "Which of the following pain medicines are safe for Mr. Smith to take for his belly pain?" Assessment methods consisted of preknowledge and postknowledge surveys, with provision of correct responses and explanations. Usability testing of the tablet-based tool was performed among 12 patients with any stage of CKD, and program tasks were rated upon completion as no error, noncritical error (self-corrected), or critical error (needing assistance). RESULTS: The 12 participants in this usability study were predominantly 65 years of age or older (n=7, 58%) and female (n=7, 58%); all participants owned a mobile device and used it daily. Among the 725 total tasks that the participants completed, there were 31 noncritical errors (4.3%) and 15 critical errors (2.1%); 1 participant accounted for 30 of the total errors. Of the 12 participants, 10 (83%) easily completed 90% or more of their tasks. Most participants rated the use of the tablet as very easy (n=7, 58%), the activity length as "just right" (rather than too long or too short) (n=10, 83%), and the use of clinical vignettes as helpful (n=10, 83%); all participants stated that they would recommend this activity to others. The median rating of the activity was 8 on a scale of 1 to 10 (where 10 is best). We incorporated all participant recommendations into the final version of the educational tool. CONCLUSIONS: A tablet-based patient safety educational tool is acceptable and usable by individuals with CKD. Future studies leveraging iterations of this educational tool will explore its impact on health outcomes in this high-risk population.

Associations of perceived information adequacy and knowledge with pursuit of live donor kidney transplants and living donor inquiries among African American transplant candidates.

We studied associations between perceived adequacy of live donor kidney transplant (LDKT) information or knowledge with pursuit of LDKT or receipt of live donor inquiries among 300 African American kidney transplant candidates. Participants reported via questionnaire how informed or knowledgeable they felt regarding LDKT. Participants also reported their pursuit of LDKT, categorized as "low" (no discussion with family or friends about LDKT and no identified donor), "intermediate" (discussed LDKT with family but no identified donor) or "high" (discussed LDKT with family and identified a potential donor). We reviewed participants' electronic health records to identify potential donors' transplant center inquiries on participants' behalves. A minority of participants reported they felt "very" or "extremely" well informed about LDKT (39%) or had "a great deal" of LDKT knowledge (38%). Participants perceiving themselves as "very" or "extremely" (vs "not" or "slightly") well informed about LDKT had statistically significantly greater odds of intermediate or high (vs low) pursuit of LDKT (odds ratio [95% confidence interval] 2.71 [1.02-7.17]). Perceived LDKT knowledge was not associated with pursuit of LDKT. Neither perceived information adequacy nor knowledge was associated with living donor inquiries. Efforts to better understand the role of education in the pursuit of LDKT among African American transplant candidates are needed.

Enrollment and Retention of Men and Women in Health Services Research and Development Trials.

INTRODUCTION: Sex- and gender-specific science is essential to inform patient-centered, evidence-based care. Developing such evidence requires adequate inclusion of both women and men in trials. We sought to describe study participation of women and men in Department of Veterans Affairs Health Services Research and Development trials. METHODS: We identified recent health services research trials from one Health Services Research and Development Center of Innovation and compared the participation of women and men from trial recruitment to study completion. We also calculated the participation to prevalence ratio (PPR) by sex for each trial. RESULTS: We included eight trials that started recruitment between 2011 and 2014. Only one study purposefully attempted to boost the recruitment of women. Overall, the PPR for women ranged from 0.2 to 4.5, with seven studies having a PPR of greater than 1, indicating that women participated in these trials at proportions greater than their prevalence in the disease population within the Department of Veterans Affairs. The PPR for men ranged from 0.8 to 1.1. Retention was best with those studies that used administrative data for final outcomes assessment. No studies provided results stratified by sex or conducted analyses to explore treatment effect by sex. CONCLUSIONS: At a single site, women participated in Health Services Research and Development trials at similar or greater rates to men without cross-study efforts to enrich the recruitment or retention of women. Adding strategic recruitment approaches could further boost the proportion of women in Department of Veterans Affairs trials and enable adequately powered sex-based analyses.

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.

The Cholesterol, Hypertension, and Glucose Education (CHANGE) study for African Americans with diabetes: study design and methodology.

BACKGROUND: Cardiovascular disease (CVD) and diabetes account for over one third of the mortality difference between African Americans and white patients. The increased CVD risk in African Americans is due in large part to the clustering of multiple CVD risk factors. OBJECTIVES: The current study is aimed at improving CVD outcomes in African-American adults with diabetes by addressing the modifiable risk factors of systolic blood pressure , glycosylated hemoglobin, and low-density lipoprotein cholesterol. METHODS: A sample of African American patients with diabetes (N = 400) will receive written education material at baseline and be randomized to one of 2 arms: (1) usual primary care or (2) nurse-administered disease-management intervention combining patient self-management support and provider medication management. The nurse administered intervention is delivered monthly over the telephone. The nurses also interacts with the primary care providers at 3, 6, and 9 months to provide concise patient updates and facilitate changes in medical management. All patients are followed for 12 months after enrollment. The primary outcomes are change in glycosylated hemoglobin, systolic blood pressure, and low-density lipoprotein cholesterol over 12-months. Secondary outcomes include change in overall cardiovascular risk, aspirin use, and health behaviors. CONCLUSION: Given the continued racial disparities in CVD, the proposed study could result in significant contributions to cardiovascular risk reduction in African-American patients.