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.

Decisional Conflict About Kidney Failure Treatment Modalities Among Adults With Advanced CKD.

Rationale & Objective: Choosing from multiple kidney failure treatment modalities can create decisional conflict, but little is known about this experience before decision implementation. We explored decisional conflict about treatment for kidney failure and its associated patient characteristics in the context of advanced chronic kidney disease (CKD). Study Design: Cross-sectional study. Setting & Participants: Adults (N = 427) who had advanced CKD, received nephrology care in Pennsylvania-based clinics, and had no history of dialysis or transplantation. Predictors: Participants' sociodemographic, physical health, nephrology care/knowledge, and psychosocial characteristics. Outcomes: Participants' results on the Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) screening test for decisional conflict (no decisional conflict vs decisional conflict). Analytical Approach: We used multivariable logistic regression to quantify associations between aforementioned participant characteristics and decisional conflict. We repeated analyses among a subgroup of participants at highest risk of kidney failure within 2 years. Results: Most (76%) participants reported treatment-related decisional conflict. Participant characteristics associated with lower odds of decisional conflict included complete satisfaction with patient-kidney team treatment discussions (OR, 0.16; 95% CI, 0.03-0.88; P = 0.04), attendance of treatment education classes (OR, 0.38; 95% CI, 0.16-0.90; P = 0.03), and greater treatment-related decision self-efficacy (OR, 0.97; 95% CI, 0.94-0.99; P < 0.01). Sensitivity analyses showed a similarly high prevalence of decisional conflict (73%) and again demonstrated associations of class attendance (OR, 0.26; 95% CI, 0.07-0.96; P = 0.04) and decision self-efficacy (OR, 0.95; 95% CI, 0.91-0.99; P = 0.03) with decisional conflict. Limitations: Single-health system study. Conclusions: Decisional conflict was highly prevalent regardless of CKD progression risk. Findings suggest efforts to reduce decisional conflict should focus on minimizing the mismatch between clinical practice guidelines and patient-reported engagement in treatment preparation, facilitating patient-kidney team treatment discussions, and developing treatment education programs and decision support interventions that incorporate decision self-efficacy-enhancing strategies.

The Impact of COVID-19 on Patient, Family Member, and Stakeholder Research Engagement: Insights from the PREPARE NOW Study.

BACKGROUND: Little is known about the impact of COVID-19 on patient, family member, and stakeholder patient-centered outcomes research engagement. OBJECTIVE: To answer the research questions: (1) What is the impact of COVID-19 on the lives of patients with kidney disease and their families? (2) What is the impact of COVID-19 on research engagement for patient and family member research team members who are themselves at very high risk for poor COVID-19 outcomes? and (3) How can we help patients, family members, and stakeholder team members engage in research during COVID-19? DESIGN: We conducted virtual semi-structured interviews with patient and family member co-investigators and kidney disease stakeholders from the PREPARE NOW study during November 2020. The interview guide included questions about participants' experiences with the impact of COVID-19 on research engagement. PARTICIPANTS: Seven patient and family member co-investigators and eight kidney disease stakeholders involved in a kidney disease patient-centered outcomes research project participated in the interviews, data analysis, and writing this manuscript. APPROACH: We used a content analysis approach and identified the main themes using an inductive process. KEY RESULTS: Respondents reported three main ways that COVID-19 has impacted their lives: emotional impact, changing behaviors, and changes in health care delivery. The majority of respondents reported no negative impact of COVID-19 on their ability to engage in this research project. Suggestions for patient-centered outcomes research during COVID-19 and other emergencies include virtual research activities; active engagement; and promoting trust, honesty, transparency, and authenticity. CONCLUSIONS: COVID-19 has had a significant negative impact on patient, family member, and stakeholder research team members; however, this has not resulted in less research engagement. TRIAL REGISTRATION: Clinicaltrials.gov NCT02722382.

Preferences for and Experiences of Shared and Informed Decision Making Among Patients Choosing Kidney Replacement Therapies in Nephrology Care.

RATIONALE & OBJECTIVE: Chronic kidney disease (CKD) can progress rapidly, and patients are often unprepared to make kidney failure treatment decisions. We aimed to better understand patients' preferences for and experiences of shared and informed decision making (SDM) regarding kidney replacement therapy before kidney failure. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: Adults receiving nephrology care at CKD clinics in rural Pennsylvania. PREDICTORS: Estimated glomerular filtration rate, 2-year risk for kidney failure, duration and frequency of nephrology care, and preference for SDM. OUTCOMES: Occurrence and extent of kidney replacement therapy discussions and participants' satisfaction with those discussions. ANALYTIC APPROACH: Multivariable logistic regression to quantify associations between participants' characteristics and whether they had discussions. RESULTS: The 447 study participants had a median age of 72 (IQR, 64-80) years and mean estimated glomerular filtration rate of 33 (SD, 12) mL/min/1.73 m2. Most (96%) were White, high school educated (67%), and retired (65%). Most (72%) participants preferred a shared approach to kidney treatment decision making, and only 35% discussed dialysis or transplantation with their kidney teams. Participants who had discussions (n = 158) were often completely satisfied (63%) but infrequently discussed potential treatment-related impacts on their lives. In multivariable analyses, those with a high risk for kidney failure within 2 years (OR, 3.24 [95% CI, 1.72-6.11]; P < 0.01), longer-term nephrology care (OR, 1.12 [95% CI, 1.05-1.20] per 1 additional year; P < 0.01), and more nephrology visits in the prior 2 years (OR, 1.34 [95% CI, 1.20-1.51] per 1 additional visit; P < 0.01) had higher odds of having discussed dialysis or transplantation. LIMITATIONS: Single health system study. CONCLUSIONS: Most patients preferred sharing CKD treatment decisions with their providers, but treatment discussions were infrequent and often did not address key treatment impacts. Longitudinal nephrology care and frequent visits may help ensure that patients have optimal SDM experiences.

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study.

RATIONALE & OBJECTIVE: Digital health system tools to support shared decision making and preparation for kidney replacement treatments for patients with chronic kidney disease (CKD) are needed. STUDY DESIGN: Descriptive study of the implementation of digital infrastructure to support a patient-centered health system intervention. SETTING & PARTICIPANTS: 4 CKD clinics within a large integrated health system. EXPOSURE: We developed an integrated suite of digital engagement tools to support patients' shared decision making and preparation for kidney failure treatments. Tools included an automated CKD patient registry and risk prediction algorithm within the electronic health record (EHR) to identify and prioritize patients in need of nurse case management to facilitate shared decision making and preparation for kidney replacement treatments, an electronic patient-facing values clarification tool, a tracking application to document patients' preparation for treatments, and an EHR work flow to broadcast patients' treatment preferences to all health care providers. OUTCOMES: Uptake and acceptability. ANALYTIC APPROACH: Mixed methods. RESULTS: From July 1, 2017, through June 30, 2018, the CKD registry identified 1,032 patients in 4 nephrology clinics, of whom 243 (24%) were identified as high risk for progressing to kidney failure within 2 years. Kidney Transitions Specialists enrolled 117 (48%) high-risk patients by the end of year 1. The values tool was completed by 30/33 (91%) patients who attended kidney modality education. Nurse case managers used the tracking application for 100% of patients to document 287 planning steps for kidney replacement therapy. Most (87%) high-risk patients had their preferred kidney replacement modality documented and displayed in the EHR. Nurse case managers reported that the tools facilitated their identification of patients needing support and their navigation activities. LIMITATIONS: Single institution, short duration. CONCLUSIONS: Digital health system tools facilitated rapid identification of patients needing shared and informed decision making and their preparation for kidney replacement treatments. FUNDING: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (IHS-1409-20967). TRIAL REGISTRATION: ClinicalTrials.gov NCT02722382.

African Americans' discussions about living-donor kidney transplants with family or friends: Who, what, and why not?

BACKGROUND: Although discussions with family or friends can improve access to living-donor kidney transplantation (LDKT), they remain an understudied step in the LDKT process. METHODS: Among 300 African American transplant candidates, we examined how sociodemographic, clinical, LDKT-related, and psychosocial characteristics related to the occurrence of LDKT discussions with family or friends. We also analyzed the relation between discussion occurrence and donor activation on transplant candidates' behalves (at least one donor inquiry or completed donor evaluation in the medical record). We assessed associations of discussion characteristics (context, content, and perceptions) with donor activation among discussants, and we identified discussion barriers among non-discussants. RESULTS: Most candidates (90%) had discussed LDKT. Only family functioning was statistically significantly associated with discussion occurrence. Specifically, family dysfunction was associated with 62% lower odds of discussion than family function. Family functioning, discussion occurrence, and different discussion characteristics were statistically significantly related to donor activation. The most prevalent discussion barrier was never having thought about discussing LDKT. CONCLUSIONS: Family functioning affected the likelihood of discussing LDKT, and family functioning, discussion occurrence, and discussion characteristics were associated with donor activation. Advancing understanding of how family functioning and LDKT discussions affect progression to LDKT may benefit interventions to increase LDKT.

Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access.

Background: Guidelines recommend pre-emptive creation of arteriovenous (AV) access. However, <20% of US patients initiate hemodialysis (HD) with a functional AV access. We implemented a quality improvement (QI) program to improve pre-HD vascular access care. Methods: After conducting qualitative research with key informants, we implemented a 7-month vascular access support QI program at Geisinger Health. The program targeted patient and health system barriers to AV access through education, needs assessment, peer support, care navigation, and electronic supports. We performed pre-, intra-, and postprogram stakeholder interviews to identify program barriers and facilitators and to assess acceptability. In a research substudy, we compared pre- and postprogram self-efficacy, knowledge, and confidence navigating vascular access care. Results: There were 37 patient and 32 clinician/personnel participants. Of the 37 patients, 34 (92%) completed vascular access-specific education, 33 (89%) underwent needs assessment, eight (22%) engaged with peer mentors, 21 (57%) had vein mapping, 18 (49%) had an initial surgical appointment, 15 (40%) underwent AV access surgery, and six (16%) started HD during the 7-month program. Qualitative findings demonstrated program acceptability to participants and suggested that education provision and emotional barrier identification were important to engaging patients in vascular access care. Research findings showed pre- to postprogram improvements in patient self-efficacy (28.1-30.8, P=0.05) and knowledge (4.9-6.9, P=0.004), and trends toward improvements in confidence among patients (8.0-8.7, P=0.2) and providers (7.5-7.8, P=0.1). Conclusions: Our intervention targeting patient and health system barriers improved patient vascular access knowledge and self-efficacy. Clinical Trial registry name and registration number: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation, NCT04032613.

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).

Advanced CKD Care and Decision Making: Which Health Care Professionals Do Patients Rely on for CKD Treatment and Advice?

RATIONALE & OBJECTIVE: Chronic kidney disease (CKD) care is often fragmented across multiple health care providers. It is unclear whether patients rely mostly on their nephrologists or non-nephrologist providers for medical care, including CKD treatment and advice. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: Adults receiving nephrology care at CKD clinics in Pennsylvania. PREDICTORS: Frequency, duration, and patient-centeredness (range, 1 [least] to 4 [most]) of participants' nephrology care. OUTCOME: Participants' reliance on nephrologists, primary care providers, or other specialists for medical care, including CKD treatment and advice. ANALYTICAL APPROACH: Multivariable logistic regression to quantify associations between participants' reliance on their nephrologists (vs other providers) and their demographics, comorbid conditions, kidney function, and nephrology care. RESULTS: Among 1,412 patients in clinics targeted for the study, 676 (48%) participated. Among these, 453 (67%) were eligible for this analysis. Mean age was 71 (SD, 12) years, 59% were women, 97% were white, and 65% were retired. Participants were in nephrology care for a median of 3.8 (IQR, 2.0-6.6) years and completed a median of 4 (IQR, 3-5) nephrology appointments in the past 2 years. Half (56%) the participants relied primarily on their nephrologists, while 23% relied on primary care providers, 18% relied on all providers equally, and 3% relied on other specialists. Participants' adjusted odds of relying on their nephrologists were higher for those in nephrology care for longer (OR, 1.08 [95% CI, 1.02-1.15]; P = 0.02), those who completed more nephrology visits in the previous 2 years (OR, 1.16 [95% CI, 1.05-1.29]; P = 0.005), and those who perceived their last interaction with their nephrologists as more patient-centered (OR, 2.63 [95% CI, 1.70-4.09]; P < 0.001). LIMITATIONS: Single health system study. CONCLUSIONS: Many nephrology patients relied on non-nephrologist providers for medical care. Longitudinal patient-centered nephrology care may encourage more patients to follow nephrologists' recommendations.

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.

The TALKS study to improve communication, logistical, and financial barriers to live donor kidney transplantation in African Americans: protocol of a randomized clinical trial.

BACKGROUND: Live donor kidney transplantation (LDKT), an optimal therapy for many patients with end-stage kidney disease, is underutilized, particularly by African Americans. Potential recipient difficulties initiating and sustaining conversations about LDKT, identifying willing and medically eligible donors, and potential donors' logistical and financial hurdles have been cited as potential contributors to race disparities in LDKT. Few interventions specifically targeting these factors have been tested. METHODS/DESIGN: We report the protocol of the Talking about Living Kidney Donation Support (TALKS) study, a study designed to evaluate the effectiveness of behavioral, educational and financial assistance interventions to improve access to LDKT among African Americans on the deceased donor kidney transplant recipient waiting list. We adapted a previously tested educational and social worker intervention shown to improve consideration and pursuit of LDKT among patients and their family members for its use among patients on the kidney transplant waiting list. We also developed a financial assistance intervention to help potential donors overcome logistical and financial challenges they might face during the pursuit of live kidney donation. We will evaluate the effectiveness of these interventions by conducting a randomized controlled trial in which patients on the deceased donor waiting list receive 1) usual care while on the transplant waiting list, 2) the educational and social worker intervention, or 3) the educational and social worker intervention plus the option of participating in the financial assistance program. The primary outcome of the randomized controlled trial will measure potential recipients' live kidney donor activation (a composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) at 1 year. DISCUSSION: The TALKS study will rigorously assess the effectiveness of promising interventions to reduce race disparities in LDKT. TRIAL REGISTRATION: NCT02369354.

Design of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).

The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.

Intentions to maintain adherence to mammography.

OBJECTIVE: Recent attention has focused on moving women from having initial mammograms to maintaining adherence to regular mammography schedules. We examined behavioral intentions to maintain mammography adherence, which include the likelihood of performing a behavior, and implementation intentions, specific action plans to obtain mammograms. Potential predictors were Theory of Planned Behavior constructs, previous barriers, previous mammography maintenance, and age. METHODS: Respondents were 2062 currently adherent women due for their next mammograms in 3-4 months according to American Cancer Society recommendations for annual screening. Statistical models were used to examine predictors of behavioral and two implementation intentions, including having thought about where women would get their next mammograms and having thought about making appointments. RESULTS: With the exception of pros, cons, and subjective norms, all variables predicted behavioral intentions (p

Patients' interest in discussing cancer risk and risk management with primary care physicians.

Little is known about patients' preferences for discussing cancer risks and risk management with primary care physicians. We sought to determine whether patients want to discuss such topics and what factors are associated with this interest. Participants (375 patients ages 40-85, of diverse race and education level) completed a telephone survey prior to scheduled physician visits. Survey included items on perceived health, perceived cancer risk, education level, and whether participants would like to discuss with a physician their breast, ovarian or colon cancer risk, tamoxifen, cancer genetic counseling, and colon cancer screening. Greater proportions were interested in discussing risks for each cancer, compared with those who were not (P < 0.0001). More participants were interested in discussing mammograms (80%) and cancer genetic counseling (60%) than tamoxifen (49%) or colon cancer screening modalities (43-53%). For many topics, poorer perceived health was associated with greater interest in future discussion; higher education level was associated with less interest.

Provider characteristics and mammography recommendation among women in their 40s and 50s.

OBJECTIVES: Healthcare provider recommendation for mammography is one of the strongest predictors of women's mammography use, but few studies have examined the association of provider characteristics with mammography recommendations. We examined the relationship of provider gender, age, medical specialty, and duration of relationship with the patient to report mammography recommendation. METHODS: Participants were women ages 40-45 and 50-55 who were part of a larger intervention study of decision making about mammography. We examined the relationship of provider characteristics to patient-reported mammography recommendations at baseline and at 24-month follow-up. RESULTS: At baseline, 74% of women in their 40s and 79% of women in their 50s reported provider mammography recommendations within the prior 2 years. Proportions were similar at the 24-month follow-up. In multivariate logistic regression models including both patient and provider characteristics, women in their 40s who had female providers were more likely to report mammography recommendations than those with male providers at baseline (OR=1.83, p=0.01) and follow-up (OR=1.74, p=0.03). Among women in their 50s, participants whose regular providers were primary care physicians were more likely to report recommendations at baseline than those whose regular providers were obstetrician/gynecologists (OR=1.68, p=0.03). CONCLUSIONS: About one fourth of women in this study reported not having been advised by a healthcare provider to have a mammogram. All women in the study had health insurance. Among women in their 40s, for whom mammography guidelines were controversial at the time of data collection, provider gender was an important predictor of patient-reported mammography recommendation.

Effects of a mammography decision-making intervention at 12 and 24 months.

BACKGROUND: Most women are not getting regular mammograms, and there is confusion about several mammography-related issues, including the age at which women should begin screening. Numerous groups have called for informed decision making about mammography, but few programs have resulted. Our research is intended to fill this gap. METHODS: We conducted a randomized controlled trial, which ran from 1997 to 2000. Women aged 40 to 44 and 50 to 54, who were enrolled in Blue Cross Blue Shield of North Carolina, were randomly assigned to one of three groups: usual care (UC), tailored print (TP) materials, or TP plus tailored telephone counseling (TP+TC). We assessed the impact of tailored interventions on knowledge about breast cancer and mammography, accuracy of breast cancer risk perceptions, and use of mammography at two time points after intervention-12 and 24 months. RESULTS: At 12 and 24 months, women who received TP+TC had significantly greater knowledge and more accurate breast cancer risk perceptions. Compared to UC, they were 40% more likely to have had mammograms (odds ratio=0.9-2.1). The effect was primarily for women in their 50s. TP had significant effects for knowledge and accuracy, but women who received TP were less likely to have had mammography. CONCLUSIONS: Decision-making interventions, comprised of two tailored print interventions (booklet and newsletter), delivered a year apart, with or without two tailored telephone calls, significantly increased knowledge and accuracy of perceived breast cancer risk at 12 and 24 months post-intervention. The effect on mammography use was significant in bivariate relationships but had a much more modest impact in multivariate analyses.