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Sarah J Flynn,1,2 Jessica M Ameling,1,2 Felicia Hill-Briggs,1–3 Jennifer L Wolff,4,5 Lee R Bone,1,3 David M Levine,1,4 Debra L Roter,3 LaPricia Lewis-Boyer,1,2 Annette R Fisher,6 Leon Purnell,6 Patti L Ephraim,2,7 Jeffrey Barbers,1,2 Stephanie L Fitzpatrick,1,2 Michael C Albert,1,8 Lisa A Cooper,1,2 Peter J Fagan,9,10 Destiny Martin,1 Hema C Ramamurthi,1,2 L Ebony Boulware1,2,7 1Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 2Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, MD, USA; 3Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; 4Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; 5Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 6Community and Provider Advisory Board, Johns Hopkins Center to Eliminate Cardiovascular Health Disparities, Baltimore, MD, USA; 7Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; 8Johns Hopkins Community Physicians, Johns Hopkins Medical Institutions, Baltimore, MD, USA; 9Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 10Johns Hopkins HealthCare LLC, Glen Burnie, MD, USA Introduction: We aimed to inform the design of behavioral interventions by identifying patients’ and their family members’ perceived facilitators and barriers to hypertension self-management. Materials and methods: We conducted focus groups of African American patients with hypertension and their family members to elicit their views about factors influencing patients’ hypertension self-management. We recruited African American patients with hypertension (n = 18) and their family members (n = 12) from an urban, community-based clinical practice in Baltimore, Maryland. We conducted four separate 90-minute focus groups among patients with controlled (one group) and uncontrolled (one group) hypertension, as well as their family members (two groups). Trained moderators used open-ended questions to assess participants’ perceptions regarding patient, family, clinic, and community-level factors influencing patients’ effective hypertension self-management. Results: Patient participants identified several facilitators (including family members’ support and positive relationships with doctors) and barriers (including competing health priorities, lack of knowledge about hypertension, and poor access to community resources) that influence their hypertension self-management. Family members also identified several facilitators (including their participation in patients’ doctor’s visits and discussions with patients’ doctors outside of visits) and barriers (including their own limited health knowledge and patients’ lack of motivation to sustain hypertension self-management behaviors) that affect their efforts to support patients’ hypertension self-management. Conclusion: African American patients with hypertension and their family members reported numerous patient, family, clinic, and community-level facilitators and barriers to patients’ hypertension self-management. Patients’ and their family members’ views may help guide efforts to tailor behavioral interventions designed to improve hypertension self-management behaviors and hypertension control in minority populations. Keywords: hypertension, patient perspective, qualitative research, health disparities

Abstract Background Little is known regarding the types of information African American and non-African American patients with chronic kidney disease (CKD) and their families need to inform renal replacement therapy (RRT) decisions. Methods In 20 structured group interviews, we elicited views of African American and non-African American patients with CKD and their families about factors that should be addressed in educational materials informing patients’ RRT selection decisions. We asked participants to select factors from a list and obtained their open-ended feedback. Results Ten groups of patients (5 African American, 5 non-African American; total 68 individuals) and ten groups of family members (5 African American, 5 non-African American; total 62 individuals) participated. Patients and families had a range (none to extensive) of experiences with various RRTs. Patients identified morbidity or mortality, autonomy, treatment delivery, and symptoms as important factors to address. Family members identified similar factors but also cited the effects of RRT decisions on patients’ psychological well-being and finances. Views of African American and non-African American participants were largely similar. Conclusions Educational resources addressing the influence of RRT selection on patients’ morbidity and mortality, autonomy, treatment delivery, and symptoms could help patients and their families select RRT options closely aligned with their values. Including information about the influence of RRT selection on patients’ personal relationships and finances could enhance resources’ cultural relevance for African Americans.

Abstract Background Few educational resources have been developed to inform patients’ renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients’ treatment and support patients’ decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function. Methods We designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in “stages.” For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families. Results The video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals’ testimonials regarding various considerations that might influence patients’ and families’ treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably. Conclusions This rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values.

Abstract Background Living related kidney transplantation (LRT) is underutilized, particularly among African Americans. The effectiveness of informational and financial interventions to enhance informed decision-making among African Americans with end stage renal disease (ESRD) and improve rates of LRT is unknown. Methods/design We report the protocol of the Providing Resources to Enhance African American Patients’ Readiness to Make Decisions about Kidney Disease (PREPARED) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test the effectiveness of informational (focused on shared decision-making) and financial interventions to overcome barriers to pursuit of LRT among African American patients and their families. Study Phase I involved the evidence-based development of informational materials as well as a financial intervention to enhance African American patients’ and families’ proficiency in shared decision-making regarding LRT. In Study Phase 2, we are currently conducting a randomized controlled trial in which patients with new-onset ESRD receive 1) usual dialysis care by their nephrologists, 2) the informational intervention (educational video and handbook), or 3) the informational intervention in addition to the option of participating in a live kidney donor financial assistance program. The primary outcome of the randomized controlled trial will include patients’ self-reported rates of consideration of LRT (including family discussions of LRT, patient-physician discussions of LRT, and identification of a LRT donor). Discussion Results from the PREPARED study will provide needed evidence on ways to enhance the decision to pursue LRT among African American patients with ESRD. Trial registration ClinicalTrials.gov NCT01439516

Background: We aimed to evaluate how urine chemistry tests are impacted by collection using a female external urinary catheter employing wicking and suction, to assess this catheter's potential as an alternative to transurethral catheters for collecting urine samples from incontinent patients., Methods: We obtained 50 random 40 mL refrigerated urine specimens from excess volume submitted to the Michigan Medicine Biochemical Laboratory. Specimens were split into a 10 mL "control" sample simulating voided urine, and a 30 mL paired "wicked" sample applied dropwise to and collected from a fresh PureWick system simulating collection from an incontinent patient. Each sample pair was tested for glucose, sodium, potassium, creatinine, urea, total protein, and derived ratios of sodium/creatinine, urea/creatinine, and protein/creatinine, then compared using Pearson correlation coefficients. Wicking materials were imaged via absorption contrast tomography on a laboratory X-ray microscope, to study the structure through which urine passes., Results: Control and wicked urine samples had very similar results for all chemical tests evaluated: strong Pearson correlation coefficients ranging from 0.955 (potassium) to 0.997 (glucose). Microscopic assessment of the amorphous wicking materials demonstrated an average pore spacing of 95.38 µm., Conclusions: Common urine chemistry tests were unaltered by collection using the PureWick female external catheter system. This external device can be used to collect urine for chemistry tests as an alternative to transurethral catheters., (Published by Elsevier Inc.)

Importance: Acute urinary retention (UR) is common, yet variations in diagnosis and management can lead to inappropriate catheterization and harm., Objective: To develop an algorithm for screening and management of UR among adult inpatients., Design, Setting, and Participants: In this mixed-methods study using the RAND/UCLA Appropriateness Method and qualitative interviews, an 11-member multidisciplinary expert panel of nurses and physicians from across the US used a formal multi-round process from March to May 2015 to rate 107 clinical scenarios involving diagnosis and management of adult UR in postoperative and medical inpatients. The panel ratings informed the first algorithm draft. Semistructured interviews were conducted from October 2020 to May 2021 with 33 frontline clinicians-nurses and surgeons from 5 Michigan hospitals-to gather feedback and inform algorithm refinements., Main Outcomes and Measures: Panelists categorized scenarios assessing when to use bladder scanners, catheterization at various scanned bladder volumes, and choice of catheterization modalities as appropriate, inappropriate, or uncertain. Next, qualitative methods were used to understand the perceived need, usability, and potential algorithm uses., Results: The 11-member expert panel (10 men and 1 woman) used the RAND/UCLA Appropriateness Method to develop a UR algorithm including the following: (1) bladder scanners were preferred over catheterization for UR diagnosis in symptomatic patients or starting as soon as 3 hours since last void if asymptomatic, (2) bladder scanner volumes appropriate to prompt catheterization were 300 mL or greater in symptomatic patients and 500 mL or greater in asymptomatic patients, and (3) intermittent was preferred to indwelling catheterization for managing lower bladder volumes. Interview findings were organized into 3 domains (perceived need, feedback on algorithm, and implementation suggestions). The 33 frontline clinicians (9 men and 24 women) who reviewed the algorithm reported that an evidence-based protocol (1) was needed and could be helpful to clinicians, (2) should be simple and graphically appealing to improve rapid clinician review, and (3) should be integrated within the electronic medical record and prominently displayed in hospital units to increase awareness. The draft algorithm was iteratively refined based on stakeholder feedback., Conclusions and Relevance: In this study using a systematic, multidisciplinary, evidence- and expert opinion-based approach, a UR evaluation and catheterization algorithm was developed to improve patient safety by increasing appropriate use of bladder scanners and catheterization. This algorithm addresses the need for practical guidance to manage UR among adult inpatients.

Background: Female patients using indwelling urinary catheters (IUCs) are disproportionately at risk for developing catheter-associated urinary tract infections (CAUTIs) compared to males. Female external urine wicking devices (FEUWDs) have emerged as potential alternatives to IUCs for incontinence management., Objectives: To assess the clinical risks and benefits of FEUWDs as alternatives to IUCs., Methods: Ovid MEDLINE, Embase, Scopus, Web of Science Core Collection, CINAHL Complete, and ClinicalTrials.gov were searched from inception to July 10, 2023. Included studies used FEUWDs as an intervention and reported measures of urinary tract infections and secondary outcomes related to incontinence management., Results: Of 2,580 returned records, 50 were systematically reviewed. Meta-analyses assessed rates of indwelling CAUTIs and IUC utilization. Following FEUWD implementation, IUC utilization rates decreased 14% (RR = 0.86, 95% CI = [0.76, 0.97]) and indwelling CAUTI rates nonsignificantly decreased up to 32% (IRR = 0.68, 95% CI = [0.39, 1.17]). Limited only to studies that described protocols for implementation, the incidence rate of indwelling CAUTIs decreased significantly up to 54% (IRR = 0.46, 95% CI = [0.32, 0.66]). Secondary outcomes were reported less routinely., Conclusions: Overall, FEUWDs nonsignificantly reduced indwelling CAUTI rates, though reductions were significant among studies describing FEUWD implementation protocols. We recommend developing standard definitions for consistent reporting of non-indwelling CAUTI complications such as FEUWD-associated UTIs, skin injuries, and mobility-related complications.

Background: The effects of non-infectious urinary catheter-related complications such as measurements of indwelling urinary catheter overuse, catheter-related trauma, and urinary retention are not well understood., Methods: This was a retrospective cohort study of 200 patients undergoing general surgery operations. Variables to measure urinary catheter use, trauma, and retention were developed, then surgical cases were abstracted. Inter- and intra-rater reliability were calculated for measure validation., Results: 129 of 200 (65%) had an indwelling urinary catheter placed at the time of surgery. 32 patients (16%) had urinary retention, and variation was observed in the treatment of urinary retention. 12 patients (6%) had urinary trauma. Rater reliability was high (>90% agreement for all) for the dichotomous outcomes of urinary catheter use, urinary catheter-related trauma, and urinary retention., Conclusions: This study suggests a persistent high rate of catheter use, significant rates of urinary retention and trauma, and variation in the management of retention., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Co-Author Jennifer Meddings reports a relationship with Agency for Healthcare Research and Quality that includes: funding grants. Jennifer Meddings reports a relationship with Centers for Disease Control and Prevention that includes: funding grants. Jennifer Meddings reports a relationship with Ralph E. Wilson Fundation that includes: funding grants. Jennifer Meddings reports a relationship with VHA Health Services Research & Development that includes: funding grants. Jennifer Meddings has patent US Patent #10279145 and Japanese Patent #6933385 issued to Jennifer Meddings. Jennifer Meddings has received royalties for “Preventing Hospital Infection” book, published by Oxford., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Preventing central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) remains challenging in intensive care units (ICUs)., Objective: The Agency for Healthcare Research and Quality Safety Program for ICUs aimed to reduce CLABSI and CAUTI in units with elevated rates., Methods: Invited hospitals had at least one adult ICU with elevated CLABSI or CAUTI rates, defined by a positive cumulative attributable difference metric (CAD >0) in the Centers for Disease Control and Prevention's Targeted Assessment for Prevention strategy. This externally facilitated programme implemented by a national project team and state hospital associations included on-demand video modules and live webinars reviewing a two-tiered approach for implementing key technical and socioadaptive factors to prevent catheter infections, using principles and tools based on the Comprehensive Unit-based Safety Program. CLABSI, CAUTI and catheter use data were collected (preintervention 13 months, intervention 12 months). Multilevel negative binomial models assessed changes in catheter-associated infection rates and catheter use., Results: Of 366 recruited ICUs from 220 hospitals in 16 states and Puerto Rico for two cohorts, 280 ICUs completed the programme including infection outcome reporting; 274 ICUs had complete outcome data for analyses. Statistically significant reductions in adjusted infection rates were not observed (CLABSI incidence rate ratio (IRR)=0.75, 95% CI 0.52 to 1.08, p=0.13; CAUTI IRR=0.79, 95% CI 0.59 to 1.06, p=0.12). Adjusted central line utilisation (IRR=0.97, 95% CI 0.93 to 1.00, p=0.09) and adjusted urinary catheter utilisation were unchanged (IRR=0.98, 95% CI 0.95 to 1.01, p=0.14)., Conclusion: This multistate programme targeted ICUs with elevated catheter infection rates, but yielded no statistically significant reduction in CLABSI, CAUTI or catheter utilisation in the first two of six planned cohorts. Improvements in the interventions based on lessons learnt from these initial cohorts are being applied to subsequent cohorts., Competing Interests: Competing interests: JM has reported receiving honoraria for lectures and teaching related to prevention and value-based policies involving catheter-associated urinary tract infection and hospital-acquired pressure ulcers. SS has reported receiving honoraria for lectures and teaching related to prevention of catheter-associated urinary tract infection, and is on the medical advisory boards of Doximity and Jvion. JM and SS hold a provisional US patent on a technology to improve aseptic placement of urinary catheters, which was not part of this study., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The objective of this study was to determine the association between sociodemographic factors and intakes of 4 nutrients and associations between intakes and markers of kidney disease to identify opportunities to improve outcomes among clinically high-risk African Americans., Design and Methods: We conducted a cross-sectional study of baseline data from the Achieving Blood Pressure Control Together study, a randomized controlled trial of 159 African Americans (117 females) with uncontrolled hypertension in Baltimore MD. To determine the association between sociodemographic factors and nutrient intakes, we constructed linear and logistic regression models. Using logistic regression, we determined the association between below-median nutrient intakes and kidney disease. Our outcomes of interest were daily intakes of vitamin C, magnesium, dietary fiber, and potassium as estimated by the Block Fruit-Vegetable-Fiber Screener and kidney disease defined as estimated glomerular filtration rate <60 mL/min per 1.73 m2 or urinary albumin-to-creatinine ratio >=30 mg/g., Setting and Subjects: Baseline data from the Achieving Blood Pressure Control Together study, a randomized controlled trial of 159 African Americans (117 females) with uncontrolled hypertension, were obtained., Methods: To determine the association between sociodemographic factors and nutrient intakes, we constructed linear and logistic regression models. Using logistic regression, we determined the association between below-median nutrient intakes and kidney disease., Main Outcome Measures: Our outcomes of interest were daily intakes of vitamin C, magnesium, dietary fiber, and potassium as estimated by the Block Fruit-Vegetable-Fiber Screener and kidney disease defined as estimated glomerular filtration rate <60 mL/min per 1.73 m 2 or urinary albumin-to-creatinine ratio ≥30 mg/g., Results: Overall, compared to Institute of Medicine recommendations, participants had lower intakes of magnesium, fiber, and potassium but higher vitamin C intakes. For females, sociodemographic factors that significantly associated with lower intake of the 4 nutrients were older age, obesity, lower health numeracy, and lesser educational attainment. For males, none of the sociodemographic factors were significantly associated with nutrient intakes. Below-median intake was significantly associated with albumin-to-creatinine ratio ≥30 (adjusted odds ratio [95% confidence interval]: 3.4 [1.5, 7.8] for vitamin C; 3.6 [1.6, 8.4] for magnesium; 2.9 [1.3, 6.5] for fiber; 3.6 [1.6, 8.4] for potassium), but not with estimated glomerular filtration rate <60., Conclusion: African Americans with uncontrolled hypertension may have low intakes of important nutrients, which could increase their risk of chronic kidney disease. Tailored dietary interventions for African Americans at high risk for chronic kidney disease may be warranted., (Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Identifying characteristics associated with struggling healthcare organisations may help inform improvement. Thus, we systematically reviewed the literature to: (1) Identify organisational factors associated with struggling healthcare organisations and (2) Summarise these factors into actionable domains., Methods: Systematic review of qualitative studies that evaluated organisational characteristics of healthcare organisations that were struggling as defined by below-average patient outcomes (eg, mortality) or quality of care metrics (eg, Patient Safety Indicators). Searches were conducted in MEDLINE (via Ovid), EMBASE, Cochrane Library, CINAHL, and Web of Science from database inception through February 8 2018. Qualitative data were analysed using framework-based synthesis and summarised into key domains. Study quality was evaluated using the Critical Appraisal Skills Program tool., Results: Thirty studies (33 articles) from multiple countries and settings (eg, acute care, outpatient) with a diverse range of interviewees (eg, nurses, leadership, staff) were included in the final analysis. Five domains characterised struggling healthcare organisations: poor organisational culture (limited ownership, not collaborative, hierarchical, with disconnected leadership), inadequate infrastructure (limited quality improvement, staffing, information technology or resources), lack of a cohesive mission (mission conflicts with other missions, is externally motivated, poorly defined or promotes mediocrity), system shocks (ie, events such as leadership turnover, new electronic health record system or organisational scandals that detract from daily operations), and dysfunctional external relations with other hospitals, stakeholders, or governing bodies., Conclusions: Struggling healthcare organisations share characteristics that may affect their ability to provide optimal care. Understanding and identifying these characteristics may provide a first step to helping low performers address organisational challenges to improvement., Systematic Review Registration: PROSPERO: CRD42017067367., Competing Interests: Competing interests: SS has received fees for serving on advisory boards for Doximity and Jvion. JM has received honoraria for lectures and teaching related to prevention and value-based purchasing policies involving catheter-associated urinary tract infection and hospital-acquired pressure ulcers. She has also received honoraria from RAND Corporation/AHRQ for preparation of an AHRQ Chapter update on prevention of catheter-associated UTI., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: African Americans have persistently poor access to living donor kidney transplants (LDKT). We conducted a small randomized trial to provide preliminary evidence of the effect of informational decision support and donor financial assistance interventions on African American hemodialysis patients' pursuit of LDKT., Methods: Study participants were randomly assigned to receive (1) Usual Care; (2) the Providing Resources to Enhance African American Patients' Readiness to Make Decisions about Kidney Disease (PREPARED); or (3) PREPARED plus a living kidney donor financial assistance program. Our primary outcome was patients' actions to pursue LDKT (discussions with family, friends, or doctor; initiation or completion of the recipient LDKT medical evaluation; or identification of a donor). We also measured participants' attitudes, concerns, and perceptions of interventions' usefulness., Results: Of 329 screened, 92 patients were eligible and randomized to Usual Care (n = 31), PREPARED (n = 30), or PREPARED plus financial assistance (n = 31). Most participants reported interventions helped their decision making about renal replacement treatments (62%). However there were no statistically significant improvements in LDKT actions among groups over 6 months. Further, no participants utilized the living donor financial assistance benefit., Conclusions: Findings suggest these interventions may need to be paired with personal support or navigation services to overcome key communication, logistical, and financial barriers to LDKT., Trial Registration: ClinicalTrials.gov [ NCT01439516 ] [August 31, 2011].