Relationship between renal pelvis pressure and post-ureteroscopy infection in a live swine model.

OBJECTIVE: To evaluate the relationship between renal pelvis pressure and infection after ureteroscopy, using a live swine model. MATERIALS AND METHODS: In anaesthetised pigs, a 1-h ureteroscopy was performed using a pressure-sensing guidewire, with renal pelvis pressure maintained at either 37 mmHg or 75 mmHg for the entire procedure and infusion with saline alone or with a standardised concentration of uropathogenic Escherichia coli strain CFT073 (1.5 × 107 colony-forming units [CFU]/mL). Venous blood sampling was performed during and after the procedure. Vital signs, inflammatory biomarkers, and renal tissue and blood cultures were assessed. RESULTS: In 21 pig kidneys, study groups were: 37 mmHg with saline irrigation (n = 3); 75 mmHg with saline irrigation (n = 4); 37 mmHg with saline irrigation with 1.5 × 107 CFU/mL E. coli (n = 7); and 75 mmHg with saline irrigation with 1.5 × 107 CFU/mL E. coli (n = 7). Statistically significant changes in inflammatory biomarkers were most pronounced in the group with 75 mmHg saline irrigation + E. coli and were significantly elevated compared with the control group and the group receiving E. coli irrigation at 37 mmHg. Positive blood cultures were noted in 5/7 animals treated with E. coli at 75 mmHg; no others developed bacteraemia. CONCLUSION: In this swine model of ureteroscopy, irrigation with saline + E. coli at a renal pelvis pressure of 75 mmHg resulted in bacteraemia and inflammatory biomarker elevations significantly greater than both E. coli irrigation with renal pelvis pressure maintained at 37 mmHg and the control.

Health Literacy in Patients Considering a Left Ventricular Assist Device: Findings From the DECIDE-LVAD Trial.

OBJECTIVE: To assess the interaction of health literacy and a shared intervention concerning decision quality in patients considering the destination therapy of left ventricular assist device (DT LVAD) implantation. BACKGROUND: Evidence is limited for the use of decision aids by patients with low health literacy and with life-threatening illnesses. METHODS: We performed a secondary analysis of the DECIDE-LVAD Trial, a randomized, stepped-wedge trial conducted from 2015-2017 in the United States. The intervention was the integration of a formal shared decision-making intervention. The main outcome was decision quality as measured by LVAD knowledge and values-treatment concordance. Two components of health literacy were measured by the Rapid Estimate of Adult Literacy in Medicine and Subjective Numeracy Scale instruments. RESULTS: Of the 228 patients studied, 44% (n = 101) received the formal shared decision-making intervention, and half had low health literacy. Knowledge of LVAD improved for patients with low literacy in the intervention group compared to the control group: the difference in increased knowledge score was 10.6%; P = 0.04. Values-treatment concordance improved significantly for patients with low literacy in the intervention group compared to the control group: the median improvement in values-treatment correlation coefficient was 0.43; P = 0.03. These benefits were not significant in those with adequate literacy (n = 171). Patients with low numeracy (n = 94) did not show significant improvements in either measure of decision quality, and patients with adequate numeracy (n = 134) showed improvement in LVAD knowledge but not in values-treatment concordance. CONCLUSIONS: Patients considering DT LVAD implantation with low literacy showed improvement in decision quality after the integration of a shared decision-making intervention.

Social Determinants of Health and Rates of Implantation for Patients Considering Destination Therapy Left Ventricular Assist Device.

BACKGROUND: A left ventricular assist device (LVAD) is a treatment option available to select patients with advanced heart failure. However, there are important social determinants of health that can play a role in determining patients' outcomes after device placement. METHODS AND RESULTS: We leveraged the DECIDE-LVAD Trial to assess social determinants of health-relationship status, household income, race/ethnicity, educational attainment, and health insurance-at the time of evaluation, and their association with rate of LVAD placement in the subsequent year. About a quarter of patients were unpartnered (i.e., single/divorced/widowed/separated; n = 55 [26%]). A similar proportion had a household income of less than $20,000 per year (n = 50 [24%]). Few patients were other race (n = 39 [18%]), had less than a high school education (n = 14 [6.6%]), or had Medicaid as their primary payor (n = 17 [8.4%]). LVAD implantation was significantly lower among patients who were unpartnered compared with patients who were married or partnered. LVAD implantation was not associated with income, race, educational attainment or insurance status. CONCLUSIONS: Our data from diverse LVAD centers at U.S. private and academic hospitals found that, among a broad sample of patients being evaluated for LVAD, married or partnered status was favorably associated with LVAD implantation, but other social determinants of health were not. Future research and policy changes should consider novel interventions for improving access to LVAD implantation for patients with inadequate social support.

Comorbidities and the decision to undergo or forego destination therapy left ventricular assist device implantation: An analysis from the Trial of a Shared Decision Support Intervention for Patients and their Caregivers Offered Destination Therapy for End-Stage Heart Failure (DECIDE-LVAD) study.

BACKGROUND: Patients considering destination therapy left ventricular assist devices (DT LVAD) often have high comorbid burden but the association between these comorbidities and post-decision outcomes is unknown. METHODS: We included subjects in DECIDE-LVAD (NCT02344576), a stepped-wedge multicenter trial of patients considering LVADs, recording comorbidities per INTERMACS protocol. We compared decisional conflict, regret, perceived stress, quality of life (EQ-VAS), depression (PHQ-2), struggle with- and acceptance of illness by comorbid burden and amongst the most common comorbidities. RESULTS: Of 239 patients, LVAD recipients (n = 164) and non-recipients (n = 75) had a similar proportion with ≥1 comorbidity (70% v. 80%, P = .09). Patients with comorbidities were younger regardless of LVAD implantation status. After adjusting for age, overall and amongst LVAD recipients, patients with ≥1 comorbidity had higher mean decision conflict at baseline (23.2 ±â€¯1.5 vs. 17.4 ±â€¯2.2), and at 6 months, higher stress (13.0 ±â€¯0.6 vs. 10.4 ±â€¯1.0) and struggle with illness (13.3 ±â€¯0.4 vs. 11.1 ±â€¯0.6) than those without comorbidities (P < .05). No difference was noted in decision regret, PHQ-2, EQ-VAS, acceptance of illness and survival overall and amongst LVAD recipients. Of the three most common comorbidities, while patients with pulmonary hypertension had worse decision regret, depression, stress and acceptance of illness at 6-month follow-up than those who did not have pulmonary hypertension, no difference was noted in patients with chronic renal disease or high body mass index. CONCLUSION: Patients considering LVAD implantation with comorbidities experience increased decision conflict, stress and struggle with illness. These findings provide insights in the role comorbidities play in patient decision-making and decisional outcomes.

A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial.

BACKGROUND: There is a need for new strategies to improve the success of obesity treatment within the primary care setting. OBJECTIVE: To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care. DESIGN: Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital. PARTICIPANTS: From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention. INTERVENTIONS: Medical weight management tools-partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program-for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months. MAIN MEASURES: The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss. KEY RESULTS: Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes. CONCLUSIONS: Access to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01922934.

Disease Management in Skilled Nursing Facilities Improves Outcomes for Patients With a Primary Diagnosis of Heart Failure.

OBJECTIVE: Skilled nursing facilities (SNFs) are common destinations after hospitalization for patients with heart failure (HF). Our objective was to determine if patients in SNFs with a primary hospital discharge diagnosis of HF benefit from an HF disease management program (HF-DMP). DESIGN: This is a subgroup analysis of multisite, physician and practice blocked, cluster-randomized controlled trial of HF-DMP vs usual care for patients in SNF with an HF diagnosis. The HF-DMP standardized SNF HF care using HF practice guidelines and performance measures and was delivered by an HF nurse advocate. SETTING AND PARTICIPANTS: Patients with a primary hospital discharge diagnosis of HF discharged to SNF. METHODS: Composite outcome of all-cause hospitalization, emergency department visits, and mortality were evaluated at 30 and 60 days post SNF admission. Linear mixed models accounted for patient clustering at the physician level. RESULTS: Of 671 individuals enrolled in the main study, 125 had a primary hospital discharge diagnosis of HF (50 HF-DMP; 75 usual care). Mean age was 79 ± 10 years, 53% women, and mean ejection fraction 46% ± 15%. At 60 days post SNF admission, the rate of the composite outcome was lower in the HF-DMP group (30%) compared with usual care (52%) (P = .02). The rate of the composite outcome at 30 days for the HF-DMP group was 18% vs 31% in the usual care group (P = .11). CONCLUSIONS AND IMPLICATIONS: Patients with a primary hospital discharge diagnosis of HF who received HF-DMP while cared for in an SNF had lower rates of the composite outcome at 60 days. Standardized HF management during SNF stays may be important for patients with a primary discharge diagnosis of HF.

A Randomized Controlled Trial of Heart Failure Disease Management in Skilled Nursing Facilities.

OBJECTIVE: Patients discharged from the hospital to a skilled nursing facility (SNF) are not typically part of a heart failure disease management program (HF-DMP). The objective of this study is to determine if an HF-DMP in SNF improves outcomes for patients with HF. DESIGN: Cluster-randomized controlled trial. PARTICIPANTS: The trial was conducted in 47 SNFs, and 671 patients were enrolled (329 HF-DMP; 342 to usual care). METHODS: The HF-DMP included documentation of ejection fraction, symptoms, weights, diet, medication optimization, education, and 7-day visit post SNF discharge. The composite outcome was all-cause hospitalization, emergency department visits, or mortality at 60 days. Secondary outcomes included the composite endpoint at 30 days, change in the Kansas City Cardiomyopathy Questionnaire and the Self-care of HF Index at 60 days. Rehospitalization and mortality rates were calculated as an exploratory outcome. RESULTS: Mean age of the patients was 79 ± 10 years, 58% were women, and the mean ejection fraction was 51% ± 16%. At 30 and 60 days post SNF admission, the composite endpoint was not significant between DMP (29%) and usual care (32%) at 30 days and 60 days (43% vs 47%, respectively). The Kansas City Cardiomyopathy Questionnaire significantly improved in the HF-DMP vs usual care for the Physical Limitation (11.3 ± 2.9 vs 20.8 ± 3.6; P = .039) and Social Limitation subscales (6.0 ± 3.1 vs 17.9 ± 3.8; P = .016). Self-care of HF Index was not significant. The total number of events (composite endpoint) totaled 517 (231 in HF-DMP and 286 in usual care). Differences in the 60-day hospitalization rate [mean HF-DMP rate 0.43 (SE 0.03) vs usual care 0.54 (SE 0.05), P = .04] and mortality rate (HF-DMP 5.2% vs usual care 10.8%, P < .001) were significant. CONCLUSIONS AND IMPLICATIONS: The composite endpoint was high for patients with HF in SNF regardless of group. Rehospitalization and mortality rates were reduced by the HF-DMP. HF-DMPs in SNFs may be beneficial to the outcomes of patients with HF. SNFs should consider structured HF-DMPs for their patients.

Changes over Time in Patient Stated Values and Treatment Preferences Regarding Aggressive Therapies: Insights from the DECIDE-LVAD Trial.

BACKGROUND: Patient-centered care includes matching treatments to patient values and preferences. This assumes clarity and consistency of values and preferences relevant to major medical decisions. We sought to describe stability of patient-reported values regarding aggressiveness of care and preferences for left ventricular assist devices (LVADs) for advanced heart failure. METHODS AND RESULTS: We conducted a secondary analysis of patients undergoing LVAD evaluation at 6 US centers. Surveys at baseline, 1 month, and 6 months included a single 10-point scale on the value of aggressive care (score 1 = "do everything," 10 = "live with whatever time I have left") and treatment preference (LVAD, unsure, no LVAD). Data were captured for 232 patients, of whom 196 were ultimately deemed medically eligible for LVAD, and 161 were surgically implanted by 1 month. Values at baseline favored aggressive care (mean [SD], 2.49 [2.63]), trending toward less aggressive over time (1 month, 2.63 [2.05]; 6 months, 3.22 [2.70]). Between baseline and 1 month, values scores changed by ≥2 points in 28% (50/176), as did treatment preferences for 18% (29/161) of patients. Values score changes over time were associated with lower illness acceptance, depression, and eventual LVAD ineligibility. Treatment preference change was associated with values score change. CONCLUSION: Most patients considering LVAD were stable in their values and treatment preferences. This stability, as well as the association between unstable treatment preferences and changes to stated values, highlighted the clinical utility of the values scale of aggressiveness. However, a substantial minority reported significant changes over time that may complicate the process of shared decision making. Improved methods to elicit and clarify values, including support to those with depression and low illness acceptance, is critical for patient-centered care.[Box: see text].

Evaluation of a covariate-constrained randomization procedure in stepped wedge cluster randomized trials.

In stepped wedge (SW) designs, differing cluster-level characteristics or individual-level covariate distributions that differ by cluster can lead to imbalance by treatment arm and potential confounding of the treatment effect. Adapting a method used in cluster-randomized trials, we propose a covariate-constrained randomization method to be used in SW designs. First, we define a balance metric to be calculated for all possible randomizations of cluster order for a given SW design. The resulting distribution of this balance metric across all possible randomizations is used to select a candidate set of randomizations with acceptable covariate balance. One cluster order is selected at random from this candidate set to be used as the cluster order for treatment implementation. In a simulation study, we implement the covariate-constrained randomization procedure and compare treatment effect estimation, type I error, and power under varying SW design and confounding settings, and using multiple analysis methods. We observed optimal statistical properties when the balance metric was used to exclude a small set of potential randomizations with the highest level of imbalance, and when analysis methods were adjusted for the potential confounders. The covariate-constrained randomization was most beneficial in settings with a small number of clusters and in the presence of cluster-level confounding.

Stress and Coping Among Family Caregivers of Patients With a Destination Therapy Left Ventricular Assist Device: A Multicenter Mixed Methods Study.

BACKGROUND: Family caregivers of patients with a destination therapy left ventricular assist device play a central and formalized role in postimplant care. We aimed to characterize longitudinal stress, predictors and correlates of stress, and coping processes among left ventricular assist device caregivers. METHODS: We performed a sequential, exploratory, mixed-methods study from 6 diverse left ventricular assist device programs. The primary outcome for the quantitative analysis was the Perceived Stress Scale-10 at 6 months (0-40). Based on the quantitative findings and guided by the Transactional Model of Stress and Coping, semistructured interviews explored causes of stress and coping processes. Integration was performed during the qualitative and interpretation phase. RESULTS: A total of 96 caregivers met inclusion criteria for quantitative analysis. Mean (SD) Perceived Stress Scale score was 14.3 (5.5) preimplant and 11.8 (6.9) at 6 months. Preimplant, only decreased preparedness for caregiving was associated with higher Perceived Stress Scale score at 6 months. At 6 months, increased caregiver depressive symptoms, decreased caregiver preparedness for caregiving, and lower patient quality of life were associated with higher Perceived Stress Scale score. Qualitative analysis of 25 caregivers revealed the causes of stress coalesced around 3 themes: (1) lack of preparedness to be a caregiver, (2) uniqueness of stress for the caregiver and patient situation, and (3) caregiving responsibilities physically and emotionally impacting caregivers. To cope with stress, most caregivers employed emotion-focused coping. CONCLUSIONS: In family caregivers of patients with a left ventricular assist device, higher perceived stress was associated with lower caregiver preparedness, higher caregiver depressive symptoms, and lower patient quality of life. Emotion-focused coping strategies were common for caregivers. Future work should better prepare caregivers for this role and support them through the caregiving experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02344576.

Decision Aid Implementation among Left Ventricular Assist Device Programs Participating in the DECIDE-LVAD Stepped-Wedge Trial.

Background. Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision-ideal for exploring implementation of a DA. Methods. We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study. Results. From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation. Conclusions. In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.