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Perioperative pelvic floor muscle training can hasten recovery of bladder control and reduce severity of urinary incontinence following radical prostatectomy. Nevertheless, most men undergoing prostatectomy do not receive this training. The purpose of this trial was to test the effectiveness of interactive mobile telehealth (mHealth) to deliver an evidence-based perioperative behavioral training program for post-prostatectomy incontinence.This was a 3-site, 2-arm, randomized trial (2014-2019). Men with prostate cancer scheduled to undergo radical prostatectomy were randomized to a perioperative behavioral program (education, pelvic floor muscle training, progressive exercises, bladder control techniques) or a general prostate cancer education control condition, both delivered by mHealth for 1-4 weeks preoperatively and 8 weeks postoperatively. The primary outcome was time to continence following surgery measured by the ICIQ (International Consultation on Incontinence Questionnaire) Short-Form. Secondary outcomes measured at 6, 9 and 12 months included Urinary Incontinence Subscale of Expanded Prostate Cancer Index Composite; pad use; International Prostate Symptom Score QoL Question and Global Perception of Improvement.A total of 245 men (ages 42-78 years; mean=61.7) were randomized. Survival analysis using the Kaplan-Meier estimate showed no statistically significant between-group differences in time to continence. Analyses at 6 months indicated no statistically significant between-group differences in ICIQ scores (mean=7.1 vs 7.0, p=0.7) or other secondary outcomes.mHealth delivery of a perioperative program to reduce post-prostatectomy incontinence was not more effective than an mHealth education program. More research is needed to assess whether perioperative mHealth programs can be a helpful addition to standard prostate cancer care.

To evaluate tamsulosin (α-blocker therapy) for male overactive bladder (OAB) and to examine if indicators of concomitant benign prostatic hyperplasia are associated with OAB symptom improvement.This was a planned, exploratory analysis of a 4-week, α-blocker (tamsulosin 0.4 mg) run-in phase of the Male Overactive Bladder Trial in Veterans (MOTIVE). Participants with urinary urgency and urinary frequency (8 voids/24 hours) completed bladder diaries, answered symptom questionnaires (AUA-7 SI), and had post-void residual and noninvasive uroflowmetry measurement.A total of 116 male Veterans aged 42-88 years with OAB participated. There were statistically significant reductions in voiding frequency (11.310.0 voids/24 hours, P.0001), urgency scores (mean 2.5-2.2 points, P.0001), and nightly nocturia (2.11.8, P.001). Only baseline AUA-7 SI total and voiding subscale categories (mild, moderate, severe) were associated with significant reduction in AUA-7 SI total score. For continuous variables, only AUA-7 SI baseline total score was associated with AUA-7 SI storage symptom changes. No other baseline measures were associated with changes in urgency, frequency, or nocturia.Initiation of short course tamsulosin therapy in men was associated with statistical reduction in OAB symptoms. Baseline post-void residual, uroflow rate, and the voiding symptom subscore of the AUA-7 SI were not predictive of OAB symptom improvement with tamsulosin. These findings merits further exploration.

Objective To explore the perspectives of normal bladder function among women with lower urinary tract symptoms. Methods This was a secondary analysis of qualitative data from structured interviews with 50 adult women with lower urinary tract symptoms. A directed content analysis of the transcripts explored women's perspectives on normal bladder function. Results Participants’ descriptions of “normal” took many forms and were based on several aspects of bladder function. A prominent feature of normal was that voiding occurred as a seamless process, beginning with an urge sensation, followed by voiding with ease and to completion, and then “being done.” Descriptions of normal were based largely on concepts of voiding regularity, including voiding frequency, intervals, and patterns during the day and night. Another aspect of normal bladder function was the notion of having control in terms of not leaking urine, as well as the ability to hold urine and defer urination. Views of normal bladder function extended to the absence of symptoms and the impact of being symptom-free on day-to-day life, including not having to think about or worry about the bladder or limit daily activities. Conclusion Women's perspectives on normal bladder function are multifaceted, reflecting attributes most salient to each individual and likely informed by their personal experience with symptoms and their influence on daily life. This work has implications for how clinicians might engage women in discussing bladder symptoms and can inform future research and public health messaging about normal bladder function.

(s): Existing bladder-specific measures lack ability to assess a range of bladder health from poor to optimal health. We report evidence for validity of the self-administered, multidimensional Bladder Health Scales and Function Indices for research in adult women.A cross-sectional population-based validation study with random assignment to paper or electronic administration was conducted using national address-based probability sampling supplemented by purposive sampling of women with lower urinary tract symptoms surrounding 7 clinical research centers. Construct validity of the Bladder Health Scales and Function Indices was guided by Multitrait-Multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and noninvasive bladder function testing. Internal dimensional validity was evaluated using factor analysis; internal reliability was assessed using paired t-tests and 2-way mixed effects Intraclass Correlation Coefficient models. Mode comparisons used chi-square, Fisher Exact or t-tests. Convergent validity was evaluated using Pearson correlations with the external construct measures and known-group validity was established with comparison of women known and unknown to be symptomatic with urinary conditions.The sample included 1,072 participants. Factor analysis identified ten scales with Cronbach's alpha ranging 0.74-0.94. Intraclass correlation coefficients of scales ranged from 0.55-0.94. Convergent validity of ten scales and six indices ranged from 0.52- 0.83. Known-group validity was confirmed for all scales and indices. Item distribution was similar by mode of administration.The paper and electronic forms of the Bladder Health Scales and Function Indices are reliable and valid measures of bladder health for use in women's health research.

BACKGROUND: There is an ongoing need for interventions to improve quality of end-of-life care for patients in inpatient settings. OBJECTIVE: To compare two methods for implementing a Comfort Care Education Intervention for Palliative Care Consultation Teams (PCCT) in Veterans Affairs Medical Centers (VAMCs). DESIGN: Cluster randomized implementation trial conducted March 2015–April 2019. PCCTs were assigned to a traditional implementation approach using a teleconference or to an in-person, train-the-champion workshop to prepare PCCTs to be clinical champions at their home sites. PARTICIPANTS: One hundred thirty-two providers from PCCTs at 47 VAMCs. INTERVENTIONS: Both training modalities involved review of educational materials, instruction on using an electronic Comfort Care Order Set, and coaching to deliver the intervention to other providers. MAIN MEASUREMENTS: Several processes of care were identified a priori as quality endpoints for end-of-life care (last 7 days) and abstracted from medical records of veterans who died within 9 months before or after implementation (n = 6,491). The primary endpoint was the presence of an active order for opioid medication at time of death. Secondary endpoints were orders/administration of antipsychotics, benzodiazepines, and scopolamine, do-not-resuscitate orders, advance directives, locations of death, palliative care consultations, nasogastric tubes, intravenous lines, physical restraints, pastoral care visits, and family presence at/near time of death. Generalized estimating equations were conducted adjusting for potential covariates. KEY RESULTS: Eighty-eight providers from 23 VAMCs received teleconference training; 44 providers from 23 VAMCs received in-person workshop training. Analyses found no significant differences between intervention groups in any process-of-care endpoints (primary endpoint AOR (CI) = 1.18 (0.74, 1.89). Furthermore, pre-post changes were not significant for any endpoints (primary endpoint AOR (CI) = 1.16 (0.92, 1.46). Analyses may have been limited by high baseline values on key endpoints with little room for improvement. CONCLUSION: Findings suggest the clinical effectiveness of palliative care educational intervention was not dependent on which of the two implementation methods was used. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02383173

Little is known about social processes shaping adolescent and adult women’s toileting behaviors. The “Study of Habits, Attitudes, Realities, and Experiences” (SHARE) examines adolescent and adult women’s experiences related to bladder health across the life course. Forty-four focus groups with 360 participants organized by six age groups were conducted across seven sites. A transdisciplinary team used social cognitive theory as an interpretive lens across a five-stage analysis. The act of observing was identified as the overarching social process informing women’s toileting behaviors in three ways: (a) observing others’ toileting behavior, (b) being aware that one’s own toileting behaviors are monitored by others, and (c) observing oneself relative to others. We found that underlying processes of toileting behaviors, seemingly private are, in fact, highly social. We suggest, given this social embeddedness that health promotion efforts should leverage interpersonal networks for “social norming” interventions and policies to promote healthy toileting behaviors.

This analysis explored and characterized the ideas adult women have about how the bladder works, the assumptions guiding their bladder-related behaviors, and the beliefs they hold about how their behaviors affect bladder health.This was a directed content analysis of qualitative data from the Study of Habits, Attitudes, Realities, and Experiences, a focus group study conducted at seven United States research centers (July 2017 to April 2018). Participants were 316 adult women organized by four age categories (age range: 18-93 years). Analysis and interpretation focused on the "bladder assumptions and beliefs" code using a transdisciplinary lens and inductive approach.During their focus group discourse, participants exhibited a speculative mode of thinking about bladder health and function characterized by uncertainty about how the bladder works. They described the bladder as a mechanism for cleansing the body of impurities, viewing it as part of a larger interconnected bodily system to enable the body to stay healthy. They saw it as susceptible to anatomical changes, such as those related to pregnancy and aging. The women also postulated perceived relationships between bladder function and several health behaviors, including eating healthy foods, staying hydrated, engaging in physical activity and exercise, and adopting specific toileting and hygiene practices.The findings underscore the importance of guidance from healthcare professionals and systematic community based educational programs for promoting women's understanding about bladder health and empowering them to exert agency to engage in healthy bladder behaviors.

Background: Toileting behaviors are increasingly recognized as factors potentially contributing to development of lower urinary tract symptoms (LUTS). Objectives: To examine adult women's toileting behaviors and LUTS across age and race/ethnicity groups and relationships between toileting behaviors and LUTS. Design: Planned secondary analysis of questionnaire data collected in a focus group study on bladder health. Settings: Questionnaires were completed at the conclusion of focus groups conducted in community settings affiliated with seven research centers across the United States. Participants: Community-living women regardless of LUTS status. Methods: Forty-four focus groups were conducted with 360 adolescent and adult cisgender women. After each focus group, participants completed questionnaires to assess toileting behaviors (Toileting Behaviors-Women's Elimination Behaviors Scale (TB-WEB)) and their experience of LUTS (Lower Urinary Tract Symptom Tool), This analysis includes quantitative data from the subgroup of 316 participants who completed the questionnaires. Results: Participants ranged in age from 18 to 93 years (Mean= 50.2 years). A significant effect for age was found for delayed voiding behavior, reported by 76.5% of women ages 18–25 years and 21.9% of those 75+ years (p

Author(s): Schmitz, Kathryn H; Bavendam, Tamara; Brady, Sonya S; Brubaker, Linda; Burgio, Kathryn; Harlow, Bernard L; James, Aimee; Lukacz, Emily S; Miller, Janis M; Newman, Diane K; Palmer, Mary H; Rudser, Kyle; Sutcliffe, Siobhan; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium | Abstract: AimsPrior research on lower urinary tract symptoms (LUTS) has focused on the treatment and management of these conditions with scant attention to prevention. The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium was formed to address the complexities of preventing LUTS and promoting bladder health.MethodsHerein, we describe challenges faced and strategies used to develop the PLUS Research Consortium into an engaged and productive transdisciplinary scientific team. We apply four previously defined team science phases (development, conceptualization, implementation, and translation) to frame our progress.ResultsStrategies to progress through the development phase included the generation of a shared mission, and valuing of other disciplinary perspectives. The conceptualization phase included generating a shared language and developing a team transdisciplinary orientation. During the implementation phase, the group developed roles and procedures and focused on conflict management. The translation phase includes continued refinement of the mission and goals, implementation of research protocols, and robust dissemination of the scientific work products related to bladder health.ConclusionA diverse group has matured into a productive transdisciplinary team science consortium. Achieving this outcome required dedicated effort for each member to engage in activities that often required more time than single discipline research activities. Provision of the necessary time and tools has fostered a transdisciplinary team science culture and rich research agenda that reflects the complexity of the health issue to be addressed. Our experience may be useful for others embarking on team science projects.

AIMS: While behavioral-based pelvic floor muscle exercise therapy is an effective treatment for overactive bladder in Parkinson disease (PD) patients, cognitive function may be a predictor of rehabilitation outcomes. METHODS: In a planned exploratory analysis, participants who had a Montreal Cognitive Assessment (MoCA) with a score ≥18 who were randomized in a clinical trial to behavioral treatment were classified by perceived improvement (Benefit vs. No Benefit) as reported on a validated Satisfaction and Benefit Questionnaire. General cognition (MoCA), motor procedural learning (Serial Reaction Time Task), verbal memory (Buschke Delayed Recall), spatial memory (Nonverbal/Spatial Selective Reminding Test), and working memory (Wisconsin Card Sorting Task) were compared between the two groups using Wilcoxon Rank Sum Test. RESULTS: Of the 26 participants randomized to behavioral treatment (70% male, mean age 71 ± 6.1 years), 22 participants (85%) reported Benefit and 4 reported No Benefit. General cognition, motor procedural learning, verbal memory, spatial memory, and working memory did not differ between these groups. While the difference between the time to complete the final practiced series and the random series of the Serial Reaction Time Task (SRTT) was statistically similar between the groups, the Benefit group performed the random sequence more quickly (567.0 ± 136.5 msec) compared to the No Benefit group (959.4 ± 443.0 msec (p=0.03)) and trended toward faster performance in the final practiced series. CONCLUSIONS: Perceived benefit from behavioral treatment for overactive bladder was not associated with measures of baseline cognition other than faster completion of the SRTT. This is noteworthy because many behavioral-based therapy studies exclude participants with mild cognitive impairment. Additional studies may evaluate if domain-specific cognitive function, particularly assessment of implicit memory, could lead to individualized behavioral therapy recommendations.

Nocturia and chronic insomnia disorder are common conditions that frequently coexist in older adults. Existing medication treatments for each condition have risks, particularly in older adults. While treatment guidelines recommend starting with behavioural therapy for each condition, no existing program simultaneously addresses nocturia and insomnia. Existing behavioural interventions for nocturia or insomnia contain concordant and discordant components. An expert panel (including geriatricians with sleep or nocturia research expertise, sleep psychologists and a behavioural psychologist) was convened to combine and reconcile elements of behavioural treatment for each condition. Concordant treatment recommendations involve using situational self-management strategies such as urge suppression or techniques to influence homeostatic drive for sleep. Fluid modification such as avoiding alcohol and evening caffeine and regular self-monitoring through a daily diary is also appropriate for both conditions. The expert panel resolved discordant recommendations by eliminating overnight completion of voiding diaries (which can interfere with sleep) and discouraging routine overnight voiding (a stimulus control strategy). The final product is an integrated cognitive behavioural treatment that is delivered by advanced practice providers weekly over 5 weeks. This integrated program addresses the common scenario of coexisting nocturia and chronic insomnia disorder.

Aim To develop and pilot test an interactive mobile telehealth program (mHealth) for behavioral treatment of women veterans with urinary incontinence (UI). Methods We developed an evidence-based 8-week behavioral mHealth program, MyHealtheBladder, with input from women veterans, behavioral medicine and health education experts, and clinical providers treating UI in the VA system. The program was story-based and included pelvic floor muscle exercises, bladder control strategies, fluid management, risk factor reduction, and self-monitoring. Participants were women veterans seeking outpatient treatment for UI occurring at least twice weekly. The primary efficacy estimate was the change in UI frequency, volume and impact on the quality of life as measured by the validated International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; range: 0-21, 2.5 points for minimal clinically important difference [MCID]). Results We enrolled 29 women veterans (ages 29-77 years; mean = 54.4 ± 10.4), including 15 (52%) African-American women, 13 (45%) women with high school education, and 16 (55%) with a college degree. Twenty of 29 women (69%) completed all 8 weeks of the intervention with a 97% adherence rate to the daily sessions among completers. We found reductions in ICIQ-SF scores from a mean 12.6 ± 3.9 at baseline to 10.4 ± 4.11 at 5 weeks, to 8.7 ± 4.0 at the end of the 8-week intervention. Conclusions Women veterans using an 8-week behavioral mHealth program for the treatment of UI had symptom improvements that exceeded the MCID for the ICIQ-SF. Our next step involves comparing the effectiveness of MyHealtheBladder to usual care in a larger clinical trial.

Aim Determine the efficacy of behavioral therapy for urinary symptoms in Parkinson's disease. Methods Randomized trial of behavioral therapy compared with control condition among adults (aged 54-85 years, 74% male, 10% Black/ 83% White) with Parkinson's and greater than or equal to 4 incontinence episodes weekly. Behavioral therapy included pelvic floor muscle exercises, bladder training, fluid and constipation management. Both groups completed bladder diary self-monitoring. Outcomes included diary-derived incontinence and ICIQ-overactive bladder (OAB) score (range, 0-16) with bother and quality of life questionnaires (higher scores = worse outcomes). Results Fifty-three participants randomized and 47 reported 8-week outcomes including 26 behavioral therapy and 21 control. Behavioral vs control participants were similar with respect to age (71.0 ± 6.1 vs 69.7 ± 8.2 years), sex (70% vs 78% male), motor score, cognition, mean weekly incontinence episodes (13.9 ± 9.6 vs 15.1 ± 11.1) and OAB symptoms (8.9 ± 2.4 vs 8.3 ± 2.2). Weekly incontinence reduction was similar between behavioral (-6.2 ± 8.7) and control participants (-6.5 ± 13.8) (P = 0.89). After multiple imputation analysis, behavioral therapy participants reported statistically similar reduction in OAB symptoms compared to control (-3.1 ± 2.8 vs -1.9 ± 2.2, P = 0.19); however quality of life (-22.6 ± 19.1 vs -7.0 ± 18.4, P = 0.048) and bother (-12.6 ± 17.2 vs - 6.7 ± 8.8, P = 0.037) improved significantly more with behavioral therapy. Conclusion Self-monitoring resulted in fewer urinary symptoms; however, only multicomponent behavioral therapy was associated with reduced bother and improved quality of life. Providers should consider behavioral therapy as initial treatment for urinary symptoms in Parkinson's disease.

This secondary analysis studied 50 transcripts of women who shared day-to-day experiences of lower urinary tract symptoms (LUTS) and characterized temporal (time-associated) features of living with LUTS. Findings revealed two overarching time-associated themes: The Complexity of LUTS and The Quest for Empowerment over LUTS. Findings suggest that the temporal burden of LUTS is the accumulated impact of symptoms and symptom management on women's daily lives within multiple contexts across the life course. Increasing nurses' knowledge of the temporal context of LUTS may heighten awareness and improve symptom detection and management.

CONTEXT: Research priority guidelines highlight the need for examining the “dose” components of palliative care (PC) interventions, such as intervention adherence and completion rates, that contribute to optimal outcomes. OBJECTIVES: Examine the “dose” effect of PC intervention completion vs. non-completion on quality of life (QoL) and healthcare use in patients with advanced heart failure (HF) over 32 weeks. METHODS: Secondary analysis of the ENABLE CHF-PC intervention trial for patients with New York Heart Association (NYHA) Class III/IV HF. ‘Completers’ defined as completing a single, in-person outpatient palliative care consultation (OPCC) plus six weekly, PC nurse coach-led telehealth sessions. ‘Non-completers’ were defined as either not attending the OPCC or completing < 6 telehealth sessions. Outcome variables were QoL and healthcare resource use (hospital days; emergency department visits). Mixed models were used to model dose effects for ‘completers’ vs ‘non-completers’ over 32 weeks. RESULTS: Of 208 intervention group participants, 81 (38.9%) were classified as ‘completers’ with a mean age of 64.6 years; 72.8% were urban-dwelling; 92.5% had NYHA Class III HF. ‘Completers’ vs. ‘non-completers’ groups were well-balanced at baseline; however ‘non-completers’ did report higher anxiety (6.0 vs 7.0, p

PURPOSE: The goal of this study was to determine if the US adult population with nocturia (waking from sleep at night to void) can easily take medications (desmopressin acetate) approved by the US Food and Drug Administration for nocturia. The study examined: (1) the prevalence of comorbid conditions, laboratory abnormalities, and concomitant medications that increase risk of desmopressin use; and (2) whether these factors are associated with age or nocturia frequency. METHODS: Using a cross-sectional analysis of four US National Health and Nutrition Examination Survey (NHANES) waves (2005–2012), a total of 4111 participants aged ≥50 years who reported ≥2 nightly episodes of nocturia were identified. The main outcome was frequency of contraindications and drug interactions as described in US Food and Drug Administration–approved prescribing information. These prescribing concerns were matched to examination findings, medical conditions, concomitant medications, and laboratory results of NHANES participants. The associations between prescribing concerns and nocturia severity and age groups were examined. FINDINGS: The mean participant age was 65.7 years (95% CI, 65.3–66.1), and 45.5% were male. Desmopressin prescribing concerns were present in 80.5% (95% CI, 78.0–82.9) of those ≥50 years of age with nocturia; 50.0% (95% CI, 47.0–53.0) had contraindications, and 41.6% (95% CI, 39.3–44.0) took a concomitant drug that could increase risk of low serum sodium. Desmopressin contraindications were higher with older age (P < 0.001) and present in 73.2% (95% CI, 69.3–77.1) of those ≥80 years of age. IMPLICATIONS: Using NHANES data, this study showed that older US adults with nocturia have a high prevalence of medical conditions, concomitant medications, and baseline laboratory abnormalities that likely increase the risk of potentially severe adverse side effects from desmopressin use. A medication designed and approved for a clinical symptom that is most common in older adults could not be taken by most of the older adults with the symptom.

Summary Background Lower urinary tract symptoms (LUTS) are common in children and adolescents. Non-invasive tests evaluating bladder function are generally preferred over invasive tests, yet few studies have explored the range of normative values for these tests in healthy, asymptomatic children. Objective To define normative reference ranges for non-invasive tests of bladder function in healthy, asymptomatic girls and adolescents. Study design A comprehensive search strategy was performed in seven electronic databases through October 2019. English-language studies reporting data on voiding frequency, voided and postvoid residual volumes (PVR) and uroflowmetry results in healthy, asymptomatic girls (mean age ≥ 5 years) were included. Two independent reviewers performed study review, data extraction, and quality assessment. Overall mean estimates and 95% confidence intervals for each bladder function parameter were calculated using random effects models, and 95% normative reference values were estimated. Results Ten studies met eligibility criteria for the meta-analysis (n = 2143 girls, age range: 3–18). Mean estimates of maximum voided volume and PVR were 233.4 ml (95% CI 204.3–262.6; n = 1 study) and 8.6 ml (95% CI 4.8–12.4; n = 2 studies) respectively. Pooled mean estimates for uroflowmetry parameters were: 21.5 ml/s (95% CI 20.5–2.5) for maximum flow rate (n = 6 studies), 12.5 ml/s (95% CI 11.2–13.8) for mean flow rate (n = 6 studies), 6.8 s (95% CI 4.4–9.3) for time to maximum flow (n = 3 studies), 15.7 s (95% CI 13.0–18.5) for flow time (n = 3 studies), and 198.7 ml (95% CI 154.2–234.2) for voided volume (n = 9 studies). No studies reported estimates of voiding frequency. Between-study heterogeneity was high (89.0–99.6%). Conclusions Although we were able to calculate pooled mean estimates for several parameters, the small number of included studies and the wide age ranges of participants preclude generalization of reference values to all healthy girls. Further research is needed to determine normative reference values within specific age groups.

Importance National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations. Objective To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure. Design, Setting, and Participants A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals. Interventions The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks. Main Outcomes and Measures Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered “fairly good” quality of life; and the Functional Assessment of Chronic Illness Therapy–Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits). Results Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7;d = 0.07 [95% CI, −0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8;d = 0.12 [95% CI, −0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety,d = −0.02 [95% CI, –0.20 to 0.16]; HADS-depression,d = –0.09 [95% CI, –0.24 to 0.06]). Conclusions and Relevance This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement. Trial Registration ClinicalTrials.gov Identifier:NCT02505425

IMPORTANCE: First-line behavioral and drug therapies for overactive bladder (OAB) symptoms in men are effective but not usually curative. OBJECTIVE: To determine whether combining behavioral and drug therapies improves outcomes compared with each therapy alone for OAB in men and to compare 3 sequences for implementing combined therapy. DESIGN, SETTING, AND PARTICIPANTS: In this 3-site, 2-stage, 3-arm randomized clinical trial, participants were randomized to 6 weeks of behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy for all groups. Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours. Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019. INTERVENTIONS: Behavioral therapy consisted of pelvic floor muscle training with urge suppression strategies and delayed voiding. Drug therapy included an antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg). MAIN OUTCOMES AND MEASURES: Seven-day bladder diaries completed before and after each 6-week treatment stage were used to calculate reduction in frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia). Other secondary outcomes included validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score. RESULTS: Of the 204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years. A total of 21 men discontinued treatment and 183 completed treatment. Mean (SD) voids per 24 hours decreased significantly in all 3 groups from baseline to 6-week follow-up (behavioral therapy: 11.7 [2.4] vs 8.8 [2.1]; change, 2.9 [2.4]; percentage change, 24.7%; P

A growing body of research has examined modalities for delivering palliative care education; however, we know little about education and training preferences of VA interdisciplinary Palliative Care Consult Teams (PCCT). In the BEACON II study, we explored training preferences of PCCTs from 46 Veterans Affairs Medical Centers (VAMCs) participating in either a multisite webinar or a small group, in-person workshop. We interviewed participants by telephone seven to eight month post-training. In all, 75.9% preferred in-person education and training, including 78.9% of workshop participants and 73.1% of webinar participants. Respondents described in-person training as fostering learning through the following processes: (1) active engagement and focus, (2) interaction and networking, (3) meaning-making and relevance, and (4) reciprocity and commitment. Although it is not possible for Web-based palliative care education programs to replicate all aspects of the in-person learning experience, building experiential, interactive, meaningful, and reciprocal components into Web-based education may help shift preferences and make interdisciplinary team-based palliative care education accessible to a larger audience.

OBJECTIVES To estimate the efficacy of vitamin D supplementation to reduce urgency urinary incontinence (UUI) episodes. DESIGN Pilot, two-arm, randomized trial conducted from 2013 to 2017. Interventions were 12 weeks of weekly oral 50,000 IU vitamin D3 or placebo. SETTING Academic, university-based outpatient clinic. PARTICIPANTS Community-dwelling postmenopausal women, 50 years or older, with at least three UUI episodes on 7-day bladder diary and serum vitamin 25-hydroxyvitamin D (25[OH]D) of 30 ng/mL or less. MEASUREMENTS The primary efficacy estimate was the percentage change in UUI episodes. Secondary estimates included changes in other lower urinary tract symptoms, along with exploratory subgroup analysis by race/ethnicity and obesity. RESULTS We randomized 56 women (aged 50-84 years; mean = 60.5 ± 8.2 years), 28 to vitamin D and 28 to placebo; 51 completed treatments. Mean serum 25(OH)D at baseline (21.2 ± 5.2 and 18.2 ± 5.6, P = .30) improved to 57.9 ± 16.3 ng/mL with vitamin D3 and 21.9 ± 8.2 ng/mL with placebo (P < .001). UUI episodes per 24-hour day decreased by 43.0% with vitamin D3 compared to 27.6% with placebo (P = .22). Among black women (n = 33), UUI episodes decreased by 63.2% with vitamin D3 compared to 22.9% with placebo (P = .03). Among obese women, UUI episodes decreased by 54.1% with vitamin D compared to 32.7% with placebo (P = .29). For all women, changes in voiding frequency (P = .40), nocturia (P = .40), urgency (P = .90), incontinence severity (P = .81), and overactive bladder symptom severity (P = .47) were not different between arms. CONCLUSIONS Postmenopausal women with UUI and vitamin D insufficiency demonstrated a greater than 40% decrease in UUI episodes, which did not reach statistical significance compared to placebo, except in the subset of black women. The results of this pilot study support further investigation of vitamin D3 alone or in combination with other treatments for UUI, particularly for women in higher-risk subgroups. J Am Geriatr Soc 67:570-575, 2019.

The objective of this study was to examine the influence of diabetes-related support in promoting aerobic activity in a sample of older African Americans. A secondary data analysis was conducted based on a diabetes self-management study of community-dwelling older African Americans. Logistic regression was conducted to examine the influence of diabetes-related support on aerobic activity. The final model demonstrated that there was a strong relationship between having diabetes-related support and aerobic activity, odds ratio =6.56, 95% confidence interval [2.14, 20.11]. The final model also demonstrated a significant influence based on the total number of chronic health conditions on aerobic activity, odds ratio = 0.63, 95% confidence interval [0.498, 0.802]. Findings suggest that older African Americans with Type 2 diabetes and other chronic health conditions may engage in physical activity if they have diabetes-related support from their family and friends.

Background Palliative care is specialized medical care for people with serious illness that is focused on providing relief from symptoms and stress and improving the quality of life (QOL) for patients and their families. To help the 6.5 million U.S. adults and families affected by heart failure manage the high symptom burden, complex decision-making, and risk of exacerbation and death, the early integration of palliative care is critical and has been recommended by numerous professional organizations. However, few trials have tested early outpatient community-based models of palliative care for patients diagnosed with advanced heart failure and their caregivers. To address this gap, through a series of formative evaluation trials, we translated an oncology early palliative care telehealth intervention for heart failure to create ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends, Comprehensive Heartcare for Patients and Caregivers). Methods/Design The primary objective of this multisite pragmatic randomized controlled trial is to test the efficacy of ENABLE CHF-PC plus usual heart failure care compared to usual care alone. Community-dwelling persons who are ≥50 years of age with New York Heart Association class III/IV or American Heart Association/American College of Cardiology stage C/D heart failure and their primary caregiver (if present) are being randomized to one of two study arms. The ENABLE CHF-PC intervention group receives usual heart failure care plus an in-person palliative care assessment by a board-certified palliative care provider (caregivers are invited to attend), a series of nurse coach-led, weekly psychoeducational 20 to 60 min phone sessions using a guidebook called Charting Your Course (patients: 6 sessions and caregivers: 4 sessions), and monthly check-in calls. Charting Your Course topical content includes problem-solving, coping, self-care and symptom management, communication, decision-making, advance care planning, and life review (patients only). Primary outcomes include patient QOL and mood (depressive symptoms/anxiety) and caregiver QOL, mood, and burden at 8 and 16 weeks after baseline. Outcomes will be examined using an intention-to-treat approach and mixed effects modeling for repeated measures. Discussion This trial will determine whether the ENABLE CHF-PC model of concurrent heart failure palliative care is superior to usual heart failure care alone in achieving higher patient and caregiver QOL, improving mood, and lowering burden. Trial registration ClinicalTrials.gov, NCT02505425. Registered on 22 July 2015. Electronic supplementary material The online version of this article (10.1186/s13063-018-2770-9) contains supplementary material, which is available to authorized users.

Adults who complete an advance directive (AD) are not consistently offered information about the risks, benefits, or alternatives (RBA) of the life-sustaining medical procedures addressed on standardized forms. The current article describes a new patient-centered nurse-supported advance care planning (NSACP) intervention focused on providing information about RBA of life-sustaining procedures. Fifty participants (mean age = 50.26 years) at a Veterans Affairs medical center were randomized to the NSACP intervention or a comparison condition. Before randomization, 78% ( n = 39) expressed interest in RBA information. Of participants in the NSACP group, 94% ( n = 30) completed an AD. Participants who received NSACP made more decisions to decline life-sustaining treatment than those who were randomized to the comparison group. Promising feasibility data include brevity (mean = 46 minutes), high patient satisfaction, participant retention, and treatment fidelity. The NSACP holds promise as a brief, educational intervention to support patients in completing an AD. [ Journal of Gerontological Nursing, 44 (7), 31–42.]

Objective To identify patterns of prevalent chronic medical conditions among women with urinary incontinence (UI). Materials and methods We combined cross-sectional data from the 2005-2006 to 2011-2012 US National Health and Nutrition Examination Surveys, and identified 3 800 women with UI and data on 12 chronic conditions. Types of UI included stress UI (SUI), urgency UI (UUI), and mixed stress and urgency UI (MUI). We categorized UI as mild, moderate or severe using validated measures. We performed a two-step cluster analysis to identify patterns between clusters for UI type and severity. We explored associations between clusters by UI subtype and severity, controlling for age, education, race/ethnicity, parity, hysterectomy status and adiposity in weighted regression analyses. Results Eleven percent of women with UI had no chronic conditions. Among women with UI who had at least one additional condition, four distinct clusters were identified: (i) cardiovascular disease (CVD) risk-younger; (ii) asthma-predominant; (iii) CVD risk-older; and (iv) multiple chronic conditions (MCC). In comparison to women with UI and no chronic diseases, women in the CVD risk-younger (age 46.7 ± 15.8 years) cluster reported the highest rate of SUI and mild UI severity. In the asthma-predominant cluster (age 51.5 ± 10.2 years), women had more SUI and MUI and more moderate UI severity. Women in the CVD risk-older cluster (age 57.9 ± 13.4 years) had the highest rate of UUI, along with more severe UI. Women in the MCC cluster (age 61.0 ± 14.8 years) had the highest rates of MUI and the highest rate of moderate/severe UI. Conclusions Women with UI rarely have no additional chronic conditions. Four patterns of chronic conditions emerged with differences by UI type and severity. Identification of women with mild UI and modifiable conditions may inform future prevention efforts.

The American Geriatrics Society (AGS), with support from the National Institute on Aging (NIA) and other funders, held its ninth Bedside-to-Bench research conference, entitled “Urinary Incontinence in the Older Adult: A Translational Research Agenda for a Complex Geriatric Syndrome,” October 16 to 18, 2016, in Bethesda, Maryland. As part of a conference series addressing three common geriatric syndromes—delirium, sleep and circadian rhythm (SCR) disturbance, and urinary incontinence—the series highlighted relationships and pertinent clinical and pathophysiological commonalities between these conditions. The conference provided a forum for discussing current epidemiology, basic science, clinical, and translational research on urinary incontinence in older adults; for identifying gaps in knowledge; and for the development of a research agenda to inform future investigative efforts. The conference also promoted networking involving emerging researchers and thought leaders in the field of incontinence, aging and other fields of research, as well as National Institutes of Health program personnel.

Nocturia, waking from sleep at night to void, is a common, bothersome symptom for which many older adults seek treatment. In 2017, the US FDA approved the first of two desmopressin analogues indicated for nocturia. While efficacious, these drugs can potentially cause severe hyponatremia that can be fatal, particularly if older adults have comorbid conditions (e.g., congestive heart failure, uncontrolled hypertension), laboratory abnormalities (e.g., low sodium, reduced renal function) and concomitant medications (e.g., diuretics, analgesics). Using secondary data from the National Health and Nutrition Examination Survey (NHANES) to identify a sample of U.S. adults 50 years and older with 2 or more nightly nocturia episodes, we determined the prevalence of contraindications, warnings, and need for more frequent monitoring indicated by the product label. Among the sample of 1,521 older respondents, 70.0% of those with nocturia had contraindications or a need for frequent sodium monitoring. Contraindications to desmopressin analogues were more prevalent with older age (27.6%, 34.5%, and 38.8%, for ages 50-64, 65-79, and 80+, respectively, p

BACKGROUND: Post-traumatic stress disorder (PTSD) can be exacerbated by subsequent trauma, but it is unclear if symptoms are worsened by impending death. PTSD symptoms, including hyperarousal, negative mood and thoughts, and traumatic re-experiencing, can impact end-of-life symptoms, including pain, mood, and poor sleep. Thus, increased symptoms may lead to increased end-of-life healthcare utilization. OBJECTIVES: To determine if veterans with PTSD have increased end-of-life healthcare utilization or medication use and to examine predictors of medication administration. DESIGN: Secondary analysis of a stepped-wedge design implementation trial to improve end-of-life care for Veterans Affairs (VA) inpatients. Outcome variables were collected via direct chart review. Analyses included hierarchical, generalized estimating equation models, clustered by medical center. SUBJECTS: Veterans, inpatient at one of six VA facilities, dying between 2005 and 2011. MAIN MEASURES: Emergency room (ER) visits, hospitalizations, and medication administration in the last 7 days of life. KEY RESULTS: Of 5341 veterans, 468 (8.76%) had PTSD. Of those, 21.4% (100/468) had major depression and 36.5% (171/468) had anxiety. Veterans with PTSD were younger (mean age 65.4 PTSD, 70.5 no PTSD, p < 0.0001) and had more VA hospitalizations and ER visits in the last 12 months of life (admissions: PTSD 2.8, no PTSD 2.4, p < 0.0001; ER visits: 3.2 vs 2.5, p < 0.0001). PTSD was associated with antipsychotic administration (OR 1.52, 95% CI 1.06–2.18). Major depression (333/5341, 6.2%) was associated with opioid administration (OR 1.348, 95% CI 1.129–1.609) and benzodiazepines (OR 1.489, 95% CI 1.141–1.943). Anxiety disorders (778/5341, 14.6%) were only associated with benzodiazepines (OR 1.598, 95% CI 1.194–2.138). CONCLUSIONS: PTSD’s association with increased end-of-life healthcare utilization and increased antipsychotic administration in the final days of life suggests increased symptom burden and potential for terminal delirium in individuals with PTSD. Understanding the burden of psychiatric illness and potential risks for delirium may facilitate the end-of-life care for these patients. TRIAL REGISTRATION: NCT00234286 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-019-05538-x) contains supplementary material, which is available to authorized users.

Health researchers are increasingly turning to qualitative research for a nuanced understanding of complex health phenomena. The quality and rigor of qualitative research relies on individual data collector skills, yet few guidelines exist for training multidisciplinary, multi-institution qualitative research teams. Specific guidance is needed on qualitative research practices that ensure scientific rigor by optimizing diverse experience and expertise across research centers. We describe our systematic approach to training a cohort of 15 focus group moderators from seven universities in the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium’s Study of Habits, Attitudes, Realities, and Experiences (SHARE). SHARE’s aim was to explore women and girls’ experiences, perceptions, beliefs, knowledge, and behaviors related to bladder health and function across the life course. Drawing on adult education and action-learning best practices, a three-phase curriculum was designed to maximize moderator proficiency and qualitative research expertise. The phases involved online, interactive web-based education, in-person didactic training with experiential components, and tailored supplemental online training. Evaluative feedback was collected before, during, and after the training. Feedback was used to identify emergent training needs. This training approach may be used by transdisciplinary research teams conducting multisite research to assure qualitative research credibility and trustworthiness.

Aims This analysis explored and characterized adolescent and adult women's lay language and discourse related to bladder health/function. Methods Forty-four focus groups were conducted across seven United States research centers with 360 adolescents and adult women, organized by six age categories. Multilevel content analyses classified emergent themes. A transdisciplinary lens and inductive approach guided data interpretation. Interpretive insights were validated by a community engagement panel. Results A repertoire of bladder function terms emerged, including explicit functional terms, formal and polite euphemistic terms, and informal familiar terms, as well as cultural and regional metaphors and idioms. Terminology usage was historically grounded, developmental, and cumulative across the life course. Lay discourse was contextual and affectively valent, suggesting unspoken, commonly understood, situation-based "rules" for talking about bladder function. Discourse appeared to be siloed within family and friendship circles. Adolescents and adult women often described, rather than named, bladder sensations or problems. Terminology for bladder issues tended to minimize severity and frequency, with medical language only relevant to extreme examples and not applicable to mild episodes. Conclusions A definitional discordance between medical and lay views of bladder problems was identified, signifying a need to clarify the meaning of medical terms for lay persons. Adolescents and adult women do not have or use standardized precise terminology for bladder health and function, relying instead on social convention and interpersonal context. Findings can be used to foster shared understandings between lay persons and health professionals, informing development of clinical, research, and public health initiatives to promote bladder health.

Aim The study purpose is to explore adolescent and adult women's experiences, perceptions, beliefs, knowledge and behaviors related to bladder health across the life course using a socioecological perspective. Lower urinary tract symptoms affect between 20-40% of young adult to middle-aged women, with symptoms increasing in incidence and severity with aging. There is limited evidence to address bladder health promotion and prevention of dysfunction. This first study of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium is designed to address gaps in existing qualitative research in this area. Design This focus group study will be implemented across seven geographically diverse United States research centers using a semi-structured focus group guide informed by a conceptual framework based on the socioecological model. Methods The study was approved in July 2017. A total of 44 focus groups composed of 6-8 participants representing six different age categories (ranging from 11 to over 65 years) will be completed. We aim to recruit participants with diverse demographic and personal characteristics including race, ethnicity, education, socioeconomic status, urban/rural residence, physical/health conditions and urinary symptom experience. Up to 10 of these focus groups will be conducted in Spanish. Focus group transcripts will undergo content analysis and data interpretation to identify and classify themes and articulate emerging themes. Discussion This foundational qualitative study seeks to develop an evidence base to inform future research on bladder health promotion in adolescent and adult women. Impact This study has the potential to provide new insights and understanding into adolescent and adult women's lived experience of bladder health, the experience of lower urinary symptoms and knowledge and beliefs across the life course. This article is protected by copyright. All rights reserved.

OBJECTIVES The aims of this study were to compare 12-week outcomes of single-therapy tolterodine (Detrol LA) extended release to intravaginal estrogen (Estrace) for overactive bladder (OAB) symptoms and characterize 24- and 52-week outcomes in women undergoing combined therapy. METHODS A single-site randomized, open-label trial in women with urinary frequency, urgency, nocturia, and/or urgency urinary incontinence symptoms was performed. Fifty-eight participants were randomized to oral tolterodine extended release daily or intravaginal estradiol cream nightly for 6 weeks then twice per week. The primary outcome was change in Overactive Bladder Questionnaire (OAB-q) symptom bother score at 12 weeks. Secondary outcomes included the Health-Related Quality of Life Questionnaire (HRQL) of the OAB-q and a 3-day bladder diary. At 12 weeks, subjects were offered addition of the alternative therapy with follow-up at 24 and 52 weeks. RESULTS There was no difference in symptom bother score improvement between the tolterodine and intravaginal estradiol groups baseline to 12 weeks (20.6 ± 21.7, -15.8 ± 23.3, respectively, P = 0.45). There was a significant within-group decrease in symptom bother score from baseline to 12 weeks (tolterodine, P < 0.0001, and intravaginal estradiol, P = 0.002). Secondary outcome improvement within groups was noted in the HRQL total, urinary incontinence episodes, and median voiding frequency (all P ≤ 0.03) in the tolterodine group and in the HRQL total score (P = 0.03) in the intravaginal estradiol group, with no differences between groups. Combined therapy outcomes at 24 and 52 weeks compared with single therapy at 12 weeks revealed significant improvement in symptom bother score in the intravaginal estradiol + tolterodine group at 24 and 52 weeks (20.0 ± 23.9, P = 0.008; -16.7 ± 23.3, P = 0.02, respectively). CONCLUSIONS Significant within-group improvement in OAB-q symptom bother was noted in both the intravaginal estradiol and tolterodine groups for OAB symptoms, with no difference between groups. Greater improvement from 12-week single therapy to 24 and 52 weeks of combined therapy was noted in the group originally assigned to intravaginal estradiol. The role of combined medical therapy for OAB symptoms needs further investigation.

The objective of this study was to develop and validate a new diabetes self-management instrument for older African-Americans 65 years of age and older. The Self-Care Utility Geriatric African-American Rating (SUGAAR) was developed using the American Diabetes Association’s standards for the management of type 2 diabetes in older adults and cognitive interviews with older African-Americans. The instrument underwent extensive review by a panel of experts, two rounds of cognitive interviews, and a pilot test before it was administered in an interview format to 125 community-dwelling older African-Americans. The instrument demonstrated content validity and significant, but modest, convergent validity with items from an established diabetes self-management instrument. Social workers and health care professionals can use the SUGARR to assess diabetes self-management and to identify areas for education and support for older African-Americans with type 2 diabetes.

This study's main objective was to examine care transition experiences of older veterans and their caregivers. Fifty patients age 65 years and older, discharged from a Veterans Affairs Medical Center hospital, completed the Care Transitions Measure-15 survey three to four weeks postdischarge. Seven patients and six caregivers participated in semistructured interviews. Overall, the quality of care transitions was rated as good; however, some items were indicated as problematic for veterans. Themes that emerged included agreeableness, frustration with complex information, caregiver education, and the timing and methods of information delivery. These findings have implications for all clinical staff working with veterans, and particularly for social workers facilitating care transitions for veterans and their caregivers.

Objectives The objective of this study was to characterize symptom prevalence, awareness of pelvic floor disorders (PFDs) in family/friends, and understanding of factors contributing to the development of PFDs in women aged 19 to 30 years. Methods This study is a cross-sectional study via online questionnaire survey of female students aged 19 to 30 years enrolled at the University of Alabama at Birmingham. Results of "adolescent women" aged 19 to 24 years were compared with "young women" aged 25 to 30 years. Results A total of 1092 questionnaires were completed with the mean age being 23.5 ± 3.1 years. The overall rate of urinary incontinence (UI) was 10.3% without a difference between adolescent and young women (P = 0.61). There were no differences in rates of urgency UI (P = 0.061), stress UI (P = 0.29), or pelvic organ prolapse (POP) symptoms (P = 0.56) between groups. There was no difference between groups in awareness of family members with UI, fecal incontinence (FI), or POP symptoms (P ≥ 0.24). However, logistic regression showed that the young women were more likely to have received education regarding UI (adjusted odds ratio [aOR], 2.6; 95% confidence interval [CI], 1.8-3.6), FI (aOR, 3.3; 95% CI, 2.2-4.8), POP (aOR, 2.9; 95% CI, 2.1-4.2), and have greater understanding regarding causes of UI (aOR, 2.9; 95% CI, 1.7-4.8), FI (aOR, 1.6; 95% CI, 1.1-2.3), and POP (aOR, 1.9; 95% CI, 1.3-2.9). Conclusions Women aged 25 to 30 years had more awareness and understanding of PFDs compared with adolescent women. These data may have implications for primary prevention strategies of PFDs.

Importance Family caregivers of persons with advanced heart failure perform numerous daily tasks to assist their relatives and are at high risk for distress and poor quality of life. Objective To determine the effect of a nurse-led palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends Comprehensive Heart Failure for Patients and Caregivers [ENABLE CHF-PC]) on quality of life and mood of family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks. Design, Setting, and Participants This single-blind randomized clinical trial enrolled caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care. Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018. Intervention Four weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks. The usual care group received no additional intervention. Main Outcomes and Measures The primary outcomes were quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales) over 16 weeks. Secondary outcomes were global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving. Results A total of 158 family caregivers were randomized, 82 to the intervention and 76 to usual care. The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient’s spouse or partner. At week 16, the mean (SE) Bakas Caregiver Outcomes Scale score was 66.9 (2.1) in the intervention group and 63.9 (1.7) in the usual care group; over 16 weeks, the mean (SE) Bakas Caregiver Outcomes Scale score improved 0.7 (1.7) points in the intervention group and 1.1 (1.6) points in the usual care group (difference, −0.4; 95% CI, −5.1 to 4.3; Cohend = −0.03). At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, −0.1 [0.5];d = −0.02) or depression measure (mean [SE] improvement from baseline, −0.2 [0.4] vs −0.3 [0.3]; difference, 0.1 [0.5];d = 0.03). No between-group differences were observed in the Montgomery-Borgatta Caregiver Burden scales (drange, −0.18 to 0.0). Differences in secondary outcomes were also not significant (drange, −0.22 to 0.0). Conclusions and Relevance This 2-site randomized clinical trial of a telehealth intervention for family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks. Future interventions should target distressed caregivers and assess caregiver effects on patient outcomes. Trial Registration ClinicalTrials.gov Identifier:NCT02505425

Importance Urinary incontinence (UI) guidelines recommend behavioral interventions as first-line treatment using individualized approaches. A one-time, group-administered behavioral treatment (GBT) could enhance access to behavioral treatment. Objective To compare the effectiveness, cost, and cost-effectiveness of GBT with no treatment for UI in older women. Design, Setting, and Participants Multisite randomized clinical trial (the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms [GLADIOLUS] study), conducted from July 7, 2014, to December 31, 2016. The setting was outpatient practices at 3 academic medical centers. Community-dwelling women 55 years or older with UI were recruited by mail and screened for eligibility, including a score of 3 or higher on the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF), symptoms of at least 3 months’ duration, and absence of medical conditions or treatments that could affect continence status. Of 2171 mail respondents, 1125 were invited for clinical screening; 463 were eligible and randomized; 398 completed the 12-month study. Interventions The GBT group received a one-time 2-hour bladder health class, supported by written materials and an audio CD. Main Outcomes and Measures Outcomes were measured at in-person visits (at 3 and 12 months) and by mail or telephone (at 6 and 9 months). The primary outcome was the change in the ICIQ-SF score. Secondary outcome measures assessed UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs. Evaluators were masked to group assignment. Results Participants (232 in the GBT group and 231 in the control group) were aged 55 to 91 years (mean [SD] age, 64 [7] years), and 46.2% (214 of 463) were African American. In intent-to-treat analyses, the ICIQ-SF scores for GBT were consistently lower than control across all time points but did not achieve the projected 3-point difference. At 3 months, the difference in differences was 0.96 points (95% CI, −1.51 to −0.41 points), which was statistically significant but clinically modest. The mean (SE) treatment effects at 6, 9, and 12 months were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively. Significant group differences were found at all time points in favor of GBT on all secondary outcomes except pelvic floor muscle strength. The incremental cost to achieve a treatment success was $723 at 3 months; GBT dominated at 12 months. Conclusions and Relevance The GLADIOLUS study shows that a novel one-time GBT program is modestly effective and cost-effective for reducing UI frequency, severity, and bother and improving quality of life. Group-administered behavioral treatment is a promising first-line approach to enhancing access to noninvasive behavioral treatment for older women with UI. Trial Registration ClinicalTrials.gov identifier:NCT02001714