Evaluating feedback reports to support documentation of veterans' care preferences in home based primary care.

BACKGROUND: To evaluate the effectiveness of delivering feedback reports to increase completion of LST notes among VA Home Based Primary Care (HBPC) teams. The Life Sustaining Treatment Decisions Initiative (LSTDI) was implemented throughout the Veterans Health Administration (VHA) in the United States in 2017 to ensure that seriously ill Veterans have care goals and LST decisions elicited and documented. METHODS: We distributed monthly feedback reports summarizing LST template completion rates to 13 HBPC intervention sites between October 2018 and February 2020 as the sole implementation strategy. We used principal component analyses to match intervention to 26 comparison sites and used interrupted time series/segmented regression analyses to evaluate the differences in LST template completion rates between intervention and comparison sites. Data were extracted from national databases for VA HBPC in addition to interviews and surveys in a mixed methods process evaluation. RESULTS: LST template completion rose from 6.3 to 41.9% across both intervention and comparison HBPC teams between March 1, 2018, and February 26, 2020. There were no statistically significant differences for intervention sites that received feedback reports. CONCLUSIONS: Feedback reports did not increase documentation of LST preferences for Veterans at intervention compared with comparison sites. Observed increases in completion rates across intervention and comparison sites can likely be attributed to implementation strategies used nationally as part of the national roll-out of the LSTDI. Our results suggest that feedback reports alone were not an effective implementation strategy to augment national implementation strategies in HBPC teams.

Independent Associations of Aortic Calcification with Cirrhosis and Liver Related Mortality in Veterans with Chronic Liver Disease.

INTRODUCTION: Abdominal aortic calcifications (AAC) are incidentally found on medical imaging and useful cardiovascular burden approximations. The Morphomic Aortic Calcification Score (MAC) leverages automated deep learning methods to quantify and score AACs. While associations of AAC and non-alcoholic fatty liver disease (NAFLD) have been described, relationships of AAC with other liver diseases and clinical outcome are sparse. This study's purpose was to evaluate AAC and liver-related death in a cohort of Veterans with chronic liver disease (CLD). METHODS: We utilized the VISN 10 CLD cohort, a regional cohort of Veterans with the three forms of CLD: NAFLD, hepatitis C (HCV), alcohol-associated (ETOH), seen between 2008 and 2014, with abdominal CT scans (n = 3604). Associations between MAC and cirrhosis development, liver decompensation, liver-related death, and overall death were evaluated with Cox proportional hazard models. RESULTS: The full cohort demonstrated strong associations of MAC and cirrhosis after adjustment: HR 2.13 (95% CI 1.63, 2.78), decompensation HR 2.19 (95% CI 1.60, 3.02), liver-related death HR 2.13 (95% CI 1.46, 3.11), and overall death HR 1.47 (95% CI 1.27, 1.71). These associations seemed to be driven by the non-NAFLD groups for decompensation and liver-related death [HR 2.80 (95% CI 1.52, 5.17; HR 2.34 (95% CI 1.14, 4.83), respectively]. DISCUSSION: MAC was strongly and independently associated with cirrhosis, liver decompensation, liver-related death, and overall death. Surprisingly, stratification results demonstrated comparable or stronger associations among those with non-NAFLD etiology. These findings suggest abdominal aortic calcification may predict liver disease severity and clinical outcomes in patients with CLD.

Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies.

BACKGROUND: Many men with prostate cancer will be exposed to androgen deprivation therapy (ADT). While evidence-based ADT use is common, ADT is also used in cases with no or limited evidence resulting in more harm than benefit, i.e., overuse. Since there are risks of ADT (e.g., diabetes, osteoporosis), it is important to understand the behaviors facilitating overuse to inform de-implementation strategies. For these reasons, we conducted a theory-informed survey study, including a discrete choice experiment (DCE), to better understand ADT overuse and provider preferences for mitigating overuse. METHODS: Our survey used the Action, Actor, Context, Target, Time (AACTT) framework, the Theoretical Domains Framework (TDF), the Capability, Opportunity, Motivation-Behavior (COM-B) Model, and a DCE to elicit provider de-implementation strategy preferences. We surveyed the Society of Government Service Urologists listserv in December 2020. We stratified respondents based on the likelihood of stopping overuse as ADT monotherapy for localized prostate cancer ("yes"/"probably yes," "probably no"/"no"), and characterized corresponding Likert scale responses to seven COM-B statements. We used multivariable regression to identify associations between stopping ADT overuse and COM-B responses. RESULTS: Our survey was completed by 84 respondents (13% response rate), with 27% indicating "probably no"/"no" to stopping ADT overuse. We found differences across respondents who said they would and would not stop ADT overuse in demographics and COM-B statements. Our model identified 2 COM-B domains (Opportunity-Social, Motivation-Reflective) significantly associated with a lower likelihood of stopping ADT overuse. Our DCE demonstrated in-person communication, multidisciplinary review, and medical record documentation may be effective in reducing ADT overuse. CONCLUSIONS: Our study used a behavioral theory-informed survey, including a DCE, to identify behaviors and context underpinning ADT overuse. Specifying behaviors supporting and gathering provider preferences in addressing ADT overuse requires a stepwise, stakeholder-engaged approach to support evidence-based cancer care. From this work, we are pursuing targeted improvement strategies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03579680.

Industry Payments for Vibegron and Prescribing Patterns Among Urologic Clinicians.

This cross-sectional study compares the prescribing practices among urologists and advanced practice clinicians who received vs did not receive payment from drug manufacturers.

Correction: Community-Led, Cross-Sector Partnership of Housing and Health Care to Promote Aging in Place (Unite Health Project): Protocol for a Prospective Observational Study.

[This corrects the article DOI: 10.2196/47855.].

Randomized controlled trial of tailored audit with feedback in VHA long-term care settings.

BACKGROUND: The Long-Term Care QUERI program supported implementation of the Life-Sustaining Treatment Decisions Initiative in US Veterans Health Administration long-term care settings. The program worked with eleven Community Living Centers (CLCs) and twelve Home-Based Primary Care (HBPC) programs to increase rates of completed templates, using audit with feedback. We distributed monthly feedback reports to site champions showing the number of Veterans with appropriate documentation. Although feedback reports are a common implementation tool, little is known about the most effective ways to design, distribute, and support them. We sought to test tailoring reports with tips using site-specific data, as well as national comparator data. METHODS: We conducted a cluster randomized controlled trial of monthly feedback reports utilizing site-tailored tips and national comparator data compared to our original feedback reports that included only graphical and numerical data. CLC and HBPC team members were invited to participate in brief surveys each quarter to determine if they had received and used the feedback reports. The outcome for CLC residents was the percent with a completed LST template any time prior to the 14th day of their stay. The outcome for HBPC residents was the percent of Veterans with a completed LST template by their second HBPC visit. RESULTS: The response rate to the survey ranged between 6.8 and 19.3% of staff members across the CLC and HBPC sites with 12.8-25.5% of survey respondents reporting that they had seen the feedback reports. The linear regression models showed no significant association between receiving the enhanced feedback reports and having a higher documentation completion rate. CONCLUSIONS: Receiving feedback reports tailored to sites by including tips based on baseline context assessments and qualitative findings, and reports showing national comparator data, did not have an impact on the number of Veterans with a completed LST template. Having a higher proportion of CLC or HBPC team members view the reports was not associated with an increase in LST template completion. These findings suggest that tailored audit with feedback may not have been effective at the program level, although the proportion of respondents who reported seeing the reports was small.

Indicators to measure implementation and sustainability of nursing best practice guidelines: A mixed methods analysis.

Background: The use of best practice guidelines (BPGs) has the potential to decrease the gap between best evidence and nursing and healthcare practices. We conducted an exploratory mixed method study to identify strategies, processes, and indicators relevant to the implementation and sustainability of two Registered Nurses' Association of Ontario (RNAO) BPGs at Best Practice Spotlight Organizations® (BPSOs). Methods: Our study had four phases. In Phase 1, we triangulated two qualitative studies: a) secondary analysis of 126 narrative reports detailing implementation progress from 21 BPSOs spanning four sectors to identify strategies and processes used to support the implementation and sustainability of BPGs and b) interviews with 25 guideline implementers to identify additional strategies and processes. In Phase 2, we evaluated correlations between strategies and processes identified from the narrative reports and one process and one outcome indicator for each of the guideline. In Phase 3, the results from Phases 1 and 2 informed indicator development, led by an expert panel. In Phase 4, the indicators were assessed internally by RNAO staff and externally by Ontario Health Teams. A survey was used to validate proposed indicators to determine relevance, feasibility, readability, and usability with knowledge users and BPSO leaders. Results: Triangulation of the two qualitative studies revealed 46 codes of implementation and sustainability of BPGs, classified into eight overarching themes: Stakeholder Engagement, Practice Interventions, Capacity Building, Evidence-Based Culture, Leadership, Evaluation & Monitoring, Communication, and Governance. A total of 28 structure, process, or outcome indicators were developed. End users and BPSO leaders were agreeable with the indicators according to the validation survey. Conclusions: Many processes and strategies can influence the implementation and sustainability of BPGs at BPSOs. We have developed indicators that can help BPSOs promote evidence-informed practice implementation of BPGs.

Effects of processing technologies on the antioxidant properties of common bean (Phaseolus vulgaris L.) and lentil (Lens culinaris) proteins and their hydrolysates.

The effects of ultrasound (280 W, 5 min), heat treatment (75 °C and 90 °C for 10 min) and microfluidization (125 MPa, 4 cycles) as pre or post treatments and their combination with enzymatic hydrolysis on the antioxidant properties of common bean and lentil protein hydrolysates were investigated. In general, hydrolysis resulted in increases of antioxidant activity, both in the presence and absence of processing technologies. The increases reached maximum values of 158% (ABTS), 105% (DPPH), 279% (FRAP) and 107% (TAC) for the bean protein hydrolysates submitted to post-treatment with ultrasound (ABTS, FRAP and TAC) and pre-treatment with microfluidization (DPPH), compared to their respective controls (untreated samples). For lentil proteins, the increases reached 197% (ABTS), 170% (DPPH), 690% (FRAP) and 213% (TAC) for samples submitted to ultrasound post-treatment (ABTS), microfluidization pre-treatment (DPPH) and post-treatment (FRAP), and 75 °C pre-treatment (TAC) compared to their respective controls. Surface hydrophobicity and molecular weight profile by SEC-HPLC analysis indicated modifications in the structures of proteins in function of the different processing technologies. For both proteins, electrophoresis indicated a similar profile for all hydrolysates, regardless of the process applied as pre or post treatment. Solubility of bean and lentil protein concentrates was also improved. These results indicated that different processing technologies can be successfully used in association with enzymatic hydrolysis to improve the antioxidant properties of lentil and bean proteins.

Association of the Stroke Ready Community-Based Participatory Research Intervention With Incidence of Acute Stroke Thrombolysis in Flint, Michigan.

Importance: Acute stroke treatment rates in the US lag behind those in other high-income nations. Objective: To assess whether a hospital emergency department (ED) and community intervention was associated with an increased proportion of patients with stroke receiving thrombolysis. Design, Setting, and Participants: This nonrandomized controlled trial of the Stroke Ready intervention took place in Flint, Michigan, from October 2017 to March 2020. Participants included adults living in the community. Data analysis was completed from July 2022 to May 2023. Intervention: Stroke Ready combined implementation science and community-based participatory research approaches. Acute stroke care was optimized in a safety-net ED, and then a community-wide, theory-based health behavior intervention, including peer-led workshops, mailers, and social media, was conducted. Main Outcomes and Measures: The prespecified primary outcome was the proportion of patients hospitalized with ischemic stroke or transient ischemic attack from Flint who received thrombolysis before and after the intervention. The association between thrombolysis and the Stroke Ready combined intervention, including the ED and community components, was estimated using logistic regression models, clustering at the hospital level and adjusting for time and stroke type. In prespecified secondary analyses, the ED and community intervention were explored separately, adjusting for hospital, time, and stroke type. Results: In total, 5970 people received in-person stroke preparedness workshops, corresponding to 9.7% of the adult population in Flint. There were 3327 ischemic stroke and TIA visits (1848 women [55.6%]; 1747 Black individuals [52.5%]; mean [SD] age, 67.8 [14.5] years) among patients from Flint seen in the relevant EDs, including 2305 in the preintervention period from July 2010 to September 2017 and 1022 in the postintervention period from October 2017 to March 2020. The proportion of thrombolysis usage increased from 4% in 2010 to 14% in 2020. The combined Stroke Ready intervention was not associated with thrombolysis use (adjusted odds ratio [OR], 1.13; 95% CI, 0.74-1.70; P = .58). The ED component was associated with an increase in thrombolysis use (adjusted OR, 1.63; 95% CI, 1.04-2.56; P = .03), but the community component was not (adjusted OR, 0.99; 95% CI, 0.96-1.01; P = .30). Conclusions and Relevance: This nonrandomized controlled trial found that a multilevel ED and community stroke preparedness intervention was not associated with increased thrombolysis treatments. The ED intervention was associated with increased thrombolysis usage, suggesting that implementation strategies in partnership with safety-net hospitals may increase thrombolysis usage. Trial Registration: ClinicalTrials.gov Identifier: NCT036455900.

Industry Payments to Urologists and Urologic Advanced Practice Providers in 2021.

OBJECTIVE: To compare industry payments from drug and medical device companies to urologists and urologic advanced practice providers (APPs) in 2021. METHODS: We used the 2020 Medicare Data on Provider Practice and Specialty file to identify single-specialty urology practices, defined as those where the majority of physicians were urologists. We then used the Open Payments Program Year 2021 data to summarize the value and number of industry payments to urologists and APPs, including nurse practitioners and physician assistants, in these practices. We calculated the total value and number of payments and median total value and number of payments per provider for urologists and urologic APPs. RESULTS: We identified 4418 urologists and 1099 APPs working in single-specialty urology practices in 2021 (Table 1). Of these, 3646 (87%) urologists received at least one industry payment, totaling $14,755,003 from 116,039 payments, and 954 urologic APPs (87%) received at least one industry payment, including 463 nurse practitioners (85%), totaling $401,283 from 13,035 payments, and 491 physician assistants (89%), totaling $543,429 from 14,626 payments. We observed significantly greater median total value and number of payments per provider for urologists ($620 and 24 payments) compared to urologic APPs ($473 and 21 payments; P < .001 and P = .017, respectively). CONCLUSION: A similar percentage of urologists and urologic APPs received industry payments in 2021. While urologists received a higher total number and total value of payments in 2021, urologic APPs were a common target of industry marketing payments.

Community-Led, Cross-Sector Partnership of Housing and Health Care to Promote Aging in Place (Unite Health Project): Protocol for a Prospective Observational Study.

BACKGROUND: For many older Americans, aging in place is their preferred living arrangement. Minoritized and socioeconomically disadvantaged older adults are up to 3 times more likely to experience disability than other groups, which increases their likelihood of being unable to age in place. Bold ideas to facilitate aging in place, particularly among vulnerable populations, are needed. One such idea is the Unite care model, a community-initiated, academic-supported, cross-sector initiative that combines 2 sectors: housing and health care. The Unite care model colocates a federally qualified health center clinic on an older adult affordable housing campus in Flint, Michigan. OBJECTIVE: There are two aims to this study. Aim 1 is to evaluate the implementation of the Unite care model in terms of acceptability, adoption, and penetration. Aim 2 is to determine which older adults use the care model and whether the care model promotes aging in place through risk factor reduction and improvement in the physical and social environment. METHODS: We will assess the care model using a concurrent, exploratory mixed methods design. For aim 1, acceptability will be assessed through semistructured interviews with key stakeholder groups; adoption and penetration will be assessed using housing and health care records. For aim 2, residents residing in the Unite clinic building will participate in structured outcome assessments at 6 and 12 months. Risk factor reduction will be measured by change in systolic blood pressure from baseline to 12 months and change in the physical and social environment (item counts) will also be assessed from baseline to 12 months. RESULTS: Data collection for aim 1 began in July 2021 and is anticipated to end in April 2023. Data collection for aim 2 began in June 2021 and concluded in November 2022. Data analysis for aim 1 is anticipated to begin in the summer of 2023 and analysis for aim 2 will begin in the spring of 2023. CONCLUSIONS: If successful, the Unite care model could serve as a new care model to promote aging in place among older adults living in poverty and older Black Americans. The results of this proposal will inform whether larger scale testing of this new model of care is warranted. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47855.

Evolving a national clinical trials learning health system.

Clinical trials generate key evidence to inform decision making, and also benefit participants directly. However, clinical trials frequently fail, often struggle to enroll participants, and are expensive. Part of the problem with trial conduct may be the disconnected nature of clinical trials, preventing rapid data sharing, generation of insights and targeted improvement interventions, and identification of knowledge gaps. In other areas of healthcare, a learning health system (LHS) has been proposed as a model to facilitate continuous learning and improvement. We propose that an LHS approach could greatly benefit clinical trials, allowing for continuous improvements to trial conduct and efficiency. A robust trial data sharing system, continuous analysis of trial enrollment and other success metrics, and development of targeted trial improvement interventions are potentially key components of a Trials LHS reflecting the learning cycle and allowing for continuous trial improvement. Through the development and use of a Trials LHS, clinical trials could be treated as a system, producing benefits to patients, advancing care, and decreasing costs for stakeholders.

Exploring implementation outcomes in the clinical trial context: a qualitative study of physician trial stakeholders.

INTRODUCTION: Cancer clinical trials can be considered evidence-based interventions with substantial benefits, but suffer from poor implementation leading to low enrollment and frequent failure. Applying implementation science approaches such as outcomes frameworks to the trial context could aid in contextualizing and evaluating trial improvement strategies. However, the acceptability and appropriateness of these adapted outcomes to trial stakeholders are unclear. For these reasons, we interviewed cancer clinical trial physician stakeholders to explore how they perceive and address clinical trial implementation outcomes. METHODS: We purposively selected 15 cancer clinical trial physician stakeholders from our institution representing different specialties, trial roles, and trial sponsor types. We performed semi-structured interviews to explore a previous adaptation of Proctor's Implementation Outcomes Framework to the clinical trial context. Emergent themes from each outcome were developed. RESULTS: The implementation outcomes were well understood and applicable (i.e., appropriate and acceptable) to clinical trial stakeholders. We describe cancer clinical trial physician stakeholder understanding of these outcomes and current application of these concepts. Trial feasibility and implementation cost were felt to be most critical to trial design and implementation. Trial penetration was most difficult to measure, primarily due to eligible patient identification. In general, we found that formal methods for trial improvement and trial implementation evaluation were poorly developed. Cancer clinical trial physician stakeholders referred to some design and implementation techniques used to improve trials, but these were infrequently formally evaluated or theory-based. CONCLUSION: Implementation outcomes adapted to the trial context were acceptable and appropriate to cancer clinical trial physician stakeholders. Use of these outcomes could facilitate the evaluation and design of clinical trial improvement interventions. Additionally, these outcomes highlight potential areas for the development of new tools, for example informatics solutions, to improve the evaluation and implementation of clinical trials.