Advancing Translation of Clinical Research Into Practice and Population Health Impact Through Implementation Science.

Translational and implementation sciences aim to prioritize and guide efforts to create greater efficiency and speed of scientific innovation across the translational science continuum to improve patient and population health. Key principles and practices rooted in translational and implementation science may be incorporated into clinical trials research, particularly pragmatic trials, to improve the relevance and impact of scientific innovation. This thematic review intends to raise awareness on the value of translational and implementation science in clinical research and to encourage its use in designing and implementing clinical trials across the translational research continuum. Herein, we describe the gap in translating research findings into clinical practice, introduce translational and implementation science, and describe the principles and practices from implementation science that can be used in clinical trial research across the translational continuum to inform clinical practice, to improve population health impact, and to address health care inequities.

The Association Between Perceived Discrimination, Age and Proportion of Lifetime in the United States Among Somali Immigrants: A Cross-Sectional Analysis.

Discrimination is detrimental to health. Little is known about perceived discrimination among Somali immigrants. We examined whether age or proportion of lifetime in the United States was associated with perceived discrimination among Somali immigrants. Guided by Intersectionality, we described a secondary analysis of Everyday Discrimination Scale (EDS) survey data from the Healthy Immigrant Community study. Younger participants ( ≤40 years) experienced more discrimination than older participants ( >40 years). Higher education, being male, and earning $20,000-$39,999 was associated with more perceived discrimination. These findings suggest that Somali immigrants who are younger, more formally educated, male, and/or earn $20,000-$39,000 report more discrimination than their counterparts. Possible explanations include exposure to discrimination outside the Somali community or more awareness about racism. Alternatively, the EDS may not capture the discrimination experienced by Somali women or older adults. Further research is needed to address the discrimination experienced by Somali immigrants. Clinical Trial Registration: NCT05136339, November 29,2021.

Developing and describing a typology of lucid episodes among people with Alzheimer's disease and related dementias.

INTRODUCTION: This study examined lucid episodes among people living with late-stage Alzheimer's disease and related dementias (PLWD) and then developed a typology of these episodes to help characterize them. METHODS: Family caregivers of PLWD provided information about witnessed episodes, including proximity to death, cognitive status, duration, communication quality, and circumstances prior to lucid episodes on up to two episodes (caregiver N = 151; episode N = 279). Latent class analysis was used to classify and characterize empirically distinct clusters of lucid episodes. RESULTS: Four lucid episode types were identified. The most common type occurred during visits with family and among PLWD who lived > 6 months after the episode. The least common type coincided with family visits and occurred within 7 days of the PLWD's death. DISCUSSION: Findings suggest that multiple types of lucid episodes exist; not all signal impending death; and some, but not all, are precipitated by external stimuli.

Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention.

Background: Pragmatic trials may need to adapt interventions to enhance local fit, and adaptation tracking is critical to evaluation. This study describes the tracking approach for a multisite, stepped-wedge hybrid pragmatic trial testing implementation and effectiveness of a cancer symptom management intervention. Methods: Study activities were documented in a spreadsheet by date and category. Intervention adaptations were tracked across multiple workgroups in a database structured around the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) domains, e.g., reasons for change. Implementation strategies were tracked longitudinally and by cluster in a database using the Longitudinal Implementation Strategy Tracking System (LISTS) method. A logic model was created at the end of the study to describe core intervention components and implementation strategies with dates of adaptations. Results: Between January 2019 and January 2023, 187 study activities were documented. Most intervention activities took place early, but there were important intervention refinements during the course of the trial, including the expansion of interventionist roles to add two new disciplines. Eleven intervention adaptations were documented. Most were unplanned and aimed at improving fit or increasing engagement. Thirty-three implementation strategies were documented, the largest number of which were related to educating stakeholders. Most (but not all) component and strategy additions were consistent with the mechanisms of change as hypothesized at trial launch. Conclusions: A multifaceted approach to adaptation tracking, combined with a logic model, supported identification of meaningful changes for use in evaluation, but further work is needed to minimize burden and ensure robust and practical systems that inform both evaluation and timely decision-making. Trial: Registration: ClinicalTrials.gov, NCT03892967. Registered on March 25, 2019. https://www.clinicaltrials.gov/.

Multilevel Implementation Strategies for Adolescent Human Papillomavirus Vaccine Uptake: A Cluster Randomized Clinical Trial.

Importance: Despite availability of a safe and effective vaccine, an estimated 36 500 new cancers in the US result from human papillomavirus (HPV) annually. HPV vaccine uptake falls short of national public health goals and lags other adolescent vaccines. Objective: To evaluate the individual and combined impact of 2 evidence-based interventions on HPV vaccination rates among 11- and 12-year-old children. Design, Setting, and Participants: The study team conducted a cluster randomized clinical trial with a stepped-wedge factorial design at 6 primary care practices affiliated with Mayo Clinic in southeastern Minnesota. Using block randomization to ensure balance of patient volumes across interventions, each practice was allocated to a sequence of four 12-month steps with the initial baseline step followed by 2 intermediate steps (none, 1, or both interventions) and a final step wherein all practices implemented both interventions. Each month, all eligible children who turned 11 or 12 years in the 2 months prior were identified and followed until the end of the step. Data were analyzed from April 2018 through March 2019. Participants included children who turned 11 or 12 years old and were due for a dose of the HPV vaccine. Interventions: Parents of eligible patients were mailed reminder/recalls following their child's birthdays. Health care professionals received confidential audit/feedback on their personal in-office success with HPV vaccine uptake via intra-campus mail. These 2 interventions were assessed separately and in combination. Main Outcomes and Measures: Eligible patients' receipt of any valid dose of HPV vaccine during the study step. Results: The cohort was comprised of 9242 11-year-olds (5165 [55.9%]) and 12-year-olds (4077 [44.1%]), and slightly more males (4848 [52.5%]). Parent reminder/recall resulted in 34.6% receiving a dose of HPV vaccine, health care professional audit/feedback, 30.4%, both interventions together resulted in 39.7%-all contrasted to usual care, 21.9%. Compared with usual care, the odds of HPV vaccination were higher for parent reminder/recall (odds ratio [OR], 1.56; 95% CI, 1.23-1.97) and for the combination of parent reminder/recall and health care professional audit/feedback (OR, 2.03; 95% CI, 1.44-2.85). Health care professional audit/feedback alone did not differ significantly from usual care (OR, 1.19; 95% CI, 0.94-1.51). Conclusions and Relevance: In this cluster randomized trial, the combination of parent reminder/recall and health care professional audit/feedback increased the odds of HPV vaccination compared with usual care. These findings underscore the value of simultaneous implementation of evidence-based strategies to improve HPV vaccination.

Implementation Costs of Technology-Enhanced Transitional Palliative Care for Rural Caregivers.

OBJECTIVES: Compared to urban family caregivers (FCG), rural FCG experience greater burdens accessing coordinated care for their loved ones during and after hospitalization. The impact of technology-enhanced transitional palliative care (TPC) on caregiver outcomes is currently being evaluated in a randomized control trial. This study evaluates resource use and health system costs of this FCG-focused TPC intervention and potential Medicare reimbursement mechanisms. METHODS: Rural caregivers of hospitalized patients were randomized into an 8-week intervention consisting of video visits conducted by a registered nurse certified in palliative care, supplemented with phone calls and texts (n = 215), or attentional control. Labor costs were estimated for a registered nurse and compared to scenario analyses using a nurse practitioner or social worker wages. Medicare reimbursement scenarios included Transitional Care Management (TCM) and Chronic Care Management (CCM) CPT codes. RESULTS: In the base case, TPC cost was $395 per FCG facilitated by a registered nurse, compared to $337 and $585 if facilitated by a social worker or nurse practitioner, respectively. Mean Medicare reimbursement in the TCM-only scenario was $322 and $260 for high or moderate complexity patients, respectively. Reimbursement in the CCM only scenario was $348 and $274 for complex and non-complex patients, respectively. Reimbursement in the TCM+CCM scenario was $496 and $397, for high/complex and moderate/non-complex patients, respectively. CONCLUSION: TPC is a feasible, low cost and sustainable strategy to enhance FCG support in rural areas. Potential reimbursement mechanisms are available to offset the costs to the health system for providing transitional palliative care to caregivers of patients recently hospitalized.

Development of a Digital Storytelling Intervention to Increase Breast, Cervical, and Colorectal Cancer Screening in the Hispanic/Latino Community: a Qualitative Evaluation.

Digital storytelling (DST) interventions may be one way to address disparities in cancer screening experienced by the Hispanic/Latino population. Digital stories are short, first-person narratives that include voice-over narration and images. With storytellers' permission, researchers can screen digital stories as a health intervention. Digital stories can inspire viewers to adopt or change their behavior, such as completing cancer screening. Rochester Healthy Community Partnership (a 20-year community-based participatory research partnership) together with eight Hispanic/Latino, Spanish speaking cancer survivors, co-survivors, or recently screened individuals, developed digital stories about breast, cervical, and colorectal cancer screening. Here, we describe our qualitative evaluation of the DST workshop. To understand what the storytellers thought viewers would find relatable in their digital stories, we applied Narrative Theory. We also assessed workshop successes and opportunities for improvement. We used the constant comparative method for data analysis. We learned that the storytellers anticipated their stories would be engaging and that viewers would connect with Hispanic/Latino cultural values. During the workshop, the storytellers felt like they were making an important contribution. The storytellers highlighted specific opportunities for improvement including sharing the stories more quickly after the workshop. Future research is needed to test whether this intervention follows the Narrative Theory causal pathway by persuading viewers to complete recommended cancer screenings.

Exploring social determinants of health and physical activity levels in older adults living with mild cognitive impairment and dementia in the Upper Midwest of the United States.

BACKGROUND: Physical activity can improve physical health for people living with mild cognitive impairment (MCI) and dementia and may have cognitive benefits. Identifying modifiable social factors inhibiting physical activity among this group is needed. We sought to examine the relationship between reported physical activity levels and social determinants of health (SDOH) in a population of older adults living with MCI or dementia. METHODS: This descriptive study included people with a diagnosis of MCI or dementia followed by Community Internal Medicine at Mayo Clinic (Rochester, Minnesota, United States), aged over 55 years, who had a clinic visit between June 1, 2019 and June 30, 2021 and had completed a SDOH questionnaire. We focused on 8 SDOH domains: education, depression, alcohol use, stress, financial resource strain, social connections, food insecurity, and transportation needs. Data were analyzed based on physical activity level (inactive, insufficiently active, sufficiently active). SDOH domains were compared according to physical activity level using the χ2 test and multinomial logistic regression. RESULTS: A total of 3224 persons with MCI (n = 1371) or dementia (n = 1853) who had completed questions on physical activity were included. Of these, 1936 (60%) were characterized as physically inactive and 837 (26%) insufficiently active. Characteristics associated with an increased likelihood of physical inactivity were older age, female sex, obesity, lower education, dementia diagnosis, screening positive for depression and increased social isolation (p < 0.001). CONCLUSIONS: Physical inactivity is common among people living with MCI and dementia. Physical activity levels may be influenced by many factors, highlighting potential areas for intervention.

Implementing cancer symptom management interventions utilizing patient-reported outcomes: a pre-implementation evaluation of barriers and facilitators.

PURPOSE: Symptoms can negatively impact quality of life for patients with a history of cancer. Digital, electronic health record (EHR)-integrated approaches to routine symptom monitoring accompanied by evidence-based interventions for symptom management have been explored as a scalable way to improve symptom management, particularly between clinic visits. However, little research has evaluated barriers and facilitators to implementing these approaches in real-world settings, particularly during the pre-implementation phase. Pre-implementation assessment is critical for informing the selection and sequencing of implementation strategies and intervention adaptation. Thus, this study sought to understand pre-implementation perceptions of a remote cancer symptom monitoring and management intervention that uses electronic patient-reported outcome measures for symptom assessment. METHODS: We interviewed 20 clinical and administrative stakeholders from 4 geographic regions within an academic medical center and its affiliated health system during the months prior to initiation of a stepped-wedge, cluster randomized pragmatic trial. Transcripts were coded using the Consolidated Framework for Implementation Research [CFIR] 2.0. Two study team members reviewed coded transcripts to understand how determinants were relevant in the pre-implementation phase of the trial and prepared analytic memos to identify themes. RESULTS: Findings are summarized in four themes: (1) ability of the intervention to meet patient needs [recipient characteristics], (2) designing with care team needs in mind [innovation design and adaptability], (3) fit of the intervention with existing practice workflows [compatibility], and (4) engaging care teams early [engaging deliverers]. CONCLUSION: Attention to these aspects when planning intervention protocols can promote intervention compatibility with patients, providers, and practices thereby increasing implementation success.

Disparities in Electronic Health Record Portal Access and Use among Patients with Cancer.

BACKGROUND: Electronic health record (EHR)-linked portals may improve healthcare quality for cancer patients. Barriers to portal access and use undermine interventions leveraging portals to reduce cancer care disparities. This study examined portal access and persistence of portal use and associations with patient- and structural-factors prior to the implementation of three portal-based interventions within the Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium. METHODS: Portal use data were extracted from EHRs for the 12 months preceding intervention implementation. Sociodemographic factors, mode of accessing portals (web vs. mobile), and number of clinical encounters prior to intervention implementation were also extracted. Rurality was derived using Rural Urban Commuting Area codes. Broadband access was estimated using the 2015-2019 American Community Survey. Multiple logistic regression models tested associations of these factors with portal access (ever access/never accessed) and persistence of portal use (accessed the portal ≤20 weeks vs. ≥21 weeks in the 35 week study period). RESULTS: Of the 28,942 eligible patients, 10,061 (35%) never accessed the portal. Male, racial/ethnic minority, rural dwelling, not working, and limited broadband access were significantly associated with lower odds of portal access. Younger age and more clinical encounters were associated with higher odds of portal access. Of those with portal access, 25% were persistent users. Using multiple modalities for portal access, being middle-aged, and having more clinical encounters were significantly associated with persistent portal use. CONCLUSION: Patient- and structural-factors affect portal access and use and may exacerbate disparities in EHR-based cancer symptom surveillance and management.

Relationships Among Health Insurance Literacy, Financial Toxicity, and Sociodemographic Factors in Patients With Cancer.

PURPOSE: The objective of the study was to describe the prevalence of health insurance literacy (HIL) and investigate how patient-reported outcome measures assessing HIL are related to financial toxicity in patients with cancer. METHODS: We assessed HIL and financial toxicity in 404 patients enrolled between December 2019 and January 2021 at two medical centers in the United States. We conducted exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) to explore and test the relationships among the factors and items. We fit structural equation models (SEMs) to find the relationships among the factors and sociodemographic/clinical characteristics. RESULTS: The EFA revealed items loaded on four factors: knowledge about health insurance, confidence related to HIL (HIL confidence), information-seeking behavior related to health insurance, and financial toxicity. The four-factor CFA model had good fit statistics (comparative fit index, 0.960; Tucker-Lewis index, 0.958; root mean square error of approximation, 0.046; and standardized root mean square residual, 0.086). In SEM, income, education level, and race positively predicted knowledge about health insurance. Knowledge about health insurance and number of total lines of cancer treatment was positively associated with HIL confidence. Higher income, older age, and HIL confidence were associated with less financial toxicity. Higher levels of financial toxicity, HIL confidence, and knowledge were associated with greater information-seeking behavior. CONCLUSION: Our findings showed how different aspects of HIL are related to financial toxicity even after adjustment for sociodemographic and clinical characteristics. Future studies should investigate the longitudinal relationships among these factors to help develop interventions to mitigate financial toxicity.

A Single-Center Retrospective Evaluation of Decision-Making and Factors Motivating Hand Transplant Candidates.

INTRODUCTION: Advancements in vascularized composite allotransplantation have made hand transplants possible for persons living with upper limb loss. Hand transplantation is not a life-saving procedure, but rather a quality-of-life enhancing procedure; hence the risk of morbidity and mortality must be weighed against improvements in function and appearance. This study explored the decision-making process of patients evaluated for hand transplantation. METHODS/APPROACH: A qualitative case series study using retrospective chart data of evaluations was conducted between January 1, 2011 and February 28, 2020. Notes were extracted and read by three reviewers. Each case was summarized noting similarities and differences. FINDINGS: Nine patients underwent evaluation. Eight were no longer under evaluation and did not receive transplant; one was still undergoing evaluation. Patient motivations for evaluation were dissatisfaction with prostheses or self-image, chronic pain, performing activities of daily living, occupation, burden placed on caregivers, and concerns about overuse of non-affected limbs. Patients chose not to pursue transplantation due to rehabilitation time, immunosuppression, alternative treatments, and social and financial challenges. The clinical team discontinued evaluations due to unmet evaluation requirements, medical contraindications, or treatment alternatives. Different modes of shared decision-making were present depending on the party most heavily featured in the charts as driving decisions. DISCUSSION: This was an examination of shared decision-making with hand transplant candidates who did not proceed to transplant. Reasons for choosing alternative strategies for management were multifactorial. Lessons learned regarding patient motivations and shared decision-making can inform future interventions to better support patients.

Comprehensive Acute Kidney Injury Survivor Care: Protocol for the Randomized Acute Kidney Injury in Care Transitions Pilot Trial.

BACKGROUND: Innovative care models are needed to address gaps in kidney care follow-up among acute kidney injury (AKI) survivors. We developed the multidisciplinary AKI in Care Transitions (ACT) program, which embeds post-AKI care in patients' primary care clinic. OBJECTIVE: The objective of this randomized pilot trial is to test the feasibility and acceptability of the ACT program and study protocol, including recruitment and retention, procedures, and outcome measures. METHODS: The study will be conducted at Mayo Clinic in Rochester, Minnesota, a tertiary care center with a local primary care practice. Individuals who are included have stage 3 AKI during their hospitalization, do not require dialysis at discharge, have a local primary care provider, and are discharged to their home. Patients unable or unwilling to provide informed consent and recipients of any transplant within 100 days of enrollment are excluded. Consented patients are randomized to receive the intervention (ie, ACT program) or usual care. The ACT program intervention includes predischarge kidney health education from nurses and coordinated postdischarge laboratory monitoring (serum creatinine and urine protein assessment) and follow-up with a primary care provider and pharmacist within 14 days. The usual care group receives no specific study-related intervention, and any aspects of AKI care are at the direction of the treating team. This study will examine the feasibility of the ACT program, including recruitment, randomization and retention in a trial setting, and intervention fidelity. The feasibility and acceptability of participating in the ACT program will also be examined in qualitative interviews with patients and staff and through surveys. Qualitative interviews will be deductively and inductively coded and themes compared across data types. Observations of clinical encounters will be examined for discussion and care plans related to kidney health. Descriptive analyses will summarize quantitative measures of the feasibility and acceptability of ACT. Participants' knowledge about kidney health, quality of life, and process outcomes (eg, type and timing of laboratory assessments) will be described for both groups. Clinical outcomes (eg, unplanned rehospitalization) up to 12 months will be compared with Cox proportional hazards models. RESULTS: This study received funding from the Agency for Health Care Research and Quality on April 21, 2021, and was approved by the Institutional Review Board on December 14, 2021. As of March 14, 2023, seventeen participants each have been enrolled in the intervention and usual care groups. CONCLUSIONS: Feasible and generalizable AKI survivor care delivery models are needed to improve care processes and health outcomes. This pilot trial will test the ACT program, which uses a multidisciplinary model focused on primary care to address this gap. TRIAL REGISTRATION: ClinicalTrials.gov NCT05184894; https://www.clinicaltrials.gov/ct2/show/NCT05184894. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48109.

Impact of Menopause Symptoms on Women in the Workplace.

OBJECTIVE: To evaluate the impact of menopause symptoms on work outcomes and to assess the estimated economic impact. PATIENTS AND METHODS: Women aged 45 to 60 years receiving primary care at 1 of the 4 Mayo Clinic sites were invited to participate in a survey study (Hormones and ExpeRiences of Aging) from March 1 through June 30, 2021. A total of 32,469 surveys were sent, with 5219 responses (16.1% response rate). Of the 5219 respondents, 4440 (85.1%) reported current employment information and were included in the study. The primary outcome was self-reported adverse work outcomes related to menopause symptoms assessed by the Menopause Rating Scale (MRS). RESULTS: The mean age of the 4440 participants was 53.9±4.5 years, with the majority being White (4127 [93.0%]), married (3398 [76.5%]), and educated (2632 [59.3%] college graduate or higher); the mean total MRS score was 12.1, signifying moderate menopause symptom burden. Overall, 597 women (13.4%) reported at least one adverse work outcome due to menopause symptoms; 480 women (10.8%) reported missing work in the preceding 12 months (median, 3 days missed). The odds of reporting an adverse work outcome increased with increasing menopause symptom severity; women in the highest quartile of total MRS scores were 15.6 (95% CI, 10.7 to 22.7; P<.001) times more likely to have an adverse work outcome vs those in the first quartile. Based on workdays missed due to menopause symptoms, we estimate an annual loss of $1.8 billion in the United States. CONCLUSION: This large cross-sectional study identified a major negative impact of menopause symptoms on work outcomes and the need to improve medical treatment for these women and make the workplace environment more supportive. Additional studies are needed to confirm these findings in larger and more diverse groups of women.

Parent-reported Barriers and Parental Beliefs Associated with Intentions to Obtain HPV Vaccination for Children in a Primary care Patient Population in Minnesota, USA.

Human papillomavirus (HPV) vaccine uptake among adolescents remains suboptimal in the US. The COVID-19 pandemic posed new challenges to increase HPV vaccination rates. To characterize parent-reported barriers to obtain HPV vaccination for their children and to identify psychosocial factors associated with parents' intention to vaccinate their children for HPV, we administered parent surveys between April 2020 and January 2022 during a randomized pragmatic trial assessing the impact of evidence-based implementation strategies on HPV vaccination rates for adolescent patients at six Mayo Clinic primary care practices in Southeast Minnesota. A total of 342 surveys were completed (response rate 34.1%). Analyses were focused on parents of unvaccinated children (n = 133). The survey assessed the main reason the child did not receive the HPV vaccine, parental beliefs about the vaccine, and the parent's intention to vaccinate the child for HPV in the next 12 months. Frequently reported awareness and access barriers to HPV vaccination included not knowing the child was due (17.8%) and COVID-19 related delay (11.6%). Frequently reported attitudinal barriers include the belief that the child was too young for the vaccine (17.8%) and that the vaccine is not proven to be safe (16.3%). Injunctive social norm (Adjusted-OR = 3.15, 95%CI: 1.94, 5.41) and perceived harm beliefs (Adjusted-OR = 0.58, 95%CI: 0.35, 0.94) about the HPV vaccine were positively and negatively associated with HPV vaccination intention, respectively. Our findings suggest that continued efforts to overcome parental awareness, access, and attitudinal barriers to HPV vaccination are needed and underscore the importance of utilizing evidence-based health system-level interventions.

Acute Kidney Injury Survivor Care Following Hospital Discharge: A Mixed-Methods Study of Nephrologists and Primary Care Providers.

Rationale & Objective: Widespread delivery of high-quality care for acute kidney injury (AKI) survivors after hospital discharge requires a multidisciplinary team. We aimed to compare management approaches between nephrologists and primary care providers (PCPs) and explored strategies to optimize collaboration. Study Design: Explanatory sequential mixed-methods study using a case-based survey followed by semi-structured interviews. Setting & Participants: Nephrologists and PCPs providing AKI survivor care at 3 Mayo Clinic sites and the Mayo Clinic Health System were included. Outcomes: Survey questions and interviews elucidated participants' recommendations for post-AKI care. Analytical Approach: Descriptive statistics were used to summarize survey responses. Qualitative data analysis used deductive and inductive strategies. A connecting and merging approach was used for mixed-methods data integration. Results: 148 of 774 (19%) providers submitted survey responses (24/72 nephrologists and 105/705 PCPs). Nephrologists and PCPs recommended laboratory monitoring and follow-up with a PCP shortly after hospital discharge. Both indicated that the need for nephrology referral, and its timing should be dictated by clinical and non-clinical patient-specific factors. There were opportunities for improvement in medication and comorbid condition management in both groups. Incorporation of multidisciplinary specialists (eg, pharmacists) was recommended to expand knowledge, optimize patient-centered care, and alleviate provider workload. Limitations: Survey findings may have been affected by non-response bias and the unique challenges facing clinicians and health systems during the COVID-19 pandemic. Participants were from a single health system, and their views or experiences may differ from those in other health systems or serving different populations. Conclusions: A multidisciplinary team-based model of post-AKI care may facilitate implementation of a patient-centered care plan, improve adherence to best practices, and reduce clinician and patient burden. Individualizing care for AKI survivors based on clinical and non-clinical patient-specific factors is needed to optimize outcomes for patients and health systems.

Prevalence, Severity, and Co-Occurrence of SPPADE Symptoms in 31,866 Patients With Cancer.

OBJECTIVES: To examine the prevalence, severity, and co-occurrence of SPPADE symptoms as well as their association with cancer type and patient characteristics. BACKGROUND: The SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy /fatigue) are prevalent, co-occurring, and undertreated in oncology and other clinical populations. METHODS: Baseline SPPADE symptom data were analyzed from the E2C2 study, a stepped wedge pragmatic, population-level, cluster randomized clinical trial designed to evaluate a guideline-informed symptom management model targeting the six SPPADE symptoms. Symptom prevalence and severity were measured with a 0-10 numeric rating (NRS) scale for each of the six symptoms. Prevalence of severe (NRS ≥ 7) and potential clinically relevant (NRS ≥ 5) symptoms as well as co-occurrence of clinical symptoms were determined. Distribution-based methods were used to estimate the minimally important difference (MID). Associations of cancer type and patient characteristics with a SPPADE composite score were analyzed. RESULTS: A total of 31,886 patients were assessed for SPPADE symptoms prior to, during, or soon after an outpatient medical oncology encounter. The proportion of patients with a potential clinically relevant symptom ranged from 17.5% for depression to 33.4% for fatigue. Co-occurrence of symptoms was high, with the proportion of patients with three or more additional clinically relevant symptoms ranging from 45.2% for fatigue to 68.6% for depression. The summed SPPADE composite score demonstrated good internal reliability (Cronbach's alpha of 0.86), with preliminary MID estimates of 4.1-4.3. Symptom burden differed across several types of cancer but was generally similar across most sociodemographic characteristics. CONCLUSION: The high prevalence and co-occurrence of SPPADE symptoms in patients with all types of cancer warrants clinical approaches that optimize detection and management.

A Methodological Approach for Documenting Multi-Component Interventions Targeting Family Caregivers.

Managing the complex care needs of seriously ill patients transitioning from hospital to home can have detrimental effects on family caregivers (FCG). Multi-component interventions tailored to FCG needs are most effective at reducing caregiver burden, distress, and depression. However, gaps exist in determining best methods to assess, document, and analyze intervention components for FCGs. Common methods used to capture patient data during transitions in care may not be appropriate or allowed for FCG needs. As such, we present a methodological approach for electronically capturing, reporting, and analyzing multiple intervention components. This approach uses a standardized terminology and pathway for tailoring intervention components in real time while evaluating intervention effects across time. We use examples from a randomized controlled trial to illustrate the benefits of the current approach for analyzing the effectiveness of multi-component interventions in the context of caregiving research.

Toward harmonization of strategies for investigating lucidity in AD/ADRD: A preliminary research framework.

Episodes of lucidity (ELs) in Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD), have garnered increasing attention as an important area of research. Efforts to study lucidity suffer from a lack of clear definitional criteria, inconsistent conceptualization, and diverse approaches to operationalizing features of these events. To advance systematic investigation of ELs in AD/ADRD, there is a need for clarity and precision in labeling event attributes, markers, and specific measurement strategies that enable operational harmonization across distinct approaches to investigating the relatively broad and nascent phenomenon. To that end, we propose a preliminary research framework to guide harmonization of approaches to investigating ELs in AD/ADRD. Our goal is to provide an initial schematic that encourages uniform labeling of operational decisions about ELs.

Factors influencing colorectal cancer screening decision-making among average-risk US adults.

Colorectal cancer (CRC) screening rates remain suboptimal in the US. We examined patient-focused concerns and influence of various factors (e.g., test attributes, provider recommendation) on CRC screening decision-making. We conducted a web survey with 1595 US adults aged 40-75 from a nationally representative panel in November 2019 (completion rate: 31.3 %). Analyses focused on individuals aged 45-75 years at average-risk for CRC (n = 1062). All participants rated their level of concern about various CRC screening test/procedure attributes. Participants who have screened previously designated the three most important attributes for choosing a screening method and rated how various factors influenced their decision to use a particular method. The top concern for participants who have not screened previously was having an invasive procedure (54.2 %) while the top concerns for participants who have screened previously were completing a colon prep (41.3 %) and test/procedure accuracy (41 %). Cost/insurance coverage was most frequently ranked among the most important attributes (48.5 %), followed by where the test can be taken (45.7 %) and test accuracy (43.6 %). Provider recommendation was reported as the major motivator across screening methods. Other factors that were frequently reported as very influential included convenience and comfort for the stool-based methods and scientific/clinical evidence and insurance coverage for colonoscopy. Variations by age, sex, and race/ethnicity were noted. Findings demonstrate that along with provider recommendation, patient preferences regarding test/procedure attributes and preparation requirements are influential in screening decision-making, highlighting the need for clinicians to involve patients in shared decision-making and incorporate patient needs and preferences in establishing screening strategies.