Improving the Approach to Defining, Classifying, Reporting and Monitoring Adverse Events in Seriously Ill Older Adults: Recommendations from a Multi-stakeholder Convening.

BACKGROUND: Clinical trials are needed to study topics relevant to older adults with serious illness. Investigators conducting clinical trials with this population are challenged by how to appropriately define, classify, report, and monitor serious and non-serious adverse events (SAEs/AEs), given that some traditionally reported AEs (pressure ulcers, delirium) and SAEs (death, hospitalization) are common in persons with serious illness, and may be consistent with their goals of care. OBJECTIVES: A multi-stakeholder group convened to establish greater clarity on and new approaches to address this critical issue. PARTICIPANTS: Thirty-two study investigators, members of regulatory and sponsor agencies, and patient stakeholders took part. APPROACH: The group met virtually four times and, using a collaborative approach, conducted a survey, select interviews, and reviewed regulatory guidance to collectively define the problem and identify a new approach. RESULTS: SAE/AE challenges fell into two areas: (1) definitions and classifications, including (a) implausible relationships, (b) misalignment with patient-centered care goals, and (c) well-known associations, and (2) reporting and monitoring, including (a) limited guidance, (b) inconsistent standards across regulators, and (c) Data Safety Monitoring Board (DSMB) member knowledge gaps. Problems largely reflected practice norms rather than regulatory requirements that already support context-specific and aggregate reporting. Approaches can be improved by adopting principles that better align strategies for addressing adverse events with the type of intervention being tested, favoring routine and aggregate over expedited reporting, and prioritizing how SAE/AEs relate to patient-centered care goals. Reporting plans and decisions should follow an algorithm underpinned by these principles. CONCLUSIONS: Adoption of the proposed approach-and supporting it with education and better alignment with regulatory guidance and procedures-could improve the quality and efficiency of clinical trials' safety involving older adults with serious illness and other vulnerable populations.

Evaluation of a one-hour asynchronous video training for eating disorder screening and referral in U.S. Pediatric Primary Care: A pilot study.

OBJECTIVE: Develop and pilot-test the efficacy of an online training in improving comfort, knowledge, and behaviors related to eating disorders (EDs) screening among U.S.-based pediatric primary care providers (PCPs). METHODS: PCPs (N = 84) completed a baseline survey assessing comfort, knowledge, and behaviors regarding ED screening and referral, then watched a 1-h training video followed by a post-video survey. Half of the participants were randomly assigned to complete spaced-education questions in the following 2 months. All participants completed a 2-month follow-up survey. We used McNemar's and McNemar-Bowker tests to assess differences from baseline to post-video and post-video to follow-up, and logistic models to assess differences by spaced-education condition. RESULTS: From baseline to post-video, there were significant improvements in PCPs' knowledge about and comfort in screening and making referrals for EDs (p < .05). There were no differences between spaced-education conditions in knowledge and behaviors from baseline or post-video to follow-up, but spaced-education participants reported significantly greater comfort in screening for BN (p < .01) and BED (p < .01) compared to non-spaced-education participants. DISCUSSION: Findings suggest that a 1-h asynchronous training can improve PCP comfort, knowledge, and behavior in screening for EDs; spaced-education may provide slight additional benefits in PCP comfort. PUBLIC SIGNIFICANCE: The delivery of an 1-h asynchronous online video training helped to improve PCPs' comfort, knowledge, and behavior in screening and referral for EDs among pediatric populations. This has implications for future evaluations of brief trainings among this provider population, which could ultimately help to improve early identification of EDs and referrals to appropriate treatment.

Residential Setting and the Cumulative Financial Burden of Dementia in the 7 Years Before Death.

OBJECTIVES: Care for older adults with dementia during the final years of life is costly, and families shoulder much of this burden. We aimed to assess the financial burden of care for those with and without dementia, and to explore differences across residential settings. DESIGN: Using the Health and Retirement Study (HRS) and linked claims, we examined total healthcare spending and proportion by payer-Medicare, Medicaid, out-of-pocket, and calculated costs of informal caregiving-over the last 7 years of life, comparing those with and without dementia and stratifying by residential setting. SETTING: The HRS is a nationally representative longitudinal study of older adults in the United States. PARTICIPANTS: We sampled HRS decedents from 2004 to 2015. To ensure complete data, we limited the sample to those 72 years or older at death who had continuous fee-for-service Medicare Parts A and B coverage during the 7-year period (n = 2909). MEASUREMENTS: We compared decedents with dementia at last HRS assessment with those without dementia across annual and cumulative 7-year spending measures, and personal characteristics. We present annual and cumulative spending by payer, and the changing proportion of spending by payer over time, comparing those with and without dementia and stratifying results by residential setting. RESULTS: We found that, consistent with prior studies, people with dementia experience significantly higher costs, with a disproportionate share falling on patients and families. This pattern is most striking among community residents with dementia, whose families shoulder 64% of total expenditures (including $176,180 informal caregiving costs and $55,550 out-of-pocket costs), compared with 43% for people with dementia residing in nursing homes ($60,320 informal caregiving costs and $105,590 out-of-pocket costs). CONCLUSION: These findings demonstrate disparities in financial burden shouldered by families of those with dementia, particularly among those residing in the community. They highlight the importance of considering the residential setting in research, programs, and policies. J Am Geriatr Soc 68:1319-1324, 2020.

Implications of 2020 Skilled Home Healthcare Payment Reform for Persons with Dementia.

BACKGROUND/OBJECTIVES: The Medicare home health benefit provides episodic skilled home-based clinical care to the growing population of community-dwelling persons with dementia. As of January 1, 2020, home health payment changed: episodes shortened from 60 to 30 days, and episodes initiated in the community are now reimbursed at lower rates than episodes following institutional stays. We aim to assess the potential impact of these policy changes on this population. DESIGN/SETTING: Cross-sectional study using the Medicare claims-linked National Health and Aging Trends Study (NHATS). PARTICIPANTS: A total of 1,867 NHATS respondents who received home health between 2011 and 2017. MEASUREMENTS: Dementia was defined through both self-report and a validated cognitive assessment through NHATS. We described the demographic, socioeconomic, and health characteristics of older adults with dementia receiving home health compared with those without dementia. We then assessed the association of dementia with both receiving community-initiated home health (vs postinstitutional) and visit timing during the home health episode. RESULTS: Over a follow-up period of just over 4 years, 50.2% of persons with dementia used home health compared with 15.3% of persons without dementia. Most home health provided to persons with dementia was initiated in the community (61%), compared with 37% of episodes provided to persons without dementia. Persons with dementia were more likely to receive care in days 31 to 60 of the episode compared with those without dementia. CONCLUSIONS: Shortening episodes and reimbursing community-initiated episodes at lower rates may disproportionately impact the highly vulnerable population of older adults with dementia, who receive more community-initiated care over longer time periods. Our work highlights the need to better understand the unique role of home health in meeting gaps in both acute- and long-term care systems for older adults with dementia. J Am Geriatr Soc 68:2303-2309, 2020.

The Association Between Income and Incident Homebound Status Among Older Medicare Beneficiaries.

IMPORTANCE: A large and growing population of older adults with multimorbidity, cognitive impairment, and functional disability live in the community, but many never or rarely leave their homes. Being homebound is associated with decreased access to medical services, poor health outcomes, and increased mortality. Yet, it is unknown what factors, in particular socioeconomic factors, are associated with new onset of homebound status. OBJECTIVE: To evaluate the association between income and risk of becoming homebound. DESIGN: Observational cohort study using 2011 to 2018 data from the National Health and Aging Trends Study, a nationally representative sample of Medicare beneficiaries aged 65 years and older. SETTING: Population-based study in the United States. PARTICIPANTS: A total of 7,042 initially nonhomebound community-dwelling older adults. EXPOSURE: Total annual household income at baseline (in 2011) measured via self-report. OUTCOME: Annual measure of homebound status, defined as leaving home an average of 1 d/wk or less. RESULTS: Over 7 years, 15.81% of older adults in the lowest income quartile (≤$15,003) became homebound, compared with only 4.64% of those in the highest income quartile (>$60,000). In a competing risks analysis accounting for risks of death and nursing home admission, and adjusted for clinical and demographic characteristics, those in the lowest income quartile had a substantially higher subhazard of becoming homebound than those in the highest income quartile (1.65; 95% confidence interval = 1.20-2.29). Moreover, we see evidence of a gradient in risk of homebound status by income quartile. CONCLUSION AND RELEVANCE: Our work demonstrates that financial resources shape the risk of becoming homebound, which is associated with negative health consequences. In the context of existing income disparities, more support is needed to assist older adults with limited financial resources who wish to remain in the community.

Identifying Older Adults With Serious Illness: Transitioning From ICD-9 to ICD-10.

CONTEXT: Identifying the seriously ill population is integral to improving the value of health care. Efforts to identify this population using existing data are anchored to a list of severe medical conditions (SMCs) using diagnostic codes. Published approaches have used International Classification of Diseases, Ninth Revision (ICD-9) codes, which has since been replaced by ICD-10. OBJECTIVES: We translated SMCs from ICD-9 to ICD-10 using a refined code list. We aimed to test the hypothesis that people identified by ICD-9 or ICD-10 codes would have similar Medicare costs, health care utilization, and mortality. METHODS: Using data from the National Health and Aging Trends Study linked to Medicare claims, we compared samples from periods using ICD-9 (2014) and ICD-10 (2016). We included participants with six-month fee-for-service Medicare data before their interview date who had an SMC identified within that period. We compared the groups' demographic, functional, and medical characteristics and followed up them for six months to compare outcomes. RESULTS: Among subjects in the 2016 (ICD-10) sample, 19.9% were hospitalized, 24.6% used the emergency department, 7.2% died, and average Medicare spending totaled $9902.04 over six months of follow-up. We observed no significant differences between the 2014 and 2016 samples (P > 0.05); both samples represent 18% of Medicare fee-for-service beneficiaries. CONCLUSION: Identifying the seriously ill population using currently available data requires using ICD-10 to define SMCs. Routine measurement of function, quality of life, and caregiver strain will further enhance the identification process and efficiently target palliative care services and appropriate quality measures.