Commentary: Determining Economic Factors That Matter to People With Intellectual and Developmental Disabilities and Their Caregivers: A Process Framework.

BACKGROUND: The 2020-2029 strategic plan for the Patient-Centered Outcomes Research Trust Fund calls for addressing data infrastructure gaps that are critical for studying issues around intellectual and developmental disabilities (I/DD). Specifically, the plan calls for data collection on economic factors that affect person-centered approaches to health care decision-making. Among people with I/DD and their caregivers, such economic factors may include financial costs of care, decreased opportunities for leisure and recreation, income losses associated with caregiving, and foregone opportunities for skill acquisition or other human capital investments. OBJECTIVE: This commentary supports responsiveness to the Patient-Centered OutcomesResearch Trust Fund (PCORTF) calls by conceptualizing and operationalizing a framework for identifying preferences on economic factors that are relevant to people with I/DD and their caregivers. MAIN ARGUMENTS: The framework outlined in this commentary addresses barriers to data collection that hinder measure development in the study of I/DD. This work is significant and timely given the continued movement to integrate and maintain people with I/DD within communities and recent methodological advances for eliciting preferences among people with I/DD. RELEVANCE TO THE SPECIAL ISSUE: Readers will be introduced to a framework for building data capacity in the study of economic outcomes among a population that is a high research priority for federal funding agencies. This commentary aims to be useful to researchers in planning, developing, and initiating projects in this area.

Addressing racial inequality and its effects on vaccination rate: A trial comparing a pharmacist and peer educational program (MOTIVATE) in diverse older adults.

BACKGROUND: The mortality, morbidity, health care utilization, and cost attributable to vaccine-preventable diseases are substantial for those aged 50 years and older. Although vaccination is the most cost-effective strategy to prevent common infectious diseases in older adults, vaccination rates remain below US Centers for Disease Control and Prevention benchmarks, especially among racial minorities. Historical mistrust, structural racism within the US medical system, and misinformation contributed to lower immunization rates among minorities, especially Black Americans. To address the critical need to increase knowledge and trust in vaccination, 2 community-based educational interventions were tested: a pharmacist-led didactic session (PHARM) and a peer-led educational workshop (PEER). OBJECTIVE: To determine and compare the effectiveness and costs of PEER and PHARM community-based education models in improving knowledge and trust in vaccinations. METHODS: The Motivating Older adults to Trust Information about Vaccines And Their Effects (MOTIVATE) study was a cluster-randomized trial conducted in the greater Delaware Valley Region sites from 2017 to 2020. The included sites (7 senior centers, 3 housing units, 1 church, and 1 neighborhood family center) predominantly served Black communities. Participants were randomized to either PHARM or PEER sessions covering influenza, pneumococcal disease, herpes zoster, and beliefs related to vaccines. Peer leaders facilitated smaller workshops (5-10 participants), whereas pharmacists conducted larger didactic lectures with 15-43 participants. Outcomes were captured through a self-administered survey at baseline, postprogram, and 1 month after the program. Intervention costs were measured in 2017 US dollars. RESULTS: 287 participants were included. Their mean age was 74.5 years (SD = 8.94), 80.5% were women, 64.2% were Black, and 48.1% completed some college. Knowledge scores within groups for all 3 diseases significantly increased postprogram for both PEER and PHARM and were sustained at 1 month. Between-group knowledge differences were significant only for influenza (PEER participants had significantly larger improvement vs PHARM). Vaccination trust significantly increased in both groups. Total program costs were $11,411 for PEER and $5,104 for PHARM. CONCLUSIONS: Both interventions significantly improved knowledge and trust toward vaccination and retained their effect 1 month after the program. The 2 effective community-based education models should be expanded to ensure timely and trusted information is available to educate older adults about vaccine-preventable diseases. Further research is encouraged to assess the long-term cost-effectiveness of these models' utilization on a larger scale. DISCLOSURES: Dr Schafer is an employee of Merck; however, at the time of the project, he was a professor at Thomas Jefferson University. The other authors have no conflicts of interest to disclose. This study was supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp. The opinions expressed in this article are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp. The sponsor played no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the article. Study Registration Number: NCT03239665.

Cost effectiveness of non-drug interventions that reduce nursing home admissions for people living with dementia.

INTRODUCTION: Six million Americans live with Alzheimer's disease and Alzheimer's disease and related dementias (AD/ADRD), a major health-care cost driver. We evaluated the cost effectiveness of non-pharmacologic interventions that reduce nursing home admissions for people living with AD/ADRD. METHODS: We used a person-level microsimulation to model the hazard ratios (HR) on nursing home admission for four evidence-based interventions compared to usual care: Maximizing Independence at Home (MIND), NYU Caregiver (NYU); Alzheimer's and Dementia Care (ADC); and Adult Day Service Plus (ADS Plus). We evaluated societal costs, quality-adjusted life years and incremental cost-effectiveness ratios. RESULTS: All four interventions cost less and are more effective (i.e., cost savings) than usual care from a societal perspective. Results did not materially change in 1-way, 2-way, structural, and probabilistic sensitivity analyses. CONCLUSION: Dementia-care interventions that reduce nursing home admissions save societal costs compared to usual care. Policies should incentivize providers and health systems to implement non-pharmacologic interventions.

Economic Analysis of the Tailored Activity Program: A Nonpharmacological Approach to Improve Quality of Life in People Living With Dementia and their Caregivers.

We investigated costs of delivering the Tailored Activity Program (TAP) and cost savings from two perspectives (health sector and societal) for people living with dementia (PLWD) and their caregivers (dyads) compared to attention control (AC) using data from a randomized controlled trial. The evaluation assessed intervention delivery costs and caregiver reported health care utilization. The total intervention cost of TAP was $1707/dyad versus $864/dyad for AC, and total costs over 6 months for TAP dyads as compared to AC were $1299 (CI: -$10,496, $7898) less from the healthcare perspective, and $761 (CI: -$10,133, $8611) less from the societal perspective. TAP cost savings are driven by lower use of healthcare services among participating dyads, but further analyses with larger samples is warranted to confirm its financial impact.

Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): Baseline Results and Costs of a Cluster-Randomized Trial.

PURPOSE: To describe the 15-month baseline results and costs of the Manhattan Vision Screening and Follow-up Study, which aims to investigate whether innovative community-based eye health screening can improve early detection and management of glaucoma and other eye diseases among high-risk populations. DESIGN: Five-year prospective, cluster-randomized controlled trial. METHODS: Individuals aged 40+ years were recruited from public housing buildings in New York City for an eye health screening (visual acuity (VA) with correction, intraocular pressure measurements (IOP), and fundus photography). Participants with VA 20/40 or worse, IOP 23-29 mm Hg, or an unreadable fundus image failed the screening and were scheduled for an optometric examination at the same location; those with an abnormal image were referred to ophthalmology. A cost analysis was conducted alongside the study. RESULTS: A total of 708 participants were screened; mean age 68.6±11.9 years, female (65.1%), African American (51.8%) and Hispanic (42%). 78.4% (n = 555) failed the eye health screening; 35% (n= 250) had an abnormal image and were also referred to ophthalmology. 308 participants attended the optometric exam; 218 were referred to ophthalmology. Overall, 66.1% were referred to ophthalmology. The cost per participant to deliver the eye health screening and optometric examination was $180.88. The cost per case of eye disease detected was $273.64. CONCLUSIONS: This innovative study in public housing developments targeted high-risk populations, provided access to eye-care, and improved early detection of ocular diseases in New York City. The study has identified strategies to overcoming barriers to eye care to reduce eye health disparities.

Cost-Benefit Analysis of the COPE Program for Persons Living With Dementia: Toward a Payment Model.

BACKGROUND AND OBJECTIVES: There is a critical need for effective interventions to support quality of life for persons living with dementia and their caregivers. Growing evidence supports nonpharmacologic programs that provide care management, disease education, skills training, and support. This cost-benefit analysis examined whether the Care of Persons with Dementia in their Environments (COPE) program achieves cost savings when incorporated into Connecticut's home- and community-based services (HCBS), which are state- and Medicaid-funded. RESEARCH DESIGN AND METHODS: Findings are based on a pragmatic trial where persons living with dementia and their caregiver dyads were randomly assigned to COPE with HCBS, or HCBS alone. Cost measures included those relevant to HCBS decision makers: intervention delivery, health care utilization, caregiver time, formal care, and social services. Data sources included care management records and caregiver report. RESULTS: Per-dyad mean cost savings at 12 months were $2 354 for those who received COPE with a mean difference-in-difference of -$6 667 versus HCBS alone (95% CI: -$15 473, $2 734; not statistically significant). COPE costs would consume 5.6%-11.3% of Connecticut's HCBS annual spending limit, and HCBS cost-sharing requirements align with participants' willingness to pay for COPE. DISCUSSION AND IMPLICATIONS: COPE represents a potentially cost-saving dementia care service that could be financed through existing Connecticut HCBS. HCBS programs represent an important, sustainable payment model for delivering nonpharmacological dementia interventions such as COPE.

Economic implications of FDA platelet bacterial guidance compliance options: Comparison of single-step strategies.

BACKGROUND: Bloodborne pathogens pose a major safety risk in transfusion medicine. To mitigate the risk of bacterial contamination in platelet units, FDA issues updated guidance materials on various bacterial risk control strategies (BRCS). This analysis presents results of a budget impact model updated to include 5- and 7-day pathogen reduced (PR) and large volumed delayed sampling (LVDS) BRCS. STUDY DESIGN AND METHODS: Model base-case parameter inputs were based on scientific literature, a survey distributed to 27 US hospitals, and transfusion experts' opinion. The outputs include hospital budget and shelf-life impacts for 5- and 7-day LVDS, and 5- and 7-day PR units under three different scenarios: (1) 100% LVDS, (2) 100% PR, and (3) mix of 50% LVDS - and 50% PR. RESULTS: Total annual costs from the hospital perspective were highest for 100% LVDS platelets (US$2.325M) and lowest for 100% PR-7 units (US$2.170M). Net budget impact after offsetting annual costs by outpatient reimbursements was 5.5% lower for 5-day PR platelets as compared to 5-day LVDS (US$1.663 vs. US$1.760M). A mix of 7-day LVDS and 5-day PR platelets had net annual costs that were 1.3% lower than for 100% 7-day LVDS, but 1.3% higher than for 100% 5-day PR. 7-day PR platelets had the longest shelf life (4.63 days), while 5-day LVDS had the shortest (2.00 days). DISCUSSION: The model identifies opportunities to minimize transfusion center costs for 5- and 7-day platelets. Budget impact models such as this are important for understanding the financial implications of evolving FDA guidance and new platelet technologies.

Polypharmacy and Potentially Inappropriate Medication Use in Older Blacks with Diabetes Mellitus Presenting to the Emergency Department.

Background: Medication-related problems in older Blacks with diabetes mellitus (DM) are not well established. Objectives: To describe the frequency of medication-related problems in older Blacks with DM presenting to the emergency department (ED). Methods: The study was a cross-sectional analysis of baseline data from a randomized controlled trial evaluating Blacks aged ≥60 years of age presenting to the ED. Polypharmacy, potentially inappropriate medication (PIM) use, and anticholinergic score were evaluated. Results: Of 168 patients (median age = 68, range 60-92), most (n = 164, 98%) were taking ≥5 medications, and 67 (39.9%) were taking a PIM. A majority (n = 124, 74%) were taking a medication with an anticholinergic score ≥1. Number of medications was correlated with number of PIMs (r = .22, p = .004) and anticholinergic score (r = .50, p < .001). Conclusion: Polypharmacy and PIM use was common in older Blacks with DM.

A longitudinal evaluation of family caregivers' willingness to pay for an in-home nonpharmacologic intervention for people living with dementia: results from a randomized trial.

OBJECTIVE: To determine the willingness-to-pay (WTP) of family caregivers to learn care strategies for persons living with dementia (PLwD). DESIGN: Randomized clinical trial. SETTING: Community-dwelling PLwD and their caregivers (dyads) in Maryland and Washington, DC. PARTICIPANTS: 250 dyads. INTERVENTION: Tailored Activity Program (TAP) compared to attention control. TAP provides activities tailored to the PLwD and instructs caregivers in their use. MEASUREMENT: At baseline, 3 and 6 months, caregivers were asked their WTP per session for an 8-session 3-month in-home nonpharmacologic intervention to address behavioral symptoms and functional dependence. RESULTS: At baseline, 3 and 6 months, caregivers assigned to TAP were willing to pay $26.10/session (95%CI:$20.42, $33.00), $28.70 (95%CI:$19.73, $39.30), and $22.79 (95%CI: $16.64, $30.09), respectively; attention control caregivers were willing to pay $37.90/session (95%CI: $27.10, $52.02), $30.92 (95%CI: $23.44, $40.94), $27.44 (95%CI: $20.82, $35.34), respectively. The difference in baseline to 3 and 6 months change in WTP between TAP and the attention control was $9.58 (95%CI: -$5.00, $25.47) and $7.15 (95%CI: -$5.72, $21.81). The difference between TAP and attention control in change in the proportion of caregivers willing to pay something from baseline to 3 and 6 months was -12% (95%CI: -28%, -5%) and -7% (95%CI:-25%, -11%), respectively. The difference in change in WTP, among caregivers willing to pay something, between TAP and attention control from baseline to 3 and 6 months was $17.93 (95%CI: $0.22, $38.30) and $11.81 (95%CI: -$2.57, $28.17). CONCLUSIONS: Family caregivers are willing to pay more for an intervention immediately following participation in a program similar to which they were asked to value.

Manhattan Vision Screening and Follow-Up Study in Vulnerable Populations: 1-Month Feasibility Results.

Purpose/Aim: In the United States, high rates of vision impairment and eye disease disproportionately impact those who lack access to eye care, specifically vulnerable populations. The objective of our study was to test instruments, implement protocols, and collect preliminary data for a larger 5-year study, which aims to improve detection of eye diseases and follow-up eye care in vulnerable populations using community health workers (CHW) and patient navigators. In the study, trained CHWs conducted vision screening and patient navigators scheduled on-site eye exams and arranged appointments for those referred to ophthalmology to improve adherence to follow-up eye care.Materials and Methods: Eligible individuals age 40-and-older were recruited from the Riverstone Senior Center in Upper Manhattan, New York City. Participants underwent on-site vision screening (visual acuity with correction, intraocular pressure measurements, and fundus photography). Individuals who failed the vision screening were scheduled with an on-site optometrist for an eye exam; those with ocular pathologies were referred to an ophthalmologist. Participants were also administered the National Eye Institute Visual Function Questionnaire-8 (NEI-VFQ-8) and Stopping Elderly Accidents, Deaths, and Injuries (STEADI) test by community health workers.Results:Participants (n = 42) were predominantly older adults, with a mean age of 70.0 ± 9.8, female (61.9%), and Hispanic (78.6%). Most individuals (78.6%, n = 33) failed vision screening. Of those who failed, 84.8% (n = 28) attended the on-site eye exam with the optometrist. Ocular diagnoses: refractive error 13/28 (46.4%), glaucoma/glaucoma suspect 9/28 (32.1%), cataract 7/28 (25.0%), retina abnormalities 6/28 (21.4%); 13 people required eyeglasses.Conclusion: This study demonstrates the feasibility of using CHWs and patient navigators for reducing barriers to vision screening and optometrist-based eye exams in vulnerable populations, ultimately improving early detection of eye disease and linking individuals to additional eye care appointments. The full five-year study aims to further examine these outcomes.

Reducing the Costs of an Eye Care Adherence Program for Underserved Children Referred Through Inner-City Vision Screenings.

PURPOSE: We previously reported costs and outcomes of the Children's Eye Care Adherence Program (CECAP1), a social worker intervention designed to improve adherence to eye care for underserved children in urban Philadelphia. Using cost findings from CECAP1, we revised the intervention to reduce costs. The aim of this study was to evaluate costs and effectiveness of the revised intervention (CECAP2). DESIGN: Retrospective cohort study. METHODS: Records of children needing ophthalmic follow-up after 2 community-based vision screening programs were reviewed. We modified CECAP1 to prioritize children more likely to visit, decreased phone calls and scheduling attempts, better documented children already followed by other doctors, and constricted our geographic catchment area for better accessibility. Cost was calculated using time spent executing CECAP2 by our salaried social worker. Effectiveness was defined as the percentage of patients completing at least 1 follow-up visit within the recommended time frame. RESULTS: Of 462 children referred to CECAP2 from our in-school and on-campus screening programs, 242 (52.4%) completed subsequent recommended eye examinations, a proportion identical to our prior report (52.3%). Social worker time per patient was 0.8 hours; a significant reduction from the previous 2.6 hours (P < .01). Cost per patient was $32.73; a significant reduction compared to the previous $77.20 (P < .01). CONCLUSIONS: Programmatic changes to reduce social worker intervention time and target potential patients by likelihood to attend along with constriction of the catchment area led to reduced costs by more than 50%, without impairing CECAP effectiveness.

Economic Analyses of Pathogen-Reduction Technologies in Blood Transfusion: A Systematic Literature Review.

BACKGROUND: Technologies used in the processing of whole blood and blood component products, including pathogen reduction, are continuously being adopted into blood transfusion workflows to improve process efficiencies. However, the economic implications of these technologies are not well understood. With the advent of these new technologies and regulatory guidance on bacterial risk-control strategies, an updated systematic literature review on this topic was warranted. OBJECTIVE: The objective of this systematic literature review was to summarize the current literature on the economic analyses of pathogen-reduction technologies (PRTs). METHODS: A systematic literature review was conducted using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines to identify newly published articles in PubMed, MEDLINE Complete, and EconLit from 1 January 2000 to 17 July 2019 related to economic evaluations of PRTs. Only full-text studies in humans published in English were included in the review. Both budget-impact and cost-effectiveness studies were included; common outcomes included cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: The initial searches identified 433 original abstracts, of which 16 articles were included in the final data extraction and reporting. Seven articles presented cost-effectiveness analyses and nine assessed budget impact. The introduction of PRT increased overall costs, and ICER values ranged widely across cost-effectiveness studies, from below $US150,000/QALY to upwards of $US20,000,000/QALY. This wide range of results was due to a multitude of factors, including comparator selection, target patient population, and scenario analyses included. CONCLUSIONS: Overall, the results of economic evaluations of bacterial risk-control strategies, regardless of mechanism, were highly dependent on the current screening protocols in place. The optimization of blood transfusion safety may not result in decisions made at the willingness-to-pay thresholds commonly seen in pharmaceutical evaluations. Given the critical public health role of blood products, and the potential safety benefits introduced by advancements, it is important to continue building this body of evidence with more transparency and data source heterogeneity. This updated literature review provides global context when making local decisions for the coverage of new and emerging bacterial risk-control strategies.

Manhattan Vision Screening and Follow-up Study in Vulnerable Populations (NYC-SIGHT): Design and Methodology.

PRCIS: The Manhattan Vision Screening and Follow-up Study in Vulnerable Populations is a 5-year prospective, cluster-randomized study to improve detection and management of glaucoma and other eye diseases in vulnerable populations living in affordable housing developments. PURPOSE: To describe the study design and methodology of the Manhattan Vision Screening and Follow-up Study in Vulnerable Populations, which aims to investigate whether community-based vision screenings can improve detection and management of glaucoma, vision impairment, cataract, and other eye diseases among vulnerable populations living in affordable housing developments in upper Manhattan. MATERIALS AND METHODS: This 5-year prospective, cluster-randomized, controlled trial consists of vision screening and referral for follow-up eye care among eligible residents aged 40 and older. Visual acuity, intraocular pressure (IOP), and fundus photography are measured. Participants with visual worse than 20/40, or IOP 23 to 29 mm Hg, or unreadable fundus images fail the screening and are scheduled with the on-site optometrist. Those with an abnormal image and/or IOP ≥30 mm Hg, are assigned as "fast-track" and referred to ophthalmology. Participants living in 7 developments randomized to the Enhanced Intervention Group who fail the screening and need vision correction receive complimentary eyeglasses. Those referred to ophthalmology receive enhanced support with patient navigators to assist with follow-up eye care. Participants living in 3 developments randomized to the Usual Care Group who fail the screening and need vision correction are given an eyeglasses prescription only and a list of optical shops. No enhanced support is given to the Usual Care Group. All participants referred to ophthalmology are assisted in making their initial eye exam appointment. CONCLUSION: This study targets vulnerable populations where they live to ensure improved access to and utilization of eye care services in those who are least likely to seek eye care.

Exploring beliefs about pneumococcal vaccination in a predominantly older African American population: the Pharmacists' Pneumonia Prevention Program (PPPP).

Objectives: To assess the association of the Pharmacists' Pneumonia Prevention Program (PPPP) with changes in beliefs related to pneumonia vaccination (PV) in a predominately older African American population.Methods: PPPP was an educational intervention delivered using a senior center model of care consisting of a formal pharmacist presentation, live skit, small group action planning, and optional PV. A 15-item instrument assessed participants' beliefs at baseline, post-test, and three months across four domains: pharmacists and pharmacies, vaccination, pneumococcal disease, and physicians. Friedman tests and pairwise Wilcoxon signed rank tests were used to determine the statistical significance of the mean change in belief responses across timepoints.Results: 190 older adults participated; the sample was majority female (76.3%) and African American (80.5%), and had a mean age of 74.3 years. Statistically significant improvements in beliefs at post-test were observed in the following domains: pharmacists and pharmacies, vaccination, and the pneumococcal disease; however, some of these gains were incompletely sustained at three months.Conclusion: PPPP positively impacted beliefs post-program regarding the pneumococcal disease, pharmacists and pharmacies, and vaccination; however, sustained efforts may be needed to reinforce these gains.Policy implications: Support for pharmacist educational services in senior centers should be considered.

Prevalence of depressive symptoms and associated factors in an urban, ophthalmic population.

OBJECTIVE: To determine the prevalence of depressive symptoms in an adult ophthalmic patient population and to delineate correlates. DESIGN: Cross-sectional study. PARTICIPANTS: Adult patients (⩾18 years) were approached in general and sub-specialty cornea, retina, and glaucoma ophthalmic clinics. A total of 367 patients from the four clinics were enrolled. METHODS: Depressive symptoms were assessed using the Patient Health Questionnaire-9. A cut-off score of ⩾10 was used to indicate clinically significant depressive symptoms. Patient Health Questionnaire-9 scores were used to evaluate bivariate relationships between depressive symptoms and distance visual acuity, ocular diagnosis, diabetes status, smoking status, demographic information, and medications. RESULTS: The majority of patients were female (52.9%) and Caucasian (48.6%). The mean age was 52.0 years (standard deviation: 16.7). Clinically significant depressive symptoms were present in 19.9% of patients overall; this rate varied slightly by clinic. Patients with low vision and blindness (visual acuity worse than 20/60) were more likely to have depressive symptoms (odds ratio = 2.82; 95% confidence interval: 1.90-4.21). Smoking and diabetes were also associated with depressive symptoms (odds ratio = 3.11 (2.66-3.64) and 3.42 (1.90-6.16), respectively). CONCLUSION: In a sample of urban ophthalmic adult patients, depressive symptoms were highly associated with low vision, smoking, and diabetes. This information can be used to target interventions to those at greatest risk of depressive symptoms.

Analysis of Stakeholder Engagement in the Public Comments of ICER Draft Evidence Reports.

BACKGROUND: Health technology assessment is becoming increasingly important to healthcare payers' decision-making. The Institute for Clinical and Economic Review (ICER) is the most established US-based research group performing value assessments. ICER provides opportunities for stakeholder engagement, including a window of opportunity for public comments on the draft evidence report. Those public comments were reviewed in this study. OBJECTIVES: To determine which stakeholders are most often commenting on ICER technology appraisal reports and to examine what aspects of the reports are the topics of these comments. METHOD: We reviewed 7 ICER reports, which were used to extract stakeholder comments. All the identified comments were evaluated by 2 trained reviewers independently for stakeholder type, comment nature (positive or negative), and focus of comments (eg, methodology, data, real-world experience). Statistical analyses were used to analyze the reports for any associations between the frequency of the comments and the stakeholder type by therapeutic area. RESULTS: A total of 463 comments were identified within the 55 letter submissions identified across the 7 ICER reviews that were included in the study. The quantity of the comments generally reflected the quantity of therapies that were included in the review. Drug manufacturers (63.1%), patients or patient advocacy groups (18.1%), and providers or provider groups (9.7%) were the stakeholders most often engaged in the public comments. The comments most often addressed the methodology of the value assessment (53.8%). Comments about missing data (14%), general criticism (8.2%), and general support (2.2%) were less common. CONCLUSION: ICER is committed to engaging stakeholders in their value assessment process and adapting their strategies to improve such communications. Although ICER aims to influence payer decision-making, drug manufacturers were the most involved stakeholder in the assessment process, and they were most concerned with ICER's methodology. These results show the impact that ICER may have on decision-making in healthcare, emphasize the incentives that ICER drives for certain stakeholders, and highlight areas for further investigation.

Effectiveness of the Care of Persons With Dementia in Their Environments Intervention When Embedded in a Publicly Funded Home- and Community-Based Service Program.

BACKGROUND AND OBJECTIVES: In the absence of effective pharmacotherapy, there is an urgent need to test evidence-based dementia care interventions using pragmatic trial approaches. We present results from a study in which an evidence-based, nonpharmacologic intervention for persons living with Alzheimer's disease and related dementia (ADRD) and their informal caregivers, Care of Persons with Dementia in their Environments (COPE), was tested in a Medicaid and state revenue-funded home and community-based service (HCBS) program. RESEARCH DESIGN AND METHODS: Using pragmatic trial design strategies, persons living with ADRD and their caregivers were randomly assigned as dyads to receive COPE plus usual HCBS (COPE; n = 145 dyads) or usual HCBS only (Usual Care or UC; n = 146 dyads). Outcomes were measured prerandomization, and 4 and 12 months postrandomization. Outcomes for persons living with ADRD included functional independence, activity engagement, self-reported quality of life, and behavioral and psychological symptoms. Caregiver outcomes included perceived well-being, confidence using dementia management strategies, and degree of distress caused by behavioral and psychological symptoms. RESULTS: After 4 months, caregivers receiving COPE reported greater perceived well-being (least squares mean = 3.2; 95% CI: 3.1-3.3) than caregivers receiving UC (3.0; 2.9-3.0; p < .001), and persons living with ADRD receiving COPE, compared to those receiving UC, showed a strong trend toward experiencing less frequent and less severe behavioral and psychological symptoms (9.7; 5.2-14.2 vs 12.7; 8.3-17.1; p = .07). After 12 months, persons living with ADRD receiving COPE were more engaged in meaningful activities (2.1; 2.0-2.1 vs 1.9; 1.9-2.0; p = .02) than those receiving UC. DISCUSSION AND IMPLICATIONS: Embedding COPE in a publicly funded HCBS program yielded positive immediate effects on caregivers' well-being, marginal positive immediate effects on behavioral and psychological symptoms, and long-term effects on meaningful activity engagement among persons living with ADRD. Findings suggest that COPE can be effectively integrated into this service system, an important step towards widespread adoption. CLINICAL TRIALS REGISTRATION NUMBER: NCT02365051.