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INTRODUCTION: 2%-10% of patients with primary hyperparathyroidism (PHPT) who undergo parathyroidectomy develop persistent/recurrent disease. The aim of this study was to determine which preoperative localization method is most cost-effective in reoperative PHPT. METHODS: Clinical decision analytic models comparing cost-effectiveness of localizing studies in reoperative PHPT were constructed using TreeAge Pro. Cost and probability assumptions were varied via Probabilistic Sensitivity Analysis (PSA) to test the robustness of the base case models. RESULTS: Base case analysis of model 1 revealed ultrasound (US)-guided fine-needle aspiration with PTH assay as most cost-effective after localizing US. This was confirmed on PSA of model 1. Model 2 showed four-dimensional computed tomography (4D-CT) as most cost-effective after negative US. If not localized by US, on PSA, 4D-CT was the next most cost-effective test. CONCLUSIONS: US-guided FNA with PTH is the most cost-effective confirmatory test after US localization. 4D-CT should be considered as the next best test after negative US.
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Hiperparatireoidismo Primário , Humanos , Hiperparatireoidismo Primário/cirurgia , Análise Custo-Benefício , Tecnécio Tc 99m Sestamibi , Paratireoidectomia , Tomografia Computadorizada Quadridimensional/métodos , Glândulas Paratireoides/cirurgiaRESUMO
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.
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Cuidadores , Deficiência Intelectual , Humanos , Criança , Deficiências do Desenvolvimento , Coleta de Dados , Fatores EconômicosRESUMO
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.
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Doença de Alzheimer , Adulto , Humanos , Doença de Alzheimer/terapia , Análise de Custo-Efetividade , Análise Custo-Benefício , Cuidadores , Casas de SaúdeRESUMO
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.
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Plaquetas , Transfusão de Plaquetas , Plaquetas/microbiologia , Transfusão de Sangue , Custos e Análise de Custo , Humanos , Transfusão de Plaquetas/métodos , Manejo de EspécimesRESUMO
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.
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Cuidadores/economia , Cuidadores/psicologia , Demência/economia , Demência/terapia , Saúde da Família/economia , Idoso de 80 Anos ou mais , Sintomas Comportamentais , District of Columbia , Feminino , Humanos , Vida Independente/economia , Estudos Longitudinais , Masculino , Maryland , Pessoa de Meia-IdadeRESUMO
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.
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Farmacêuticos , Pneumonia , Negro ou Afro-Americano , Idoso , Feminino , Humanos , Masculino , Peptidoglicano , VacinaçãoRESUMO
The need for Health Economics and Outcomes Research (HEOR) has expanded globally, fueling demand for professionals trained in the discipline. By leveraging the expertise and perspectives of its members, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) established a set of competencies for HEOR professionals. The resulting 41 competencies were organized into 13 topic domains that collectively comprise the ISPOR Health Economics and Outcomes Research Competencies Framework. In this article, we explain the collaborative process used by the ISPOR Institutional Council and Faculty Advisor Council to identify and validate the framework. This process entailed expertise from the council members combined with natural language processing to examine competencies included in ISPOR Career Center HEOR job postings, qualitative input from a focused Institutional Council-Faculty Advisor Council workgroup, and quantitative input from 3 surveys of mutually exclusive member groups: a general member survey to assess importance and relevance of each competency, a faculty member survey to assess the extent to which HEOR graduate degree programs cover each of the competencies, and a student member survey to assess exposure to each of the competencies. Organization of the competencies into topic domains was achieved by engaging the Education Council, which applied a taxonomy consistent with ISPOR's educational programming. The resulting ISPOR Health Economics and Outcomes Research Competencies Framework has the important potential of serving as a tool to guide academic curricula, fellowships, and continuing education programs, and assessment of job candidates. As the HEOR field advances, so do the job types and the breadth of topics in which professionals must demonstrate competence. Future work will entail revisiting the competencies to ensure their currency and comprehensiveness, and tailoring the framework according to major specialty areas.
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Economia Médica/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Farmacoeconomia , Humanos , Inquéritos e QuestionáriosRESUMO
How does the Patient Protection and Affordable Care Act (ACA) of 2010 differ from the act as it stands today? Many changes have occurred, in Medicaid expansion, private insurance coverage, the American Health Benefit Exchanges, and the individual mandate.
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BACKGROUND: Vaccination is the best way to prevent pneumococcal disease (PD), but 40% of older adults remain unvaccinated nationwide, with even greater nonvaccination rates among African Americans (AAs). Prior studies suggest that insufficient knowledge contributes to low vaccination rates. The Pharmacists' Pneumonia Prevention Program (PPPP) was designed to improve older adults' knowledge about PD and pneumococcal vaccination (PV). OBJECTIVE: To measure PPPP's effect on knowledge and activation in a predominantly AA population and determine program costs. METHODS: PPPP uses a senior center model with a pharmacist presentation, actors' skit, and small-group action planning. Knowledge about PD risk, transmission, symptoms, and PV side effects was assessed at baseline (BL), postintervention (PT), and 3 months (M3) and analyzed using an intention-to-treat (ITT) approach. Actions taken (got vaccinated, spoke to doctor or pharmacist, discussed with family/friends) were assessed at M3. PPPP costs ($US 2013) included staff time, PV, actor, and site fees. RESULTS: Of 276 attending PPPP, 190 consented and were included in the ITT sample, which was largely black (80.5%) and female (76.3%) and had a mean age of 74.4 years. Knowledge improved by 46.8% (BL vs PT), with significant gains in all domains. At M3, knowledge improved by 54.2% vs BL, indicating sustained gains; 37.2% of previously unvaccinated participants reported receiving PV by M3. Program cost was $119 per attendee. CONCLUSION: PPPP significantly improved PD and PV knowledge. It could be delivered more efficiently by holding larger events on fewer dates, staffing with volunteers where appropriate, and utilizing a local pharmacy to manage the vaccine supply.
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Promoção da Saúde , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/administração & dosagem , Pneumonia/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Custos e Análise de Custo , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Promoção da Saúde/economia , Humanos , Masculino , Pessoa de Meia-Idade , Farmacêuticos , Vacinas Pneumocócicas/economia , Centros Comunitários para Idosos , Vacinação/economiaRESUMO
PURPOSE: To evaluate the effect of written communication between an ophthalmologist and a primary care physician (PCP) on patient adherence to diabetic eye examination recommendations. METHODS: In a retrospective cohort study of a multiethnic population at an urban ophthalmology center, records of all patients with diabetes and clinic visits between 2007 and 2010 were reviewed. Data collected included patient demographics, insurance status, hemoglobin A1C, severity of diabetic retinopathy, follow-up examinations, and written communication between a patient's ophthalmologist and PCP. Statistical analyses were performed to examine the relationship between physician communication and adherence to diabetic eye examination based on the American Academy of Ophthalmology-published recommendations. RESULTS: A total of 1,968 people with diabetes were included. Written communication from an ophthalmologist to a PCP was associated with increased adherence to follow-up eye examination recommendations (Odds Ratio: 1.49; 95% Confidence Interval: 1.16-1.92; P = 0.0018). Communication from a PCP to an ophthalmologist was also associated with increased adherence (Odds Ratio: 1.94; 95% Confidence Interval: 1.37-2.77; P = 0.0002). Multivariable analysis controlling for other factors associated with examination adherence confirmed that communication both to and from an ophthalmologist was independently and significantly associated with increased follow-up adherence. CONCLUSION: Patients with communication between ophthalmologists and PCPs are more likely to adhere to diabetic eye examinations.
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Comunicação , Retinopatia Diabética/diagnóstico , Relações Interprofissionais , Oftalmologia , Cooperação do Paciente/estatística & dados numéricos , Exame Físico/estatística & dados numéricos , Médicos de Atenção Primária , Adulto , Idoso , Glicemia/metabolismo , Estudos de Coortes , Feminino , Hemoglobinas Glicadas/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , RedaçãoRESUMO
BACKGROUND: Gout is the most common inflammatory arthritis in the United States. OBJECTIVE: To evaluate the cost-effectiveness of urate-lowering treatment strategies for the management of gout. DESIGN: Markov model. DATA SOURCES: Published literature and expert opinion. TARGET POPULATION: Patients for whom allopurinol or febuxostat is a suitable initial urate-lowering treatment. TIME HORIZON: Lifetime. PERSPECTIVE: Health care payer. INTERVENTION: 5 urate-lowering treatment strategies were evaluated: no treatment; allopurinol- or febuxostat-only therapy; allopurinol-febuxostat sequential therapy; and febuxostat-allopurinol sequential therapy. Two dosing scenarios were investigated: fixed dose (80 mg of febuxostat daily, 0.80 success rate; 300 mg of allopurinol daily, 0.39 success rate) and dose escalation (≤120 mg of febuxostat daily, 0.82 success rate; ≤800 mg of allopurinol daily, 0.78 success rate). OUTCOME MEASURES: Discounted costs, discounted quality-adjusted life-years, and incremental cost-effectiveness ratios. RESULTS OF BASE-CASE ANALYSIS: In both dosing scenarios, allopurinol-only therapy was cost-saving. Dose-escalation allopurinol-febuxostat sequential therapy was more costly but more effective than dose-escalation allopurinol therapy, with an incremental cost-effectiveness ratio of $39 400 per quality-adjusted life-year. RESULTS OF SENSITIVITY ANALYSIS: The relative rankings of treatments did not change. Our results were relatively sensitive to several potential variations of model assumptions; however, the cost-effectiveness ratios of dose escalation with allopurinol-febuxostat sequential therapy remained lower than the willingness-to-pay threshold of $109 000 per quality-adjusted life-year. LIMITATION: Long-term outcome data for patients with gout, including medication adherence, are limited. CONCLUSION: Allopurinol single therapy is cost-saving compared with no treatment. Dose-escalation allopurinol-febuxostat sequential therapy is cost-effective compared with accepted willingness-to-pay thresholds. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.
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Alopurinol/economia , Supressores da Gota/economia , Gota/tratamento farmacológico , Anos de Vida Ajustados por Qualidade de Vida , Tiazóis/economia , Alopurinol/administração & dosagem , Redução de Custos , Análise Custo-Benefício , Quimioterapia Combinada/economia , Febuxostat , Gota/economia , Supressores da Gota/administração & dosagem , Humanos , Cadeias de Markov , Modelos Teóricos , Tiazóis/administração & dosagemRESUMO
PURPOSE OF REVIEW: To discuss the risks, benefits and value of genetic testing for ocular genetic disease. RECENT FINDINGS: Testing for ocular genetics diseases is becoming more available and successful gene therapy is being reported. Clinicians must prepare for this trend by considering diagnostic genetic testing for their patients. SUMMARY: As advances continually occur in genetic testing for ocular genetic disorders, clinicians must develop an understanding of the potential risks and benefits for their patients.
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Oftalmopatias Hereditárias/genética , Doenças Genéticas Inatas/genética , Predisposição Genética para Doença , Testes Genéticos , Análise Custo-Benefício , Aconselhamento Genético , Humanos , Medição de RiscoRESUMO
BACKGROUND: Effective care models for treating older African Americans with depressive symptoms are needed. OBJECTIVE: To determine whether a home-based intervention alleviates depressive symptoms and improves quality of life in older African Americans. DESIGN: Parallel, randomized trial stratified by recruitment site. Interviewers assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov: NCT00511680). SETTING: A senior center and participants' homes from 2008 to 2010. PATIENTS: African Americans aged 55 years or older with depressive symptoms. INTERVENTION: A multicomponent, home-based intervention delivered by social workers or a wait-list control group that received the intervention at 4 months. MEASUREMENTS: Self-reported depression severity at 4 months (primary outcome) and depression knowledge, quality of life, behavioral activation, anxiety, function, and remission at 4 and 8 months. RESULTS: Of 208 participants (106 and 102 in the intervention and wait-list groups, respectively), 182 (89 and 93, respectively) completed 4 months and 160 (79 and 81, respectively) completed 8 months. At 4 months, participants in the intervention group showed reduced depression severity (difference in mean change in Patient Health Questionnaire-9 score from baseline, -2.9 [95% CI, -4.6 to -1.2]; difference in mean change in Center for Epidemiologic Studies Depression Scale score from baseline, -3.7 [CI, -5.4 to -2.1]); improved depression knowledge, quality of life, behavioral activation, and anxiety (P < 0.001); and improved function (P = 0.014) compared with wait-list participants. More intervention than wait-list participants entered remission at 4 months (43.8% vs. 26.9%). After treatment, control participants showed benefits similar in magnitude to those of participants in the initial intervention group. Those in the initial intervention group maintained benefits at 8 months. LIMITATION: The study had a small sample, short duration, and differential withdrawal rate. CONCLUSION: A home-based intervention delivered by social workers could reduce depressive symptoms and enhance quality of life in most older African Americans. PRIMARY FUNDING SOURCE: National Institute of Mental Health.
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Negro ou Afro-Americano , Depressão/etnologia , Depressão/terapia , Serviços de Assistência Domiciliar , Afeto , Idoso , Ansiedade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Método Simples-Cego , Listas de EsperaRESUMO
PURPOSE: To compare societal values across three health-state classification systems in older African Americans with depression and to describe the association of these instruments to depression severity. METHODS: We summarized baseline values for EQ-5D (US weights) and HUI2/3 (Canadian weights) and their subscales for 118 older African American participants enrolled in a randomized depression treatment trial and calculated correlations between the different instruments. We evaluated ceiling and floor effects for each instrument by comparing the proportion at the highest and lowest possible score for each tool. Also, utility scores were assessed by level of depression severity (mild, moderate, moderate severe, severe) scores as measured by the Patient Health Questionnaire (PHQ-9). RESULTS: Mean utility values were 0.58 (SD = 0.21) for EQ-5D, 0.52 (SD = 0.21) for HUI2, and 0.36 (SD = 0.31) for HUI3. For the EQ-5D, 72 % of participants reported having some problems on the anxiety/depression domain. On the emotion domain for the HUI2, 23 % reported the highest level of impairment compared to only 3 % on the HUI3. No participant scored at the floor for the EQ-5D, HUI2, or HUI3 index; one participant scored at the ceiling value on the HUI3 index. Correlations ranged from 0.63 to 0.82 (all of which were significant at an alpha level of 0.05). In general, utility scores trended inversely with depression level. CONCLUSION: Small differences in the three preference-weighted health-state classification systems were evident for this sample of older African Americans with depressive symptoms, with HUI scores lower than EQ-5D. For this sample, utility scores were lower (i.e., poorer) than the general United States population with depression on each utility measure.
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Negro ou Afro-Americano/psicologia , Efeitos Psicossociais da Doença , Depressão/psicologia , Medição da Dor/normas , Psicometria/instrumentação , Qualidade de Vida , Inquéritos e Questionários , Atividades Cotidianas , Adulto , Idoso , Análise de Variância , Análise Custo-Benefício , Depressão/economia , Depressão/etnologia , Depressão/terapia , Feminino , Nível de Saúde , Indicadores Básicos de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor/métodos , Índice de Gravidade de Doença , Perfil de Impacto da Doença , Fatores Socioeconômicos , Resultado do Tratamento , Estados UnidosRESUMO
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.
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Demência , Qualidade de Vida , Humanos , Cuidadores , Custos de Cuidados de Saúde , Aceitação pelo Paciente de Cuidados de Saúde , Demência/terapiaRESUMO
Black individuals with diabetes have high rates of emergency department (ED) use. This randomized controlled trial compared the efficacy of Diabetes Interprofessional Team to Enhance Adherence to Medical Care (DM I-TEAM) versus Usual Medical Care (UMC) to reduce number of return ED visits/hospitalizations over 12 months in 200 Black individuals with diabetes after an ED visit. DM I-TEAM consisted of community health worker-delivered diabetes education and behavior activation, telehealth visits with a diabetes nurse educator and primary care physicians, and clinical pharmacist recommendations to reduce potentially inappropriate medications (PIMs). Secondary outcomes included glycemic control, PIMs use, diabetes self-management, diabetes self-efficacy, depression, and medical trust. Participants had a mean age of 64.9 years and 73.0% were women. The 2 treatment groups were similar in baseline characteristics. Sixty-eight (69.4%) DM I-TEAM participants and 69 (67.6%) UMC participants had at least 1 incident ED visit/hospitalization over 12 months. The adjusted incidence rate ratio for DM I-TEAM versus UMC was 1.11 (95% confidence interval 0.79-1.56; P = 0.54). DM I-TEAM participants attained significantly better diabetes self-management, diabetes self-efficacy, and institutional trust than UMC participants. There were no treatment group differences in hemoglobin A1c level nor PIMs use. Among Black individuals with diabetes, a novel culturally relevant intervention was no better than usual care at preventing return ED visits/hospitalizations over 1 year. Before reasonable clinical interventions such as DM I-TEAM can be effective, reducing system-level barriers to health, building community health care capacity, and designing interventions that better align with the everyday realities of patients' lives are necessary. clinicaltrials.gov NCT03393338.