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Improving TRansitions ANd outcomeS for heart FailurE patients in home health CaRe (I-TRANSFER-HF): a type 1 hybrid effectiveness-implementation trial: study protocol

Sterling, Madeline R; Espinosa, Cisco G; Spertus, Daniel; Shum, Michelle; McDonald, Margaret V; Ryvicker, Miriam B; Barrón, Yolanda; Tobin, Jonathan N; Kern, Lisa M; Safford, Monika M; Banerjee, Samprit; Goyal, Parag; Ringel, Joanna Bryan; Rajan, Mangala; Arbaje, Alicia I; Jones, Christine D; Dodson, John A; Cené, Crystal; Bowles, Kathryn H
BACKGROUND:Some of the most promising strategies to reduce hospital readmissions in heart failure (HF) is through the timely receipt of home health care (HHC), delivered by Medicare-certified home health agencies (HHAs), and outpatient medical follow-up after hospital discharge. Yet national data show that only 12% of Medicare beneficiaries receive these evidence-based practices, representing an implementation gap. To advance the science and improve outcomes in HF, we will test the effectiveness and implementation of an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF), comprised of early and intensive HHC nurse visits combined with an early outpatient medical visit post-discharge, among HF patients receiving HHC. METHODS:This study will use a Hybrid Type 1, stepped wedge randomized trial design, to test the effectiveness and implementation of I-TRANSFER-HF in partnership with four geographically diverse dyads of hospitals and HHAs ("hospital-HHA" dyads) across the US. Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome), and increase days at home (secondary outcome) among HF patients who receive timely follow-up compared to usual care. Hospital-HHA dyads will be randomized to cross over from a baseline period of no intervention to the intervention in a randomized sequential order. Medicare claims data from each dyad and from comparison dyads selected within the national dataset will be used to ascertain outcomes. Hypotheses will be tested with generalized mixed models. Aim 2 will assess the determinants of I-TRANSFER-HF's implementation using a mixed-methods approach and is guided by the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0). Qualitative interviews will be conducted with key stakeholders across the hospital-HHA dyads to assess acceptability, barriers, and facilitators of implementation; feasibility and process measures will be assessed with Medicare claims data. DISCUSSION/CONCLUSIONS:As the first pragmatic trial of promoting timely HHC and outpatient follow-up in HF, this study has the potential to dramatically improve care and outcomes for HF patients and produce novel insights for the implementation of HHC nationally. TRIAL REGISTRATION/BACKGROUND:This trial has been registered on ClinicalTrials.Gov (#NCT06118983). Registered on 10/31/2023, https://clinicaltrials.gov/study/NCT06118983?id=NCT06118983&rank=1 .
PMCID:11443790
PMID: 39354472
ISSN: 1472-6963
CID: 5706792

Developing an Individualized Patient Decision Aid for Chronic Coronary Disease Based on the ISCHEMIA Trial: A Mixed-Methods Study

Nguyen, Dan D; Decker, Carole; Pacheco, Christina M; Farr, Stacy L; Fuss, Christine; Masterson Creber, Ruth M; Pena, Stephanie; Ikemura, Nobuhiro; Uzendu, Anezi I; Maron, David J; Hochman, Judith S; Dodson, John A; Spertus, John A
BACKGROUND/UNASSIGNED:Pursuing initial invasive or conservative management of chronic coronary disease (CCD) is a preference-sensitive decision that should include shared decision-making. Communicating the benefits of either approach is challenging, as individual patients rarely achieve the population-averaged outcomes reported in clinical trials. Our objective was to develop a patient decision aid (PDA) with patient-specific estimates of outcomes for initial invasive versus conservative management of CCD, based on the ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches). METHODS/UNASSIGNED:This was a multiphase mixed-methods study using focus groups of outpatients with CCD, caregivers, clinicians, and researchers. Focus groups were held in Kansas City, MO and New York City, NY between September 2021 and June 2022. Patients with CCD were included if they had a positive stress test within 1 year. Phase 1 focused on patient priorities for outcomes to guide treatment decisions. Phase 2 involved PDA development and refinement. Phase 3 involved further refinement and member checking. Key themes involving shared decision-making and treatment preferences were elicited from focus groups using a deductive approach to develop a PDA representing the outcomes most important to patients. RESULTS/UNASSIGNED:Of 46 patient and caregiver participants, the mean age was 63.5 years, 53% were female, 61% were White, 24% were Black, and 9% were Hispanic. When deciding between treatments, participants valued shared decision-making but generally deferred decisions to clinicians. The outcomes most important to participants were survival and quality of life, followed by physical functioning and symptoms. To represent these outcomes, participants favored simple visualizations, such as a speedometer or health meter. When deciding between treatment options, participants preferred to use the PDA collaboratively with a clinician instead of as a stand-alone tool. CONCLUSIONS/UNASSIGNED:Our novel, patient-centered approach to developing a PDA for CCD with patient-specific outcomes has the potential to rapidly translate clinical trial results to individual patients and support shared decision-making.
PMID: 39301725
ISSN: 1941-7705
CID: 5711202

Progression of frailty and cardiovascular outcomes among Medicare beneficiaries

Gong, Yusi; Song, Yang; Xu, Jiaman; Dong, Huaying; Kramer, Daniel B; Orkaby, Ariela R; Dodson, John A; Strom, Jordan B
BACKGROUND:Frailty is associated with adverse cardiovascular outcomes independent of age and comorbidities, yet the independent influence of frailty progression on cardiovascular outcomes remains uncertain. METHODS:To determine whether frailty progression is associated with adverse cardiovascular outcomes, independent of baseline frailty and age, we evaluated all Medicare Fee-for-Service beneficiaries ≥65 years at cohort inception with continuous enrollment from 2003 to 2015. Linear mixed effects models, adjusted for baseline frailty and age, were used to estimate change in a validated claims-based frailty index (CFI) over a 5-year period. Survival analysis was used to examine frailty progression and risk of adverse health outcomes. RESULTS:There were 8.9 million unique patients identified, mean age 77.3 ± 7.2 years, 58.7% female, 10.9% non-White race. In total, 60% had frailty progression and 40% frailty regression over median follow-up of 2.4 years. Compared to those with frailty regression, when adjusting for age and baseline CFI, those with frailty progression had a significantly greater risk of incident major adverse cardiovascular and cerebrovascular events (MACCE) (hazard ratio [HR] 1.31, 95% confidence interval [CI] 1.31-1.31), all-cause mortality (HR 1.34, 95% CI 1.34-1.34), acute myocardial infarction (HR 1.08, 95% CI 1.07-1.09), heart failure exacerbation (HR 1.30, 95% CI 1.29-1.30), ischemic stroke (HR 1.14, 95% CI 1.14-1.15). There was also a graded increase in risk of each outcome with more rapid progression, as well as significantly fewer days alive at home (DAH) with more rapid progression compared to the slowest progression group (270.4 ± 112.3 vs. 308.6 ± 93.0 days, rate ratio 0.88, 95% CI 0.87-0.88, p < 0.001). CONCLUSIONS:In this large, nationwide sample of older Medicare beneficiaries, frailty progression, independent of age and baseline frailty, was associated with fewer DAH and a graded risk of MACCE, all-cause mortality, myocardial infarction, heart failure, and ischemic stroke compared to those with frailty regression.
PMID: 39091085
ISSN: 1532-5415
CID: 5705632

Decline in use of high-risk agents for tight glucose control among older adults with diabetes in New York City: 2017-2022

Zhang, Jeff; Kanchi, Rania; Conderino, Sarah; Levy, Natalie K; Adhikari, Samrachana; Blecker, Saul; Davis, Nichola; Divers, Jasmin; Rabin, Catherine; Weiner, Mark; Thorpe, Lorna; Dodson, John A
BACKGROUND:This study aimed to examine the prevalence of inappropriate tight glycemic control in older adults with type 2 diabetes and other chronic conditions in New York City, and to identify factors associated with this practice. METHODS:We conducted a retrospective cohort study using the INSIGHT Clinical Research Network. The study population included 11,728 and 15,196 older adults in New York City (age ≥ 75 years) with a diagnosis of type 2 diabetes, and at least one other chronic medical condition, in 2017 and 2022, respectively. The main outcome of interest was inappropriate tight glycemic control, defined as HbA1c <7.0% (<53 mmol/mol) with prescription of at least one high-risk agent (insulin or insulin secretagogue). RESULTS:The proportion of older adults with inappropriate tight glycemic control decreased by nearly 19% over a five-year period (19.4% in 2017 to 15.8% in 2022). There was a significant decrease in insulin (27.8% in 2017; 24.3% in 2022) and sulfonylurea (29.4% in 2017; 21.7% in 2022) medication prescription, and increase in use of GLP-1 agonists (1.8% in 2017; 11.4% in 2022) and SGLT-2 inhibitors (5.8% in 2017; 25.1% in 2022), among the total population. Factors associated with inappropriate tight glycemic control in 2022 included history of heart failure (adjusted odds ratio [aOR] 1.38), chronic kidney disease ([aOR] 1.93), colorectal cancer ([aOR] 1.38), acute myocardial infarction ([aOR] 1.28), "other" ([aOR] 0.72) or "unknown" ([aOR] 0.72) race, and a point increase in BMI ([aOR] 0.98). CONCLUSIONS:We found an encouraging trend toward less use of high-risk medication strategies for older adults with type 2 diabetes and multiple chronic conditions. However, one in six patients in 2022 still had inappropriate tight glycemic control, indicating a need for continued efforts to optimize diabetes management in this population.
PMCID:11368607
PMID: 38980267
ISSN: 1532-5415
CID: 5687172

Sarcopenia Is a Risk Factor for Postoperative Complications Among Older Adults With Inflammatory Bowel Disease

Minawala, Ria; Kim, Michelle; Delau, Olivia; Ghiasian, Ghoncheh; McKenney, Anna Sophia; Da Luz Moreira, Andre; Chodosh, Joshua; McAdams-DeMarco, Mara; Segev, Dorry L; Adhikari, Samrachana; Dodson, John; Shaukat, Aasma; Dane, Bari; Faye, Adam S
BACKGROUND:Sarcopenia has been associated with adverse postoperative outcomes in older age cohorts, but has not been assessed in older adults with inflammatory bowel disease (IBD). Further, current assessments of sarcopenia among all aged individuals with IBD have used various measures of muscle mass as well as cutoffs to define its presence, leading to heterogeneous findings. METHODS:In this single-institution, multihospital retrospective study, we identified all patients aged 60 years and older with IBD who underwent disease-related intestinal resection between 2012 and 2022. Skeletal Muscle Index (SMI) and Total Psoas Index (TPI) were measured at the superior L3 endplate on preoperative computed tomography scans and compared through receiver operating characteristic curve. We then performed multivariable logistic regression to assess risk factors associated with an adverse 30-day postoperative outcome. Our primary outcome included a 30-day composite of postoperative mortality and complications, including infection, bleeding, cardiac event, cerebrovascular accident, acute kidney injury, venous thromboembolism, reoperation, all-cause rehospitalization, and need for intensive care unit-level care. RESULTS:A total of 120 individuals were included. Overall, 52% were female, 40% had ulcerative colitis, 60% had Crohn's disease, and median age at time of surgery was 70 years (interquartile range: 65-75). Forty percent of older adults had an adverse 30-day postoperative outcome, including infection (23%), readmission (17%), acute kidney injury (13%), bleeding (13%), intensive care unit admission (10%), cardiac event (8%), venous thromboembolism (7%), reoperation (6%), mortality (5%), and cerebrovascular accident (2%). When evaluating the predictive performance of SMI vs TPI for an adverse 30-day postoperative event, SMI had a significantly higher area under the curve of 0.66 (95% CI, 0.56-0.76) as compared to 0.58 (95% CI, 0.48-0.69) for TPI (P = .02). On multivariable logistic regression, prior IBD-related surgery (adjusted odds ratio [adjOR] 6.46, 95% CI, 1.85-22.51) and preoperative sepsis (adjOR 5.74, 95% CI, 1.36-24.17) significantly increased the odds of adverse postoperative outcomes, whereas increasing SMI was associated with a decreased risk of an adverse postoperative outcome (adjOR 0.88, 95% CI, 0.82-0.94). CONCLUSIONS:Sarcopenia, as measured by SMI, is associated with an increased risk of postoperative complications among older adults with IBD. Measurement of SMI from preoperative imaging can help risk stratify older adults with IBD undergoing intestinal resection.
PMID: 39177976
ISSN: 1536-4844
CID: 5681162

Severe Polypharmacy Increases Risk of Hospitalization Among Older Adults with IBD

Drittel, Darren; Schreiber-Stainthorp, William; Delau, Olivia; Gurunathan, Sakteesh V; Chodosh, Joshua; Segev, Dorry L; McAdams-DeMarco, Mara; Katz, Seymour; Dodson, John; Shaukat, Aasma; Faye, Adam S
BACKGROUND:As the inflammatory bowel disease (IBD) patient population is aging, the prevalence of polypharmacy is rising. However, data exploring the prevalence, risk factors, and clinical outcomes associated with polypharmacy among older adults with IBD are limited. AIMS/OBJECTIVE:To determine (i) prevalence of polypharmacy (≥5 medications) and potentially inappropriate medication (PIM) utilization in older adults with IBD, (ii) changes in medications over time (iii) predictors of polypharmacy, and (iv) the impact of polypharmacy/PIMs on one-year hospitalization rates. METHODS:We conducted a retrospective single-center study of older adults with IBD from September 1st 2011 to December 31st 2022. Wilcoxon-signed rank and McNemar's tests were used to assess changes in polypharmacy between visits, with ordinal logistic regression and Cox proportional hazards models used to determine risk factors for polypharmacy and time to hospitalization, respectively. RESULTS:Among 512 older adults with IBD, 74.0% experienced polypharmacy at initial visit, with 42.6% receiving at least one PIM. Additionally, severe polypharmacy (≥10 medications) was present among 28.6% individuals at index visit and increased to 38.6% by last visit (p<0.01). Multivariable analysis revealed that age ≥70 years, BMI ≥30.0 kg/m2, prior IBD-related surgery, and the presence of comorbidities were associated with polypharmacy. Moreover, severe polypharmacy (adjHR 1.95, 95%CI 1.29-2.92), as well as PIM use (adjHR 2.16, 95%CI 1.37-3.43) among those with polypharmacy, were significantly associated with all-cause hospitalization within a year of index visit. DISCUSSION/CONCLUSIONS:Severe polypharmacy was initially present in more than 25% of older adults with IBD and increased to 34% within 4 years of index visit. Severe polypharmacy, as well as PIM utilization among those with polypharmacy, were also associated with an increased risk of hospitalization at one-year, highlighting the need for deprescribing efforts in this population.
PMID: 39162710
ISSN: 1572-0241
CID: 5680582

Descriptive Epidemiology of New York City Older Adult Patients With Multiple Chronic Conditions

Conderino, Sarah; Dodson, John; Meng, Yuchen; Weiner, Mark G; Rabin, Catherine; Jacobs, Wilson; Bakshi, Parampreet; Lee, Melissa; Uguru, Jenny; Thorpe, Lorna E
We characterized comorbidity profiles and cardiometabolic risk factors among older adults with multiple chronic conditions (MCCs) in New York City using an intersectionality approach. Electronic health record data were obtained from the INSIGHT Clinical Research Network on 367,901 New York City residents aged 50 years or older with MCCs. Comorbidity profiles were heterogeneous. The most common profile across sex and racial and ethnic groups was co-occurring hypertension and hyperlipidemia; prevalence of these 2 conditions differed across groups (4.7%-7.3% co-occurrence alone, 65.1%-88.0% with other conditions). Significant sex and racial and ethnic differences were observed, which may reflect accumulated disparities in risk factors and health care access across the life course.
PMCID:11318948
PMID: 39089737
ISSN: 1545-1151
CID: 5696582

Goal setting among older adults starting mobile health cardiac rehabilitation in the RESILIENT trial

Shwayder, Elianna; Dodson, John A; Tellez, Kelly; Johanek, Camila; Adhikari, Samrachana; Meng, Yuchen; Schoenthaler, Antoinette; Jennings, Lee A
BACKGROUND:There is growing recognition that healthcare should align with individuals' health priorities; however, these priorities remain undefined, especially among older adults. The Rehabilitation Using Mobile Health for Older Adults with Ischemic Heart Disease in the Home Setting (RESILIENT) trial, designed to test the efficacy of mobile health cardiac rehabilitation (mHealth-CR) in an older cohort, also measures the attainment of participant-defined health outcome goals as a prespecified secondary endpoint. This study aimed to characterize the health priorities of older adults with ischemic heart disease (IHD) using goal attainment scaling-a technique for measuring individualized goal achievement-in a sample of 100 RESILIENT participants. METHODS:The ongoing RESILIENT trial randomizes patients aged ≥65 years with IHD (defined as hospitalization for acute coronary syndrome and/or coronary revascularization), to receive mHealth-CR or usual care. For the current study, we qualitatively coded baseline goal attainment scales from randomly selected batches of 20 participants to identify participants' cardiac rehabilitation outcome goals and their perceptions of barriers and action plans for goal attainment. We used a deductive framework (i.e., 4 value categories from Patient Priorities Care) and inductive approaches to code and analyze interviews until thematic saturation. RESULTS:This sample of 100 older adults set diverse health outcome goals. Most (54.6%) prioritized physical activity, fewer (17.1%) identified symptom management, fewer still (13.7%) prioritized health metrics, mostly comprised of weight loss goals (10.3%), and the fewest (<4%) were related to clinical metrics such as reducing cholesterol or preventing hospital readmission. Participants anticipated extrinsic (access to places to exercise, time) and intrinsic (non-cardiac pain, motivation) barriers. Action plans detailed strategies for exercise, motivation, accountability, and overcoming time constraints. CONCLUSIONS:Using goal attainment scaling, we elicited specific and measurable goals among older adults with IHD beginning cardiac rehabilitation. Priorities were predominantly functional, diverging from clinical metrics emphasized by clinicians and healthcare systems.
PMCID:11226380
PMID: 38450759
ISSN: 1532-5415
CID: 5694552

Predicting Risk of Alzheimer's Diseases and Related Dementias with AI Foundation Model on Electronic Health Records

Zhu, Weicheng; Tang, Huanze; Zhang, Hao; Rajamohan, Haresh Rengaraj; Huang, Shih-Lun; Ma, Xinyue; Chaudhari, Ankush; Madaan, Divyam; Almahmoud, Elaf; Chopra, Sumit; Dodson, John A; Brody, Abraham A; Masurkar, Arjun V; Razavian, Narges
Early identification of Alzheimer's disease (AD) and AD-related dementias (ADRD) has high clinical significance, both because of the potential to slow decline through initiating FDA-approved therapies and managing modifiable risk factors, and to help persons living with dementia and their families to plan before cognitive loss makes doing so challenging. However, substantial racial and ethnic disparities in early diagnosis currently lead to additional inequities in care, urging accurate and inclusive risk assessment programs. In this study, we trained an artificial intelligence foundation model to represent the electronic health records (EHR) data with a vast cohort of 1.2 million patients within a large health system. Building upon this foundation EHR model, we developed a predictive Transformer model, named TRADE, capable of identifying risks for AD/ADRD and mild cognitive impairment (MCI), by analyzing the past sequential visit records. Amongst individuals 65 and older, our model was able to generate risk predictions for various future timeframes. On the held-out validation set, our model achieved an area under the receiver operating characteristic (AUROC) of 0.772 (95% CI: 0.770, 0.773) for identifying the AD/ADRD/MCI risks in 1 year, and AUROC of 0.735 (95% CI: 0.734, 0.736) in 5 years. The positive predictive values (PPV) in 5 years among individuals with top 1% and 5% highest estimated risks were 39.2% and 27.8%, respectively. These results demonstrate significant improvements upon the current EHR-based AD/ADRD/MCI risk assessment models, paving the way for better prognosis and management of AD/ADRD/MCI at scale.
PMCID:11071573
PMID: 38712223
CID: 5662732

Association between visit frequency, continuity of care, and pharmacy fill adherence in heart failure patients

Hamo, Carine E; Mukhopadhyay, Amrita; Li, Xiyue; Zheng, Yaguang; Kronish, Ian M; Chunara, Rumi; Dodson, John; Adhikari, Samrachana; Blecker, Saul
BACKGROUND:Despite advances in medical therapy for heart failure with reduced ejection fraction (HFrEF), major gaps in medication adherence to guideline-directed medical therapies (GDMT) remain. Greater continuity of care may impact medication adherence and reduced hospitalizations. METHODS:We conducted a cross-sectional study of adults with a diagnosis of HF and EF ≤40% with ≥2 outpatient encounters between January 1, 2017 and January 10, 2021, prescribed ≥1 of the following GDMT: 1) Beta Blocker, 2) Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker/Angiotensin Receptor Neprilysin Inhibitor, 3) Mineralocorticoid Receptor Antagonist, 4) Sodium Glucose Cotransporter-2 Inhibitor. Continuity of care was calculated using the Bice-Boxerman Continuity of Care Index (COC) and the Usual Provider of Care (UPC) index, categorized by quantile. The primary outcome was adherence to GDMT, defined as average proportion of days covered ≥80% over 1 year. Secondary outcomes included all-cause and HF hospitalization at 1-year. We performed multivariable logistic regression analyses adjusted for demographics, insurance status, comorbidity index, number of visits and neighborhood SES index. RESULTS:Overall, 3,971 individuals were included (mean age 72 years (SD 14), 71% male, 66% White race). In adjusted analyses, compared to individuals in the highest COC quartile, individuals in the third COC quartile had higher odds of GDMT adherence (OR 1.26, 95% CI 1.03-1.53, P = .024). UPC tertile was not associated with adherence (all P > .05). Compared to the highest quantiles, the lowest UPC and COC quantiles had higher odds of all-cause (UPC: OR 1.53, 95%CI 1.23-1.91; COC: OR 2.54, 95%CI 1.94-3.34) and HF (UPC: OR 1.81, 95%CI 1.23-2.67; COC: OR 1.77, 95%CI 1.09-2.95) hospitalizations. CONCLUSIONS:Continuity of care was not associated with GDMT adherence among patients with HFrEF but lower continuity of care was associated with increased all-cause and HF-hospitalizations.
PMID: 38621576
ISSN: 1097-6744
CID: 5657402