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Impact of Visit Volume on the Effectiveness of Electronic Tools to Improve Heart Failure Care

Mukhopadhyay, Amrita; Reynolds, Harmony R; King, William C; Phillips, Lawrence M; Nagler, Arielle R; Szerencsy, Adam; Saxena, Archana; Klapheke, Nathan; Katz, Stuart D; Horwitz, Leora I; Blecker, Saul
BACKGROUND:Electronic health record (EHR) tools can improve prescribing of guideline-recommended therapies for heart failure with reduced ejection fraction (HFrEF), but their effectiveness may vary by physician workload. OBJECTIVES/OBJECTIVE:This paper aims to assess whether physician workload modifies the effectiveness of EHR tools for HFrEF. METHODS:This was a prespecified subgroup analysis of the BETTER CARE-HF (Building Electronic Tools to Enhance and Reinforce Cardiovascular Recommendations for Heart Failure) cluster-randomized trial, which compared effectiveness of an alert vs message vs usual care on prescribing of mineralocorticoid antagonists (MRAs). The trial included adults with HFrEF seen in cardiology offices who were eligible for and not prescribed MRAs. Visit volume was defined at the cardiologist-level as number of visits per 6-month study period (high = upper tertile vs non-high = remaining). Analysis at the patient-level used likelihood ratio test for interaction with log-binomial models. RESULTS:Among 2,211 patients seen by 174 cardiologists, 932 (42.2%) were seen by high-volume cardiologists (median: 1,853; Q1-Q3: 1,637-2,225 visits/6 mo; and median: 10; Q1-Q3: 9-12 visits/half-day). MRA was prescribed to 5.5% in the high-volume vs 14.8% in the non-high-volume groups in the usual care arm, 10.3% vs 19.6% in the message arm, and 31.2% vs 28.2% in the alert arm, respectively. Visit volume modified treatment effect (P for interaction = 0.02) such that the alert was more effective in the high-volume group (relative risk: 5.16; 95% CI: 2.57-10.4) than the non-high-volume group (relative risk: 1.93; 95% CI: 1.29-2.90). CONCLUSIONS:An EHR-embedded alert increased prescribing by >5-fold among patients seen by high-volume cardiologists. Our findings support use of EHR alerts, especially in busy practice settings. (Building Electronic Tools to Enhance and Reinforce Cardiovascular Recommendations for Heart Failure [BETTER CARE-HF]; NCT05275920).
PMID: 38043045
ISSN: 2213-1787
CID: 5597482

Efficacy and Impact of a Multimodal Intervention on CT Pulmonary Angiography Ordering Behavior in the Emergency Department

Gyftopoulos, Soterios; Simon, Emma; Swartz, Jordan L; Smith, Silas W; Martinez, Leticia Santos; Babb, James S; Horwitz, Leora I; Makarov, Danil V
OBJECTIVE:To evaluate the efficacy of a multimodal intervention in reducing CT pulmonary angiography (CTPA) overutilization in the evaluation of suspected pulmonary embolism in the emergency department (ED). METHODS:Previous mixed-methods analysis of barriers to guideline-concordant CTPA ordering results was used to develop a provider-focused behavioral intervention consisting of a clinical decision support tool and an audit and feedback system at a multisite, tertiary academic network. The primary outcome (guideline concordance) and secondary outcomes (yield and CTPA and D-dimer order rates) were compared using a pre- and postintervention design. ED encounters for adult patients from July 5, 2017, to January 3, 2019, were included. Fisher's exact tests and statistical process control charts were used to compare the pre- and postintervention groups for each outcome. RESULTS:Of the 201,912 ED patient visits evaluated, 3,587 included CTPA. Guideline concordance increased significantly after the intervention, from 66.9% to 77.5% (P < .001). CTPA order rate and D-dimer order rate also increased significantly, from 17.1 to 18.4 per 1,000 patients (P = .035) and 30.6 to 37.3 per 1,000 patients (P < .001), respectively. Percent yield showed no significant change (12.3% pre- versus 10.8% postintervention; P = .173). Statistical process control analysis showed sustained special-cause variation in the postintervention period for guideline concordance and D-dimer order rates, temporary special-cause variation for CTPA order rates, and no special-cause variation for percent yield. CONCLUSION/CONCLUSIONS:Our success in increasing guideline concordance demonstrates the efficacy of a mixed-methods, human-centered approach to behavior change. Given that neither of the secondary outcomes improved, our results may demonstrate potential limitations to the guidelines directing the ordering of CTPA studies and D-dimer ordering.
PMID: 37247831
ISSN: 1558-349x
CID: 5543162

Measuring Equity in Readmission as a Distinct Assessment of Hospital Performance

Nash, Katherine A; Weerahandi, Himali; Yu, Huihui; Venkatesh, Arjun K; Holaday, Louisa W; Herrin, Jeph; Lin, Zhenqiu; Horwitz, Leora I; Ross, Joseph S; Bernheim, Susannah M
IMPORTANCE:Equity is an essential domain of health care quality. The Centers for Medicare & Medicaid Services (CMS) developed 2 Disparity Methods that together assess equity in clinical outcomes. OBJECTIVES:To define a measure of equitable readmissions; identify hospitals with equitable readmissions by insurance (dual eligible vs non-dual eligible) or patient race (Black vs White); and compare hospitals with and without equitable readmissions by hospital characteristics and performance on accountability measures (quality, cost, and value). DESIGN, SETTING, AND PARTICIPANTS:Cross-sectional study of US hospitals eligible for the CMS Hospital-Wide Readmission measure using Medicare data from July 2018 through June 2019. MAIN OUTCOMES AND MEASURES:We created a definition of equitable readmissions using CMS Disparity Methods, which evaluate hospitals on 2 methods: outcomes for populations at risk for disparities (across-hospital method); and disparities in care within hospitals' patient populations (within-a-single-hospital method). EXPOSURES:Hospital patient demographics; hospital characteristics; and 3 measures of hospital performance-quality, cost, and value (quality relative to cost). RESULTS:Of 4638 hospitals, 74% served a sufficient number of dual-eligible patients, and 42% served a sufficient number of Black patients to apply CMS Disparity Methods by insurance and race. Of eligible hospitals, 17% had equitable readmission rates by insurance and 30% by race. Hospitals with equitable readmissions by insurance or race cared for a lower percentage of Black patients (insurance, 1.9% [IQR, 0.2%-8.8%] vs 3.3% [IQR, 0.7%-10.8%], P < .01; race, 7.6% [IQR, 3.2%-16.6%] vs 9.3% [IQR, 4.0%-19.0%], P = .01), and differed from nonequitable hospitals in multiple domains (teaching status, geography, size; P < .01). In examining equity by insurance, hospitals with low costs were more likely to have equitable readmissions (odds ratio, 1.57 [95% CI, 1.38-1.77), and there was no relationship between quality and value, and equity. In examining equity by race, hospitals with high overall quality were more likely to have equitable readmissions (odds ratio, 1.14 [95% CI, 1.03-1.26]), and there was no relationship between cost and value, and equity. CONCLUSION AND RELEVANCE:A minority of hospitals achieved equitable readmissions. Notably, hospitals with equitable readmissions were characteristically different from those without. For example, hospitals with equitable readmissions served fewer Black patients, reinforcing the role of structural racism in hospital-level inequities. Implementation of an equitable readmission measure must consider unequal distribution of at-risk patients among hospitals.
PMID: 38193960
ISSN: 1538-3598
CID: 5626522

Perceptions of Factors Associated With Sustainability of Health Care Innovation Centers

Krelle, Holly; Martinez, Michael; Garry, Kira; Horwitz, Leora I
IMPORTANCE:Innovation centers in US health care systems are increasingly common but variably successful and sustainable. Few studies have examined how and why some centers achieve sustainable success but others do not. OBJECTIVE:To explore whether and how innovation centers in US health care systems are able to successfully sustain themselves over multiple years. DESIGN, SETTING, AND PARTICIPANTS:In this qualitative study, semistructured, qualitative interviews of leaders at 9 innovation centers across the US were conducted from January 1, 2019, to December 31, 2020. Data analysis was conducted from December 2020 to April 2021 using qualitative methods and a deductive framework based on the Consolidated Framework for Implementation Research. Centers were identified through purposeful sampling. The 9 study centers had a mean age of 6 years (range, 2-15 years); most were affiliated with an academic teaching hospital and half with a medical school. Two were wholly separate from the health care system. Two-thirds had fewer than 10 full-time staff members. EXPOSURES:All interviewees were staff of a US-based innovation center. This study did not evaluate particular interventions or innovations. MAIN OUTCOMES AND MEASURES:Perceptions of and views on factors associated with the success and sustainability of innovation centers. RESULTS:Staff interviewed at 9 innovation centers across the US described 3 key activities that appeared to be associated with long-term sustainability: facilitating innovation projects that were valued for quality improvement and cost avoidance, not just return on investment; acting as networking nodes for their institutions; and upskilling staff. These activities were associated with improved institutional culture. Two structural characteristics underpinned successful centers: finding an effective balance between being "internal" and being "external" to the organization and providing practical support and skills otherwise lacking within the wider institution. CONCLUSIONS AND RELEVANCE:This qualitative study of 9 innovation centers explored how centers sustained themselves within US health care institutions and showed that success was often associated with interpersonal relationships and cultural benefits. Independent financial sustainability was not always essential to longevity; systems also valued how centers could create cultures of innovation and upskill staff.
PMID: 37889488
ISSN: 2574-3805
CID: 5614382

Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection

Thaweethai, Tanayott; Jolley, Sarah E; Karlson, Elizabeth W; Levitan, Emily B; Levy, Bruce; McComsey, Grace A; McCorkell, Lisa; Nadkarni, Girish N; Parthasarathy, Sairam; Singh, Upinder; Walker, Tiffany A; Selvaggi, Caitlin A; Shinnick, Daniel J; Schulte, Carolin C M; Atchley-Challenner, Rachel; Alba, George A; Alicic, Radica; Altman, Natasha; Anglin, Khamal; Argueta, Urania; Ashktorab, Hassan; Baslet, Gaston; Bassett, Ingrid V; Bateman, Lucinda; Bedi, Brahmchetna; Bhattacharyya, Shamik; Bind, Marie-Abele; Blomkalns, Andra L; Bonilla, Hector; Bush, Patricia A; Castro, Mario; Chan, James; Charney, Alexander W; Chen, Peter; Chibnik, Lori B; Chu, Helen Y; Clifton, Rebecca G; Costantine, Maged M; Cribbs, Sushma K; Davila Nieves, Sylvia I; Deeks, Steven G; Duven, Alexandria; Emery, Ivette F; Erdmann, Nathan; Erlandson, Kristine M; Ernst, Kacey C; Farah-Abraham, Rachael; Farner, Cheryl E; Feuerriegel, Elen M; Fleurimont, Judes; Fonseca, Vivian; Franko, Nicholas; Gainer, Vivian; Gander, Jennifer C; Gardner, Edward M; Geng, Linda N; Gibson, Kelly S; Go, Minjoung; Goldman, Jason D; Grebe, Halle; Greenway, Frank L; Habli, Mounira; Hafner, John; Han, Jenny E; Hanson, Keith A; Heath, James; Hernandez, Carla; Hess, Rachel; Hodder, Sally L; Hoffman, Matthew K; Hoover, Susan E; Huang, Beatrice; Hughes, Brenna L; Jagannathan, Prasanna; John, Janice; Jordan, Michael R; Katz, Stuart D; Kaufman, Elizabeth S; Kelly, John D; Kelly, Sara W; Kemp, Megan M; Kirwan, John P; Klein, Jonathan D; Knox, Kenneth S; Krishnan, Jerry A; Kumar, Andre; Laiyemo, Adeyinka O; Lambert, Allison A; Lanca, Margaret; Lee-Iannotti, Joyce K; Logarbo, Brian P; Longo, Michele T; Luciano, Carlos A; Lutrick, Karen; Maley, Jason H; Marathe, Jai G; Marconi, Vincent; Marshall, Gailen D; Martin, Christopher F; Matusov, Yuri; Mehari, Alem; Mendez-Figueroa, Hector; Mermelstein, Robin; Metz, Torri D; Morse, Richard; Mosier, Jarrod; Mouchati, Christian; Mullington, Janet; Murphy, Shawn N; Neuman, Robert B; Nikolich, Janko Z; Ofotokun, Ighovwerha; Ojemakinde, Elizabeth; Palatnik, Anna; Palomares, Kristy; Parimon, Tanyalak; Parry, Samuel; Patterson, Jan E; Patterson, Thomas F; Patzer, Rachel E; Peluso, Michael J; Pemu, Priscilla; Pettker, Christian M; Plunkett, Beth A; Pogreba-Brown, Kristen; Poppas, Athena; Quigley, John G; Reddy, Uma; Reece, Rebecca; Reeder, Harrison; Reeves, W B; Reiman, Eric M; Rischard, Franz; Rosand, Jonathan; Rouse, Dwight J; Ruff, Adam; Saade, George; Sandoval, Grecio J; Schlater, Shannon M; Shepherd, Fitzgerald; Sherif, Zaki A; Simhan, Hyagriv; Singer, Nora G; Skupski, Daniel W; Sowles, Amber; Sparks, Jeffrey A; Sukhera, Fatima I; Taylor, Barbara S; Teunis, Larissa; Thomas, Robert J; Thorp, John M; Thuluvath, Paul; Ticotsky, Amberly; Tita, Alan T; Tuttle, Katherine R; Urdaneta, Alfredo E; Valdivieso, Daisy; VanWagoner, Timothy M; Vasey, Andrew; Verduzco-Gutierrez, Monica; Wallace, Zachary S; Ward, Honorine D; Warren, David E; Weiner, Steven J; Welch, Shelley; Whiteheart, Sidney W; Wiley, Zanthia; Wisnivesky, Juan P; Yee, Lynn M; Zisis, Sokratis; Horwitz, Leora I; Foulkes, Andrea S
IMPORTANCE:SARS-CoV-2 infection is associated with persistent, relapsing, or new symptoms or other health effects occurring after acute infection, termed postacute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID. Characterizing PASC requires analysis of prospectively and uniformly collected data from diverse uninfected and infected individuals. OBJECTIVE:To develop a definition of PASC using self-reported symptoms and describe PASC frequencies across cohorts, vaccination status, and number of infections. DESIGN, SETTING, AND PARTICIPANTS:Prospective observational cohort study of adults with and without SARS-CoV-2 infection at 85 enrolling sites (hospitals, health centers, community organizations) located in 33 states plus Washington, DC, and Puerto Rico. Participants who were enrolled in the RECOVER adult cohort before April 10, 2023, completed a symptom survey 6 months or more after acute symptom onset or test date. Selection included population-based, volunteer, and convenience sampling. EXPOSURE:SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES:PASC and 44 participant-reported symptoms (with severity thresholds). RESULTS:A total of 9764 participants (89% SARS-CoV-2 infected; 71% female; 16% Hispanic/Latino; 15% non-Hispanic Black; median age, 47 years [IQR, 35-60]) met selection criteria. Adjusted odds ratios were 1.5 or greater (infected vs uninfected participants) for 37 symptoms. Symptoms contributing to PASC score included postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements. Among 2231 participants first infected on or after December 1, 2021, and enrolled within 30 days of infection, 224 (10% [95% CI, 8.8%-11%]) were PASC positive at 6 months. CONCLUSIONS AND RELEVANCE:A definition of PASC was developed based on symptoms in a prospective cohort study. As a first step to providing a framework for other investigations, iterative refinement that further incorporates other clinical features is needed to support actionable definitions of PASC.
PMID: 37278994
ISSN: 1538-3598
CID: 5536662

Assessment of Patient Education Delivered at Time of Hospital Discharge

Trivedi, Shreya P; Corderman, Sara; Berlinberg, Elyse; Schoenthaler, Antoinette; Horwitz, Leora I
IMPORTANCE:Patient education at time of hospital discharge is critical for smooth transitions of care; however, empirical data regarding discharge communication are limited. OBJECTIVE:To describe whether key communication domains (medication changes, follow-up appointments, disease self-management, red flags, question solicitation, and teach-back) were addressed at the bedside on the day of hospital discharge, by whom, and for how long. DESIGN, SETTING, AND PARTICIPANTS:This quality improvement study was conducted from September 2018 through October 2019 at inpatient medicine floors in 2 urban, tertiary-care teaching hospitals and purposefully sampled patients designated as "discharge before noon." Data analysis was performed from September 2018 to May 2020. EXPOSURES:A trained bedside observer documented all content and duration of staff communication with a single enrolled patient from 7 am until discharge. MAIN OUTCOMES AND MEASURES:Presence of the key communication domains, role of team members, and amount of time spent at the bedside. RESULTS:Discharge days for 33 patients were observed. Patients had a mean (SD) age of 63 (18) years; 14 (42%) identified as White, 15 (45%) were female, and 6 (18%) had a preferred language of Spanish. Thirty patients were discharged with at least 1 medication change. Of these patients, 8 (27%) received no verbal instruction on the change, while 16 of 30 (53%) were informed but not told the purpose of the changes. About half of the patients (15 of 31, 48%) were not told the reason for follow-up appointments, and 18 of 33 (55%) were not given instructions on posthospital disease self-management. Most patients (27 of 33, 81%) did not receive guidance on red-flag signs. While over half of the patients (19 of 33, 58%) were asked if they had any questions, only 1 patient was asked to teach back his understanding of the discharge plan. Median (IQR) total time spent with patients on the day of discharge by interns, senior residents, attending physicians, and nurses was 4.0 (0.75-6.0), 1.0 (0-2.0), 3.0 (0.5-7.0), and 22.5 (15.5-30.0) minutes, respectively. Most of the time was spent discussing logistics rather than discharge education. CONCLUSIONS AND RELEVANCE:In this quality improvement study, patients infrequently received discharge education in key communication domains, potentially leaving gaps in patient knowledge. Interventions to improve the hospital discharge process should address the content, method of delivery, and transparency among team members regarding patient education.
PMID: 36939674
ISSN: 2168-6114
CID: 5502462

Cluster-Randomized Trial Comparing Ambulatory Decision Support Tools to Improve Heart Failure Care

Mukhopadhyay, Amrita; Reynolds, Harmony R; Phillips, Lawrence M; Nagler, Arielle R; King, William C; Szerencsy, Adam; Saxena, Archana; Aminian, Rod; Klapheke, Nathan; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Mineralocorticoid receptor antagonists (MRA) are under-prescribed for patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVE:To compare effectiveness of two automated, electronic health record (EHR)-embedded tools vs. usual care on MRA prescribing in eligible patients with HFrEF. METHODS:BETTER CARE-HF (Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) was a three-arm, pragmatic, cluster-randomized trial comparing the effectiveness of an alert during individual patient encounters vs. a message about multiple patients between encounters vs. usual care on MRA prescribing. We included adult patients with HFrEF, no active MRA prescription, no contraindication to MRA, and an outpatient cardiologist in a large health system. Patients were cluster-randomized by cardiologist (60 per arm). RESULTS:The study included 2,211 patients (alert: 755, message: 812, usual care [control]: 644), with average age 72.2 years, average EF 33%, who were predominantly male (71.4%) and White (68.9%). New MRA prescribing occurred in 29.6% of patients in the alert arm, 15.6% in the message arm, and 11.7% in the control arm. The alert more than doubled MRA prescribing compared to control (RR: 2.53, 95% CI: 1.77-3.62, p<0.0001), and improved MRA prescribing compared to the message (RR: 1.67, 95% CI: 1.21-2.29, p=0.002). The number of patients with alert needed to result in an additional MRA prescription was 5.6. CONCLUSIONS:An automated, patient-specific, EHR-embedded alert increased MRA prescribing compared to both a message and usual care. Our findings highlight the potential for EHR-embedded tools to substantially increase prescription of life-saving therapies for HFrEF. (NCT05275920).
PMID: 36882134
ISSN: 1558-3597
CID: 5430312

Using Rapid Randomized Trials to Improve Health Care Systems

Horwitz, Leora I; Krelle, Holly A
Rapid randomized controlled trials have been surprisingly rare in health care quality improvement (QI) and systems interventions. Applying clinical trials methodology QI work brings two distinct fields together, applying the robustness of randomized controlled trials (RCTs) to the practical, operational learnings of the well-established QI field. Rapid trials also add a third element-speed-that enables health care systems to rapidly test multiple variations of an intervention in much the same way that A/B testing is done in the technology sector. When performed well, these rapid trials free researchers and health care systems from the requirement to be correct the first time (because it is low cost and quick to try something else) while offering a standard of evidence often absent in QI. Here we outline the historical underpinnings of this approach, provide guidance about how best to implement it, and describe lessons learned from running more than 20 randomized projects in the NYU Langone Health system. Expected final online publication date for the Annual Review of Public Health, Volume 44 is April 2023. Please see for revised estimates.
PMID: 36400154
ISSN: 1545-2093
CID: 5385022

Design and pilot implementation for the BETTER CARE-HF trial: A pragmatic cluster-randomized controlled trial comparing two targeted approaches to ambulatory clinical decision support for cardiologists

Mukhopadhyay, Amrita; Reynolds, Harmony R; Xia, Yuhe; Phillips, Lawrence M; Aminian, Rod; Diah, Ruth-Ann; Nagler, Arielle R; Szerencsy, Adam; Saxena, Archana; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Beart failure with reduced ejection fraction (HFrEF) is a leading cause of morbidity and mortality. However, shortfalls in prescribing of proven therapies, particularly mineralocorticoid receptor antagonist (MRA) therapy, account for several thousand preventable deaths per year nationwide. Electronic clinical decision support (CDS) is a potential low-cost and scalable solution to improve prescribing of therapies. However, the optimal timing and format of CDS tools is unknown. METHODS AND RESULTS/RESULTS:We developed two targeted CDS tools to inform cardiologists of gaps in MRA therapy for patients with HFrEF and without contraindication to MRA therapy: (1) an alert that notifies cardiologists at the time of patient visit, and (2) an automated electronic message that allows for review between visits. We designed these tools using an established CDS framework and findings from semistructured interviews with cardiologists. We then pilot tested both CDS tools (n = 596 patients) and further enhanced them based on additional semistructured interviews (n = 11 cardiologists). The message was modified to reduce the number of patients listed, include future visits, and list date of next visit. The alert was modified to improve noticeability, reduce extraneous information on guidelines, and include key information on contraindications. CONCLUSIONS:The BETTER CARE-HF (Building Electronic Tools to Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) trial aims to compare the effectiveness of the alert vs. the automated message vs. usual care on the primary outcome of MRA prescribing. To our knowledge, no study has directly compared the efficacy of these two different types of electronic CDS interventions. If effective, our findings can be rapidly disseminated to improve morbidity and mortality for patients with HFrEF, and can also inform the development of future CDS interventions for other disease states. (Trial registration: NCT05275920).
PMID: 36640860
ISSN: 1097-6744
CID: 5403312

Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design

Horwitz, Leora I; Thaweethai, Tanayott; Brosnahan, Shari B; Cicek, Mine S; Fitzgerald, Megan L; Goldman, Jason D; Hess, Rachel; Hodder, S L; Jacoby, Vanessa L; Jordan, Michael R; Krishnan, Jerry A; Laiyemo, Adeyinka O; Metz, Torri D; Nichols, Lauren; Patzer, Rachel E; Sekar, Anisha; Singer, Nora G; Stiles, Lauren E; Taylor, Barbara S; Ahmed, Shifa; Algren, Heather A; Anglin, Khamal; Aponte-Soto, Lisa; Ashktorab, Hassan; Bassett, Ingrid V; Bedi, Brahmchetna; Bhadelia, Nahid; Bime, Christian; Bind, Marie-Abele C; Black, Lora J; Blomkalns, Andra L; Brim, Hassan; Castro, Mario; Chan, James; Charney, Alexander W; Chen, Benjamin K; Chen, Li Qing; Chen, Peter; Chestek, David; Chibnik, Lori B; Chow, Dominic C; Chu, Helen Y; Clifton, Rebecca G; Collins, Shelby; Costantine, Maged M; Cribbs, Sushma K; Deeks, Steven G; Dickinson, John D; Donohue, Sarah E; Durstenfeld, Matthew S; Emery, Ivette F; Erlandson, Kristine M; Facelli, Julio C; Farah-Abraham, Rachael; Finn, Aloke V; Fischer, Melinda S; Flaherman, Valerie J; Fleurimont, Judes; Fonseca, Vivian; Gallagher, Emily J; Gander, Jennifer C; Gennaro, Maria Laura; Gibson, Kelly S; Go, Minjoung; Goodman, Steven N; Granger, Joey P; Greenway, Frank L; Hafner, John W; Han, Jenny E; Harkins, Michelle S; Hauser, Kristine S P; Heath, James R; Hernandez, Carla R; Ho, On; Hoffman, Matthew K; Hoover, Susan E; Horowitz, Carol R; Hsu, Harvey; Hsue, Priscilla Y; Hughes, Brenna L; Jagannathan, Prasanna; James, Judith A; John, Janice; Jolley, Sarah; Judd, S E; Juskowich, Joy J; Kanjilal, Diane G; Karlson, Elizabeth W; Katz, Stuart D; Kelly, J Daniel; Kelly, Sara W; Kim, Arthur Y; Kirwan, John P; Knox, Kenneth S; Kumar, Andre; Lamendola-Essel, Michelle F; Lanca, Margaret; Lee-Lannotti, Joyce K; Lefebvre, R Craig; Levy, Bruce D; Lin, Janet Y; Logarbo, Brian P; Logue, Jennifer K; Longo, Michele T; Luciano, Carlos A; Lutrick, Karen; Malakooti, Shahdi K; Mallett, Gail; Maranga, Gabrielle; Marathe, Jai G; Marconi, Vincent C; Marshall, Gailen D; Martin, Christopher F; Martin, Jeffrey N; May, Heidi T; McComsey, Grace A; McDonald, Dylan; Mendez-Figueroa, Hector; Miele, Lucio; Mittleman, Murray A; Mohandas, Sindhu; Mouchati, Christian; Mullington, Janet M; Nadkarni, Girish N; Nahin, Erica R; Neuman, Robert B; Newman, Lisa T; Nguyen, Amber; Nikolich, Janko Z; Ofotokun, Igho; Ogbogu, Princess U; Palatnik, Anna; Palomares, Kristy T S; Parimon, Tanyalak; Parry, Samuel; Parthasarathy, Sairam; Patterson, Thomas F; Pearman, Ann; Peluso, Michael J; Pemu, Priscilla; Pettker, Christian M; Plunkett, Beth A; Pogreba-Brown, Kristen; Poppas, Athena; Porterfield, J Zachary; Quigley, John G; Quinn, Davin K; Raissy, Hengameh; Rebello, Candida J; Reddy, Uma M; Reece, Rebecca; Reeder, Harrison T; Rischard, Franz P; Rosas, Johana M; Rosen, Clifford J; Rouphael, Nadine G; Rouse, Dwight J; Ruff, Adam M; Saint Jean, Christina; Sandoval, Grecio J; Santana, Jorge L; Schlater, Shannon M; Sciurba, Frank C; Selvaggi, Caitlin; Seshadri, Sudha; Sesso, Howard D; Shah, Dimpy P; Shemesh, Eyal; Sherif, Zaki A; Shinnick, Daniel J; Simhan, Hyagriv N; Singh, Upinder; Sowles, Amber; Subbian, Vignesh; Sun, Jun; Suthar, Mehul S; Teunis, Larissa J; Thorp, John M; Ticotsky, Amberly; Tita, Alan T N; Tragus, Robin; Tuttle, Katherine R; Urdaneta, Alfredo E; Utz, P J; VanWagoner, Timothy M; Vasey, Andrew; Vernon, Suzanne D; Vidal, Crystal; Walker, Tiffany; Ward, Honorine D; Warren, David E; Weeks, Ryan M; Weiner, Steven J; Weyer, Jordan C; Wheeler, Jennifer L; Whiteheart, Sidney W; Wiley, Zanthia; Williams, Natasha J; Wisnivesky, Juan P; Wood, John C; Yee, Lynn M; Young, Natalie M; Zisis, Sokratis N; Foulkes, Andrea S
IMPORTANCE/OBJECTIVE:SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. METHODS:RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. DISCUSSION/CONCLUSIONS:RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options. REGISTRATION/BACKGROUND:NCT05172024.
PMID: 37352211
ISSN: 1932-6203
CID: 5538502