Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial
Abstract Background Assessment for risks associated with acute stable COVID-19 is important to optimize clinical trial enrollment and target patients for scarce therapeutics. To assess whether healthcare system engagement location is an independent predictor of outcomes we performed a secondary anal...
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-023-08295-9 |
| _version_ | 1797823037800710144 |
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| author | Joseph Bledsoe Scott C. Woller Maria Brooks Frank C. Sciurba Jerry A. Krishnan Deborah Martin Peter Hou Janet Y. Lin Andrei Kindzelski Eileen Handberg Bridget-Anne Kirwan Elaine Zaharris Lauren Castro Nancy L. Shapiro Carl J. Pepine Sarah Majercik Zhuxuan Fu Yongqi Zhong Vidya Venugopal Yu-Hsuan Lai Paul M. Ridker Jean M. Connors |
| author_facet | Joseph Bledsoe Scott C. Woller Maria Brooks Frank C. Sciurba Jerry A. Krishnan Deborah Martin Peter Hou Janet Y. Lin Andrei Kindzelski Eileen Handberg Bridget-Anne Kirwan Elaine Zaharris Lauren Castro Nancy L. Shapiro Carl J. Pepine Sarah Majercik Zhuxuan Fu Yongqi Zhong Vidya Venugopal Yu-Hsuan Lai Paul M. Ridker Jean M. Connors |
| author_sort | Joseph Bledsoe |
| collection | DOAJ |
| description | Abstract Background Assessment for risks associated with acute stable COVID-19 is important to optimize clinical trial enrollment and target patients for scarce therapeutics. To assess whether healthcare system engagement location is an independent predictor of outcomes we performed a secondary analysis of the ACTIV-4B Outpatient Thrombosis Prevention trial. Methods A secondary analysis of the ACTIV-4B trial that was conducted at 52 US sites between September 2020 and August 2021. Participants were enrolled through acute unscheduled episodic care (AUEC) enrollment location (emergency department, or urgent care clinic visit) compared to minimal contact (MC) enrollment (electronic contact from test center lists of positive patients).We report the primary composite outcome of cardiopulmonary hospitalizations, symptomatic venous thromboembolism, myocardial infarction, stroke, transient ischemic attack, systemic arterial thromboembolism, or death among stable outpatients stratified by enrollment setting, AUEC versus MC. A propensity score for AUEC enrollment was created, and Cox proportional hazards regression with inverse probability weighting (IPW) was used to compare the primary outcome by enrollment location. Results Among the 657 ACTIV-4B patients randomized, 533 (81.1%) with known enrollment setting data were included in this analysis, 227 from AUEC settings and 306 from MC settings. In a multivariate logistic regression model, time from COVID test, age, Black race, Hispanic ethnicity, and body mass index were associated with AUEC enrollment. Irrespective of trial treatment allocation, patients enrolled at an AUEC setting were 10-times more likely to suffer from the adjudicated primary outcome, 7.9% vs. 0.7%; p < 0.001, compared with patients enrolled at a MC setting. Upon Cox regression analysis adjustment patients enrolled at an AUEC setting remained at significant risk of the primary composite outcome, HR 3.40 (95% CI 1.46, 7.94). Conclusions Patients with clinically stable COVID-19 presenting to an AUEC enrollment setting represent a population at increased risk of arterial and venous thrombosis complications, hospitalization for cardiopulmonary events, or death, when adjusted for other risk factors, compared with patients enrolled at a MC setting. Future outpatient therapeutic trials and clinical therapeutic delivery programs of clinically stable COVID-19 patients may focus on inclusion of higher-risk patient populations from AUEC engagement locations. Trial Registration ClinicalTrials.gov Identifier: NCT04498273. |
| first_indexed | 2024-03-13T10:17:06Z |
| format | Article |
| id | doaj.art-c3b73704cacf4ebf9f124b1a93adb25d |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-03-13T10:17:06Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-c3b73704cacf4ebf9f124b1a93adb25d2023-05-21T11:09:46ZengBMCBMC Infectious Diseases1471-23342023-05-012311910.1186/s12879-023-08295-9Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trialJoseph Bledsoe0Scott C. Woller1Maria Brooks2Frank C. Sciurba3Jerry A. Krishnan4Deborah Martin5Peter Hou6Janet Y. Lin7Andrei Kindzelski8Eileen Handberg9Bridget-Anne Kirwan10Elaine Zaharris11Lauren Castro12Nancy L. Shapiro13Carl J. Pepine14Sarah Majercik15Zhuxuan Fu16Yongqi Zhong17Vidya Venugopal18Yu-Hsuan Lai19Paul M. Ridker20Jean M. Connors21Intermountain Healthcare, Emergency Medicine and TraumaIntermountain Medical Center, Department of MedicineSchool of Medicine, University of PittsburghSchool of Medicine, University of PittsburghDivision of Pulmonary, Critical Care, Sleep, and Allergy, University of IllinoisSchool of Medicine, University of PittsburghBrigham and Women’s HospitalDepartment of Emergency Medicine, University of IllinoisNational Heart, Lung, and Blood InstituteSchool of Medicine, University of FloridaSOCAR Research SABrigham and Women’s HospitalDivision of Pulmonary, Critical Care, Sleep, and Allergy, University of IllinoisDepartment of Pharmacy Practice, College of Pharmacy, University of IllinoisSchool of Medicine, University of FloridaIntermountain Healthcare, Emergency Medicine and TraumaSchool of Medicine, University of PittsburghSchool of Medicine, University of PittsburghSchool of Medicine, University of PittsburghSchool of Medicine, University of PittsburghBrigham and Women’s HospitalBrigham and Women’s HospitalAbstract Background Assessment for risks associated with acute stable COVID-19 is important to optimize clinical trial enrollment and target patients for scarce therapeutics. To assess whether healthcare system engagement location is an independent predictor of outcomes we performed a secondary analysis of the ACTIV-4B Outpatient Thrombosis Prevention trial. Methods A secondary analysis of the ACTIV-4B trial that was conducted at 52 US sites between September 2020 and August 2021. Participants were enrolled through acute unscheduled episodic care (AUEC) enrollment location (emergency department, or urgent care clinic visit) compared to minimal contact (MC) enrollment (electronic contact from test center lists of positive patients).We report the primary composite outcome of cardiopulmonary hospitalizations, symptomatic venous thromboembolism, myocardial infarction, stroke, transient ischemic attack, systemic arterial thromboembolism, or death among stable outpatients stratified by enrollment setting, AUEC versus MC. A propensity score for AUEC enrollment was created, and Cox proportional hazards regression with inverse probability weighting (IPW) was used to compare the primary outcome by enrollment location. Results Among the 657 ACTIV-4B patients randomized, 533 (81.1%) with known enrollment setting data were included in this analysis, 227 from AUEC settings and 306 from MC settings. In a multivariate logistic regression model, time from COVID test, age, Black race, Hispanic ethnicity, and body mass index were associated with AUEC enrollment. Irrespective of trial treatment allocation, patients enrolled at an AUEC setting were 10-times more likely to suffer from the adjudicated primary outcome, 7.9% vs. 0.7%; p < 0.001, compared with patients enrolled at a MC setting. Upon Cox regression analysis adjustment patients enrolled at an AUEC setting remained at significant risk of the primary composite outcome, HR 3.40 (95% CI 1.46, 7.94). Conclusions Patients with clinically stable COVID-19 presenting to an AUEC enrollment setting represent a population at increased risk of arterial and venous thrombosis complications, hospitalization for cardiopulmonary events, or death, when adjusted for other risk factors, compared with patients enrolled at a MC setting. Future outpatient therapeutic trials and clinical therapeutic delivery programs of clinically stable COVID-19 patients may focus on inclusion of higher-risk patient populations from AUEC engagement locations. Trial Registration ClinicalTrials.gov Identifier: NCT04498273.https://doi.org/10.1186/s12879-023-08295-9SARS-CoV-2COVID-19Pulmonary embolismPEVenous thromboembolic diseaseVTE |
| spellingShingle | Joseph Bledsoe Scott C. Woller Maria Brooks Frank C. Sciurba Jerry A. Krishnan Deborah Martin Peter Hou Janet Y. Lin Andrei Kindzelski Eileen Handberg Bridget-Anne Kirwan Elaine Zaharris Lauren Castro Nancy L. Shapiro Carl J. Pepine Sarah Majercik Zhuxuan Fu Yongqi Zhong Vidya Venugopal Yu-Hsuan Lai Paul M. Ridker Jean M. Connors Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial BMC Infectious Diseases SARS-CoV-2 COVID-19 Pulmonary embolism PE Venous thromboembolic disease VTE |
| title | Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial |
| title_full | Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial |
| title_fullStr | Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial |
| title_full_unstemmed | Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial |
| title_short | Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial |
| title_sort | clinically stable covid 19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization secondary analysis of a randomized control trial |
| topic | SARS-CoV-2 COVID-19 Pulmonary embolism PE Venous thromboembolic disease VTE |
| url | https://doi.org/10.1186/s12879-023-08295-9 |
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