A randomized trial of at-home COVID-19 tests, telemedicine, and rapid prescription delivery for immunocompromised individuals

{ 'institution': [{'name': 'Research Square'}], 'indexed': { 'date-parts': [[2024, 10, 28]], 'date-time': '2024-10-28T08:10:34Z', 'timestamp': 1730103034518, 'version': '3.28.0'}, 'posted': {'date-parts': [[2024, 10, 28]]}, 'group-title': 'In Review', 'reference-count': 27, 'publisher': 'Springer Science and Business Media LLC', 'license': [ { 'start': { 'date-parts': [[2024, 10, 28]], 'date-time': '2024-10-28T00:00:00Z', 'timestamp': 1730073600000}, 'content-version': 'unspecified', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0/'}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'accepted': {'date-parts': [[2024, 10, 22]]}, 'abstract': '<title>Abstract</title>\n' ' <p><bold>Background: </bold>COVID-19 continues to impose substantial risks to people ' 'who are immunocompromised and over 65 years old.\n' '<bold>Objective: </bold>Using a randomized control trial, we evaluated whether access to ' 'at-home COVID-19 tests, telemedicine, and same-day prescription delivery could reduce COVID ' 'cases, hospitalizations, and the cost of COVID care for the high-risk populations.\n' '<bold>Design: </bold>Individuals participated remotely, half (n = 346) receiving the option ' 'to access 10 at-home COVID-19 tests per month for themselves and others in their household as ' 'well as telemedicine and same-day Paxlovid delivery, and half following their standard ' 'testing and treatment practices (n = 325).\n' '<bold>Data sources: </bold>Outcome data were collected from surveys, electronic health ' 'records (EHR) and claims.\n' '<bold>Results: </bold>Intensive care unit (ICU) admissions were significantly reduced for ' 'intervention participants vs. control participants, (0.3% vs 4.6%, p &lt; 0.001). COVID case ' 'incidence did not significantly differ (19.0% vs 20.4%, p = 0.69), nor did hospitalizations ' '(5.2% vs 7.7%, p = 0.14). The intervention was estimated to result in a reduction of $3,650 ' 'in the cost of COVID care per person.\n' '<bold>Limitations: </bold>The specific intervention used is no longer available in the market ' 'and alternatives should be considered. Evolution of SARS-CoV-2 could change the effect ' 'observed. Survey completion is higher in the intervention group.\n' '<bold>Conclusions: </bold>In immunocompromised individuals and those at least aged 65 years, ' 'access to at-home COVID tests, telemedicine, and rapid Paxlovid delivery reduced the severity ' 'of COVID-19 infections, as reflected by a reduced need for ICU care; this has the potential ' 'to reduce the cost of COVID care.</p>', 'DOI': '10.21203/rs.3.rs-5314583/v1', 'type': 'posted-content', 'created': { 'date-parts': [[2024, 10, 28]], 'date-time': '2024-10-28T07:04:29Z', 'timestamp': 1730099069000}, 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'A randomized trial of at-home COVID-19 tests, telemedicine, and rapid prescription delivery for ' 'immunocompromised individuals', 'prefix': '10.21203', 'author': [ { 'given': 'Julia Moore', 'family': 'Vogel', 'sequence': 'first', 'affiliation': [{'name': 'Scripps Research Institute'}]}, { 'given': 'Ting-Yang', 'family': 'Hung', 'sequence': 'additional', 'affiliation': [{'name': 'Scripps Research Institute'}]}, { 'given': 'Erin', 'family': 'Coughlin', 'sequence': 'additional', 'affiliation': [{'name': 'Scripps Research Institute'}]}, { 'given': 'Felipe', 'family': 'Delgado', 'sequence': 'additional', 'affiliation': [{'name': 'Scripps Research Institute'}]}, { 'given': 'Vik', 'family': 'Kheterpal', 'sequence': 'additional', 'affiliation': [{'name': 'CareEvolution (United States)'}]}, { 'given': 'Giorgio', 'family': 'Quer', 'sequence': 'additional', 'affiliation': [{'name': 'Scripps Research Institute'}]}, { 'given': 'Eric', 'family': 'Topol', 'sequence': 'additional', 'affiliation': [{'name': 'Scripps Research Institute'}]}], 'member': '297', 'reference': [ { 'key': 'ref1', 'doi-asserted-by': 'crossref', 'first-page': 'e1004086', 'DOI': '10.1371/journal.pmed.1004086', 'article-title': 'Outcome of COVID-19 in hospitalised immunocompromised patients: An ' 'analysis of the WHO ISARIC CCP-UK prospective cohort study', 'volume': '20', 'author': 'Turtle L', 'year': '2023', 'unstructured': 'Turtle L, Thorpe M, Drake TM, Swets M, Palmieri C, Russell CD, et al. ' 'Outcome of COVID-19 in hospitalised immunocompromised patients: An ' 'analysis of the WHO ISARIC CCP-UK prospective cohort study. PLoS Med. ' '2023;20: e1004086.', 'journal-title': 'PLoS Med'}, { 'key': 'ref2', 'doi-asserted-by': 'crossref', 'first-page': '1075', 'DOI': '10.1007/s12325-023-02754-0', 'article-title': 'Assessing the burden and cost of COVID-19 across variants in ' 'commercially insured immunocompromised populations in the United ' 'States: Updated results and trends from the ongoing EPOCH-US study', 'volume': '41', 'author': 'Ketkar A', 'year': '2024', 'unstructured': 'Ketkar A, Willey V, Glasser L, Dobie C, Wenziger C, Teng C-C, et al. ' 'Assessing the burden and cost of COVID-19 across variants in ' 'commercially insured immunocompromised populations in the United States: ' 'Updated results and trends from the ongoing EPOCH-US study. Adv Ther. ' '2024;41: 1075–1102.', 'journal-title': 'Adv Ther'}, { 'key': 'ref3', 'doi-asserted-by': 'publisher', 'DOI': '10.1136/bmjgh-2021-006434', 'article-title': 'The isolated effect of age on the risk of COVID-19 severe outcomes: a ' 'systematic review with meta-analysis', 'volume': '6', 'author': 'Romero Starke K', 'year': '2021', 'unstructured': 'Romero Starke K, Reissig D, Petereit-Haack G, Schmauder S, Nienhaus A, ' 'Seidler A. The isolated effect of age on the risk of COVID-19 severe ' 'outcomes: a systematic review with meta-analysis. BMJ Glob Health. ' '2021;6. doi:10.1136/bmjgh-2021-006434', 'journal-title': 'BMJ Glob Health'}, { 'key': 'ref4', 'doi-asserted-by': 'crossref', 'first-page': '2547', 'DOI': '10.1001/jama.2016.16477', 'article-title': 'Prevalence of Immunosuppression Among US Adults, 2013', 'volume': '316', 'author': 'Harpaz R', 'year': '2016', 'unstructured': 'Harpaz R, Dahl RM, Dooling KL. Prevalence of Immunosuppression Among US ' 'Adults, 2013. JAMA. 2016;316: 2547–2548.', 'journal-title': 'JAMA'}, { 'key': 'ref5', 'doi-asserted-by': 'crossref', 'first-page': '880', 'DOI': '10.1001/jama.2023.28019', 'article-title': 'Prevalence of Immunosuppression Among US Adults', 'volume': '331', 'author': 'Martinson ML', 'year': '2024', 'unstructured': 'Martinson ML, Lapham J. Prevalence of Immunosuppression Among US Adults. ' 'JAMA. 2024;331: 880–882.', 'journal-title': 'JAMA'}, { 'key': 'ref6', 'unstructured': 'US Census Bureau. U.S. Older Population Grew From 2010 to 2020 at ' 'Fastest Rate Since 1880 to 1890. 2023 [cited 1 Aug 2024]. Available: ' 'https://www.census.gov/library/stories/2023/05/2020-census-united-states-older-population-grew.html'}, { 'key': 'ref7', 'unstructured': 'CDC. Covid-net. In: COVID-19 [Internet]. 18 Jul 2024 [cited 1 Aug 2024]. ' 'Available: https://www.cdc.gov/covid/php/covid-net/index.html'}, { 'key': 'ref8', 'first-page': 'e068632', 'article-title': 'Efficacy of covid-19 vaccines in immunocompromised patients: systematic ' 'review and meta-analysis', 'volume': '376', 'author': 'Lee ARYB', 'year': '2022', 'unstructured': 'Lee ARYB, Wong SY, Chai LYA, Lee SC, Lee MX, Muthiah MD, et al. Efficacy ' 'of covid-19 vaccines in immunocompromised patients: systematic review ' 'and meta-analysis. BMJ. 2022;376: e068632.', 'journal-title': 'BMJ'}, { 'key': 'ref9', 'doi-asserted-by': 'crossref', 'first-page': 'e461', 'DOI': '10.1016/S2665-9913(23)00160-1', 'article-title': 'Antibody prevalence after three or more COVID-19 vaccine doses in ' 'individuals who are immunosuppressed in the UK: a cross-sectional study ' 'from MELODY', 'volume': '5', 'author': 'Pearce FA', 'year': '2023', 'unstructured': 'Pearce FA, Lim SH, Bythell M, Lanyon P, Hogg R, Taylor A, et al. ' 'Antibody prevalence after three or more COVID-19 vaccine doses in ' 'individuals who are immunosuppressed in the UK: a cross-sectional study ' 'from MELODY. Lancet Rheumatol. 2023;5: e461–e473.', 'journal-title': 'Lancet Rheumatol'}, { 'key': 'ref10', 'doi-asserted-by': 'crossref', 'first-page': '132', 'DOI': '10.1186/s12985-022-01858-3', 'article-title': 'Seroconversion following the first, second, and third dose of ' 'SARS-CoV-2 vaccines in immunocompromised population: a systematic ' 'review and meta-analysis', 'volume': '19', 'author': 'Mehrabi Nejad M-M', 'year': '2022', 'unstructured': 'Mehrabi Nejad M-M, Shobeiri P, Dehghanbanadaki H, Tabary M, Aryannejad ' 'A, Haji Ghadery A, et al. Seroconversion following the first, second, ' 'and third dose of SARS-CoV-2 vaccines in immunocompromised population: a ' 'systematic review and meta-analysis. Virol J. 2022;19: 132.', 'journal-title': 'Virol J'}, { 'key': 'ref11', 'doi-asserted-by': 'crossref', 'first-page': '1760', 'DOI': '10.1038/s41591-023-02414-4', 'article-title': 'SARS-CoV-2-specific immune responses and clinical outcomes after ' 'COVID-19 vaccination in patients with immune-suppressive disease', 'volume': '29', 'author': 'Barnes E', 'year': '2023', 'unstructured': 'Barnes E, Goodyear CS, Willicombe M, Gaskell C, Siebert S, I de Silva T, ' 'et al. SARS-CoV-2-specific immune responses and clinical outcomes after ' 'COVID-19 vaccination in patients with immune-suppressive disease. Nat ' 'Med. 2023;29: 1760–1774.', 'journal-title': 'Nat Med'}, { 'key': 'ref12', 'doi-asserted-by': 'crossref', 'first-page': 'e1397', 'DOI': '10.1093/cid/ciab397', 'article-title': 'Improving the Outcomes of Immunocompromised Patients With Coronavirus ' 'Disease 2019', 'volume': '73', 'author': 'Haidar G', 'year': '2021', 'unstructured': 'Haidar G, Mellors JW. Improving the Outcomes of Immunocompromised ' 'Patients With Coronavirus Disease 2019. Clin Infect Dis. 2021;73: ' 'e1397–e1401.', 'journal-title': 'Clin Infect Dis'}, { 'key': 'ref13', 'doi-asserted-by': 'crossref', 'first-page': '562', 'DOI': '10.1056/NEJMsb2104756', 'article-title': 'SARS-CoV-2 variants in patients with immunosuppression', 'volume': '385', 'author': 'Corey L', 'year': '2021', 'unstructured': 'Corey L, Beyrer C, Cohen MS, Michael NL, Bedford T, Rolland M. ' 'SARS-CoV-2 variants in patients with immunosuppression. N Engl J Med. ' '2021;385: 562–566.', 'journal-title': 'N Engl J Med'}, { 'key': 'ref14', 'doi-asserted-by': 'crossref', 'first-page': '342', 'DOI': '10.1093/cid/ciac769', 'article-title': 'Remdesivir Resistance in Transplant Recipients With Persistent ' 'Coronavirus Disease 2019', 'volume': '76', 'author': 'Hogan JI', 'year': '2023', 'unstructured': 'Hogan JI, Duerr R, Dimartino D, Marier C, Hochman SE, Mehta S, et al. ' 'Remdesivir Resistance in Transplant Recipients With Persistent ' 'Coronavirus Disease 2019. Clin Infect Dis. 2023;76: 342–345.', 'journal-title': 'Clin Infect Dis'}, { 'key': 'ref15', 'doi-asserted-by': 'crossref', 'first-page': '305', 'DOI': '10.1056/NEJMoa2116846', 'article-title': 'Early Remdesivir to Prevent Progression to Severe Covid-19 in ' 'Outpatients', 'volume': '386', 'author': 'Gottlieb Robert L', 'year': '2022', 'unstructured': 'Gottlieb Robert L., Vaca Carlos E., Paredes Roger, Mera Jorge, Webb ' 'Brandon J., Perez Gilberto, et al. Early Remdesivir to Prevent ' 'Progression to Severe Covid-19 in Outpatients. N Engl J Med. 2022;386: ' '305–315.', 'journal-title': 'N Engl J Med'}, { 'key': 'ref16', 'unstructured': 'CDC. Infection control guidance: SARS-CoV-2. In: COVID-19 [Internet]. 23 ' 'Jul 2024 [cited 1 Aug 2024]. Available: ' 'https://www.cdc.gov/covid/hcp/infection-control/index.html'}, { 'key': 'ref17', 'unstructured': 'ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of ' 'Immunocompromised Individuals. In: ClinicalTrials.Gov [Internet]. [cited ' '22 Jul 2024]. Available: https://clinicaltrials.gov/study/NCT05655546'}, { 'key': 'ref18', 'doi-asserted-by': 'crossref', 'DOI': '10.1001/jamanetworkopen.2021.4920', 'article-title': 'Prevalence of immunosuppressive drug use among commercially insured US ' 'adults, 2018–2019', 'volume': '4', 'author': 'Wallace BI', 'year': '2021', 'unstructured': 'Wallace BI, Kenney B, Malani PN, Clauw DJ, Nallamothu BK, Waljee AK. ' 'Prevalence of immunosuppressive drug use among commercially insured US ' 'adults, 2018–2019. JAMA Netw Open. 2021;4: e214920.', 'journal-title': 'JAMA Netw Open'}, { 'key': 'ref19', 'unstructured': 'Center for Devices, Radiological Health. Do Not Use Cue Health’s ' 'COVID-19 Tests Due to Risk of False Results: FDA Safety Communication. ' 'In: U.S. Food and Drug Administration [Internet]. FDA; 22 Jul 2024 ' '[cited 31 Jul 2024]. Available: ' 'https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication'}, { 'key': 'ref20', 'unstructured': 'FH trackers: COVID-19 cost tracker. [cited 31 Jul 2024]. Available: ' 'https://www.fairhealth.org/fh-trackers/covid19-heatmap'}, { 'key': 'ref21', 'doi-asserted-by': 'crossref', 'first-page': '878', 'DOI': '10.15585/mmwr.mm7127a3', 'article-title': 'Factors associated with severe outcomes among immunocompromised adults ' 'hospitalized for COVID-19 — COVID-NET, 10 states, march 2020–February ' '2022', 'volume': '71', 'author': 'Singson JRC', 'year': '2022', 'unstructured': 'Singson JRC, Kirley PD, Pham H, Rothrock G, Armistead I, Meek J, et al. ' 'Factors associated with severe outcomes among immunocompromised adults ' 'hospitalized for COVID-19 — COVID-NET, 10 states, march 2020–February ' '2022. MMWR Morb Mortal Wkly Rep. 2022;71: 878–884.', 'journal-title': 'MMWR Morb Mortal Wkly Rep'}, { 'key': 'ref22', 'doi-asserted-by': 'crossref', 'first-page': '365', 'DOI': '10.15585/mmwr.mm7316a2', 'article-title': 'SARS-CoV-2 viral shedding and rapid antigen test performance — ' 'respiratory virus transmission network, November 2022–may 2023', 'volume': '73', 'author': 'Smith-Jeffcoat SE', 'year': '2024', 'unstructured': 'Smith-Jeffcoat SE, Mellis AM, Grijalva CG, Talbot HK, Schmitz J, Lutrick ' 'K, et al. SARS-CoV-2 viral shedding and rapid antigen test performance — ' 'respiratory virus transmission network, November 2022–may 2023. MMWR ' 'Morb Mortal Wkly Rep. 2024;73: 365–371.', 'journal-title': 'MMWR Morb Mortal Wkly Rep'}, { 'key': 'ref23', 'doi-asserted-by': 'crossref', 'first-page': '1148637', 'DOI': '10.3389/fpubh.2023.1148637', 'article-title': 'To PCR or not? The impact of shifting policy from PCR to rapid antigen ' 'tests to diagnose COVID-19 during the omicron epidemic: a nationwide ' 'surveillance study', 'volume': '11', 'author': 'Chi H', 'year': '2023', 'unstructured': 'Chi H, Chiu N-C, Chen C-C, Weng S-L, Lien C-H, Lin C-H, et al. To PCR or ' 'not? The impact of shifting policy from PCR to rapid antigen tests to ' 'diagnose COVID-19 during the omicron epidemic: a nationwide surveillance ' 'study. Front Public Health. 2023;11: 1148637.', 'journal-title': 'Front Public Health'}, { 'key': 'ref24', 'doi-asserted-by': 'crossref', 'first-page': '701', 'DOI': '10.1001/jamainternmed.2022.1827', 'article-title': 'Comparison of Home Antigen Testing With RT-PCR and Viral Culture During ' 'the Course of SARS-CoV-2 Infection', 'volume': '182', 'author': 'Chu VT', 'year': '2022', 'unstructured': 'Chu VT, Schwartz NG, Donnelly MAP, Chuey MR, Soto R, Yousaf AR, et al. ' 'Comparison of Home Antigen Testing With RT-PCR and Viral Culture During ' 'the Course of SARS-CoV-2 Infection. JAMA Intern Med. 2022;182: 701–709.', 'journal-title': 'JAMA Intern Med'}, { 'key': 'ref25', 'unstructured': 'Assistant Secretary for Public Affairs (ASPA). Fact sheet: End of the ' 'COVID-19 public health emergency. In: US Department of Health and Human ' 'Services [Internet]. 9 May 2023 [cited 14 Aug 2024]. Available: ' 'https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html'}, { 'key': 'ref26', 'doi-asserted-by': 'crossref', 'first-page': '73', 'DOI': '10.1038/s41591-020-1123-x', 'article-title': 'Wearable sensor data and self-reported symptoms for COVID-19 detection', 'volume': '27', 'author': 'Quer G', 'year': '2021', 'unstructured': 'Quer G, Radin JM, Gadaleta M, Baca-Motes K, Ariniello L, Ramos E, et al. ' 'Wearable sensor data and self-reported symptoms for COVID-19 detection. ' 'Nat Med. 2021;27: 73–77.', 'journal-title': 'Nat Med'}, { 'key': 'ref27', 'doi-asserted-by': 'crossref', 'first-page': 'e546', 'DOI': '10.1016/S2589-7500(24)00096-7', 'article-title': 'Feasibility of wearable sensor signals and self-reported symptoms to ' 'prompt at-home testing for acute respiratory viruses in the USA ' '(DETECT-AHEAD): a decentralised, randomised controlled trial', 'volume': '6', 'author': 'Quer G', 'year': '2024', 'unstructured': 'Quer G, Coughlin E, Villacian J, Delgado F, Harris K, Verrant J, et al. ' 'Feasibility of wearable sensor signals and self-reported symptoms to ' 'prompt at-home testing for acute respiratory viruses in the USA ' '(DETECT-AHEAD): a decentralised, randomised controlled trial. Lancet ' 'Digit Health. 2024;6: e546–e554.', 'journal-title': 'Lancet Digit Health'}], 'container-title': [], 'original-title': [], 'link': [ { 'URL': 'https://www.researchsquare.com/article/rs-5314583/v1', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://www.researchsquare.com/article/rs-5314583/v1.html', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 10, 28]], 'date-time': '2024-10-28T07:04:40Z', 'timestamp': 1730099080000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.researchsquare.com/article/rs-5314583/v1'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2024, 10, 28]]}, 'references-count': 27, 'URL': 'http://dx.doi.org/10.21203/rs.3.rs-5314583/v1', 'relation': {}, 'subject': [], 'published': {'date-parts': [[2024, 10, 28]]}, 'subtype': 'preprint'}