Cargando…

Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug–Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results

Drug–drug interactions (DDIs) are a serious problem in the healthcare system, leading to excess healthcare utilization and costs. We conducted a second prospective randomized, controlled trial to further establish the real-world clinical utility of a novel assay that objectively identifies potential...

Descripción completa

Detalles Bibliográficos
Autores principales: Peabody, John, Schrecker, Joshua, Heltsley, Rebecca, Paculdo, David, de Belen, Enrico, Tamondong-Lachica, Diana, Acelajado, M. Czarina, Ouenes, Othman, Kennedy, Trina, Jeter, Elaine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8307579/
https://www.ncbi.nlm.nih.gov/pubmed/34359349
http://dx.doi.org/10.3390/diagnostics11071266
_version_ 1783728081444274176
author Peabody, John
Schrecker, Joshua
Heltsley, Rebecca
Paculdo, David
de Belen, Enrico
Tamondong-Lachica, Diana
Acelajado, M. Czarina
Ouenes, Othman
Kennedy, Trina
Jeter, Elaine
author_facet Peabody, John
Schrecker, Joshua
Heltsley, Rebecca
Paculdo, David
de Belen, Enrico
Tamondong-Lachica, Diana
Acelajado, M. Czarina
Ouenes, Othman
Kennedy, Trina
Jeter, Elaine
author_sort Peabody, John
collection PubMed
description Drug–drug interactions (DDIs) are a serious problem in the healthcare system, leading to excess healthcare utilization and costs. We conducted a second prospective randomized, controlled trial to further establish the real-world clinical utility of a novel assay that objectively identifies potentially serious DDIs in real-world patients. Re-recruiting primary care physicians (PCPs) from our first randomized, controlled, simulated-patients study on DDIs, we experimentally introduced a definitive, urine-based mass spectrometry test intervention that the physicians could use when caring for their eligible patients. Patients were eligible if taking four or more prescription medications or suspected of taking other non-prescribed substances with potential medication interactions. The primary outcome was whether DDI testing changed clinical care. We explored a secondary outcome to see if the change in practice improved symptoms in patients with potential DDIs. A total of 169 control and 162 intervention patients were enrolled in the study, and their medical records were abstracted. In real-world patients, intervention physicians identified and/or treated a DDI at 3.0x the rate in their patient population compared to controls (21.6% vs. 7.1%, p < 0.001). Intervention physicians were more likely to discontinue or adjust the interacting agent compared to controls (62.9% vs. 8.3%, p = 0.001), and patient-reported symptoms also significantly declined (29.6% vs. 20.1%, p = 0.045). These results were nearly identical to concurrent measurements that used simulated patients, wherein intervention was more likely to both make a DDI diagnosis (56.3% vs. 21.6%, p < 0.001) and stop the interacting medications (58.3% versus 26.6%, p < 0.001). Bringing a new diagnostic test to market, particularly for an under-recognized clinical problem, requires robust data on both clinical validity and clinical utility. The results of this follow-up study showed that the use of DDI testing in real-world patients significantly improved (1) primary care patient management of drug interactions and (2) patient outcomes.
format Online
Article
Text
id pubmed-8307579
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-83075792021-07-25 Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug–Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results Peabody, John Schrecker, Joshua Heltsley, Rebecca Paculdo, David de Belen, Enrico Tamondong-Lachica, Diana Acelajado, M. Czarina Ouenes, Othman Kennedy, Trina Jeter, Elaine Diagnostics (Basel) Article Drug–drug interactions (DDIs) are a serious problem in the healthcare system, leading to excess healthcare utilization and costs. We conducted a second prospective randomized, controlled trial to further establish the real-world clinical utility of a novel assay that objectively identifies potentially serious DDIs in real-world patients. Re-recruiting primary care physicians (PCPs) from our first randomized, controlled, simulated-patients study on DDIs, we experimentally introduced a definitive, urine-based mass spectrometry test intervention that the physicians could use when caring for their eligible patients. Patients were eligible if taking four or more prescription medications or suspected of taking other non-prescribed substances with potential medication interactions. The primary outcome was whether DDI testing changed clinical care. We explored a secondary outcome to see if the change in practice improved symptoms in patients with potential DDIs. A total of 169 control and 162 intervention patients were enrolled in the study, and their medical records were abstracted. In real-world patients, intervention physicians identified and/or treated a DDI at 3.0x the rate in their patient population compared to controls (21.6% vs. 7.1%, p < 0.001). Intervention physicians were more likely to discontinue or adjust the interacting agent compared to controls (62.9% vs. 8.3%, p = 0.001), and patient-reported symptoms also significantly declined (29.6% vs. 20.1%, p = 0.045). These results were nearly identical to concurrent measurements that used simulated patients, wherein intervention was more likely to both make a DDI diagnosis (56.3% vs. 21.6%, p < 0.001) and stop the interacting medications (58.3% versus 26.6%, p < 0.001). Bringing a new diagnostic test to market, particularly for an under-recognized clinical problem, requires robust data on both clinical validity and clinical utility. The results of this follow-up study showed that the use of DDI testing in real-world patients significantly improved (1) primary care patient management of drug interactions and (2) patient outcomes. MDPI 2021-07-15 /pmc/articles/PMC8307579/ /pubmed/34359349 http://dx.doi.org/10.3390/diagnostics11071266 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Peabody, John
Schrecker, Joshua
Heltsley, Rebecca
Paculdo, David
de Belen, Enrico
Tamondong-Lachica, Diana
Acelajado, M. Czarina
Ouenes, Othman
Kennedy, Trina
Jeter, Elaine
Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug–Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results
title Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug–Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results
title_full Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug–Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results
title_fullStr Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug–Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results
title_full_unstemmed Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug–Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results
title_short Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug–Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results
title_sort randomized trial to improve primary care patient management and patient outcomes using a drug–drug interaction test: confirmation of the decart simulated patient clinical utility trial results
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8307579/
https://www.ncbi.nlm.nih.gov/pubmed/34359349
http://dx.doi.org/10.3390/diagnostics11071266
work_keys_str_mv AT peabodyjohn randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults
AT schreckerjoshua randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults
AT heltsleyrebecca randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults
AT paculdodavid randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults
AT debelenenrico randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults
AT tamondonglachicadiana randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults
AT acelajadomczarina randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults
AT ouenesothman randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults
AT kennedytrina randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults
AT jeterelaine randomizedtrialtoimproveprimarycarepatientmanagementandpatientoutcomesusingadrugdruginteractiontestconfirmationofthedecartsimulatedpatientclinicalutilitytrialresults