Stakeholders' views on priorities essential for establishing a supportive environment for clinical trials in nursing homes
The U.S. clinical research enterprise in nursing homes was unprepared to mount clinical trials in nursing homes to address urgent questions relevant to prevention and treatment during the COVID-19 pandemic. We identify priorities essential for establishing a supportive environment for future clinica...
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Veröffentlicht in: | Journal of the American Geriatrics Society (JAGS) 2022-04, Vol.70 (4), p.950-959 |
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container_title | Journal of the American Geriatrics Society (JAGS) |
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creator | Delude, Christopher Abi-Elias, Ivan H Quinn, Charlene C Adams, Alyce S Magaziner, Jay S Ito, Kouta Jain, Paavani Gurwitz, Jerry H Mazor, Kathleen M |
description | The U.S. clinical research enterprise in nursing homes was unprepared to mount clinical trials in nursing homes to address urgent questions relevant to prevention and treatment during the COVID-19 pandemic. We identify priorities essential for establishing a supportive environment for future clinical trials in nursing homes.
Two cross-sectional online questionnaires were administered between January and February 2021. One was administered to nursing home providers, researchers, and policymakers; respondents rated the importance of attributes of researchers, facilities, leaders and staff for conducting clinical trials in nursing homes. Because importance may depend on trial type, respondents rated each attribute for efficacy trials (testing an intervention in ideal circumstances) and effectiveness trials (testing an intervention in "real world" circumstances). We calculated the attribute rating means and standard deviations, and used content analysis to characterize open-ended responses. The second questionnaire for resident family members and advocates included open-ended questions about nursing home research, and factors influencing willingness to participate.
The attributes rated as most essential for conducting efficacy and effectiveness trials in nursing homes are research team attributes, that is, that researchers recognize regulatory constraints; understand and adapt to nursing home workflow; and work collaboratively with nursing home leaders to identify priorities. Resident and facility diversity emerged as essential for effectiveness trials; important dimensions included resident race, ethnicity and income, as well as nursing home urban/rural location, quality ratings, geography, staffing ratios, size, and profit status. Caregivers and resident advocates stressed the importance of communication among participants, researchers, and nursing home leadership and staff at all stages of a trial.
Developing a robust U.S. clinical research enterprise capable of efficiently mounting future clinical trials in nursing homes will require a reimagining of the relationships that exist between researchers, facilities, nursing home leaders, and residents, with a research infrastructure specifically focused on supporting and fostering these connections. |
doi_str_mv | 10.1111/jgs.17710 |
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Two cross-sectional online questionnaires were administered between January and February 2021. One was administered to nursing home providers, researchers, and policymakers; respondents rated the importance of attributes of researchers, facilities, leaders and staff for conducting clinical trials in nursing homes. Because importance may depend on trial type, respondents rated each attribute for efficacy trials (testing an intervention in ideal circumstances) and effectiveness trials (testing an intervention in "real world" circumstances). We calculated the attribute rating means and standard deviations, and used content analysis to characterize open-ended responses. The second questionnaire for resident family members and advocates included open-ended questions about nursing home research, and factors influencing willingness to participate.
The attributes rated as most essential for conducting efficacy and effectiveness trials in nursing homes are research team attributes, that is, that researchers recognize regulatory constraints; understand and adapt to nursing home workflow; and work collaboratively with nursing home leaders to identify priorities. Resident and facility diversity emerged as essential for effectiveness trials; important dimensions included resident race, ethnicity and income, as well as nursing home urban/rural location, quality ratings, geography, staffing ratios, size, and profit status. Caregivers and resident advocates stressed the importance of communication among participants, researchers, and nursing home leadership and staff at all stages of a trial.
Developing a robust U.S. clinical research enterprise capable of efficiently mounting future clinical trials in nursing homes will require a reimagining of the relationships that exist between researchers, facilities, nursing home leaders, and residents, with a research infrastructure specifically focused on supporting and fostering these connections.</description><identifier>ISSN: 0002-8614</identifier><identifier>EISSN: 1532-5415</identifier><identifier>DOI: 10.1111/jgs.17710</identifier><identifier>PMID: 35188222</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Clinical trials ; Content analysis ; COVID-19 ; Cross-Sectional Studies ; Humans ; Leadership ; Nursing Homes ; Pandemics ; Surveys and Questionnaires</subject><ispartof>Journal of the American Geriatrics Society (JAGS), 2022-04, Vol.70 (4), p.950-959</ispartof><rights>2022 The American Geriatrics Society.</rights><rights>2022 American Geriatrics Society and Wiley Periodicals LLC</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c403t-70af46daaf96fa0868b0b6b2b55ff3ac9ecc8287540bd92393587d6ad67e05b43</citedby><cites>FETCH-LOGICAL-c403t-70af46daaf96fa0868b0b6b2b55ff3ac9ecc8287540bd92393587d6ad67e05b43</cites><orcidid>0000-0002-6066-2984 ; 0000-0002-9306-7487</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,781,785,886,27929,27930</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35188222$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Delude, Christopher</creatorcontrib><creatorcontrib>Abi-Elias, Ivan H</creatorcontrib><creatorcontrib>Quinn, Charlene C</creatorcontrib><creatorcontrib>Adams, Alyce S</creatorcontrib><creatorcontrib>Magaziner, Jay S</creatorcontrib><creatorcontrib>Ito, Kouta</creatorcontrib><creatorcontrib>Jain, Paavani</creatorcontrib><creatorcontrib>Gurwitz, Jerry H</creatorcontrib><creatorcontrib>Mazor, Kathleen M</creatorcontrib><title>Stakeholders' views on priorities essential for establishing a supportive environment for clinical trials in nursing homes</title><title>Journal of the American Geriatrics Society (JAGS)</title><addtitle>J Am Geriatr Soc</addtitle><description>The U.S. clinical research enterprise in nursing homes was unprepared to mount clinical trials in nursing homes to address urgent questions relevant to prevention and treatment during the COVID-19 pandemic. We identify priorities essential for establishing a supportive environment for future clinical trials in nursing homes.
Two cross-sectional online questionnaires were administered between January and February 2021. One was administered to nursing home providers, researchers, and policymakers; respondents rated the importance of attributes of researchers, facilities, leaders and staff for conducting clinical trials in nursing homes. Because importance may depend on trial type, respondents rated each attribute for efficacy trials (testing an intervention in ideal circumstances) and effectiveness trials (testing an intervention in "real world" circumstances). We calculated the attribute rating means and standard deviations, and used content analysis to characterize open-ended responses. The second questionnaire for resident family members and advocates included open-ended questions about nursing home research, and factors influencing willingness to participate.
The attributes rated as most essential for conducting efficacy and effectiveness trials in nursing homes are research team attributes, that is, that researchers recognize regulatory constraints; understand and adapt to nursing home workflow; and work collaboratively with nursing home leaders to identify priorities. Resident and facility diversity emerged as essential for effectiveness trials; important dimensions included resident race, ethnicity and income, as well as nursing home urban/rural location, quality ratings, geography, staffing ratios, size, and profit status. Caregivers and resident advocates stressed the importance of communication among participants, researchers, and nursing home leadership and staff at all stages of a trial.
Developing a robust U.S. clinical research enterprise capable of efficiently mounting future clinical trials in nursing homes will require a reimagining of the relationships that exist between researchers, facilities, nursing home leaders, and residents, with a research infrastructure specifically focused on supporting and fostering these connections.</description><subject>Clinical trials</subject><subject>Content analysis</subject><subject>COVID-19</subject><subject>Cross-Sectional Studies</subject><subject>Humans</subject><subject>Leadership</subject><subject>Nursing Homes</subject><subject>Pandemics</subject><subject>Surveys and Questionnaires</subject><issn>0002-8614</issn><issn>1532-5415</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkU1v1DAQhq0KRJe2h_4BZIkDcEg7tmPHuVRCFV9SJQ5tz5bjOLteEnuxk0Xw65l-UAG-WB4_8-qdeQk5ZXDG8Jxv1-WMNQ2DA7JiUvBK1kw-IysA4JVWrD4kL0vZAjAOWr8gh0IyrTnnK_Lrerbf_CaNvc_lDd0H_6PQFOkuh5TDHHyhvhQf52BHOqSMr9l2YyibENfU0rLsdinPYe-pj_uQU5wQvifdGGJw2DZnbC40RBqXXO76Nmny5Zg8H7DuTx7vI3L78cPN5efq6uunL5fvrypXg5irBuxQq97aoVWDBa10B53qeCflMAjrWu-c5rqRNXR9y0UrpG56ZXvVeJBdLY7IxYPubukm3zv0l-1ocMLJ5p8m2WD-_YlhY9Zpb3SrleISBd4-CuT0fcEFmCkU58fRRp-WYrgSTNWgZIvo6__QbVpyxPGQqhuQLW4eqXcPlMuplOyHJzMMzF2iBhM194ki--pv90_knwjFb_cIn9k</recordid><startdate>20220401</startdate><enddate>20220401</enddate><creator>Delude, Christopher</creator><creator>Abi-Elias, Ivan H</creator><creator>Quinn, Charlene C</creator><creator>Adams, Alyce S</creator><creator>Magaziner, Jay S</creator><creator>Ito, Kouta</creator><creator>Jain, Paavani</creator><creator>Gurwitz, Jerry H</creator><creator>Mazor, Kathleen M</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7TK</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-6066-2984</orcidid><orcidid>https://orcid.org/0000-0002-9306-7487</orcidid></search><sort><creationdate>20220401</creationdate><title>Stakeholders' views on priorities essential for establishing a supportive environment for clinical trials in nursing homes</title><author>Delude, Christopher ; Abi-Elias, Ivan H ; Quinn, Charlene C ; Adams, Alyce S ; Magaziner, Jay S ; Ito, Kouta ; Jain, Paavani ; Gurwitz, Jerry H ; Mazor, Kathleen M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c403t-70af46daaf96fa0868b0b6b2b55ff3ac9ecc8287540bd92393587d6ad67e05b43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Clinical trials</topic><topic>Content analysis</topic><topic>COVID-19</topic><topic>Cross-Sectional Studies</topic><topic>Humans</topic><topic>Leadership</topic><topic>Nursing Homes</topic><topic>Pandemics</topic><topic>Surveys and Questionnaires</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Delude, Christopher</creatorcontrib><creatorcontrib>Abi-Elias, Ivan H</creatorcontrib><creatorcontrib>Quinn, Charlene C</creatorcontrib><creatorcontrib>Adams, Alyce S</creatorcontrib><creatorcontrib>Magaziner, Jay S</creatorcontrib><creatorcontrib>Ito, Kouta</creatorcontrib><creatorcontrib>Jain, Paavani</creatorcontrib><creatorcontrib>Gurwitz, Jerry H</creatorcontrib><creatorcontrib>Mazor, Kathleen M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of the American Geriatrics Society (JAGS)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Delude, Christopher</au><au>Abi-Elias, Ivan H</au><au>Quinn, Charlene C</au><au>Adams, Alyce S</au><au>Magaziner, Jay S</au><au>Ito, Kouta</au><au>Jain, Paavani</au><au>Gurwitz, Jerry H</au><au>Mazor, Kathleen M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Stakeholders' views on priorities essential for establishing a supportive environment for clinical trials in nursing homes</atitle><jtitle>Journal of the American Geriatrics Society (JAGS)</jtitle><addtitle>J Am Geriatr Soc</addtitle><date>2022-04-01</date><risdate>2022</risdate><volume>70</volume><issue>4</issue><spage>950</spage><epage>959</epage><pages>950-959</pages><issn>0002-8614</issn><eissn>1532-5415</eissn><abstract>The U.S. clinical research enterprise in nursing homes was unprepared to mount clinical trials in nursing homes to address urgent questions relevant to prevention and treatment during the COVID-19 pandemic. We identify priorities essential for establishing a supportive environment for future clinical trials in nursing homes.
Two cross-sectional online questionnaires were administered between January and February 2021. One was administered to nursing home providers, researchers, and policymakers; respondents rated the importance of attributes of researchers, facilities, leaders and staff for conducting clinical trials in nursing homes. Because importance may depend on trial type, respondents rated each attribute for efficacy trials (testing an intervention in ideal circumstances) and effectiveness trials (testing an intervention in "real world" circumstances). We calculated the attribute rating means and standard deviations, and used content analysis to characterize open-ended responses. The second questionnaire for resident family members and advocates included open-ended questions about nursing home research, and factors influencing willingness to participate.
The attributes rated as most essential for conducting efficacy and effectiveness trials in nursing homes are research team attributes, that is, that researchers recognize regulatory constraints; understand and adapt to nursing home workflow; and work collaboratively with nursing home leaders to identify priorities. Resident and facility diversity emerged as essential for effectiveness trials; important dimensions included resident race, ethnicity and income, as well as nursing home urban/rural location, quality ratings, geography, staffing ratios, size, and profit status. Caregivers and resident advocates stressed the importance of communication among participants, researchers, and nursing home leadership and staff at all stages of a trial.
Developing a robust U.S. clinical research enterprise capable of efficiently mounting future clinical trials in nursing homes will require a reimagining of the relationships that exist between researchers, facilities, nursing home leaders, and residents, with a research infrastructure specifically focused on supporting and fostering these connections.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>35188222</pmid><doi>10.1111/jgs.17710</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-6066-2984</orcidid><orcidid>https://orcid.org/0000-0002-9306-7487</orcidid><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; Wiley Online Library All Journals |
subjects | Clinical trials Content analysis COVID-19 Cross-Sectional Studies Humans Leadership Nursing Homes Pandemics Surveys and Questionnaires |
title | Stakeholders' views on priorities essential for establishing a supportive environment for clinical trials in nursing homes |
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