Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team.
Identifieur interne : 000168 ( Main/Exploration ); précédent : 000167; suivant : 000169Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team.
Auteurs : Felicity A. Baker [Australie, Norvège] ; Phoebe A. Stretton-Smith [Australie] ; Tanara Vieira Sousa [Australie] ; Imogen Clark [Australie] ; Alice Cotton [Australie] ; Christian Gold [Norvège] ; Young-Eun C. Lee [Australie]Source :
- Contemporary clinical trials communications [ 2451-8654 ] ; 2020.
Abstract
Background
The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. This paper describes process and resource assessment during recruitment, collection of outcome measures and intervention delivery, and presents learnings and considerations for conducting trials in RACFs with people living with dementia.
Methods
Data were collected across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as reasons for participant non-attendance at the interventions.
Results
Time between contacting next of kin and receiving formal consent often exceeded 45 days. The ratio of time between direct and indirect research activity was approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations.
Conclusions
Research planning should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines.
Trial registration Australian and New Zealand Clinical Trial Registry ANZCTR12618000156280 1/02/2018 http//anzctrorgau/Trial/Registration/TrialReviewaspx?ACTRN=12618000156280
A.
DOI: 10.1016/j.conctc.2020.100675
PubMed: 33305065
PubMed Central: PMC7711137
Affiliations:
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Baker</name><affiliation wicri:level="4"><nlm:affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation><affiliation wicri:level="3"><nlm:affiliation>Centre for Music and Health, Norwegian Academy of Music, Oslo, Norway.</nlm:affiliation><country xml:lang="fr">Norvège</country><wicri:regionArea>Centre for Music and Health, Norwegian Academy of Music, Oslo</wicri:regionArea><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Stretton Smith, Phoebe A" sort="Stretton Smith, Phoebe A" uniqKey="Stretton Smith P" first="Phoebe A" last="Stretton-Smith">Phoebe A. 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Baker</name><affiliation wicri:level="4"><nlm:affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation><affiliation wicri:level="3"><nlm:affiliation>Centre for Music and Health, Norwegian Academy of Music, Oslo, Norway.</nlm:affiliation><country xml:lang="fr">Norvège</country><wicri:regionArea>Centre for Music and Health, Norwegian Academy of Music, Oslo</wicri:regionArea><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Stretton Smith, Phoebe A" sort="Stretton Smith, Phoebe A" uniqKey="Stretton Smith P" first="Phoebe A" last="Stretton-Smith">Phoebe A. Stretton-Smith</name><affiliation wicri:level="4"><nlm:affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Sousa, Tanara Vieira" sort="Sousa, Tanara Vieira" uniqKey="Sousa T" first="Tanara Vieira" last="Sousa">Tanara Vieira Sousa</name><affiliation wicri:level="4"><nlm:affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Clark, Imogen" sort="Clark, Imogen" uniqKey="Clark I" first="Imogen" last="Clark">Imogen Clark</name><affiliation wicri:level="4"><nlm:affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Cotton, Alice" sort="Cotton, Alice" uniqKey="Cotton A" first="Alice" last="Cotton">Alice Cotton</name><affiliation wicri:level="4"><nlm:affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Gold, Christian" sort="Gold, Christian" uniqKey="Gold C" first="Christian" last="Gold">Christian Gold</name><affiliation wicri:level="1"><nlm:affiliation>NORCE Norwegian Research Centre AS, Bergen, Norway.</nlm:affiliation><country xml:lang="fr">Norvège</country><wicri:regionArea>NORCE Norwegian Research Centre AS, Bergen</wicri:regionArea><wicri:noRegion>Bergen</wicri:noRegion></affiliation></author><author><name sortKey="Lee, Young Eun C" sort="Lee, Young Eun C" uniqKey="Lee Y" first="Young-Eun C" last="Lee">Young-Eun C. Lee</name><affiliation wicri:level="4"><nlm:affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author></analytic><series><title level="j">Contemporary clinical trials communications</title><idno type="eISSN">2451-8654</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>Background</b></p><p>The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. This paper describes process and resource assessment during recruitment, collection of outcome measures and intervention delivery, and presents learnings and considerations for conducting trials in RACFs with people living with dementia.</p></div><div type="abstract" xml:lang="en"><p><b>Methods</b></p><p>Data were collected across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as reasons for participant non-attendance at the interventions.</p></div><div type="abstract" xml:lang="en"><p><b>Results</b></p><p>Time between contacting next of kin and receiving formal consent often exceeded 45 days. The ratio of time between direct and indirect research activity was approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations.</p></div><div type="abstract" xml:lang="en"><p><b>Conclusions</b></p><p>Research planning should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines.</p></div><div type="abstract" xml:lang="en"><p><b>Trial registration Australian and New Zealand Clinical Trial Registry ANZCTR12618000156280 1/02/2018 http//anzctrorgau/Trial/Registration/TrialReviewaspx?ACTRN=12618000156280</b></p><p>A.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33305065</PMID><DateRevised><Year>2020</Year><Month>12</Month><Day>12</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">2451-8654</ISSN><JournalIssue CitedMedium="Internet"><Volume>20</Volume><PubDate><Year>2020</Year><Month>Dec</Month></PubDate></JournalIssue><Title>Contemporary clinical trials communications</Title><ISOAbbreviation>Contemp Clin Trials Commun</ISOAbbreviation></Journal><ArticleTitle>Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team.</ArticleTitle><Pagination><MedlinePgn>100675</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.conctc.2020.100675</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. This paper describes process and resource assessment during recruitment, collection of outcome measures and intervention delivery, and presents learnings and considerations for conducting trials in RACFs with people living with dementia.</AbstractText><AbstractText Label="Methods" NlmCategory="UNASSIGNED">Data were collected across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as reasons for participant non-attendance at the interventions.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">Time between contacting next of kin and receiving formal consent often exceeded 45 days. The ratio of time between direct and indirect research activity was approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations.</AbstractText><AbstractText Label="Conclusions" NlmCategory="UNASSIGNED">Research planning should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines.</AbstractText><AbstractText Label="Trial registration Australian and New Zealand Clinical Trial Registry ANZCTR12618000156280 1/02/2018 http//anzctrorgau/Trial/Registration/TrialReviewaspx?ACTRN=12618000156280" NlmCategory="UNASSIGNED">A.</AbstractText><CopyrightInformation>© 2020 The Authors.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Baker</LastName><ForeName>Felicity A</ForeName><Initials>FA</Initials><AffiliationInfo><Affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Centre for Music and Health, Norwegian Academy of Music, Oslo, Norway.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stretton-Smith</LastName><ForeName>Phoebe A</ForeName><Initials>PA</Initials><AffiliationInfo><Affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sousa</LastName><ForeName>Tanara Vieira</ForeName><Initials>TV</Initials><AffiliationInfo><Affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Clark</LastName><ForeName>Imogen</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cotton</LastName><ForeName>Alice</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gold</LastName><ForeName>Christian</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>NORCE Norwegian Research Centre AS, Bergen, Norway.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Young-Eun C</ForeName><Initials>YC</Initials><AffiliationInfo><Affiliation>Creative Arts and Music Therapy Research Unit, The University of Melbourne, Melbourne, Australia.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>11</Month><Day>25</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Contemp Clin Trials Commun</MedlineTA><NlmUniqueID>101671157</NlmUniqueID><ISSNLinking>2451-8654</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Dementia</Keyword><Keyword MajorTopicYN="N">Intervention adherence</Keyword><Keyword MajorTopicYN="N">Music therapy</Keyword><Keyword MajorTopicYN="N">Nursing homes</Keyword><Keyword MajorTopicYN="N">Project management</Keyword><Keyword MajorTopicYN="N">Recruitment</Keyword><Keyword MajorTopicYN="N">Residential aged care</Keyword><Keyword MajorTopicYN="N">Resource assessment</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>08</Month><Day>10</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>11</Month><Day>10</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>11</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>12</Month><Day>11</Day><Hour>6</Hour><Minute>5</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>12</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>12</Month><Day>12</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33305065</ArticleId><ArticleId IdType="doi">10.1016/j.conctc.2020.100675</ArticleId><ArticleId IdType="pii">S2451-8654(20)30159-9</ArticleId><ArticleId IdType="pmc">PMC7711137</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Trials. 2018 Jul 13;19(1):378</Citation><ArticleIdList><ArticleId IdType="pubmed">30005659</ArticleId></ArticleIdList></Reference><Reference><Citation>West J Nurs Res. 2002 Jun;24(4):373-89</Citation><ArticleIdList><ArticleId IdType="pubmed">12035911</ArticleId></ArticleIdList></Reference><Reference><Citation>Res Gerontol Nurs. 2016 Jul 1;9(4):158-60</Citation><ArticleIdList><ArticleId IdType="pubmed">27434890</ArticleId></ArticleIdList></Reference><Reference><Citation>BMJ Open. 2019 Mar 30;9(3):e023436</Citation><ArticleIdList><ArticleId IdType="pubmed">30928926</ArticleId></ArticleIdList></Reference><Reference><Citation>BMC Geriatr. 2009 Aug 24;9:38</Citation><ArticleIdList><ArticleId IdType="pubmed">19703277</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>Norvège</li></country><region><li>Victoria (État)</li><li>Østlandet</li></region><settlement><li>Melbourne</li><li>Oslo</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="Australie"><region name="Victoria (État)"><name sortKey="Baker, Felicity A" sort="Baker, Felicity A" uniqKey="Baker F" first="Felicity A" last="Baker">Felicity A. Baker</name></region><name sortKey="Clark, Imogen" sort="Clark, Imogen" uniqKey="Clark I" first="Imogen" last="Clark">Imogen Clark</name><name sortKey="Cotton, Alice" sort="Cotton, Alice" uniqKey="Cotton A" first="Alice" last="Cotton">Alice Cotton</name><name sortKey="Lee, Young Eun C" sort="Lee, Young Eun C" uniqKey="Lee Y" first="Young-Eun C" last="Lee">Young-Eun C. Lee</name><name sortKey="Sousa, Tanara Vieira" sort="Sousa, Tanara Vieira" uniqKey="Sousa T" first="Tanara Vieira" last="Sousa">Tanara Vieira Sousa</name><name sortKey="Stretton Smith, Phoebe A" sort="Stretton Smith, Phoebe A" uniqKey="Stretton Smith P" first="Phoebe A" last="Stretton-Smith">Phoebe A. Stretton-Smith</name></country><country name="Norvège"><region name="Østlandet"><name sortKey="Baker, Felicity A" sort="Baker, Felicity A" uniqKey="Baker F" first="Felicity A" last="Baker">Felicity A. Baker</name></region><name sortKey="Gold, Christian" sort="Gold, Christian" uniqKey="Gold C" first="Christian" last="Gold">Christian Gold</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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