Establishing an electronic health record–supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience
Aims To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record–supported and conventional recruitment methods. Methods Observational analysis of recruitment approac...
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| Veröffentlicht in: | Clinical trials (London, England) England), 2019-06, Vol.16 (3), p.306-315 |
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| creator | Aroda, Vanita R Sheehan, Patricia R Vickery, Ellen M Staten, Myrlene A LeBlanc, Erin S Phillips, Lawrence S Brodsky, Irwin G Chadha, Chhavi Chatterjee, Ranee Ouellette, Miranda G Desouza, Cyrus Pittas, Anastassios G |
| description | Aims
To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record–supported and conventional recruitment methods.
Methods
Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record–supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record–supported versus non–electronic health record methods.
Results
In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non–electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record–supported recruitment was adopted by 21 of 22 sites. Electronic health record–supported recruitment was associated with more participants screened versus non–electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record–supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level.
Conclusion
Establishing electronic health record–supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments. |
| doi_str_mv | 10.1177/1740774519839062 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6764596</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_1740774519839062</sage_id><sourcerecordid>2229908284</sourcerecordid><originalsourceid>FETCH-LOGICAL-c462t-aa2f9322f8e2e4ef8a8a1e94b7e068d4259f4ee22f925477049c14f679a5b12f3</originalsourceid><addsrcrecordid>eNp1ks2O1SAUgBujccbRvStD4mZcVIHSAi5MzMz4k0ziZlw3lB5uGVuoQCfene_gs_kCPonUO171Jq6Aw3e-wyGnKB4T_JwQzl8QzjDnrCZSVBI39E5xvIZKzuvq7n7P6qPiQYzXGFNRi-p-cVQRjDlm8rj4fhGT6kYbB-s2SDkEI-gUvLMaDaDGNKAA2of-x9dvcZlnHxL0SM1z8EoPyPiA_JICrIfks6Bf-bDYNIFLyBs0Q4jeRaQSGuwm62z8tMbTdgZEUW9VBwkisg7p0ea6akQpWDXGl-hqAHRjk5ry5fkv-WHW6Tntn6GYln6L4EuuZcFpeFjcM1kAj27Xk-Ljm4urs3fl5Ye3789eX5aaNTSVSlEjK0qNAAoMjFBCEZCs44Ab0TNaS8MAMiBpzfj6Y5ow03Cp6o5QU50Ur3beeekm6HVuOaixnYOdVNi2Xtn23xtnh3bjb9qGN6yWTRac3gqC_7xATO1ko4ZxVA78EltKCeWkqQXP6NMD9NovweX2MkWlxIIKlim8o3TwMQYw-8cQ3K4z0x7OTE558ncT-4TfQ5KBcgdEtYE_Vf8r_Ans3842</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2229908284</pqid></control><display><type>article</type><title>Establishing an electronic health record–supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience</title><source>Access via SAGE</source><source>MEDLINE</source><creator>Aroda, Vanita R ; Sheehan, Patricia R ; Vickery, Ellen M ; Staten, Myrlene A ; LeBlanc, Erin S ; Phillips, Lawrence S ; Brodsky, Irwin G ; Chadha, Chhavi ; Chatterjee, Ranee ; Ouellette, Miranda G ; Desouza, Cyrus ; Pittas, Anastassios G</creator><creatorcontrib>Aroda, Vanita R ; Sheehan, Patricia R ; Vickery, Ellen M ; Staten, Myrlene A ; LeBlanc, Erin S ; Phillips, Lawrence S ; Brodsky, Irwin G ; Chadha, Chhavi ; Chatterjee, Ranee ; Ouellette, Miranda G ; Desouza, Cyrus ; Pittas, Anastassios G ; D2d Research Group ; for the D2d Research Group</creatorcontrib><description>Aims
To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record–supported and conventional recruitment methods.
Methods
Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record–supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record–supported versus non–electronic health record methods.
Results
In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non–electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record–supported recruitment was adopted by 21 of 22 sites. Electronic health record–supported recruitment was associated with more participants screened versus non–electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record–supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level.
Conclusion
Establishing electronic health record–supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments.</description><identifier>ISSN: 1740-7745</identifier><identifier>EISSN: 1740-7753</identifier><identifier>DOI: 10.1177/1740774519839062</identifier><identifier>PMID: 31007049</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Aged ; Blood Glucose ; Cholecalciferol - administration & dosage ; Cholecalciferol - therapeutic use ; Clinical trials ; Comorbidity ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - prevention & control ; Diet ; Dietary Supplements ; Double-Blind Method ; Electronic health records ; Electronic Health Records - organization & administration ; Electronic medical records ; Feasibility Studies ; Glycated Hemoglobin ; Health care ; Health risks ; Humans ; Initiatives ; Medical research ; Middle Aged ; Minority & ethnic groups ; Patient Selection ; Prediabetic State - drug therapy ; Randomization ; Recruitment ; Research Design ; Vitamin D</subject><ispartof>Clinical trials (London, England), 2019-06, Vol.16 (3), p.306-315</ispartof><rights>The Author(s) 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c462t-aa2f9322f8e2e4ef8a8a1e94b7e068d4259f4ee22f925477049c14f679a5b12f3</citedby><cites>FETCH-LOGICAL-c462t-aa2f9322f8e2e4ef8a8a1e94b7e068d4259f4ee22f925477049c14f679a5b12f3</cites><orcidid>0000-0001-8610-8917</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/1740774519839062$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/1740774519839062$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>230,314,780,784,885,21819,27924,27925,43621,43622</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31007049$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Aroda, Vanita R</creatorcontrib><creatorcontrib>Sheehan, Patricia R</creatorcontrib><creatorcontrib>Vickery, Ellen M</creatorcontrib><creatorcontrib>Staten, Myrlene A</creatorcontrib><creatorcontrib>LeBlanc, Erin S</creatorcontrib><creatorcontrib>Phillips, Lawrence S</creatorcontrib><creatorcontrib>Brodsky, Irwin G</creatorcontrib><creatorcontrib>Chadha, Chhavi</creatorcontrib><creatorcontrib>Chatterjee, Ranee</creatorcontrib><creatorcontrib>Ouellette, Miranda G</creatorcontrib><creatorcontrib>Desouza, Cyrus</creatorcontrib><creatorcontrib>Pittas, Anastassios G</creatorcontrib><creatorcontrib>D2d Research Group</creatorcontrib><creatorcontrib>for the D2d Research Group</creatorcontrib><title>Establishing an electronic health record–supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience</title><title>Clinical trials (London, England)</title><addtitle>Clin Trials</addtitle><description>Aims
To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record–supported and conventional recruitment methods.
Methods
Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record–supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record–supported versus non–electronic health record methods.
Results
In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non–electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record–supported recruitment was adopted by 21 of 22 sites. Electronic health record–supported recruitment was associated with more participants screened versus non–electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record–supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level.
Conclusion
Establishing electronic health record–supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments.</description><subject>Aged</subject><subject>Blood Glucose</subject><subject>Cholecalciferol - administration & dosage</subject><subject>Cholecalciferol - therapeutic use</subject><subject>Clinical trials</subject><subject>Comorbidity</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - prevention & control</subject><subject>Diet</subject><subject>Dietary Supplements</subject><subject>Double-Blind Method</subject><subject>Electronic health records</subject><subject>Electronic Health Records - organization & administration</subject><subject>Electronic medical records</subject><subject>Feasibility Studies</subject><subject>Glycated Hemoglobin</subject><subject>Health care</subject><subject>Health risks</subject><subject>Humans</subject><subject>Initiatives</subject><subject>Medical research</subject><subject>Middle Aged</subject><subject>Minority & ethnic groups</subject><subject>Patient Selection</subject><subject>Prediabetic State - drug therapy</subject><subject>Randomization</subject><subject>Recruitment</subject><subject>Research Design</subject><subject>Vitamin D</subject><issn>1740-7745</issn><issn>1740-7753</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1ks2O1SAUgBujccbRvStD4mZcVIHSAi5MzMz4k0ziZlw3lB5uGVuoQCfene_gs_kCPonUO171Jq6Aw3e-wyGnKB4T_JwQzl8QzjDnrCZSVBI39E5xvIZKzuvq7n7P6qPiQYzXGFNRi-p-cVQRjDlm8rj4fhGT6kYbB-s2SDkEI-gUvLMaDaDGNKAA2of-x9dvcZlnHxL0SM1z8EoPyPiA_JICrIfks6Bf-bDYNIFLyBs0Q4jeRaQSGuwm62z8tMbTdgZEUW9VBwkisg7p0ea6akQpWDXGl-hqAHRjk5ry5fkv-WHW6Tntn6GYln6L4EuuZcFpeFjcM1kAj27Xk-Ljm4urs3fl5Ye3789eX5aaNTSVSlEjK0qNAAoMjFBCEZCs44Ab0TNaS8MAMiBpzfj6Y5ow03Cp6o5QU50Ur3beeekm6HVuOaixnYOdVNi2Xtn23xtnh3bjb9qGN6yWTRac3gqC_7xATO1ko4ZxVA78EltKCeWkqQXP6NMD9NovweX2MkWlxIIKlim8o3TwMQYw-8cQ3K4z0x7OTE558ncT-4TfQ5KBcgdEtYE_Vf8r_Ans3842</recordid><startdate>20190601</startdate><enddate>20190601</enddate><creator>Aroda, Vanita R</creator><creator>Sheehan, Patricia R</creator><creator>Vickery, Ellen M</creator><creator>Staten, Myrlene A</creator><creator>LeBlanc, Erin S</creator><creator>Phillips, Lawrence S</creator><creator>Brodsky, Irwin G</creator><creator>Chadha, Chhavi</creator><creator>Chatterjee, Ranee</creator><creator>Ouellette, Miranda G</creator><creator>Desouza, Cyrus</creator><creator>Pittas, Anastassios G</creator><general>SAGE Publications</general><general>Sage Publications Ltd</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>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>C1K</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-8610-8917</orcidid></search><sort><creationdate>20190601</creationdate><title>Establishing an electronic health record–supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience</title><author>Aroda, Vanita R ; Sheehan, Patricia R ; Vickery, Ellen M ; Staten, Myrlene A ; LeBlanc, Erin S ; Phillips, Lawrence S ; Brodsky, Irwin G ; Chadha, Chhavi ; Chatterjee, Ranee ; Ouellette, Miranda G ; Desouza, Cyrus ; Pittas, Anastassios G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c462t-aa2f9322f8e2e4ef8a8a1e94b7e068d4259f4ee22f925477049c14f679a5b12f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Blood Glucose</topic><topic>Cholecalciferol - administration & dosage</topic><topic>Cholecalciferol - therapeutic use</topic><topic>Clinical trials</topic><topic>Comorbidity</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - prevention & control</topic><topic>Diet</topic><topic>Dietary Supplements</topic><topic>Double-Blind Method</topic><topic>Electronic health records</topic><topic>Electronic Health Records - organization & administration</topic><topic>Electronic medical records</topic><topic>Feasibility Studies</topic><topic>Glycated Hemoglobin</topic><topic>Health care</topic><topic>Health risks</topic><topic>Humans</topic><topic>Initiatives</topic><topic>Medical research</topic><topic>Middle Aged</topic><topic>Minority & ethnic groups</topic><topic>Patient Selection</topic><topic>Prediabetic State - drug therapy</topic><topic>Randomization</topic><topic>Recruitment</topic><topic>Research Design</topic><topic>Vitamin D</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Aroda, Vanita R</creatorcontrib><creatorcontrib>Sheehan, Patricia R</creatorcontrib><creatorcontrib>Vickery, Ellen M</creatorcontrib><creatorcontrib>Staten, Myrlene A</creatorcontrib><creatorcontrib>LeBlanc, Erin S</creatorcontrib><creatorcontrib>Phillips, Lawrence S</creatorcontrib><creatorcontrib>Brodsky, Irwin G</creatorcontrib><creatorcontrib>Chadha, Chhavi</creatorcontrib><creatorcontrib>Chatterjee, Ranee</creatorcontrib><creatorcontrib>Ouellette, Miranda G</creatorcontrib><creatorcontrib>Desouza, Cyrus</creatorcontrib><creatorcontrib>Pittas, Anastassios G</creatorcontrib><creatorcontrib>D2d Research Group</creatorcontrib><creatorcontrib>for the D2d Research Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</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>Clinical trials (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Aroda, Vanita R</au><au>Sheehan, Patricia R</au><au>Vickery, Ellen M</au><au>Staten, Myrlene A</au><au>LeBlanc, Erin S</au><au>Phillips, Lawrence S</au><au>Brodsky, Irwin G</au><au>Chadha, Chhavi</au><au>Chatterjee, Ranee</au><au>Ouellette, Miranda G</au><au>Desouza, Cyrus</au><au>Pittas, Anastassios G</au><aucorp>D2d Research Group</aucorp><aucorp>for the D2d Research Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Establishing an electronic health record–supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience</atitle><jtitle>Clinical trials (London, England)</jtitle><addtitle>Clin Trials</addtitle><date>2019-06-01</date><risdate>2019</risdate><volume>16</volume><issue>3</issue><spage>306</spage><epage>315</epage><pages>306-315</pages><issn>1740-7745</issn><eissn>1740-7753</eissn><abstract>Aims
To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record–supported and conventional recruitment methods.
Methods
Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record–supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record–supported versus non–electronic health record methods.
Results
In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non–electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record–supported recruitment was adopted by 21 of 22 sites. Electronic health record–supported recruitment was associated with more participants screened versus non–electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record–supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level.
Conclusion
Establishing electronic health record–supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>31007049</pmid><doi>10.1177/1740774519839062</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-8610-8917</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Clinical trials (London, England), 2019-06, Vol.16 (3), p.306-315 |
| issn | 1740-7745 1740-7753 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6764596 |
| source | Access via SAGE; MEDLINE |
| subjects | Aged Blood Glucose Cholecalciferol - administration & dosage Cholecalciferol - therapeutic use Clinical trials Comorbidity Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - prevention & control Diet Dietary Supplements Double-Blind Method Electronic health records Electronic Health Records - organization & administration Electronic medical records Feasibility Studies Glycated Hemoglobin Health care Health risks Humans Initiatives Medical research Middle Aged Minority & ethnic groups Patient Selection Prediabetic State - drug therapy Randomization Recruitment Research Design Vitamin D |
| title | Establishing an electronic health record–supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience |
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