An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine
Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research. A multi-arm randomized controlled trial was...
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| Veröffentlicht in: | Annals of family medicine 2021-01, Vol.19 (1), p.16-23 |
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| container_title | Annals of family medicine |
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| creator | Golembiewski, Elizabeth H Mainous, 3rd, Arch G Rahmanian, Kiarash P Brumback, Babette Rooks, Benjamin J Krieger, Janice L Goodman, Kenneth W Moseley, Ray E Harle, Christopher A |
| description | Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research.
A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months.
A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09; |
| doi_str_mv | 10.1370/afm.2610 |
| format | Article |
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A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months.
A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09;
<.001) and subjective understanding (B = 18.04; SE = 2.58;
<.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0;
<.001) and subjective understanding (B = 32.2; SE = 2.6,
<.001).
Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.</description><identifier>ISSN: 1544-1709</identifier><identifier>EISSN: 1544-1717</identifier><identifier>DOI: 10.1370/afm.2610</identifier><identifier>PMID: 33431386</identifier><language>eng</language><publisher>United States: Annals of Family Medicine</publisher><subject>Electronic records ; Informed consent (Medical law) ; Medical informatics ; Medical records ; Medical research ; Medicine, Experimental ; Methods ; Original Research ; Patient satisfaction</subject><ispartof>Annals of family medicine, 2021-01, Vol.19 (1), p.16-23</ispartof><rights>2021 Annals of Family Medicine, Inc.</rights><rights>COPYRIGHT 2021 Annals of Family Medicine</rights><rights>2021 Annals of Family Medicine, Inc. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c574t-37e12a2d4d4a09495c36ef60a83f1f591257e1c24fbfd785ea6967c65cb789453</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7800739/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7800739/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33431386$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Golembiewski, Elizabeth H</creatorcontrib><creatorcontrib>Mainous, 3rd, Arch G</creatorcontrib><creatorcontrib>Rahmanian, Kiarash P</creatorcontrib><creatorcontrib>Brumback, Babette</creatorcontrib><creatorcontrib>Rooks, Benjamin J</creatorcontrib><creatorcontrib>Krieger, Janice L</creatorcontrib><creatorcontrib>Goodman, Kenneth W</creatorcontrib><creatorcontrib>Moseley, Ray E</creatorcontrib><creatorcontrib>Harle, Christopher A</creatorcontrib><title>An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine</title><title>Annals of family medicine</title><addtitle>Ann Fam Med</addtitle><description>Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research.
A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months.
A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09;
<.001) and subjective understanding (B = 18.04; SE = 2.58;
<.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0;
<.001) and subjective understanding (B = 32.2; SE = 2.6,
<.001).
Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.</description><subject>Electronic records</subject><subject>Informed consent (Medical law)</subject><subject>Medical informatics</subject><subject>Medical records</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Methods</subject><subject>Original Research</subject><subject>Patient satisfaction</subject><issn>1544-1709</issn><issn>1544-1717</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNptkl1rFDEUhgdRbK2Cv0ACgngzaz4mkxkvhHFoVWhRdL0O2czJbiSTbDOZQv31Zum6dGEJnIST57w5Sd6ieE3wgjCBPygzLmhN8JPinPCqKokg4ulhjduz4sU0_cGYEsro8-KMsYoR1tTnxV3n0aUDnWLwVqNlCA6lgH7N222ICf1QyYJPZZ8DRBjQ5xjUgPrgp5z5iDp0M7tkyy6O6KfyQxjt30z1zmY15dAy2hytR1dqtO4e3cBgtfXwsnhmlJvg1X6-KH5fXS77r-X19y_f-u661FxUqWQCCFV0qIZK4bZquWY1mBqrhhlieEsoz4SmlVmZQTQcVN3WQtdcr0TTVpxdFJ8edLfzaoRB56ajcnIb7ajivQzKyuMdbzdyHe6kaDAWrM0C7_cCMdzOMCU52kmDc8pDmCdJKyFoboThjL59QNfKgbTehKyod7js6tw7x4SzTJUnqDV4yMcHD8bm9BG_OMHnMcBo9cmCd48KNqBc2kzBzcnmTzsG91fTMUxTBHN4FoLlzlYy20rubJXRN4-f8QD-9xH7Bz8Oxfc</recordid><startdate>202101</startdate><enddate>202101</enddate><creator>Golembiewski, Elizabeth H</creator><creator>Mainous, 3rd, Arch G</creator><creator>Rahmanian, Kiarash P</creator><creator>Brumback, Babette</creator><creator>Rooks, Benjamin J</creator><creator>Krieger, Janice L</creator><creator>Goodman, Kenneth W</creator><creator>Moseley, Ray E</creator><creator>Harle, Christopher A</creator><general>Annals of Family Medicine</general><general>American Academy of Family Physicians</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>202101</creationdate><title>An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine</title><author>Golembiewski, Elizabeth H ; Mainous, 3rd, Arch G ; Rahmanian, Kiarash P ; Brumback, Babette ; Rooks, Benjamin J ; Krieger, Janice L ; Goodman, Kenneth W ; Moseley, Ray E ; Harle, Christopher A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c574t-37e12a2d4d4a09495c36ef60a83f1f591257e1c24fbfd785ea6967c65cb789453</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Electronic records</topic><topic>Informed consent (Medical law)</topic><topic>Medical informatics</topic><topic>Medical records</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Methods</topic><topic>Original Research</topic><topic>Patient satisfaction</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Golembiewski, Elizabeth H</creatorcontrib><creatorcontrib>Mainous, 3rd, Arch G</creatorcontrib><creatorcontrib>Rahmanian, Kiarash P</creatorcontrib><creatorcontrib>Brumback, Babette</creatorcontrib><creatorcontrib>Rooks, Benjamin J</creatorcontrib><creatorcontrib>Krieger, Janice L</creatorcontrib><creatorcontrib>Goodman, Kenneth W</creatorcontrib><creatorcontrib>Moseley, Ray E</creatorcontrib><creatorcontrib>Harle, Christopher A</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Annals of family medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Golembiewski, Elizabeth H</au><au>Mainous, 3rd, Arch G</au><au>Rahmanian, Kiarash P</au><au>Brumback, Babette</au><au>Rooks, Benjamin J</au><au>Krieger, Janice L</au><au>Goodman, Kenneth W</au><au>Moseley, Ray E</au><au>Harle, Christopher A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine</atitle><jtitle>Annals of family medicine</jtitle><addtitle>Ann Fam Med</addtitle><date>2021-01</date><risdate>2021</risdate><volume>19</volume><issue>1</issue><spage>16</spage><epage>23</epage><pages>16-23</pages><issn>1544-1709</issn><eissn>1544-1717</eissn><abstract>Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research.
A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months.
A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09;
<.001) and subjective understanding (B = 18.04; SE = 2.58;
<.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0;
<.001) and subjective understanding (B = 32.2; SE = 2.6,
<.001).
Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.</abstract><cop>United States</cop><pub>Annals of Family Medicine</pub><pmid>33431386</pmid><doi>10.1370/afm.2610</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1544-1709 |
| ispartof | Annals of family medicine, 2021-01, Vol.19 (1), p.16-23 |
| issn | 1544-1709 1544-1717 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7800739 |
| source | EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Electronic records Informed consent (Medical law) Medical informatics Medical records Medical research Medicine, Experimental Methods Original Research Patient satisfaction |
| title | An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine |
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