User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial
IntroductionThe goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).MethodsA pragmatic cluster rando...
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| Veröffentlicht in: | BMJ open 2019-05, Vol.9 (5), p.e028488 |
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| creator | Melnick, Edward R Jeffery, Molly Moore Dziura, James D Mao, Jodi A Hess, Erik P Platts-Mills, Timothy F Solad, Yauheni Paek, Hyung Martel, Shara Patel, Mehul D Bankowski, Laura Lu, Charles Brandt, Cynthia D’Onofrio, Gail |
| description | IntroductionThe goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).MethodsA pragmatic cluster randomised trial is planned to be carried out in 20 emergency departments (EDs) across five healthcare systems over 18 months. The intervention consists of a user-centred CDS integrated into ED clinician electronic workflow and available for guidance to: (1) determine whether patients presenting to the ED meet criteria for OUD, (2) assess withdrawal symptoms and (3) ascertain and motivate patient willingness to initiate treatment. The CDS guides the ED clinician to initiate BUP and facilitate follow-up. The primary outcome is the rate of BUP initiated in the ED. Secondary outcomes are: (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training. Primary and secondary outcomes will be analysed using generalised linear mixed models, with fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site.Ethics and disseminationThe protocol has been approved by the Western Institutional Review Board. No identifiable private information will be collected from patients. A waiver of informed consent was obtained for the collection of data for clinician prescribing and other activities. As a minimal risk implementation study of established best practices, an Independent Study Monitor will be utilised in place of a Data Safety Monitoring Board. Results will be reported in ClinicalTrials.gov and published in open-access, peer-reviewed journals, presented at national meetings and shared with the clinicians at participating sites via a broadcast email notification of publications.Trial registration number NCT03658642; Pre-results. |
| doi_str_mv | 10.1136/bmjopen-2018-028488 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6550013</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2233850880</sourcerecordid><originalsourceid>FETCH-LOGICAL-b3878-b9dc27653f989f17d15bb6bbdbf1d35385d543eb0f39b2d655dee5283585ca223</originalsourceid><addsrcrecordid>eNqNkk9vFCEYxidGY5vaT2BiSLx4mZY_wyzjwUTrWk1qvNgz4c87u2xmAIEx6cfyG8p216Z6kgOQl9_zwEuepnlJ8AUhrL_U8y5E8C3FRLSYik6IJ80pxV3X9pjzp4_2J815zjtcR8cHzunz5oQRwilmw2nz6zZDag34ksAiMznvjJqQBeOyCx7lJcaQCioBuTlOMFcS1TltwJu7ykWVyr7YVmVxqlQXvcQEPqS4dR7QGBIK0QVn0ZIBWZdDspDeophCCSZM90TZQi2ozayKM2iTwhJRUt6G2eVquf76Yf0RleTU9KJ5Nqopw_lxPWtuP62_X31ub75df7l6f9NqJlai1YM1dNVzNg5iGMnKEq51r7XVI7GMM8Et7xhoPLJBU9tzbgE4FYwLbhSl7Kx5d_CNi57B3n-RmmRMblbpTgbl5N8n3m3lJvyU1QpjwqrBm6NBCj8WyEXWXgxMk_IQlizrHfUVWAhc0df_oLuwJF_b21OU81Un-kqxA2VSyDnB-PAYguU-FfKYCrlPhTykoqpePe7jQfMnAxW4OABV_V-OvwE148kH</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2232557486</pqid></control><display><type>article</type><title>User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial</title><source>BMJ Open Access Journals</source><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><source>PubMed Central Open Access</source><creator>Melnick, Edward R ; Jeffery, Molly Moore ; Dziura, James D ; Mao, Jodi A ; Hess, Erik P ; Platts-Mills, Timothy F ; Solad, Yauheni ; Paek, Hyung ; Martel, Shara ; Patel, Mehul D ; Bankowski, Laura ; Lu, Charles ; Brandt, Cynthia ; D’Onofrio, Gail</creator><creatorcontrib>Melnick, Edward R ; Jeffery, Molly Moore ; Dziura, James D ; Mao, Jodi A ; Hess, Erik P ; Platts-Mills, Timothy F ; Solad, Yauheni ; Paek, Hyung ; Martel, Shara ; Patel, Mehul D ; Bankowski, Laura ; Lu, Charles ; Brandt, Cynthia ; D’Onofrio, Gail</creatorcontrib><description>IntroductionThe goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).MethodsA pragmatic cluster randomised trial is planned to be carried out in 20 emergency departments (EDs) across five healthcare systems over 18 months. The intervention consists of a user-centred CDS integrated into ED clinician electronic workflow and available for guidance to: (1) determine whether patients presenting to the ED meet criteria for OUD, (2) assess withdrawal symptoms and (3) ascertain and motivate patient willingness to initiate treatment. The CDS guides the ED clinician to initiate BUP and facilitate follow-up. The primary outcome is the rate of BUP initiated in the ED. Secondary outcomes are: (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training. Primary and secondary outcomes will be analysed using generalised linear mixed models, with fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site.Ethics and disseminationThe protocol has been approved by the Western Institutional Review Board. No identifiable private information will be collected from patients. A waiver of informed consent was obtained for the collection of data for clinician prescribing and other activities. As a minimal risk implementation study of established best practices, an Independent Study Monitor will be utilised in place of a Data Safety Monitoring Board. Results will be reported in ClinicalTrials.gov and published in open-access, peer-reviewed journals, presented at national meetings and shared with the clinicians at participating sites via a broadcast email notification of publications.Trial registration number NCT03658642; Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2018-028488</identifier><identifier>PMID: 31152039</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Adult ; Buprenorphine - administration & dosage ; Clinical decision making ; Clinical trials ; Cluster Analysis ; Decision making ; Decision support systems ; Decision Support Systems, Clinical - statistics & numerical data ; Drug abuse ; Electronic health records ; Emergency medical care ; Emergency Service, Hospital ; Evidence-based medicine ; Female ; Health Informatics ; Health promotion ; Humans ; Intervention ; Male ; Middle Aged ; Multicenter Studies as Topic ; Narcotic Antagonists - administration & dosage ; Narcotics ; Opiate Substitution Treatment ; Opioid-Related Disorders - drug therapy ; Opioid-Related Disorders - epidemiology ; Patients ; Pragmatic Clinical Trials as Topic ; Randomized Controlled Trials as Topic ; Substance abuse treatment ; Substance use disorder ; United States - epidemiology ; Young Adult</subject><ispartof>BMJ open, 2019-05, Vol.9 (5), p.e028488</ispartof><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2019 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b3878-b9dc27653f989f17d15bb6bbdbf1d35385d543eb0f39b2d655dee5283585ca223</citedby><cites>FETCH-LOGICAL-b3878-b9dc27653f989f17d15bb6bbdbf1d35385d543eb0f39b2d655dee5283585ca223</cites><orcidid>0000-0002-6509-9537</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/9/5/e028488.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/9/5/e028488.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27526,27527,27901,27902,53766,53768,77570,77601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31152039$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Melnick, Edward R</creatorcontrib><creatorcontrib>Jeffery, Molly Moore</creatorcontrib><creatorcontrib>Dziura, James D</creatorcontrib><creatorcontrib>Mao, Jodi A</creatorcontrib><creatorcontrib>Hess, Erik P</creatorcontrib><creatorcontrib>Platts-Mills, Timothy F</creatorcontrib><creatorcontrib>Solad, Yauheni</creatorcontrib><creatorcontrib>Paek, Hyung</creatorcontrib><creatorcontrib>Martel, Shara</creatorcontrib><creatorcontrib>Patel, Mehul D</creatorcontrib><creatorcontrib>Bankowski, Laura</creatorcontrib><creatorcontrib>Lu, Charles</creatorcontrib><creatorcontrib>Brandt, Cynthia</creatorcontrib><creatorcontrib>D’Onofrio, Gail</creatorcontrib><title>User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionThe goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).MethodsA pragmatic cluster randomised trial is planned to be carried out in 20 emergency departments (EDs) across five healthcare systems over 18 months. The intervention consists of a user-centred CDS integrated into ED clinician electronic workflow and available for guidance to: (1) determine whether patients presenting to the ED meet criteria for OUD, (2) assess withdrawal symptoms and (3) ascertain and motivate patient willingness to initiate treatment. The CDS guides the ED clinician to initiate BUP and facilitate follow-up. The primary outcome is the rate of BUP initiated in the ED. Secondary outcomes are: (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training. Primary and secondary outcomes will be analysed using generalised linear mixed models, with fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site.Ethics and disseminationThe protocol has been approved by the Western Institutional Review Board. No identifiable private information will be collected from patients. A waiver of informed consent was obtained for the collection of data for clinician prescribing and other activities. As a minimal risk implementation study of established best practices, an Independent Study Monitor will be utilised in place of a Data Safety Monitoring Board. Results will be reported in ClinicalTrials.gov and published in open-access, peer-reviewed journals, presented at national meetings and shared with the clinicians at participating sites via a broadcast email notification of publications.Trial registration number NCT03658642; Pre-results.</description><subject>Adult</subject><subject>Buprenorphine - administration & dosage</subject><subject>Clinical decision making</subject><subject>Clinical trials</subject><subject>Cluster Analysis</subject><subject>Decision making</subject><subject>Decision support systems</subject><subject>Decision Support Systems, Clinical - statistics & numerical data</subject><subject>Drug abuse</subject><subject>Electronic health records</subject><subject>Emergency medical care</subject><subject>Emergency Service, Hospital</subject><subject>Evidence-based medicine</subject><subject>Female</subject><subject>Health Informatics</subject><subject>Health promotion</subject><subject>Humans</subject><subject>Intervention</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multicenter Studies as Topic</subject><subject>Narcotic Antagonists - administration & dosage</subject><subject>Narcotics</subject><subject>Opiate Substitution Treatment</subject><subject>Opioid-Related Disorders - drug therapy</subject><subject>Opioid-Related Disorders - epidemiology</subject><subject>Patients</subject><subject>Pragmatic Clinical Trials as Topic</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Substance abuse treatment</subject><subject>Substance use disorder</subject><subject>United States - epidemiology</subject><subject>Young Adult</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkk9vFCEYxidGY5vaT2BiSLx4mZY_wyzjwUTrWk1qvNgz4c87u2xmAIEx6cfyG8p216Z6kgOQl9_zwEuepnlJ8AUhrL_U8y5E8C3FRLSYik6IJ80pxV3X9pjzp4_2J815zjtcR8cHzunz5oQRwilmw2nz6zZDag34ksAiMznvjJqQBeOyCx7lJcaQCioBuTlOMFcS1TltwJu7ykWVyr7YVmVxqlQXvcQEPqS4dR7QGBIK0QVn0ZIBWZdDspDeophCCSZM90TZQi2ozayKM2iTwhJRUt6G2eVquf76Yf0RleTU9KJ5Nqopw_lxPWtuP62_X31ub75df7l6f9NqJlai1YM1dNVzNg5iGMnKEq51r7XVI7GMM8Et7xhoPLJBU9tzbgE4FYwLbhSl7Kx5d_CNi57B3n-RmmRMblbpTgbl5N8n3m3lJvyU1QpjwqrBm6NBCj8WyEXWXgxMk_IQlizrHfUVWAhc0df_oLuwJF_b21OU81Un-kqxA2VSyDnB-PAYguU-FfKYCrlPhTykoqpePe7jQfMnAxW4OABV_V-OvwE148kH</recordid><startdate>20190530</startdate><enddate>20190530</enddate><creator>Melnick, Edward R</creator><creator>Jeffery, Molly Moore</creator><creator>Dziura, James D</creator><creator>Mao, Jodi A</creator><creator>Hess, Erik P</creator><creator>Platts-Mills, Timothy F</creator><creator>Solad, Yauheni</creator><creator>Paek, Hyung</creator><creator>Martel, Shara</creator><creator>Patel, Mehul D</creator><creator>Bankowski, Laura</creator><creator>Lu, Charles</creator><creator>Brandt, Cynthia</creator><creator>D’Onofrio, Gail</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PIMPY</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-6509-9537</orcidid></search><sort><creationdate>20190530</creationdate><title>User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial</title><author>Melnick, Edward R ; Jeffery, Molly Moore ; Dziura, James D ; Mao, Jodi A ; Hess, Erik P ; Platts-Mills, Timothy F ; Solad, Yauheni ; Paek, Hyung ; Martel, Shara ; Patel, Mehul D ; Bankowski, Laura ; Lu, Charles ; Brandt, Cynthia ; D’Onofrio, Gail</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b3878-b9dc27653f989f17d15bb6bbdbf1d35385d543eb0f39b2d655dee5283585ca223</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Buprenorphine - administration & dosage</topic><topic>Clinical decision making</topic><topic>Clinical trials</topic><topic>Cluster Analysis</topic><topic>Decision making</topic><topic>Decision support systems</topic><topic>Decision Support Systems, Clinical - statistics & numerical data</topic><topic>Drug abuse</topic><topic>Electronic health records</topic><topic>Emergency medical care</topic><topic>Emergency Service, Hospital</topic><topic>Evidence-based medicine</topic><topic>Female</topic><topic>Health Informatics</topic><topic>Health promotion</topic><topic>Humans</topic><topic>Intervention</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multicenter Studies as Topic</topic><topic>Narcotic Antagonists - administration & dosage</topic><topic>Narcotics</topic><topic>Opiate Substitution Treatment</topic><topic>Opioid-Related Disorders - drug therapy</topic><topic>Opioid-Related Disorders - epidemiology</topic><topic>Patients</topic><topic>Pragmatic Clinical Trials as Topic</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Substance abuse treatment</topic><topic>Substance use disorder</topic><topic>United States - epidemiology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Melnick, Edward R</creatorcontrib><creatorcontrib>Jeffery, Molly Moore</creatorcontrib><creatorcontrib>Dziura, James D</creatorcontrib><creatorcontrib>Mao, Jodi A</creatorcontrib><creatorcontrib>Hess, Erik P</creatorcontrib><creatorcontrib>Platts-Mills, Timothy F</creatorcontrib><creatorcontrib>Solad, Yauheni</creatorcontrib><creatorcontrib>Paek, Hyung</creatorcontrib><creatorcontrib>Martel, Shara</creatorcontrib><creatorcontrib>Patel, Mehul D</creatorcontrib><creatorcontrib>Bankowski, Laura</creatorcontrib><creatorcontrib>Lu, Charles</creatorcontrib><creatorcontrib>Brandt, Cynthia</creatorcontrib><creatorcontrib>D’Onofrio, Gail</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Melnick, Edward R</au><au>Jeffery, Molly Moore</au><au>Dziura, James D</au><au>Mao, Jodi A</au><au>Hess, Erik P</au><au>Platts-Mills, Timothy F</au><au>Solad, Yauheni</au><au>Paek, Hyung</au><au>Martel, Shara</au><au>Patel, Mehul D</au><au>Bankowski, Laura</au><au>Lu, Charles</au><au>Brandt, Cynthia</au><au>D’Onofrio, Gail</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2019-05-30</date><risdate>2019</risdate><volume>9</volume><issue>5</issue><spage>e028488</spage><pages>e028488-</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionThe goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD).MethodsA pragmatic cluster randomised trial is planned to be carried out in 20 emergency departments (EDs) across five healthcare systems over 18 months. The intervention consists of a user-centred CDS integrated into ED clinician electronic workflow and available for guidance to: (1) determine whether patients presenting to the ED meet criteria for OUD, (2) assess withdrawal symptoms and (3) ascertain and motivate patient willingness to initiate treatment. The CDS guides the ED clinician to initiate BUP and facilitate follow-up. The primary outcome is the rate of BUP initiated in the ED. Secondary outcomes are: (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training. Primary and secondary outcomes will be analysed using generalised linear mixed models, with fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site.Ethics and disseminationThe protocol has been approved by the Western Institutional Review Board. No identifiable private information will be collected from patients. A waiver of informed consent was obtained for the collection of data for clinician prescribing and other activities. As a minimal risk implementation study of established best practices, an Independent Study Monitor will be utilised in place of a Data Safety Monitoring Board. Results will be reported in ClinicalTrials.gov and published in open-access, peer-reviewed journals, presented at national meetings and shared with the clinicians at participating sites via a broadcast email notification of publications.Trial registration number NCT03658642; Pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>31152039</pmid><doi>10.1136/bmjopen-2018-028488</doi><orcidid>https://orcid.org/0000-0002-6509-9537</orcidid><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access |
| subjects | Adult Buprenorphine - administration & dosage Clinical decision making Clinical trials Cluster Analysis Decision making Decision support systems Decision Support Systems, Clinical - statistics & numerical data Drug abuse Electronic health records Emergency medical care Emergency Service, Hospital Evidence-based medicine Female Health Informatics Health promotion Humans Intervention Male Middle Aged Multicenter Studies as Topic Narcotic Antagonists - administration & dosage Narcotics Opiate Substitution Treatment Opioid-Related Disorders - drug therapy Opioid-Related Disorders - epidemiology Patients Pragmatic Clinical Trials as Topic Randomized Controlled Trials as Topic Substance abuse treatment Substance use disorder United States - epidemiology Young Adult |
| title | User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-19T03%3A15%3A57IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=User-centred%20clinical%20decision%20support%20to%20implement%20emergency%20department-initiated%20buprenorphine%20for%20opioid%20use%20disorder:%20protocol%20for%20the%20pragmatic%20group%20randomised%20EMBED%20trial&rft.jtitle=BMJ%20open&rft.au=Melnick,%20Edward%20R&rft.date=2019-05-30&rft.volume=9&rft.issue=5&rft.spage=e028488&rft.pages=e028488-&rft.issn=2044-6055&rft.eissn=2044-6055&rft_id=info:doi/10.1136/bmjopen-2018-028488&rft_dat=%3Cproquest_pubme%3E2233850880%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2232557486&rft_id=info:pmid/31152039&rfr_iscdi=true |