Integrated management of atrial fibrillation including tailoring of anticoagulation in primary care: study design of the ALL-IN cluster randomised trial
IntroductionIn our ageing society, we are at the merge of an expected epidemic of atrial fibrillation (AF). AF management requires an integrated approach, including rate or rhythm control, stroke prevention with anticoagulation and treatment of comorbidities such as heart failure or type 2 diabetes....
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| Veröffentlicht in: | BMJ open 2017-09, Vol.7 (9), p.e015510-e015510 |
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| creator | van den Dries, Carline J Oudega, Ruud Elvan, Arif Rutten, Frans H van de Leur, Sjef J C M Bilo, Henk J G Hoes, Arno W Moons, Karel G M Geersing, Geert-Jan |
| description | IntroductionIn our ageing society, we are at the merge of an expected epidemic of atrial fibrillation (AF). AF management requires an integrated approach, including rate or rhythm control, stroke prevention with anticoagulation and treatment of comorbidities such as heart failure or type 2 diabetes. As such, primary care seems to be the logical healthcare setting for the chronic management of patients with AF. However, primary care has not yet played a dominant role in AF management, which has been in fact more fragmented between different healthcare providers. This fragmentation might have contributed to high healthcare costs. To demonstrate the feasibility of managing AF in primary care, studies are needed that evaluate the safety and (cost-)effectiveness of integrated AF management in primary care.Methods and analysisThe ALL-IN trial is a multicentre, pragmatic, cluster randomised, non-inferiority trial performed in primary care practices in a suburban region in the Netherlands. We aim to include a minimum of 1000 patients with AF aged 65 years or more from around 18 to 30 practices. Duration of the study is 2 years. Practices will be randomised to either the intervention arm (providing integrated AF management, involving a trained practice nurse and collaboration with secondary care) or the control arm (care as usual). The primary endpoint is all-cause mortality. Secondary endpoints are cardiovascular mortality, (non)-cardiovascular hospitalisation, major adverse cardiac events, stroke, major bleeding, clinically relevant non-major bleeding, quality of life and cost-effectiveness.Ethics and disseminationThe protocol was approved by the Medical Ethical Committee of the Isala Hospital Zwolle, the Netherlands. Patients in the intervention arm will be asked informed consent for participating in the intervention. Results are expected in 2019 and will be disseminated through both national and international journals and conferences.Trial registration numberThis trial is registered at the Netherlands Trial Register (NTR5532). |
| doi_str_mv | 10.1136/bmjopen-2016-015510 |
| format | Article |
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AF management requires an integrated approach, including rate or rhythm control, stroke prevention with anticoagulation and treatment of comorbidities such as heart failure or type 2 diabetes. As such, primary care seems to be the logical healthcare setting for the chronic management of patients with AF. However, primary care has not yet played a dominant role in AF management, which has been in fact more fragmented between different healthcare providers. This fragmentation might have contributed to high healthcare costs. To demonstrate the feasibility of managing AF in primary care, studies are needed that evaluate the safety and (cost-)effectiveness of integrated AF management in primary care.Methods and analysisThe ALL-IN trial is a multicentre, pragmatic, cluster randomised, non-inferiority trial performed in primary care practices in a suburban region in the Netherlands. We aim to include a minimum of 1000 patients with AF aged 65 years or more from around 18 to 30 practices. Duration of the study is 2 years. Practices will be randomised to either the intervention arm (providing integrated AF management, involving a trained practice nurse and collaboration with secondary care) or the control arm (care as usual). The primary endpoint is all-cause mortality. Secondary endpoints are cardiovascular mortality, (non)-cardiovascular hospitalisation, major adverse cardiac events, stroke, major bleeding, clinically relevant non-major bleeding, quality of life and cost-effectiveness.Ethics and disseminationThe protocol was approved by the Medical Ethical Committee of the Isala Hospital Zwolle, the Netherlands. Patients in the intervention arm will be asked informed consent for participating in the intervention. Results are expected in 2019 and will be disseminated through both national and international journals and conferences.Trial registration numberThis trial is registered at the Netherlands Trial Register (NTR5532).</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2016-015510</identifier><identifier>PMID: 28928175</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Aged ; Anticoagulants - adverse effects ; Anticoagulants - therapeutic use ; Atrial Fibrillation - complications ; Atrial Fibrillation - mortality ; Atrial Fibrillation - therapy ; Cardiac arrhythmia ; Cardiovascular disease ; Cause of Death ; Chronic obstructive pulmonary disease ; Comorbidity ; Cost-Benefit Analysis ; Delivery of Health Care, Integrated - methods ; Disease prevention ; Evidence-based medicine ; General practice / Family practice ; Hemorrhage - etiology ; Hospitalization ; Humans ; Interdisciplinary Communication ; Mortality ; Netherlands ; Nurse's Role ; Primary Health Care - methods ; Quality of Life ; Research Design ; Secondary Care ; Stroke - etiology</subject><ispartof>BMJ open, 2017-09, Vol.7 (9), p.e015510-e015510</ispartof><rights>Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.</rights><rights>2017 Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 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 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>Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-fbe8e957d289dbcbf411ab8c5e383ec10ca29311de312b421610fadcf2caf79a3</citedby><cites>FETCH-LOGICAL-b472t-fbe8e957d289dbcbf411ab8c5e383ec10ca29311de312b421610fadcf2caf79a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmjopen.bmj.com/content/7/9/e015510.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmjopen.bmj.com/content/7/9/e015510.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,861,882,27530,27531,27905,27906,53772,53774,77350,77381</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28928175$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van den Dries, Carline J</creatorcontrib><creatorcontrib>Oudega, Ruud</creatorcontrib><creatorcontrib>Elvan, Arif</creatorcontrib><creatorcontrib>Rutten, Frans H</creatorcontrib><creatorcontrib>van de Leur, Sjef J C M</creatorcontrib><creatorcontrib>Bilo, Henk J G</creatorcontrib><creatorcontrib>Hoes, Arno W</creatorcontrib><creatorcontrib>Moons, Karel G M</creatorcontrib><creatorcontrib>Geersing, Geert-Jan</creatorcontrib><title>Integrated management of atrial fibrillation including tailoring of anticoagulation in primary care: study design of the ALL-IN cluster randomised trial</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionIn our ageing society, we are at the merge of an expected epidemic of atrial fibrillation (AF). AF management requires an integrated approach, including rate or rhythm control, stroke prevention with anticoagulation and treatment of comorbidities such as heart failure or type 2 diabetes. As such, primary care seems to be the logical healthcare setting for the chronic management of patients with AF. However, primary care has not yet played a dominant role in AF management, which has been in fact more fragmented between different healthcare providers. This fragmentation might have contributed to high healthcare costs. To demonstrate the feasibility of managing AF in primary care, studies are needed that evaluate the safety and (cost-)effectiveness of integrated AF management in primary care.Methods and analysisThe ALL-IN trial is a multicentre, pragmatic, cluster randomised, non-inferiority trial performed in primary care practices in a suburban region in the Netherlands. We aim to include a minimum of 1000 patients with AF aged 65 years or more from around 18 to 30 practices. Duration of the study is 2 years. Practices will be randomised to either the intervention arm (providing integrated AF management, involving a trained practice nurse and collaboration with secondary care) or the control arm (care as usual). The primary endpoint is all-cause mortality. Secondary endpoints are cardiovascular mortality, (non)-cardiovascular hospitalisation, major adverse cardiac events, stroke, major bleeding, clinically relevant non-major bleeding, quality of life and cost-effectiveness.Ethics and disseminationThe protocol was approved by the Medical Ethical Committee of the Isala Hospital Zwolle, the Netherlands. Patients in the intervention arm will be asked informed consent for participating in the intervention. Results are expected in 2019 and will be disseminated through both national and international journals and conferences.Trial registration numberThis trial is registered at the Netherlands Trial Register (NTR5532).</description><subject>Aged</subject><subject>Anticoagulants - adverse effects</subject><subject>Anticoagulants - therapeutic use</subject><subject>Atrial Fibrillation - complications</subject><subject>Atrial Fibrillation - mortality</subject><subject>Atrial Fibrillation - therapy</subject><subject>Cardiac arrhythmia</subject><subject>Cardiovascular disease</subject><subject>Cause of Death</subject><subject>Chronic obstructive pulmonary disease</subject><subject>Comorbidity</subject><subject>Cost-Benefit Analysis</subject><subject>Delivery of Health Care, Integrated - methods</subject><subject>Disease prevention</subject><subject>Evidence-based medicine</subject><subject>General practice / Family practice</subject><subject>Hemorrhage - etiology</subject><subject>Hospitalization</subject><subject>Humans</subject><subject>Interdisciplinary Communication</subject><subject>Mortality</subject><subject>Netherlands</subject><subject>Nurse's Role</subject><subject>Primary Health Care - methods</subject><subject>Quality of Life</subject><subject>Research Design</subject><subject>Secondary Care</subject><subject>Stroke - etiology</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkc1u1DAUhSMEolXpEyAhS2zYpPVPnB8WSFUFdKQRbGBt3dg3qUeJPdhOpb4Jj4vDDKPCCm9syd89PsenKF4zesWYqK_7eef36EpOWV1SJiWjz4pzTquqrKmUz5-cz4rLGHc0r0p2UvKXxRlvO96yRp4XPzcu4RggoSEzOBhxRpeIHwikYGEig-2DnSZI1jtinZ4WY91IEtjJh_W0oi5Z7WFcThjZBztDeCQaAr4nMS3mkRiMdnTrQLpHcrPdlpsvJAvGhIEEcMbPNmYfvx9-VbwYYIp4edwviu-fPn67vSu3Xz9vbm-2ZV81PJVDjy12sjE5kul1P1SMQd9qiaIVqBnVwDvBmEHBeF9xVjM6gNED1zA0HYiL4sNBd7_0Mxqd0weY1NG_8mDV3zfO3qvRPyhZcyFFlwXeHQWC_7FgTCqn0Ji_zKFfomJdtkRpI-qMvv0H3fkluBxvpSiVbV21mRIHSgcfY8DhZIZRtZavjuWrtXx1KD9PvXma4zTzp-oMXB2APP1fir8Avzu_nA</recordid><startdate>20170901</startdate><enddate>20170901</enddate><creator>van den Dries, Carline J</creator><creator>Oudega, Ruud</creator><creator>Elvan, Arif</creator><creator>Rutten, Frans H</creator><creator>van de Leur, Sjef J C M</creator><creator>Bilo, Henk J G</creator><creator>Hoes, Arno W</creator><creator>Moons, Karel G M</creator><creator>Geersing, Geert-Jan</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>PIMPY</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></search><sort><creationdate>20170901</creationdate><title>Integrated management of atrial fibrillation including tailoring of anticoagulation in primary care: study design of the ALL-IN cluster randomised trial</title><author>van den Dries, Carline J ; Oudega, Ruud ; Elvan, Arif ; Rutten, Frans H ; van de Leur, Sjef J C M ; Bilo, Henk J G ; Hoes, Arno W ; Moons, Karel G M ; Geersing, Geert-Jan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-fbe8e957d289dbcbf411ab8c5e383ec10ca29311de312b421610fadcf2caf79a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Aged</topic><topic>Anticoagulants - adverse effects</topic><topic>Anticoagulants - therapeutic use</topic><topic>Atrial Fibrillation - complications</topic><topic>Atrial Fibrillation - mortality</topic><topic>Atrial Fibrillation - therapy</topic><topic>Cardiac arrhythmia</topic><topic>Cardiovascular disease</topic><topic>Cause of Death</topic><topic>Chronic obstructive pulmonary disease</topic><topic>Comorbidity</topic><topic>Cost-Benefit Analysis</topic><topic>Delivery of Health Care, Integrated - methods</topic><topic>Disease prevention</topic><topic>Evidence-based medicine</topic><topic>General practice / Family practice</topic><topic>Hemorrhage - etiology</topic><topic>Hospitalization</topic><topic>Humans</topic><topic>Interdisciplinary Communication</topic><topic>Mortality</topic><topic>Netherlands</topic><topic>Nurse's Role</topic><topic>Primary Health Care - methods</topic><topic>Quality of Life</topic><topic>Research Design</topic><topic>Secondary Care</topic><topic>Stroke - etiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van den Dries, Carline J</creatorcontrib><creatorcontrib>Oudega, Ruud</creatorcontrib><creatorcontrib>Elvan, Arif</creatorcontrib><creatorcontrib>Rutten, Frans H</creatorcontrib><creatorcontrib>van de Leur, Sjef J C M</creatorcontrib><creatorcontrib>Bilo, Henk J G</creatorcontrib><creatorcontrib>Hoes, Arno W</creatorcontrib><creatorcontrib>Moons, Karel G M</creatorcontrib><creatorcontrib>Geersing, Geert-Jan</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>Publicly Available Content Database</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>van den Dries, Carline J</au><au>Oudega, Ruud</au><au>Elvan, Arif</au><au>Rutten, Frans H</au><au>van de Leur, Sjef J C M</au><au>Bilo, Henk J G</au><au>Hoes, Arno W</au><au>Moons, Karel G M</au><au>Geersing, Geert-Jan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Integrated management of atrial fibrillation including tailoring of anticoagulation in primary care: study design of the ALL-IN cluster randomised trial</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2017-09-01</date><risdate>2017</risdate><volume>7</volume><issue>9</issue><spage>e015510</spage><epage>e015510</epage><pages>e015510-e015510</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionIn our ageing society, we are at the merge of an expected epidemic of atrial fibrillation (AF). AF management requires an integrated approach, including rate or rhythm control, stroke prevention with anticoagulation and treatment of comorbidities such as heart failure or type 2 diabetes. As such, primary care seems to be the logical healthcare setting for the chronic management of patients with AF. However, primary care has not yet played a dominant role in AF management, which has been in fact more fragmented between different healthcare providers. This fragmentation might have contributed to high healthcare costs. To demonstrate the feasibility of managing AF in primary care, studies are needed that evaluate the safety and (cost-)effectiveness of integrated AF management in primary care.Methods and analysisThe ALL-IN trial is a multicentre, pragmatic, cluster randomised, non-inferiority trial performed in primary care practices in a suburban region in the Netherlands. We aim to include a minimum of 1000 patients with AF aged 65 years or more from around 18 to 30 practices. Duration of the study is 2 years. Practices will be randomised to either the intervention arm (providing integrated AF management, involving a trained practice nurse and collaboration with secondary care) or the control arm (care as usual). The primary endpoint is all-cause mortality. Secondary endpoints are cardiovascular mortality, (non)-cardiovascular hospitalisation, major adverse cardiac events, stroke, major bleeding, clinically relevant non-major bleeding, quality of life and cost-effectiveness.Ethics and disseminationThe protocol was approved by the Medical Ethical Committee of the Isala Hospital Zwolle, the Netherlands. Patients in the intervention arm will be asked informed consent for participating in the intervention. Results are expected in 2019 and will be disseminated through both national and international journals and conferences.Trial registration numberThis trial is registered at the Netherlands Trial Register (NTR5532).</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>28928175</pmid><doi>10.1136/bmjopen-2016-015510</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Anticoagulants - adverse effects Anticoagulants - therapeutic use Atrial Fibrillation - complications Atrial Fibrillation - mortality Atrial Fibrillation - therapy Cardiac arrhythmia Cardiovascular disease Cause of Death Chronic obstructive pulmonary disease Comorbidity Cost-Benefit Analysis Delivery of Health Care, Integrated - methods Disease prevention Evidence-based medicine General practice / Family practice Hemorrhage - etiology Hospitalization Humans Interdisciplinary Communication Mortality Netherlands Nurse's Role Primary Health Care - methods Quality of Life Research Design Secondary Care Stroke - etiology |
| title | Integrated management of atrial fibrillation including tailoring of anticoagulation in primary care: study design of the ALL-IN cluster randomised trial |
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