Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh
IntroductionPeople with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortali...
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| Veröffentlicht in: | BMJ open 2018-07, Vol.8 (7), p.e024226-e024226 |
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| creator | Hossain, Mohammad Sohrab Harvey, Lisa A Liu, Hueiming Islam, Md. Shofiqul Rahman, Md. Akhlasur Muldoon, Stephen Biering-Sorensen, Fin Cameron, Ian D Chhabra, Harvinder S Lindley, Richard I Jan, Stephen |
| description | IntroductionPeople with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective.Methods and analysisOur process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome.Ethics and disseminationEthics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences.Trial registration numberACTRN12615000630516. |
| doi_str_mv | 10.1136/bmjopen-2018-024226 |
| format | Article |
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Shofiqul ; Rahman, Md. Akhlasur ; Muldoon, Stephen ; Biering-Sorensen, Fin ; Cameron, Ian D ; Chhabra, Harvinder S ; Lindley, Richard I ; Jan, Stephen</creator><creatorcontrib>Hossain, Mohammad Sohrab ; Harvey, Lisa A ; Liu, Hueiming ; Islam, Md. Shofiqul ; Rahman, Md. Akhlasur ; Muldoon, Stephen ; Biering-Sorensen, Fin ; Cameron, Ian D ; Chhabra, Harvinder S ; Lindley, Richard I ; Jan, Stephen</creatorcontrib><description>IntroductionPeople with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective.Methods and analysisOur process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome.Ethics and disseminationEthics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences.Trial registration numberACTRN12615000630516.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2018-024226</identifier><identifier>PMID: 30012798</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Aftercare - economics ; Aftercare - methods ; Bangladesh ; Cause of Death ; Clinical trials ; Community Health Services - economics ; Community Health Services - methods ; Cost-Benefit Analysis ; Delivery of Health Care ; Developing Countries ; Evidence-based medicine ; Feasibility Studies ; Health Care Costs ; House Calls ; Humans ; Intervention ; Low income groups ; Mortality ; Pressure ulcers ; Process Assessment, Health Care ; Professionals ; Public Health ; Quality of Life ; Randomized Controlled Trials as Topic ; Rehabilitation ; Spinal cord injuries ; Spinal Cord Injuries - economics ; Spinal Cord Injuries - rehabilitation ; Telephone</subject><ispartof>BMJ open, 2018-07, Vol.8 (7), p.e024226-e024226</ispartof><rights>Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2018 Author(s) (or their employer(s)) 2018. 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)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-a474c80fb71b9f6baefc9d8fd6a7a1dc2cbbe1e0be5e6fa104c0037a658ed3ef3</citedby><cites>FETCH-LOGICAL-b472t-a474c80fb71b9f6baefc9d8fd6a7a1dc2cbbe1e0be5e6fa104c0037a658ed3ef3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/8/7/e024226.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/8/7/e024226.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27526,27527,27901,27902,53766,53768,77343,77374</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30012798$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hossain, Mohammad Sohrab</creatorcontrib><creatorcontrib>Harvey, Lisa A</creatorcontrib><creatorcontrib>Liu, Hueiming</creatorcontrib><creatorcontrib>Islam, Md. Shofiqul</creatorcontrib><creatorcontrib>Rahman, Md. Akhlasur</creatorcontrib><creatorcontrib>Muldoon, Stephen</creatorcontrib><creatorcontrib>Biering-Sorensen, Fin</creatorcontrib><creatorcontrib>Cameron, Ian D</creatorcontrib><creatorcontrib>Chhabra, Harvinder S</creatorcontrib><creatorcontrib>Lindley, Richard I</creatorcontrib><creatorcontrib>Jan, Stephen</creatorcontrib><title>Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionPeople with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective.Methods and analysisOur process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome.Ethics and disseminationEthics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences.Trial registration numberACTRN12615000630516.</description><subject>Aftercare - economics</subject><subject>Aftercare - methods</subject><subject>Bangladesh</subject><subject>Cause of Death</subject><subject>Clinical trials</subject><subject>Community Health Services - economics</subject><subject>Community Health Services - methods</subject><subject>Cost-Benefit Analysis</subject><subject>Delivery of Health Care</subject><subject>Developing Countries</subject><subject>Evidence-based medicine</subject><subject>Feasibility Studies</subject><subject>Health Care Costs</subject><subject>House Calls</subject><subject>Humans</subject><subject>Intervention</subject><subject>Low income groups</subject><subject>Mortality</subject><subject>Pressure ulcers</subject><subject>Process Assessment, Health Care</subject><subject>Professionals</subject><subject>Public Health</subject><subject>Quality of Life</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Rehabilitation</subject><subject>Spinal cord injuries</subject><subject>Spinal Cord Injuries - economics</subject><subject>Spinal Cord Injuries - rehabilitation</subject><subject>Telephone</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNks-K1TAUxosozjDOEwgScOOmY5L-dyFocbQwoAudbThNT-7kkiY1aa_cp_IVJ6XXYXRlNich3_fLyeFLkpeMXjGWlW_7ce8mtCmnrE4pzzkvnyTnnOZ5WtKiePpof5ZchrCnceVFUxT8eXKWUcp41dTnye9v3s1OOkOU82TyTmIIBA9gFpi1s8Qp0na3XUs82MGNOuBApLOzd8bE7ew1mHekdeO4WD0f0x5WRWdn9LdoV0Qgs4tkPMQjCeg7t4TVMBktYROoCHO_tN2RMGkLJr7gB6LtfvHHWMhHsDsDA4a7F8kzBSbg5aleJD-uP31vv6Q3Xz937YebtM8rPqeQV7msqeor1jeq7AGVbIZaDSVUwAbJZd8jQ9pjgaUCRnNJaVZBWdQ4ZKiyi-T9xp2WfsRBxt49GDF5PYI_Cgda_H1j9Z3YuYMoac3zgkXAmxPAu58LhlnE2Uk0BizGAQhOK1aUdZPxKH39j3TvFh_HsKlow2i2ArNNJb0LwaN6aIZRsWZCnDIh1kyILRPR9erxPx48fxIQBVebILr_i3gPuuDJrQ</recordid><startdate>20180716</startdate><enddate>20180716</enddate><creator>Hossain, Mohammad Sohrab</creator><creator>Harvey, Lisa A</creator><creator>Liu, Hueiming</creator><creator>Islam, Md. 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Akhlasur</creator><creator>Muldoon, Stephen</creator><creator>Biering-Sorensen, Fin</creator><creator>Cameron, Ian D</creator><creator>Chhabra, Harvinder S</creator><creator>Lindley, Richard I</creator><creator>Jan, Stephen</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>20180716</creationdate><title>Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh</title><author>Hossain, Mohammad Sohrab ; Harvey, Lisa A ; Liu, Hueiming ; Islam, Md. 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Akhlasur</creatorcontrib><creatorcontrib>Muldoon, Stephen</creatorcontrib><creatorcontrib>Biering-Sorensen, Fin</creatorcontrib><creatorcontrib>Cameron, Ian D</creatorcontrib><creatorcontrib>Chhabra, Harvinder S</creatorcontrib><creatorcontrib>Lindley, Richard I</creatorcontrib><creatorcontrib>Jan, Stephen</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>Hossain, Mohammad Sohrab</au><au>Harvey, Lisa A</au><au>Liu, Hueiming</au><au>Islam, Md. Shofiqul</au><au>Rahman, Md. Akhlasur</au><au>Muldoon, Stephen</au><au>Biering-Sorensen, Fin</au><au>Cameron, Ian D</au><au>Chhabra, Harvinder S</au><au>Lindley, Richard I</au><au>Jan, Stephen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2018-07-16</date><risdate>2018</risdate><volume>8</volume><issue>7</issue><spage>e024226</spage><epage>e024226</epage><pages>e024226-e024226</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionPeople with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective.Methods and analysisOur process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome.Ethics and disseminationEthics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences.Trial registration numberACTRN12615000630516.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>30012798</pmid><doi>10.1136/bmjopen-2018-024226</doi><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; PubMed Central Open Access |
| subjects | Aftercare - economics Aftercare - methods Bangladesh Cause of Death Clinical trials Community Health Services - economics Community Health Services - methods Cost-Benefit Analysis Delivery of Health Care Developing Countries Evidence-based medicine Feasibility Studies Health Care Costs House Calls Humans Intervention Low income groups Mortality Pressure ulcers Process Assessment, Health Care Professionals Public Health Quality of Life Randomized Controlled Trials as Topic Rehabilitation Spinal cord injuries Spinal Cord Injuries - economics Spinal Cord Injuries - rehabilitation Telephone |
| title | Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh |
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