Cargando…

Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh

INTRODUCTION: People 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 morta...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6082451/
https://www.ncbi.nlm.nih.gov/pubmed/30012798
http://dx.doi.org/10.1136/bmjopen-2018-024226
_version_ 1783345797743509504
author 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
author_facet 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
author_sort Hossain, Mohammad Sohrab
collection PubMed
description INTRODUCTION: People 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 ANALYSIS: Our 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 DISSEMINATION: Ethics 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 NUMBER: ACTRN12615000630516.
format Online
Article
Text
id pubmed-6082451
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-60824512018-08-10 Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh 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 BMJ Open Public Health INTRODUCTION: People 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 ANALYSIS: Our 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 DISSEMINATION: Ethics 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 NUMBER: ACTRN12615000630516. BMJ Publishing Group 2018-07-16 /pmc/articles/PMC6082451/ /pubmed/30012798 http://dx.doi.org/10.1136/bmjopen-2018-024226 Text en © 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/.
spellingShingle Public Health
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
Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh
title Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh
title_full Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh
title_fullStr Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh
title_full_unstemmed Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh
title_short Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh
title_sort protocol for process evaluation of civic randomised controlled trial: community-based interventions to prevent serious complications following spinal cord injury in bangladesh
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6082451/
https://www.ncbi.nlm.nih.gov/pubmed/30012798
http://dx.doi.org/10.1136/bmjopen-2018-024226
work_keys_str_mv AT hossainmohammadsohrab protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT harveylisaa protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT liuhueiming protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT islammdshofiqul protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT rahmanmdakhlasur protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT muldoonstephen protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT bieringsorensenfin protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT cameroniand protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT chhabraharvinders protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT lindleyrichardi protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh
AT janstephen protocolforprocessevaluationofcivicrandomisedcontrolledtrialcommunitybasedinterventionstopreventseriouscomplicationsfollowingspinalcordinjuryinbangladesh