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Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial); protocol for a mixed methods process evaluation of a randomised controlled trial

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial); protocol for a mixed methods process evaluation of a randomised controlled trial
Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial); protocol for a mixed methods process evaluation of a randomised controlled trial

Introduction An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes. Methods and analysis This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored. Ethics and dissemination All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement. Trial registration number NCT03653832.

2044-6055
Aitken, Leanne M.
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Emerson, Lydia M.
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Kydonakl, Kallipo
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Blackwood, Bronagh
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Creagh-Brown, Ben
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Lone, Nazir
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McKenzie, Cathrine
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Reade, Michael C.
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Weir, Christopher J.
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Wise, Matt P.
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Walsh, Timothy S.
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Aitken, Leanne M.
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Emerson, Lydia M.
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Kydonakl, Kallipo
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Blackwood, Bronagh
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Creagh-Brown, Ben
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Lone, Nazir
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McKenzie, Cathrine
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Reade, Michael C.
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Weir, Christopher J.
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Wise, Matt P.
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Walsh, Timothy S.
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Aitken, Leanne M., Emerson, Lydia M., Kydonakl, Kallipo, Blackwood, Bronagh, Creagh-Brown, Ben, Lone, Nazir, McKenzie, Cathrine, Reade, Michael C., Weir, Christopher J., Wise, Matt P. and Walsh, Timothy S. (2024) Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial); protocol for a mixed methods process evaluation of a randomised controlled trial. BMJ Open, 14 (4), [e081637]. (doi:10.1136/bmjopen-2023-081637).

Record type: Article

Abstract

Introduction An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes. Methods and analysis This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored. Ethics and dissemination All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement. Trial registration number NCT03653832.

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Accepted/In Press date: 16 February 2024
e-pub ahead of print date: 5 April 2024
Published date: 5 April 2024
Additional Information: © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Identifiers

Local EPrints ID: 487478
URI: http://eprints.soton.ac.uk/id/eprint/487478
ISSN: 2044-6055
PURE UUID: c9ffb16e-7346-44b3-afa9-b6022c9f5cc5
ORCID for Cathrine McKenzie: ORCID iD orcid.org/0000-0002-5190-9711

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Date deposited: 21 Feb 2024 17:31
Last modified: 06 Jun 2024 02:20

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Contributors

Author: Leanne M. Aitken
Author: Lydia M. Emerson
Author: Kallipo Kydonakl
Author: Bronagh Blackwood
Author: Ben Creagh-Brown
Author: Nazir Lone
Author: Cathrine McKenzie ORCID iD
Author: Michael C. Reade
Author: Christopher J. Weir
Author: Matt P. Wise
Author: Timothy S. Walsh

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