An exploration of the factors influencing successful implementation, delivery and outcomes in an intensive care sedation study: process evaluation of the A2B RCT
Choice of sedation of critically ill patients is a core element of intensive care practice. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial tested the effectiveness of two alpha agonist sedatives versus propofol in reducing time on mechanical ventilatio...
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| Published in: | Health technology assessment (Winchester, England) pp. 1 - 18 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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NIHR Journals Library
12.11.2025
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| ISSN: | 2046-4924, 2046-4924 |
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| Abstract | Choice of sedation of critically ill patients is a core element of intensive care practice. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial tested the effectiveness of two alpha agonist sedatives versus propofol in reducing time on mechanical ventilation in 38 intensive care units in the United Kingdom. To evaluate both how this complex trial was implemented and how this may have influenced trial outcomes, an understanding of the contextual and practice variation across multiple sites was required.
The aim of this process evaluation of the A2B trial was to determine how the intervention was delivered, the extent to which it was delivered as intended and the impact this had on outcomes. Specifically, we aimed to: Establish the degree to which the A2B intervention was delivered as intended, specifically in relation to fidelity, dose and reach across patients. Understand factors that impacted on successful delivery of both the A2B intervention and trial, in relation to attitudes and perceptions of staff, including context and standard care.
A mixed-methods, multiphase design was used following extensive pre-trial exploration of current practice. Quantitative data were drawn from the main trial database covering 38 sites to assess the intervention's fidelity, dose and reach in each site. Data were analysed descriptively and provided a low-moderate-high rating. Qualitative data were collected by interviews mid trial (phase 1) and end of trial (phase 2). Participants were recruited from a random sample of 30 intensive care units active at the time of sampling and included the principal investigator, research nurses and clinical staff. Semistructured interviews, informed by the trial's logic model, lasted 45-60 minutes. Data collection focused on whether the intervention could be delivered as intended, factors that impacted upon successful delivery and understanding intervention adherence. Analysis used a framework approach based on the logic model. Data collection and qualitative analyses were completed prior to knowing the primary results of the trial.
Site intervention adherence ratings for fidelity, dose and reach were low (4), moderate (20) and high (14). Participants from 12 intensive care units in each of phase 1 (33 staff) and phase 2 (36 staff) provided qualitative data; participating intensive care units differed between phases. Factors identified in phase 1 focused on intervention delivery and trial conduct and incorporated both organisational and participant-related factors. In phase 2, participant-related factors included clinician preference, individual equipoise, clinician resistance and staff capability and capacity, while A2B trial-related factors included concerns relating to safety and side effects, overnight deep sedation practice, patient comfort and trial documentation. Many of these factors were impacted by the COVID-19 pandemic, particularly in regard to staffing numbers and experience.
Due to the impact of the COVID-19 pandemic, most data collection occurred remotely through video-conferencing rather than planned at site observation and interviews.
Optimal sedation practice is influenced by multiple factors related to clinician perceptions, capacity and capability. Priorities in care focus on short-term safety and comfort. Limitations in staffing mean that longer-term consequences related to recovery and rehabilitation are second tier considerations.
Findings highlight the multiple contextual factors, including both organisational and participant-related characteristics, that should be considered when planning both clinical trials and changes to routine care. Multiple strategies for achieving behaviour change when implementing complex interventions are essential.
This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/93/01. |
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| AbstractList | Choice of sedation of critically ill patients is a core element of intensive care practice. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial tested the effectiveness of two alpha agonist sedatives versus propofol in reducing time on mechanical ventilation in 38 intensive care units in the United Kingdom. To evaluate both how this complex trial was implemented and how this may have influenced trial outcomes, an understanding of the contextual and practice variation across multiple sites was required.
The aim of this process evaluation of the A2B trial was to determine how the intervention was delivered, the extent to which it was delivered as intended and the impact this had on outcomes. Specifically, we aimed to: Establish the degree to which the A2B intervention was delivered as intended, specifically in relation to fidelity, dose and reach across patients. Understand factors that impacted on successful delivery of both the A2B intervention and trial, in relation to attitudes and perceptions of staff, including context and standard care.
A mixed-methods, multiphase design was used following extensive pre-trial exploration of current practice. Quantitative data were drawn from the main trial database covering 38 sites to assess the intervention's fidelity, dose and reach in each site. Data were analysed descriptively and provided a low-moderate-high rating. Qualitative data were collected by interviews mid trial (phase 1) and end of trial (phase 2). Participants were recruited from a random sample of 30 intensive care units active at the time of sampling and included the principal investigator, research nurses and clinical staff. Semistructured interviews, informed by the trial's logic model, lasted 45-60 minutes. Data collection focused on whether the intervention could be delivered as intended, factors that impacted upon successful delivery and understanding intervention adherence. Analysis used a framework approach based on the logic model. Data collection and qualitative analyses were completed prior to knowing the primary results of the trial.
Site intervention adherence ratings for fidelity, dose and reach were low (4), moderate (20) and high (14). Participants from 12 intensive care units in each of phase 1 (33 staff) and phase 2 (36 staff) provided qualitative data; participating intensive care units differed between phases. Factors identified in phase 1 focused on intervention delivery and trial conduct and incorporated both organisational and participant-related factors. In phase 2, participant-related factors included clinician preference, individual equipoise, clinician resistance and staff capability and capacity, while A2B trial-related factors included concerns relating to safety and side effects, overnight deep sedation practice, patient comfort and trial documentation. Many of these factors were impacted by the COVID-19 pandemic, particularly in regard to staffing numbers and experience.
Due to the impact of the COVID-19 pandemic, most data collection occurred remotely through video-conferencing rather than planned at site observation and interviews.
Optimal sedation practice is influenced by multiple factors related to clinician perceptions, capacity and capability. Priorities in care focus on short-term safety and comfort. Limitations in staffing mean that longer-term consequences related to recovery and rehabilitation are second tier considerations.
Findings highlight the multiple contextual factors, including both organisational and participant-related characteristics, that should be considered when planning both clinical trials and changes to routine care. Multiple strategies for achieving behaviour change when implementing complex interventions are essential.
This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/93/01. Background Choice of sedation of critically ill patients is a core element of intensive care practice. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial tested the effectiveness of two alpha agonist sedatives versus propofol in reducing time on mechanical ventilation in 38 intensive care units in the United Kingdom. To evaluate both how this complex trial was implemented and how this may have influenced trial outcomes, an understanding of the contextual and practice variation across multiple sites was required. Aim and objectives The aim of this process evaluation of the A2B trial was to determine how the intervention was delivered, the extent to which it was delivered as intended and the impact this had on outcomes. Specifically, we aimed to: Establish the degree to which the A2B intervention was delivered as intended, specifically in relation to fidelity, dose and reach across patients. Understand factors that impacted on successful delivery of both the A2B intervention and trial, in relation to attitudes and perceptions of staff, including context and standard care. Design and methods A mixed-methods, multiphase design was used following extensive pre-trial exploration of current practice. Quantitative data were drawn from the main trial database covering 38 sites to assess the intervention’s fidelity, dose and reach in each site. Data were analysed descriptively and provided a low-moderate-high rating. Qualitative data were collected by interviews mid trial (phase 1) and end of trial (phase 2). Participants were recruited from a random sample of 30 intensive care units active at the time of sampling and included the principal investigator, research nurses and clinical staff. Semistructured interviews, informed by the trial’s logic model, lasted 45–60 minutes. Data collection focused on whether the intervention could be delivered as intended, factors that impacted upon successful delivery and understanding intervention adherence. Analysis used a framework approach based on the logic model. Data collection and qualitative analyses were completed prior to knowing the primary results of the trial. Results Site intervention adherence ratings for fidelity, dose and reach were low (4), moderate (20) and high (14). Participants from 12 intensive care units in each of phase 1 (33 staff) and phase 2 (36 staff) provided qualitative data; participating intensive care units differed between phases. Factors identified in phase 1 focused on intervention delivery and trial conduct and incorporated both organisational and participant-related factors. In phase 2, participant-related factors included clinician preference, individual equipoise, clinician resistance and staff capability and capacity, while A2B trial-related factors included concerns relating to safety and side effects, overnight deep sedation practice, patient comfort and trial documentation. Many of these factors were impacted by the COVID-19 pandemic, particularly in regard to staffing numbers and experience. Limitations Due to the impact of the COVID-19 pandemic, most data collection occurred remotely through video-conferencing rather than planned at site observation and interviews. Conclusion Optimal sedation practice is influenced by multiple factors related to clinician perceptions, capacity and capability. Priorities in care focus on short-term safety and comfort. Limitations in staffing mean that longer-term consequences related to recovery and rehabilitation are second tier considerations. Future work Findings highlight the multiple contextual factors, including both organisational and participant-related characteristics, that should be considered when planning both clinical trials and changes to routine care. Multiple strategies for achieving behaviour change when implementing complex interventions are essential. Funding This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/93/01. Plain language summary Patients in the intensive care unit receive pain-killers and sedatives to keep them comfortable and reduce pain. However, some patients are more deeply sedated than needed, and improving sedation and pain management is difficult. The Alpha 2 agonists for sedation to produce better outcomes from critical illness trial compared the usual sedative prescribed in intensive care unit (propofol) with medications called ‘alpha-2 agonists’ that have both sedative and pain-killing actions. We wanted to see if patients were more awake and comfortable with alpha-2 agonists and whether they came off the breathing machine quicker. Alongside the trial, we conducted a process evaluation to evaluate if study sedatives were given to patients as intended. We also wanted to evaluate if the usual sedative practice, staffing and other considerations affected how nurses and doctors delivered the sedatives. We conducted interviews with nurses and doctors who cared for trial participants, and the research nurses and doctors involved in the trial to find out their opinion. Interviews were conducted midway through (phase 1) and at the end (phase 2) of the trial. Data showed that from 38 intensive care units, 34 complied with delivering the sedation care as it was intended to a high or moderate level. Interview topics from 33 staff in 12 intensive care units (phase 1) provided a picture of how the sedative medicines were delivered to patients and how the A2B trial was implemented. Interview topics from 36 staff in 12 intensive care units (phase 2) described the clinicians’ sedative preferences, their level of comfort with uncertainty, any resistance they had to the trial, and staff skills and knowledge. Other topics involved concerns about patient safety, possible side effects, practices for deep sedation overnight, patient comfort, and management of trial paperwork. We concluded that sedation practice depends on factors related to clinical staff’s opinions, staffing levels and skills. The priorities for care raised by participants are patient safety and comfort. Choice of sedation of critically ill patients is a core element of intensive care practice. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial tested the effectiveness of two alpha agonist sedatives versus propofol in reducing time on mechanical ventilation in 38 intensive care units in the United Kingdom. To evaluate both how this complex trial was implemented and how this may have influenced trial outcomes, an understanding of the contextual and practice variation across multiple sites was required.BackgroundChoice of sedation of critically ill patients is a core element of intensive care practice. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial tested the effectiveness of two alpha agonist sedatives versus propofol in reducing time on mechanical ventilation in 38 intensive care units in the United Kingdom. To evaluate both how this complex trial was implemented and how this may have influenced trial outcomes, an understanding of the contextual and practice variation across multiple sites was required.The aim of this process evaluation of the A2B trial was to determine how the intervention was delivered, the extent to which it was delivered as intended and the impact this had on outcomes. Specifically, we aimed to: Establish the degree to which the A2B intervention was delivered as intended, specifically in relation to fidelity, dose and reach across patients. Understand factors that impacted on successful delivery of both the A2B intervention and trial, in relation to attitudes and perceptions of staff, including context and standard care.Aim and objectivesThe aim of this process evaluation of the A2B trial was to determine how the intervention was delivered, the extent to which it was delivered as intended and the impact this had on outcomes. Specifically, we aimed to: Establish the degree to which the A2B intervention was delivered as intended, specifically in relation to fidelity, dose and reach across patients. Understand factors that impacted on successful delivery of both the A2B intervention and trial, in relation to attitudes and perceptions of staff, including context and standard care.A mixed-methods, multiphase design was used following extensive pre-trial exploration of current practice. Quantitative data were drawn from the main trial database covering 38 sites to assess the intervention's fidelity, dose and reach in each site. Data were analysed descriptively and provided a low-moderate-high rating. Qualitative data were collected by interviews mid trial (phase 1) and end of trial (phase 2). Participants were recruited from a random sample of 30 intensive care units active at the time of sampling and included the principal investigator, research nurses and clinical staff. Semistructured interviews, informed by the trial's logic model, lasted 45-60 minutes. Data collection focused on whether the intervention could be delivered as intended, factors that impacted upon successful delivery and understanding intervention adherence. Analysis used a framework approach based on the logic model. Data collection and qualitative analyses were completed prior to knowing the primary results of the trial.Design and methodsA mixed-methods, multiphase design was used following extensive pre-trial exploration of current practice. Quantitative data were drawn from the main trial database covering 38 sites to assess the intervention's fidelity, dose and reach in each site. Data were analysed descriptively and provided a low-moderate-high rating. Qualitative data were collected by interviews mid trial (phase 1) and end of trial (phase 2). Participants were recruited from a random sample of 30 intensive care units active at the time of sampling and included the principal investigator, research nurses and clinical staff. Semistructured interviews, informed by the trial's logic model, lasted 45-60 minutes. Data collection focused on whether the intervention could be delivered as intended, factors that impacted upon successful delivery and understanding intervention adherence. Analysis used a framework approach based on the logic model. Data collection and qualitative analyses were completed prior to knowing the primary results of the trial.Site intervention adherence ratings for fidelity, dose and reach were low (4), moderate (20) and high (14). Participants from 12 intensive care units in each of phase 1 (33 staff) and phase 2 (36 staff) provided qualitative data; participating intensive care units differed between phases. Factors identified in phase 1 focused on intervention delivery and trial conduct and incorporated both organisational and participant-related factors. In phase 2, participant-related factors included clinician preference, individual equipoise, clinician resistance and staff capability and capacity, while A2B trial-related factors included concerns relating to safety and side effects, overnight deep sedation practice, patient comfort and trial documentation. Many of these factors were impacted by the COVID-19 pandemic, particularly in regard to staffing numbers and experience.ResultsSite intervention adherence ratings for fidelity, dose and reach were low (4), moderate (20) and high (14). Participants from 12 intensive care units in each of phase 1 (33 staff) and phase 2 (36 staff) provided qualitative data; participating intensive care units differed between phases. Factors identified in phase 1 focused on intervention delivery and trial conduct and incorporated both organisational and participant-related factors. In phase 2, participant-related factors included clinician preference, individual equipoise, clinician resistance and staff capability and capacity, while A2B trial-related factors included concerns relating to safety and side effects, overnight deep sedation practice, patient comfort and trial documentation. Many of these factors were impacted by the COVID-19 pandemic, particularly in regard to staffing numbers and experience.Due to the impact of the COVID-19 pandemic, most data collection occurred remotely through video-conferencing rather than planned at site observation and interviews.LimitationsDue to the impact of the COVID-19 pandemic, most data collection occurred remotely through video-conferencing rather than planned at site observation and interviews.Optimal sedation practice is influenced by multiple factors related to clinician perceptions, capacity and capability. Priorities in care focus on short-term safety and comfort. Limitations in staffing mean that longer-term consequences related to recovery and rehabilitation are second tier considerations.ConclusionOptimal sedation practice is influenced by multiple factors related to clinician perceptions, capacity and capability. Priorities in care focus on short-term safety and comfort. Limitations in staffing mean that longer-term consequences related to recovery and rehabilitation are second tier considerations.Findings highlight the multiple contextual factors, including both organisational and participant-related characteristics, that should be considered when planning both clinical trials and changes to routine care. Multiple strategies for achieving behaviour change when implementing complex interventions are essential.Future workFindings highlight the multiple contextual factors, including both organisational and participant-related characteristics, that should be considered when planning both clinical trials and changes to routine care. Multiple strategies for achieving behaviour change when implementing complex interventions are essential.This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/93/01.FundingThis article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/93/01. |
| Author | Emerson, Lydia M McKenzie, Cathrine Weir, Christopher J Lone, Nazir Kydonaki, Kalliopi Parker, Richard Creagh-Brown, Ben Walsh, Timothy S Reade, Michael C Wise, Matt P Aitken, Leanne M Blackwood, Bronagh |
| Author_xml | – sequence: 1 givenname: Leanne M orcidid: 0000-0001-5722-9090 surname: Aitken fullname: Aitken, Leanne M organization: School of Health & Medical Sciences, City St George’s, University of London, London, UK – sequence: 2 givenname: Lydia M orcidid: 0000-0002-4250-5758 surname: Emerson fullname: Emerson, Lydia M organization: School of Health & Medical Sciences, City St George’s, University of London, London, UK – sequence: 3 givenname: Kalliopi orcidid: 0000-0003-3400-8230 surname: Kydonaki fullname: Kydonaki, Kalliopi organization: Faculty of Nursing, National and Kapodistrian University of Athens, Athens, Greece – sequence: 4 givenname: Bronagh orcidid: 0000-0002-4583-5381 surname: Blackwood fullname: Blackwood, Bronagh organization: School of Medicine, Dentistry and Biomedical Sciences, Queens University Belfast, Belfast, UK – sequence: 5 givenname: Ben orcidid: 0000-0002-4397-1232 surname: Creagh-Brown fullname: Creagh-Brown, Ben organization: Department of Critical Care, Royal Surrey NHS Foundation Trust, Guildford, UK – sequence: 6 givenname: Nazir orcidid: 0000-0003-2707-2779 surname: Lone fullname: Lone, Nazir organization: Department of Anaesthesia, Critical Care and Pain Medicine, Usher Institute, University of Edinburgh, Edinburgh, UK – sequence: 7 givenname: Cathrine orcidid: 0000-0002-5190-9711 surname: McKenzie fullname: McKenzie, Cathrine organization: School of Medicine, NIHR Southampton Biomedical Research Centre, University of Southampton, and Perioperative and Critical Care Theme, Department of Pharmacy and Critical Care, University Hospital Southampton, Southampton, UK – sequence: 8 givenname: Richard orcidid: 0000-0002-2658-5022 surname: Parker fullname: Parker, Richard organization: Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK – sequence: 9 givenname: Michael C orcidid: 0000-0003-1570-0707 surname: Reade fullname: Reade, Michael C organization: Medical School, University of Queensland, Brisbane, Australia – sequence: 10 givenname: Christopher J orcidid: 0000-0002-6494-4903 surname: Weir fullname: Weir, Christopher J organization: Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK – sequence: 11 givenname: Matt P orcidid: 0000-0002-2763-4316 surname: Wise fullname: Wise, Matt P organization: Adult Critical Care, University Hospital of Wales, Cardiff, UK – sequence: 12 givenname: Timothy S orcidid: 0000-0002-3590-8540 surname: Walsh fullname: Walsh, Timothy S organization: Department of Anaesthesia, Critical Care and Pain Medicine, Usher Institute, University of Edinburgh, Edinburgh, UK |
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| Title | An exploration of the factors influencing successful implementation, delivery and outcomes in an intensive care sedation study: process evaluation of the A2B RCT |
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