Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study)

Timothy S Walsh, Kalliopi Kydonaki, Jean Antonelli, Jacqueline Stephen, Robert J Lee, Kirsty Everingham, Janet Hanley, Kimmo Uutelo, Petra Peltola, Christopher J Weir, Development and Evaluation of Strategies to Improve Sedation practice in in Tensive care Study Investigators, Timothy S Walsh, Kalliopi Kydonaki, Jean Antonelli, Jacqueline Stephen, Robert J Lee, Kirsty Everingham, Janet Hanley, Kimmo Uutelo, Petra Peltola, Christopher J Weir, Development and Evaluation of Strategies to Improve Sedation practice in in Tensive care Study Investigators

Abstract

Objectives: To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs).

Participants and setting: 8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis.

Design: Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period.

Main outcome measures: The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured.

Analytic approach: Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed.

Conclusions: The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex interventions on sedation-analgesia quality. Recruitment is complete and analysis ongoing.

Trial registration number: NCT01634451.

Keywords: PAIN MANAGEMENT; clinical trial; quality improvement; sedation.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
The Sedation Quality Assessment Tool (SQAT) used to capture data for each 12 h period of nursing care during ICU admission. ICU, intensive care unit.
Figure 2
Figure 2
The general structure of the DESIST trial indicating the preintervention, implementation and postintervention periods in relation to the quality improvement interventions. The total duration of each period and the timings of qualitative studies to inform the process evaluation are shown. ICU, intensive care unit.

References

    1. Barr J, Fraser GL, Puntillo K et al. . Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med 2013;41:263–306. 10.1097/CCM.0b013e3182783b72
    1. Jackson DL, Proudfoot CW, Cann KF et al. . A systematic review of the impact of sedation practice in the ICU on resource use, costs and patient safety. Crit Care 2010;14:R59 10.1186/cc8956
    1. Halpern SD, Becker D, Curtis JR et al. , Choosing Wisely Taskforce; American Thoracic Society; American Association of Critical-Care Nurses; Society of Critical Care Medicine. An official American Thoracic Society/American Association of Critical-Care Nurses/American College of Chest Physicians/Society of Critical Care Medicine policy statement: the Choosing Wisely® Top 5 list in Critical Care Medicine. Am J Respir Crit Care Med 2014;190:818–26. 10.1164/rccm.201407-1317ST
    1. Hughes CG, Girard TD, Pandharipande PP. Daily sedation interruption versus targeted light sedation strategies in ICU patients. Crit Care Med 2013;41(9 Suppl 1):S39–45. 10.1097/CCM.0b013e3182a168c5
    1. Rose L, Fitzgerald E, Cook D et al. , SLEAP Investigators; Canadian Critical Care Trials Group. Clinician perspectives on protocols designed to minimize sedation. J Crit Care 2015;30:348–52. 10.1016/j.jcrc.2014.10.021
    1. Miller MA, Krein SL, George CT et al. . Diverse attitudes to and understandings of spontaneous awakening trials: results from a statewide quality improvement collaborative*. Crit Care Med 2013;41:1976–82. 10.1097/CCM.0b013e31828a40ba
    1. Tanios M, Epstein S, Grzeskowiak M et al. . Influence of sedation strategies on unplanned extubation in a mixed intensive care unit. Am J Crit Care 2014;23:306–14; quiz 15 10.4037/ajcc20144446
    1. Chanques G, Sebbane M, Barbotte E et al. . A prospective study of pain at rest: incidence and characteristics of an unrecognized symptom in surgical and trauma versus medical intensive care unit patients. Anesthesiology 2007;107:858–60. 10.1097/01.anes.0000287211.98642.51
    1. Puntillo KA, Max A, Timsit JF et al. . Determinants of procedural pain intensity in the intensive care unit. The Europain® study. Am J Respir Crit Care Med 2014;189:39–47. 10.1164/rccm.201306-1174OC
    1. Karlsson V, Bergbom I, Forsberg A. The lived experiences of adult intensive care patients who were conscious during mechanical ventilation: a phenomenological-hermeneutic study. Intensive Crit Care Nurs 2012;28:6–15. 10.1016/j.iccn.2011.11.002
    1. Ethier C, Burry L, Martinez-Motta C et al. . Recall of intensive care unit stay in patients managed with a sedation protocol or a sedation protocol with daily sedative interruption: a pilot study. J Crit Care 2011;26:127–32. 10.1016/j.jcrc.2010.08.003
    1. Walsh TS, Kydonaki K, Lee RJ et al. . Development and Evaluation of Strategies to Improve Sedation practice in inTensive care Study Investigators. Crit Care Med 2016;44:564–74.10.1097/CCM.0000000000001463
    1. Jackson DL, Proudfoot CW, Cann KF et al. . The incidence of sub-optimal sedation in the ICU: a systematic review. Crit Care 2009;13:R204 10.1186/cc8212
    1. Moore GF, Audrey S, Barker M et al. . Process evaluation of complex interventions: Medical Research Council guidance. BMJ 2015;350:h1258 10.1136/bmj.h1258
    1. Craig P, Dieppe P, Macintyre S et al. . Developing and evaluating complex interventions: the new Medical research council guidance. BMJ 2008;337:a1655 10.1136/bmj.a1655
    1. Boutron I, Moher D, Altman DG et al. . Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295–309. 10.7326/0003-4819-148-4-200802190-00008
    1. Carrothers KM, Barr J, Spurlock B et al. . Contextual issues influencing implementation and outcomes associated with an integrated approach to managing pain, agitation, and delirium in adult ICUs. Crit Care Med 2013;41(9 Suppl 1):S128–35. 10.1097/CCM.0b013e3182a2c2b1
    1. Wøien H, Bjørk IT. Intensive care pain treatment and sedation: nurses’ experiences of the conflict between clinical judgement and standardised care: an explorative study. Intensive Crit Care Nurs 2013;29:128–36. 10.1016/j.iccn.2012.11.003
    1. Everingham K, Fawcett T, Walsh T. ‘Targeting’ sedation: the lived experience of the intensive care nurse. J Clin Nurs 2014;23:694–703. 10.1111/jocn.12058
    1. Kastrup M, Nolting MJ, Ahlborn R et al. . An electronic tool for visual feedback to monitor the adherence to quality indicators in intensive care medicine. J Int Med Res 2011;39:2187–200. 10.1177/147323001103900615
    1. Morris AC, Hay AW, Swann DG et al. . Reducing ventilator-associated pneumonia in intensive care: impact of implementing a care bundle. Crit Care Med 2011;39:2218–24. 10.1097/CCM.0b013e3182227d52
    1. Pronovost P, Needham D, Berenholtz S et al. . An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med 2006;355:2725–32. 10.1056/NEJMoa061115
    1. Benneyan JC, Lloyd RC, Plsek PE. Statistical process control as a tool for research and healthcare improvement. Qual Saf Health Care 2003;12:458–64. 10.1136/qhc.12.6.458
    1. Lapinlampi TP, Viertiö-Oja HE, Helin M et al. . Algorithm for quantifying frontal EMG responsiveness for sedation monitoring. Can J Neurol Sci 2014;41:611–19. 10.1017/cjn.2014.10
    1. Kaila MKE, Everingham K, Lapinlampi P et al. . A randomized controlled proof-of-concept trial of early sedation management using Responsiveness Index monitoring in mechanically ventilated critically ill patients. Crit Care 2015;19:333 10.1186/s13054-015-1043-1
    1. Horowitz M, Wilner N, Alvarez W. Impact of event scale: a measure of subjective stress. Psychosom Med 1979;41:209–18. 10.1097/00006842-197905000-00004
    1. Rattray J, Johnston M, Wildsmith JA. The intensive care experience: development of the ICE questionnaire. J Adv Nurs 2004;47:64–73. 10.1111/j.1365-2648.2004.03066.x
    1. Kress JP, Pohlman AS, O'Connor MF et al. . Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med 2000;342:1471–7. 10.1056/NEJM200005183422002
    1. Girard TD, Kress JP, Fuchs BD et al. . Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet 2008;371:126–34. 10.1016/S0140-6736(08)60105-1
    1. Mehta S, Burry L, Cook D et al. . Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA 2012;308:1985–92. 10.1001/jama.2012.13872
    1. Strøm T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet 2010;375:475–80. 10.1016/S0140-6736(09)62072-9
    1. Payen JF, Chanques G, Mantz J et al. . Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology 2007;106:687–95; quiz 891-2 10.1097/01.anes.0000264747.09017.da
    1. Benedict N, Felbinger M, Ridenour T et al. . Correlation of patient-reported outcomes of sedation and sedation assessment scores in critically ill patients. J Crit Care 2014;29:1132.e5–9. 10.1016/j.jcrc.2014.06.026

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다