DELirium in Intensive care reducing the incidence and duration among adults admitted to intensive care

DELirium in Intensive care reducing the incidence and duration among adults admitted to intensive care. Short Title The DELI study LIST OF INVESTIGATORS AND PARTICIPATING INSTITUTIONS Principal Investigators Joan Lynch1-3, Leanne Hunt1-3, Kathleen Brennan1,4,5, Sharon Shunker3, David Sanchez1,7, Evan Alexandrou1-5, Mariepaz Hazell3, Martin Christensen2,6, and Steve Frost1-3,5-6 1 Critical Care Research in Collaboration and Evidence Translation (CCRICET) 2 School of Nursing and Midwifery, Western Sydney University 3 Intensive Care Unit Liverpool Hospital 4 Intensive Care Bankstown Hospital 5 South Western Sydney Clinical School, UNSW 6 Centre for Applied Nursing Research, SWSLHD 7 Intensive Care Unit Campbelltown Hospital Site invesitgators/coordinators Mariepaz Hazell CNE, Intensive Care Unit Liverpool HospitalKathleen BrennanNP, Intensive Care Unit Bankstown HospitalDavid SanchezCNC, Intensive Care Unit Campbelltown HospitalNUMIntensive Care Unit Bowral HospitalFae AlbularioNUM, Intensive Care Unit Fairfield Hospital Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000411246p 2. SYNOPSIS (The synopsis is similar to an abstract and should be about 200-250 words. It is a stand-alone summary of the study and includes background, objectives and study plan) Background Delirium is an acute neurocognitive disorder that is characterised by a fluctuating level of consciousness with impaired attention and cognition. Delirium has been estimated to occur in approximately 30 of adults admitted the intensive care ADDIN EN.CITE ADDIN EN.CITE.DATA 1-3. Delirium is associated with poor outcomes which include longer stay in intensive care unit, longer stay in hospital by 10 days and experience a prolonged duration of mechanical ventilation ADDIN EN.CITE ADDIN EN.CITE.DATA 4, 5. The longer-term outcomes include long-term cognitive impairment, dependency in activities of daily living and 2-3 times higher mortality rates ADDIN EN.CITE ADDIN EN.CITE.DATA 4-10. The restlessness and agitation experienced by patients leads to increasing workload of ICU nurses who need to stay continually by the bedside to ensure the patients safety, thereby requiring one-to-one nursing care. This increases the financial burden of delirium on the Intensive Care unit as well as the hospital. Objectives This study will evaluate the impact of a nursing-led delirium-prevention protocol (the intervention) that is aimed at reducing the incidence, severity, and duration of delirium among adults admitted to ICU. The Delirium Prevention Nursing Protocol targets the risk factors for delirium which includes visual and hearing impairment, to prevent or treat sensory deprivation and ultimately the loss of orientation sleep deprivation, cognitive impairment to (re)orientate patients with regard to time, place and person to prevent or minimize decline and immobility, to improve patients functional mobility in the ICU and to stimulate patients cognition. Study Plan This study will be conducted using a multicentre stepped wedge cluster randomized controlled trial ADDIN EN.CITE EndNoteCiteAuthorEccles/AuthorYear2003/YearRecNum19/RecNumDisplayText11/DisplayTextrecordrec-number19/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102119/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorEccles, M./authorauthorGrimshaw, J./authorauthorCampbell, M./authorauthorRamsay, C./author/authors/contributorstitlestitleResearch designs for studies evaluating the effectiveness of change and improvement strategies./titlesecondary-titleQuality and Safe Health Care /secondary-title/titlesperiodicalfull-titleQuality and Safe Health Care/full-title/periodicalpages47-52/pagesvolume12/volumenumber1/numberdatesyear2003/year/datesurls/urls/record/Cite/EndNote11. The intervention will be implemented in five Intensive Care/High Dependency Units across the South Western Sydney Local Health District in a stepped process where each unit will move from a control unit to training unit to intervention unit, over a 12-month period. 3. RATIONALE / BACKGROUND This should provide an introduction to the study, what is already known (brief literature review), what is missing, what the study is going to find out, how this is going to be achieved and what impact the study will have. Delirium is a serious disorder that results in the acute disturbance of neurocognition, leading to fluctuating levels of awareness, attention and cognition. Delirium occurs in approximately 30 of critically ill adults ADDIN EN.CITE ADDIN EN.CITE.DATA 1-3, 8, 12 but in some populations such patients who stay more than 2-days, older male trauma patients and patients undergoing mechanical ventilation the incidence has been reported over 60 ADDIN EN.CITE ADDIN EN.CITE.DATA 10, 13-15. Delirium is independently associated with worse outcomes among adults admitted to intensive care. Hospital mortality has been reported 2-3 times higher in patients who experience delirium ADDIN EN.CITE ADDIN EN.CITE.DATA 4, 6, 16. Studies also report longer length of stay in the ICU and hospital ADDIN EN.CITE ADDIN EN.CITE.DATA 4, 10, longer time spent on the ventilator ADDIN EN.CITE ADDIN EN.CITE.DATA 4, higher incidence of cognitive impairment at hospital discharge ADDIN EN.CITE ADDIN EN.CITE.DATA 4, 9 and dependency in activities of daily living ADDIN EN.CITE ADDIN EN.CITE.DATA 6. Delirium is associated with serious consequences, thus reducing or preventing delirium in critical care will have significant impacts on outcomes in these patients. The risk factors for delirium have been extensively studied ADDIN EN.CITE ADDIN EN.CITE.DATA 3, 5, 10, 15. The risk factors include primary risk factors (i.e., brain damage, dementia, and cognitive impairment due to stroke), physical factors (i.e., visual and auditory disorders, fluid and electrolyte imbalance, metabolism disorders, emergency hospitalization, hypoperfusion, pain, fracture, hypertension, alcoholism, high severity of illness at admission, and infection) ADDIN EN.CITE ADDIN EN.CITE.DATA 17, and frequently, combinations of several factors (i.e., combination of sleep deprivation, use of a restraint, and exposure to noise) ADDIN EN.CITE ADDIN EN.CITE.DATA 7. Therefore, a multidisciplinary and multi-component intervention approach is recommended for delirium prevention ADDIN EN.CITE ADDIN EN.CITE.DATA 18. Recent studies that have used a non-pharmacologic multi component intervention programs to prevent delirium have shown promise in reducing the burden of delirium, mortality and length of stay in ICU. Their effectiveness though has been hampered by lack of rigorous design, insufficient sample size and problems with data collection ADDIN EN.CITE ADDIN EN.CITE.DATA 1, 2, 19. Further research that has adequate sample size from multiple ICUs and rigorous study design is required. 4. AIMS / OBJECTIVES / HYPOTHESES Provide a clear and concise statement of primary and secondary objectives and a clearly defined hypothesis (where relevant). The primary objective of this study is to determine the effectiveness of introducing a nurse led delirium-prevention protocol in reducing the incidence and severity of delirium among adults admitted to intensive care. The Primary Outcomes of interest being (1) incidence of delirium among adults admitted to the ICU and (2) the number of delirium free day, while in the ICU. Secondary Outcomes (1) ICU and hospital mortality rates (2) ICU length of stay (3) Duration of mechanical ventilation (4) among those receiving mechanical ventilation, re-intubation rates and, (5) hospital length of stay. Our hypothesis being that a tailored non-pharmacological approach to prevent delirium among adults admitted to intensive care will significantly reduce the incidence and severity of delirium. As a result, longer-term use of this protocol should reduce the length of stay within the ICU and hospital and the risk of in-hospital mortality. 5. PARTICIPATING SITES The intervention will be implemented across SWSLHD including the Intensive care units of Liverpool Hospital Bankstown Hospital Campbelltown Hospital Fairfield Hospital Bowral Hospital 6. RESEARCH PLAN / STUDY DESIGN Describe the type of study, the source of participants, datasets or collections to be accessed. Describe the sample size, sample size calculation or justification of numbers, outcome measures used. Provide details of the linkage and analysis variables used and why they are required and what study comparisons are being made. Describe the process of how records are linked and whether the datasets are held in the CHeReL Master Linkage key. Provide an analysis plan of how the aims will be met, the statistical methods to be used and who will be carrying out the analysis. Suggested sub-headings are as follows 6.1 Type of study (prospective study or involving access to data or data linkage as relevant) A multicentre stepped wedge cluster randomized controlled trial will be used ADDIN EN.CITE ADDIN EN.CITE.DATA 11, 20, 21. Five Intensive Care/High Dependency Units from the SWSLHD will participate. A cluster stepped wedge design was chosen due to the risk associated with randomization at the patient level may result in contamination between patients in the intervention group and patients in the control group ADDIN EN.CITE EndNoteCiteAuthorEccles/AuthorYear2003/YearRecNum19/RecNumDisplayText11/DisplayTextrecordrec-number19/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102119/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorEccles, M./authorauthorGrimshaw, J./authorauthorCampbell, M./authorauthorRamsay, C./author/authors/contributorstitlestitleResearch designs for studies evaluating the effectiveness of change and improvement strategies./titlesecondary-titleQuality and Safe Health Care /secondary-title/titlesperiodicalfull-titleQuality and Safe Health Care/full-title/periodicalpages47-52/pagesvolume12/volumenumber1/numberdatesyear2003/year/datesurls/urls/record/CiteCiteAuthorEccles/AuthorYear2003/YearRecNum19/RecNumrecordrec-number19/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102119/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorEccles, M./authorauthorGrimshaw, J./authorauthorCampbell, M./authorauthorRamsay, C./author/authors/contributorstitlestitleResearch designs for studies evaluating the effectiveness of change and improvement strategies./titlesecondary-titleQuality and Safe Health Care /secondary-title/titlesperiodicalfull-titleQuality and Safe Health Care/full-title/periodicalpages47-52/pagesvolume12/volumenumber1/numberdatesyear2003/year/datesurls/urls/record/Cite/EndNote11. This contamination could possibly result in a diluted effect of the program including risk for a false-negative outcome. Importantly, based on current evidence these interventions have demonstrated their safety and effectiveness ADDIN EN.CITE EndNoteCiteAuthorMoon/AuthorYear2015/YearRecNum16/RecNumDisplayText2/DisplayTextrecordrec-number16/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102016/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorMoon, K. J./authorauthorLee, S. M./author/authors/contributorsauth-addressDepartment of Nursing, Ulsan College, Ulsan, Republic of Korea.xDCollege of Nursing, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address [email protected]/auth-addresstitlestitleThe effects of a tailored intensive care unit delirium prevention protocol A randomized controlled trial/titlesecondary-titleInt J Nurs Stud/secondary-title/titlesperiodicalfull-titleInt J Nurs Stud/full-title/periodicalpages1423-32/pagesvolume52/volumenumber9/numberkeywordskeywordCognition/keywordkeywordDelirium/prevention amp control/psychology/keywordkeywordHumans/keywordkeywordIntensive Care Units/keywordkeywordSingle-Blind Method/keywordkeywordDelirium/keywordkeywordEvidence-based nursing/keywordkeywordIntensive care unit/keywordkeywordMortality/keywordkeywordPrevention/keyword/keywordsdatesyear2015/yearpub-datesdateSep/date/pub-dates/datesisbn1873-491X (Electronic)xD0020-7489 (Linking)/isbnaccession-num26032729/accession-numurlsrelated-urlsurlhttps//www.ncbi.nlm.nih.gov/pubmed/26032729/url/related-urls/urlselectronic-resource-num10.1016/j.ijnurstu.2015.04.021/electronic-resource-num/record/Cite/EndNote2, so therefore de-implementation of the intervention at the end of the study is not required. At baseline all ICUs will simultaneously start with the control period. The order in which an ICU will move to the intervention period will be randomized. Every month the intervention will be implemented in an additional ICU. From that point on the intervention will be part of the standard care in that ICU. In each ICU two months of staff training will be provided, after which the ICU moves from control to intervention (Fig. 1). All of the ICUs will participate for the entire study period. Figure 1 Timeline and Randomisation. Study period (months)Study Site1234567891011121CCCTIIIIIIII2CCCCTIIIIIII3CCCCCTIIIIII4CCCCCCTIIIII5CCCCCCCTIIIINote C control T training, and, I intervention periods. 6.2 Data sources/Collection Cognitive Screening Cognitive screening will involve overall assessment of consciousness, which involves two steps. Firstly, assessment of level of consciousness is done using the Richmond Agitation-Sedation Scale (RAAS) ADDIN EN.CITE EndNoteCiteAuthorSessler/AuthorYear2002/YearRecNum20/RecNumDisplayText22/DisplayTextrecordrec-number20/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102120/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorSessler, CN./authorauthorGosnell, MS./authorauthorGrap, MJ./authorauthorBrophy, GM./authorauthorOaposNeal, PV./authorauthorKeane, KA./author/authors/contributorstitlestitleThe Richmond Agitation-Sedation Scale vadlidity and reliability in adult intensive care unit patients/titlesecondary-titleAmerican Journal of Respiratory and Critical Care Medicine/secondary-title/titlesperiodicalfull-titleAmerican Journal of Respiratory and Critical Care Medicine/full-title/periodicalpages1338-1344/pagesvolume166/volumenumber10/numberdatesyear2002/year/datesurls/urls/record/Cite/EndNote22. This scale is currently used as standard practice in most ICUs. For patients who are in a coma or stupor (RAAS -4 or -5) do not undergo further assessment and referred to as unable to assess. Those who are rousable (RAAS -3 to 4) go on for delirium assessment. The second step involves delirium assessment and requires assessment of content of consciousness. This is done by the Confusion Assessment Method (CAM)-ICU. The CAM-ICU has been validated as a rapid, reliable (kappa 0.96 95CI 0.91-0.99) and valid (sensitivity 93 and specificity 98) tool for diagnosing delirium in the Intensive Care Unit setting ADDIN EN.CITE ADDIN EN.CITE.DATA 23. The CAM-ICU will be the assessment tool that will be used throughout the study in all ICUs. The CAM-ICU and RAAS (see appendix 2) will be collected daily by the bedside nurse at a set time each day. Patients will be diagnosed as delirious when they have at least one positive delirium screening (confusion assessment method (CAM)-ICU) ADDIN EN.CITE ADDIN EN.CITE.DATA 23 during their complete ICU stay or when they are treated for delirium with haloperidol (without a positive CAM-ICU screening). Nurse led delirium prevention protocol The intervention will incorporate a nurse led delirium prevention protocol, targeting risk factors for delirium (1) visual and hearing impairment – nurses will ensure glasses, or hearing aids are used among patients when needed (2) to prevent and treat sensory deprivation, cognitive impairment, and loss of orientation – all patients will be re-orientated to place, person, and time (3) Sleep deprivation will be minimised, and avoided where possible and, (4) lack of mobility – staff will attempt to improve functional mobility while in the intensive care, and also stimulate cognition. Patient Characteristics The baseline characteristics are incidentally collected and entered into the ANZICS database by administration officers in each Intensive Care Unit. The following patient characteristics will be retrieved Date and time of admissionAdmission sourceAdmission sourceAgeMechanical ventilationComorbiditiesSexDuration of MV SOFA scoreDOBReason for admissionDischarge statusAPACHE II-IIIPrinciple diagnosisLength of stay (ICU and Hospital) Primary Outcomes of Interest Incidence of delirium and delirium-coma-free days will be calculated from the CAM-ICU. The duration of delirium is defined as time from the first positive CAM-ICU or treatment with haloperidol, until the beginning of two consecutive days of negative delirium screenings. For ICU patients this is defined as a negative CAM-ICU screening. Reoccurrence of delirium, defined as a new delirium episode occurring after a minimum of 48 h of negative delirium scores, will be documented. Delirium-coma-free days This is defined as the number of days a patient is not delirious and not in coma in 28 days starting from the day of inclusion in the study. A delirium-coma-free day is defined as a non-delirious day with a RASS ADDIN EN.CITE EndNoteCiteAuthorSessler/AuthorYear2002/YearRecNum20/RecNumDisplayText22/DisplayTextrecordrec-number20/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102120/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorSessler, CN./authorauthorGosnell, MS./authorauthorGrap, MJ./authorauthorBrophy, GM./authorauthorOaposNeal, PV./authorauthorKeane, KA./author/authors/contributorstitlestitleThe Richmond Agitation-Sedation Scale vadlidity and reliability in adult intensive care unit patients/titlesecondary-titleAmerican Journal of Respiratory and Critical Care Medicine/secondary-title/titlesperiodicalfull-titleAmerican Journal of Respiratory and Critical Care Medicine/full-title/periodicalpages1338-1344/pagesvolume166/volumenumber10/numberdatesyear2002/year/datesurls/urls/record/Cite/EndNote22 greater than -3/-4 or -5. Secondary outcomes measures Mortality ICU and hospital mortality will be collected from ANZICS database. The following variables will be extracted from the ANZICS database ICU length of stay Hospital length of stay duration of mechanical ventilation incidence of re-intubation or restart of mechanical ventilation in case of tracheostomy patients incidence of ICU re-admission unplanned removal of tubes/catheters the use of physical restraints the use of antipsychotics/benzodiazipines 6.3 Population/Sample size The sample size of the study is based on the two main outcomes of interest (1) a clinically relevant effect on the incidence of delirium and, (2) a reduction in the number of delirium-coma-free days. The Delirium-Prevention Nursing Protocol is considered to be effective if the incidence of delirium is reduced by 10 (30 to 20) ADDIN EN.CITE ADDIN EN.CITE.DATA 2, 18, five clusters of 50 patient admission each month, before and after the intervention will provide a power of greater than 0.85, and this sample size will have over 0.9 power to detect a reduction of delirium free days by 2 (22 versus 20, among control and intervention periods, respectively). All Type I error rates set at 0.05 ADDIN EN.CITE EndNoteCiteAuthorMoerbeek/AuthorYear2015/YearRecNum22/RecNumDisplayText21, 24/DisplayTextrecordrec-number22/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102222/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorMoerbeek, M./authorauthorTeerenstra, S./author/authors/contributorstitlestitlePower analysis of trials with multilevel Data/titlesecondary-titleCRC/secondary-title/titlesperiodicalfull-titleCRC/full-title/periodicaldatesyear2015/year/datesurls/urls/record/CiteCiteAuthorHussey/AuthorYear2007/YearRecNum18/RecNumrecordrec-number18/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102118/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorHussey, MA./authorauthorHughes, JP. /author/authors/contributorstitlestitleDesign and analysis of stepped wedge clusterxDrandomized trials./titlesecondary-titleContemporary Clinical Trials/secondary-title/titlesperiodicalfull-titleContemporary Clinical Trials/full-title/periodicalpages182-191/pagesvolume28/volumenumber2/numberdatesyear2007/year/datesurls/urls/record/Cite/EndNote21, 24. The five ICUs and single HDU that are participating in the study currently admit between 50 (HDU), and 250 (largest ICU) patients each month (average 120 admission each month). 6.4 Expected duration of study and start times The study is expected to run for 12-months, beginning July 2018. 6.5 Text and Flow chart of data linkage process Not applicable. 6.6 Statistical analyses Characteristics of adult patients admitted to prior, and post implementation of the nurse-led delirium protocol will be presented as descriptive statistics. All outcomes of interest will be assessed using intention to treat analysis. Binary and continuous outcomes will be compared between pre- and post-intervention period using logistic or linear mixed models, clustered at the HDU/ICU level ADDIN EN.CITE EndNoteCiteAuthorHussey/AuthorYear2007/YearRecNum18/RecNumDisplayText21/DisplayTextrecordrec-number18/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102118/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorHussey, MA./authorauthorHughes, JP. /author/authors/contributorstitlestitleDesign and analysis of stepped wedge clusterxDrandomized trials./titlesecondary-titleContemporary Clinical Trials/secondary-title/titlesperiodicalfull-titleContemporary Clinical Trials/full-title/periodicalpages182-191/pagesvolume28/volumenumber2/numberdatesyear2007/year/datesurls/urls/record/Cite/EndNote21. 7. ETHICAL CONSIDERATIONS Provide information on where, when, how participants will be recruited, what the inclusion /exclusion criteria are. Identify and justify any dual relationships, coercion or inducement. Describe how voluntary informed consent will be sought or if a waiver of consent is being sought. Identify and justify any waiver of consent. Describe how confidentiality, anonymity and the identity of participants will be maintained, who is undertaking the data linkage, whether identifying information will be provided to researchers and a rationale for this. What security steps are in place for the transfer of data, where and how the data will be stored. Identify and justify any non-negligible risk or burden. Suggested sub-headings are as follows 7.1 Recruitment and selection of participants All patients admitted to the ICU who meet the eligibility criteria will undergo cognitive assessment and be screened for their risk for delirium as part of standard care and receive the Delirium-Prevention Nursing Protocol. Assignment of interventions The Delirium-Prevention Nursing Protocol used in this study will become standard treatment in all participating HDU/ICUs upon entering the intervention phase. These HDU/ICUs will be assigned to the intervention based on cluster randomisation, following a 3-month baseline period, each month for 5-months a study site will be randomised to the commence the teach and then intervention period (Figure 1). After 8-months of the study all study sights be have taken up the intervention, and remain so until the end of 12-month study period. 7.1.1 Inclusion and exclusion criteria Inclusion criteria Aged 18 years RAAS -3 s Expected to survive, or stay more than 24-hours Exclusion criteria Delirious on admission Stay 24 hours if reliable assessment for delirium is not possible due to sustained coma during complete ICU stay defined as Richmond agitation sedation score (RASS) of -4 to -5 inability to understand English severely mentally disabled serious receptive aphasia Informed consent A waiver for individual consent is being sought. As this study is a cluster-randomised trial- hence allocation to the intervention will be as a cluster rather than at the level of the individual patient therefore consent to the interventions cannot occur at an individual level ADDIN EN.CITE EndNoteCiteAuthorSim/AuthorYear2012/YearRecNum23/RecNumDisplayText25/DisplayTextrecordrec-number23/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102223/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorSim, Julius/authorauthorDawson, Angus/author/authors/contributorstitlestitleInformed Consent and Cluster-Randomized Trials/titlesecondary-titleAmerican Journal of Public Health/secondary-title/titlesperiodicalfull-titleAmerican Journal of Public Health/full-title/periodicalpages480-485/pagesvolume102/volumenumber3/numberdatesyear2012/yearpub-datesdate03/xD07/21/accepted/date/pub-dates/datespublisherAmerican Public Health Association/publisherisbn0090-0036xD1541-0048/isbnaccession-numPMC3487664/accession-numurlsrelated-urlsurlhttp//www.ncbi.nlm.nih.gov/pmc/articles/PMC3487664//url/related-urls/urlselectronic-resource-num10.2105/AJPH.2011.300389/electronic-resource-numremote-database-namePMC/remote-database-name/record/Cite/EndNote25. Equally, because the intervention in a cluster trial, and delivered at a unit rather than an individual level, there is little or no scope for any patient to opt out without jeopardising the internal validity of the study ADDIN EN.CITE EndNoteCiteAuthorGiraudeau/AuthorYear2012/YearRecNum24/RecNumDisplayText26/DisplayTextrecordrec-number24/rec-numberforeign-keyskey appEN db-id52ws2def4wxdvkedewt50d5i0spx99azpxxv timestamp150595102224/key/foreign-keysref-type nameJournal Article17/ref-typecontributorsauthorsauthorGiraudeau, Bruno/authorauthorCaille, Agns/authorauthorLe Gouge, Amlie/authorauthorRavaud, Philippe/author/authors/contributorstitlestitleParticipant Informed Consent in Cluster Randomized Trials Review/titlesecondary-titlePLOS ONE/secondary-title/titlesperiodicalfull-titlePLOS ONE/full-title/periodicalpagese40436/pagesvolume7/volumenumber7/numberdatesyear2012/year/datespublisherPublic Library of Science/publisherurlsrelated-urlsurlhttps//doi.org/10.1371/journal.pone.0040436/url/related-urls/urlselectronic-resource-num10.1371/journal.pone.0040436/electronic-resource-num/record/Cite/EndNote26. In addition, the nature of the intervention constitutes that of good quality nursing care, and will become standard care within the participating HDU/ICUs in the LHD, and carries no risk to participants. Therefore, the benefits from the research justify any risk of harm associated with not seeking consent. We believe that even if the participants were asked there is no known or likely reason for thinking that participants would not have consented anyway. Data collection for this study includes data that is routinely collected. All patient data outcomes will be collected from the ANZICS database. As we will be using data that is routinely collected, a waiver for use of patient information is also being sought. All patients and their families (next of kin) upon admission to the ICU will be provided with information regarding the research project. This information will detail the nursing delirium prevention protocol. Empowering family members to be active participants in this project will be instrumental to its success. The role of the families will be pivotal to this project, for example by telling the time of day and date, assisting in maintaining a day/night routine, and participating in normal activities with the patient such as reading the newspaper. 7.3 Confidentialityand Privacy Confidentiality and privacy of study participants, and study sites will be ensured through various steps, namely (1) study participant data will be limited to that needed to address the main hypothesis of the study (see data collection for specifics), identifying data that will be collected will be limited to Medical Record Number (MRN), date of birth (for calculation of age), and sex of study participants (2) specific data collection forms that will be used at each site to collect data will remain at the site (3) all study data will be placed in password protected study specific database (residing on the SWSLHD network) (4) when reporting the results of the study, specific study participants, and study sites will not be identified and, (5) access to study data will be limited to the research team (listed in this ethics application, all of whom are employees of the SWSLHD). 7.4 Data storage and Record retention As mentioned above, all study data will be entered into a password protected database, that will reside on the SWSLHD network. Hardcopy data collection forms will remain at the specific study site in a locked filing cabinet in the ICUHDU department. In accordance with SWSLHS HREC guidelines study data will be retained for 7-years. And, study data will be destroyed as recommend by the SWSLHD HREC To help the reader understand complex studies, it is very often useful to include a flow chart illustrating exactly what happens (and when) to participants as they pass through recruitment, consent and follow-up. 8. OUTCOMES AND SIGNIFICANCE The current outcomes of patients who experience delirium in ICU are poor associated with high mortality, extended hospital stays and poor cognitive function at hospital discharge. A significant proportion of ICU patients, at least 30 will experience delirium during their ICU stay. The frequency of occurrence in combination with poor outcomes makes improving care of these patients a nursing imperative. The prevention of delirium, early detection through regular assessment, and prompt interventions are essential components of delirium management. This study aims to deliver multi-component tailored intervention that will improve the outcomes and quality of care to patients who have delirium. The interventions include regular cognitive assessment and with orientation, assessing and correcting visual and auditory function, ensuring nutritional needs are met, night time routine, early mobilisation/ambulation, avoiding when administering medications, such as anti-cholinergic, narcotic, and/or sedative hypnotic drugs, monitor for signs of infection, limiting urinary catheter use, avoid hypoxia and controlling pain. Implementation of non-pharmacological multi-component interventions have shown to reduce the risk of in-hospital mortality, length of stay and incidence of delirium. This highlights the importance of the role of nurses in the care of patients as bedside healthcare providers responsible for 24-h patient care, nurses may be situated to prevent delirium, perform early delirium detection, and provide early intervention. 9. TIMELINES / MILESTONES November to December 2017Successful Ethics approval, and finalisation of training material for nurse-led delirium intervention January to March 2018All sites begin as controls, all patients admitted to ICUs undergo cognitive assessmentApril to August 2018Each Study site enters training phase (1-month) and then intervention phaseSeptember to December 2018Intervention continues for all study sites. January to MarchAnalysis of data and preparation of manuscript for publication. 10. PUBLICATION POLICY APPENDIX 1- THE DELIRIUM PREVENTION PROTOCOL Delirium Risk monitoring and key interventions (from Moon and Lee, 2015) APPENDIX 2 11. REFERENCES ADDIN EN.REFLIST 1. Foster, J. and M. Kelly, A pilot study to test the feasibility and effectiveness of a nonpharmacologic intervention for prevention of delirium in medical intensive care unit. Clinical Nurse Specialist The Journal for Advanced Nursing Practice, 2013. 27(5) p. 231-8. 2. Moon, K.J. and S.M. Lee, The effects of a tailored intensive care unit delirium prevention protocol A randomized controlled trial. Int J Nurs Stud, 2015. 52(9) p. 1423-32. 3. Salluh, J.I., et al., Delirium epidemiology in critical care (DECCA) an international study. Crit Care, 2010. 14(6) p. R210. 4. Ely, E.W., et al., Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA Journal of the American Medical Association, 2004. 291(14) p. 1753-1762. 5. Ouimet, S., et al., Incidence, risk factors and consequences of ICU delirium. Intensive Care Medicine, 2007. 33(1) p. 66-73. 6. Abelha, F.J., et al., Outcome and quality of life in patients with postoperative delirium during an ICU stay following major surgery. Critical Care, 2013. 17(3) p. R257-R257. 7. Andrews, L., et al., Delirium monitoring and patient outcomes in a general intensive care unit. American Journal of Critical Care, 2015. 24(1) p. 48-56. 8. Balas, M.C., et al., Delirium in older patients in surgical intensive care units. Journal of Nursing Scholarship, 2007. 39(2) p. 147-154. 9. Hideaki, S., et al., Severity of delirium in the ICU is associated with short term cognitive impairment. A prospective cohort study. Intensive Critical Care Nursing, 2015. 31(4) p. 250-257. 10. Mehta, S., et al., Prevalence, risk factors, and outcomes of delirium in mechanically ventilated adults. Critical Care Medicine, 2015. 43(3) p. 557-566. 11. Eccles, M., et al., Research designs for studies evaluating the effectiveness of change and improvement strategies. Quality and Safe Health Care 2003. 12(1) p. 47-52. 12. Mohammadi, M., et al., Cyproheptadine for the Prevention of Postoperative Delirium A Pilot Study. Annals of Pharmacotherapy, 2016. 50(3) p. 180-187. 13. Bounds, M., Effect of ABCDE bundle implementation on prevalence of delirium in intensive care unit patients. American Journal of Critical Care, 2016. 25(6) p. 535-544. 14. Kamdar, B.B., et al., The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Critical Care Medicine, 2013. 41(3) p. 800-809. 15. Bryczkowski, S.B., et al., Risk factors for delirium in older trauma patients admitted to the surgical intensive care unit. Journal of Trauma Acute Care Surgery, 2014. 77(6) p. 944-951. 16. Caruso, P., et al., ICU architectural design affects the delirium prevalence a comparison between single-bed and multibed rooms. Critical Care Medicine, 2014. 42(10) p. 2204-2210. 17. Barr, J., 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(1) p. 263-306. 18. Wassenaar, A., et al., Multinational development and validation of an early prediction model for delirium in ICU patients. Intensive Care Med, 2015. 41(6) p. 1048-56. 19. Rivosecchi, R.M., et al., The implementation of a nonpharmacologic protocol to prevent intensive care delirium. J Crit Care, 2016. 31(1) p. 206-11. 20. Brown, C. and R. Lilford, The stepped wedge trial design a systematic review. BMC Medical Research Methodology, 2006. 6 p. 54. 21. Hussey, M. and J. Hughes, Design and analysis of stepped wedge cluster randomized trials. Contemporary Clinical Trials, 2007. 28(2) p. 182-191. 22. Sessler, C., et al., The Richmond Agitation-Sedation Scale vadlidity and reliability in adult intensive care unit patients. American Journal of Respiratory and Critical Care Medicine, 2002. 166(10) p. 1338-1344. 23. Ely, E.W., et al., Delirium in mechanically ventilated patients validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA Journal of the American Medical Association, 2001. 286(21) p. 2703-2746. 24. Moerbeek, M. and S. Teerenstra, Power analysis of trials with multilevel Data. CRC, 2015. 25. Sim, J. and A. Dawson, Informed Consent and Cluster-Randomized Trials. American Journal of Public Health, 2012. 102(3) p. 480-485. 26. Giraudeau, B., et al., Participant Informed Consent in Cluster Randomized Trials Review. PLOS ONE, 2012. 7(7) p. e40436. Page PAGE 1 of NUMPAGES 17 Protocol DELI-STUDY Version 1 / 20171018 Add data collection point to CAM-ICU form / / / / / 6eYe)l,,rS6XeYl,,McM6m3ixlTe9df,l,7c7eY1c,rdMeY/L6Xnncr3vSY 6l,7) 6MV8mt6T0yqKwov9U-dwV8j/wIreP7gvgk4VrD77o3I2wZwJ7u lL6XnC6YlgSS SJ86js)MoslAyO3
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