<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03812861</url>
  </required_header>
  <id_info>
    <org_study_id>W16_209</org_study_id>
    <nct_id>NCT03812861</nct_id>
  </id_info>
  <brief_title>Cognitive Aids for the Management of Deteriorating Surgical Patients</brief_title>
  <acronym>CAMDS</acronym>
  <official_title>Cognitive Aids for the Management of Deteriorating Surgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background and Goal of Study: Adherence to best practice management of emergencies improves&#xD;
      through the use of cognitive aids. Aim of this study was to develop and validate cognitive&#xD;
      aids for management of deteriorating surgical ward patients (CAMDS) in order to improve&#xD;
      adherence to best practice and hereby reduce the likelihood of failure to rescue.&#xD;
&#xD;
      Materials and Methods: Fifty surgical teams will be randomly assigned to manage 150&#xD;
      standardised high fidelity simulation cases of deteriorating patients using the CAMDS or not.&#xD;
      There are 10 standardised patient scenarios; pneumonia, pneumothorax, bradycardia, cardiac&#xD;
      arrest shockable and non-shockable rhythm, bleeding, myocardial infarction, anaphylaxis,&#xD;
      sepsis and loss of consciousness. Two independent observers will score the team's performance&#xD;
      in adhering to all the management steps. To assess perceived usability of the CAMDS&#xD;
      participants will be asked about eight aspects of the CAMDS. These items will be scored on a&#xD;
      Likert scale (0= strongly disagree to 4= strongly agree).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION AND RATIONALE&#xD;
&#xD;
      The suboptimal management of deteriorating surgical patients is an important factor in&#xD;
      preventable death and morbidity in hospitals. Several studies have shown that the mortality&#xD;
      rate in different hospitals is not associated with different complication rates between these&#xD;
      hospitals but with the ability to effectively rescue patients from these complications. This&#xD;
      has been called failure to rescue. Misapplication of the early warning score, failure to&#xD;
      recognize a deteriorating patient, delays in seeking senior advice and delays in adequate&#xD;
      management or inadequate resuscitation are found to be important factors. Strategies focusing&#xD;
      on the management of complications once they occur may be essential to improve outcomes.&#xD;
&#xD;
      Recent publications emphasized human factors as a cause that contributed towards failure to&#xD;
      rescue. Medical staff often fails to recognize a deteriorating patient. Partly because there&#xD;
      is lack of insight in the development of a critically illness. Ludikhuize showed that&#xD;
      care-providers mostly rate their care, provided to patients in the hours preceding a&#xD;
      life-threatening adverse event, as good. However, independent experts felt that patients&#xD;
      often could have been identified as deteriorating, much earlier. It does not, however, seem&#xD;
      wholly unexpected that the assessment of a deteriorating patient by an experienced ICU&#xD;
      consultant is superior to the assessment made by a ward nurse or junior surgical doctor.&#xD;
&#xD;
      Another important cause of failure to rescue was the failure to react promptly tot a&#xD;
      deterioration in care. It has been reported that the Rapid Response Team (RRT) was called in&#xD;
      only 30% of cases when criteria for activating the RRT were fulfilled. Sometimes because of&#xD;
      an unclear escalation policy, sometimes because of self-doubt and insecurity of the care&#xD;
      provider or because of hierarchical barriers.&#xD;
&#xD;
      It is known that the management of intraoperative emergencies improves through the use of&#xD;
      cognitive aids.These cognitive aids remind practitioners to best practice management of these&#xD;
      emergencies and hereby increase adherence to these practices. Because the CAMDS will assist&#xD;
      surgical staff at the bedside in the assessment of deteriorating surgical patients and prompt&#xD;
      best practice management of specific complications it is likely that failure to rescue will&#xD;
      also decrease. The CAMDS can furthermore prompt a nurse or junior doctor to liaise with&#xD;
      seniors and/or critical care staff. Because they can communicate a differential diagnosis and&#xD;
      management steps taken so far from the CAMDS this might decrease self-doubt and insecurity in&#xD;
      liaising with seniors or critical care staff. A, clear escalation policy on the CAMDS,&#xD;
      embraced by the hospital can further assist in the timely escalation of care and breakdown of&#xD;
      hierarchical barriers. This will result in a decrease of the likelihood of failure to rescue.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
      Primary Objective is to answer the following research questions:&#xD;
&#xD;
      Will the correct application of the CAMDS improve adherence (measured by the omission of&#xD;
      critical steps) to best practice management of perioperative complications in surgical&#xD;
      patients?&#xD;
&#xD;
      Secondary Objective is to validate the CAMDS in terms of user perceived usability.&#xD;
&#xD;
      STUDY DESIGN Randomized study comparing adherence rates to best practice management of&#xD;
      patients with a perioperative complication in a high fidelity simulation session with and&#xD;
      without the use of the CAMDS.&#xD;
&#xD;
      The investigators will develop and validate cognitive aids for the assessment and management&#xD;
      of deteriorating surgical patients (CAMDS). These CAMDS contain instructions for doctors and&#xD;
      nursing staff to assess, manage and escalate care of deteriorating surgical patients. These&#xD;
      management instructions will be derived from best practices that are linked with improved&#xD;
      mortality and morbidity in surgical patients. The cognitive aids will be developed in an&#xD;
      expert team of 2 surgical consultants, 2 surgical registrars (one junior and one senior), 3&#xD;
      nurses from a surgical ward, 1 critical care consultant, 2 anaesthetic consultants and an&#xD;
      anaesthetic registrar. The content of the CAMDS and accompanying evidence will be determined&#xD;
      within this team. The design of the CAMDS will be done by adaptation of the local emergency&#xD;
      manual, which is a bundle of cognitive aids for intraoperative emergencies adapted from the&#xD;
      Stanford Emergency Manual (with permission). The design for this bundle has been thoroughly&#xD;
      tested. The simulation scenarios will be based upon the 10 different conditions that are in&#xD;
      the CAMDS. Scenarios will be tested and validated through a pilot study.&#xD;
&#xD;
      STUDY POPULATION Population (base) Surgical doctors from the surgical departments of several&#xD;
      Dutch hospitals will be included in the study. Doctors and nurses will be assigned to teams&#xD;
      and randomised to a management scenario with the use of the CAMDS or without the use of the&#xD;
      CAMDS. They will have to give individual consent to participate in the study and are only&#xD;
      allowed to participate in the study once.&#xD;
&#xD;
      Sample size calculation Sample size calculation is based on a cluster-randomized design. No&#xD;
      previous data on the effectiveness of CAMDS is available, thus no formal power analysis was&#xD;
      possible. Available data on the use of cognitive aids in simulated crisis scenarios in the&#xD;
      operating theatre shows a baseline omission of critical steps of about 75%.The investigators&#xD;
      therefore estimate that the correct application of the CAMDS will reduce the omission of&#xD;
      critical steps with 50%. Each team will run through three scenarios and will randomised to&#xD;
      complete the scenario with or without the CAMDS. Across these three scenarios participants&#xD;
      will be measured on a total of 45 (15 per scenario) process measures for adherence. Based on&#xD;
      this effect size and an estimated intra-cluster correlation coefficient within teams of 0.1&#xD;
      and a mean cluster size of 45, with a two-sided alpha level of 0.05 and 80% power, 25&#xD;
      surgical teams per study arm are needed.&#xD;
&#xD;
      METHODS&#xD;
&#xD;
      Main study parameter/endpoint:&#xD;
&#xD;
      Failure to adhear to best practice (omission of critical management steps) for the given&#xD;
      scenarios, as predefined by the team that developed the CAMDS.&#xD;
&#xD;
      Secondary study parameters/endpoints (if applicable):&#xD;
&#xD;
      Perceived utility, ease of use and user satisfaction of the CAMDS. Eight aspects of perceived&#xD;
      usability; ease of use, logical order of described management steps, readability of the&#xD;
      CAMDS, whether the CAMDS provided overview, interrupted treatment, improved treatment,&#xD;
      recommendation to use and suitability for daily use, will be assessed through a survey. These&#xD;
      items will be scored on a five-point Likert scale (strongly agree to strongly disagree).&#xD;
      Completion of the questionnaires will be voluntary and no compensation of any kind will be&#xD;
      provided.&#xD;
&#xD;
      Randomisation, blinding and treatment allocation This is a prospective randomised,&#xD;
      non-blinded study. Surgical teams will be randomised through a computer generated code in&#xD;
      sealed opaque envelopes to the CAMDS group or non CAMDS group. Randomisation will take place&#xD;
      only after the teams have been made familiar with the cognitive aid bundle and the high&#xD;
      fidelity simulation laboratory, so during the introduction study staff and participants will&#xD;
      be unaware of allocation.&#xD;
&#xD;
      Study procedures Surgical teams will be asked to manage a simulated scenario of a&#xD;
      deteriorating surgical patient. The simulated scenario will take place in the high fidelity&#xD;
      simulator of the Academic Medical Centre Amsterdam and will be recorded on video. Two&#xD;
      independent observers will score the key processes for managing the specific scenarios.&#xD;
      Interrater reliability will be assessed with Cohen's Kappa. There are three independent EuSim&#xD;
      trained simulation laboratory operators (CHSOS) who will run the simulated patient, the&#xD;
      Laerdal SimMan 3G. Ten standardised patient cases- pneumonia, pneumothorax, bradycardia,&#xD;
      cardiac arrest shockable and non-shockable rhythm, bleeding, myocardial infarction,&#xD;
      anaphylaxis, sepsis and loss of consciousness- were preprogrammed for the study. So a correct&#xD;
      action resulted in progression in the scenario.&#xD;
&#xD;
      Withdrawal of individual subjects Not applicable.&#xD;
&#xD;
      Premature termination of the study The study will be terminated after enclosure of the last&#xD;
      participating surgical team (n=50)&#xD;
&#xD;
      STATISTICAL ANALYSIS Will be performed using SPSS statistics. All data will be checked for&#xD;
      normal distribution using the Kolmogorov-Smirnov test and histograms. For normal distributed,&#xD;
      continuous variables, an independent Student´s t-test will be used and the variables will be&#xD;
      presented as mean ± standard deviation (SD). A p-value &lt;0.05 will be considered as&#xD;
      statistically significant. For categorical variables, cross tabulation and the Pearson chi&#xD;
      square test will be applied and variables will be allegorized as number and/or percentage of&#xD;
      the total. Not normally distributed data will be compared using the Man-Whitney U-test where&#xD;
      appropriate, and data will be presented by the median and the interquartile range. For the&#xD;
      primary outcome measure univariate analysis to test failure rates (percentage omitted&#xD;
      critical steps). Multivariate analysis will also be done to compare failure rates with and&#xD;
      without the CAMDS. Descriptive statistics will be used to describe perceived usability.&#xD;
&#xD;
      No interim analysis will be done&#xD;
&#xD;
      Handling and storage of data and documents Video data from the simulated scenarios will be&#xD;
      stored on a password protected folder in a computer drive only available by the&#xD;
      investigators. All questionnaires will be anonymously collected and electronic copies of the&#xD;
      files will be stored in the same folder as the video data. Participants will be asked to fill&#xD;
      in a training grade to allow stratification of the data. The study staff will ensure that the&#xD;
      participants' anonymity is maintained. All documents will be stored securely and only&#xD;
      accessible by study staff. The trial will comply with the Data Protection Act, which requires&#xD;
      data to be anonymised as soon as it is practical to do so.&#xD;
&#xD;
      This study is funded by an Innovation Grant from the Academic Medical Centre, Amsterdam.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2017</start_date>
  <completion_date type="Actual">December 18, 2018</completion_date>
  <primary_completion_date type="Actual">December 18, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>50 surgical teams (1 doctor, 2 nurses) will be randomly allocated to intervention or control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Study introduction and familiarisation of the simulation lab and cognitive aid bundle will be done blindly for both participant and study staff. Randomisation will be done after study introduction and familiarisation of the simulation lab and cognitive aid bundle by means of opening a opaque sealed envelope. The randomisation is done by a computer generated code for use of the CAMDS (intervention) or not (control) and 3 patient scenario's</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Failure to adhear to best practice (percentage of omitted critical management steps) for the given scenario</measure>
    <time_frame>start to end of high fidelity simulation session (aprox. 10 min)</time_frame>
    <description>Every scenario consisted of 15 predefined critical management steps (for examle cardiac arrest with a shockable rhythm critical steps would be; start basic life support, open the airway, identify shockable rhythm, defibrillate with appropriate amount of Joules etc.) Primary outcome is the failure to adhear to best practice expressed as percentage of omitted predefined critical management steps.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived usability of the CAMDS</measure>
    <time_frame>During debrief of high fidelity simulation session (aprox. 30 min)</time_frame>
    <description>Eight aspects of perceived usability; ease of use, logical order of described management steps, readability of the CAMDS, whether the CAMDS provided overview, interrupted treatment, improved treatment, recommendation to use and suitability for daily use, will be assessed through a survey. These items will be scored on a five-point Likert scale (strongly agree to strongly disagree).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Surgery--Complications</condition>
  <arm_group>
    <arm_group_label>CAMDS bundle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 surgical teams will manage 10 standardised simulated deteriorating ward patients with the help of a cognitive aid bundle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No bundle</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>25 surgical teams will manage 10 standardised simulated deteriorating ward patients without the help of a cognitive aid bundle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CAMDS bundle</intervention_name>
    <description>Cognitive aids for the assessment and management of deteriorating surgical patients (CAMDS). This bundle contains instructions for doctors and nursing staff to assess, manage and escalate care of deteriorating surgical patients. These management instructions will be derived from best practices that are linked with improved mortality and morbidity in surgical patients.</description>
    <arm_group_label>CAMDS bundle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All hospital surgical staff is eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgical staff that is unwilling to give consent&#xD;
&#xD;
          -  Staff that already has participated in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benedikt Preckel, M.D. P.h.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam UMC, location AMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amsterdam UMC, location: Academic Medical Centre</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>NCEPOD. Knowing the risk. A review of the peri-operative care of surgical patients 2011 (via: https://www.ncepod.org.uk/2011poc.html )</citation>
  </reference>
  <reference>
    <citation>Gaba DM, Howard SK, Fish KJ, Smith BE, Sowb YA. Simulation- based training in anesthesia crisis resource management (ACRM): a decade of experience. Simul Gaming 2001;32:175-93. ( via: http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.454.6344&amp;rep=rep1&amp;type=pdf )</citation>
  </reference>
  <results_reference>
    <citation>Ghaferi AA, Birkmeyer JD, Dimick JB. Hospital volume and failure to rescue with high-risk surgery. Med Care. 2011 Dec;49(12):1076-81. doi: 10.1097/MLR.0b013e3182329b97.</citation>
    <PMID>22002649</PMID>
  </results_reference>
  <results_reference>
    <citation>Ghaferi AA, Osborne NH, Birkmeyer JD, Dimick JB. Hospital characteristics associated with failure to rescue from complications after pancreatectomy. J Am Coll Surg. 2010 Sep;211(3):325-30. doi: 10.1016/j.jamcollsurg.2010.04.025. Epub 2010 Jul 14.</citation>
    <PMID>20800188</PMID>
  </results_reference>
  <results_reference>
    <citation>Symons NR, Almoudaris AM, Nagpal K, Vincent CA, Moorthy K. An observational study of the frequency, severity, and etiology of failures in postoperative care after major elective general surgery. Ann Surg. 2013 Jan;257(1):1-5. doi: 10.1097/SLA.0b013e31826d859b.</citation>
    <PMID>23044786</PMID>
  </results_reference>
  <results_reference>
    <citation>Garry DA, McKechnie SR, Culliford DJ, Ezra M, Garry PS, Loveland RC, Sharma VV, Walden AP, Keating LM; PREVENT group. A prospective multicentre observational study of adverse iatrogenic events and substandard care preceding intensive care unit admission (PREVENT). Anaesthesia. 2014 Feb;69(2):137-42. doi: 10.1111/anae.12535.</citation>
    <PMID>24443852</PMID>
  </results_reference>
  <results_reference>
    <citation>Johnston M, Arora S, King D, Stroman L, Darzi A. Escalation of care and failure to rescue: a multicenter, multiprofessional qualitative study. Surgery. 2014 Jun;155(6):989-94. doi: 10.1016/j.surg.2014.01.016. Epub 2014 Feb 7.</citation>
    <PMID>24768480</PMID>
  </results_reference>
  <results_reference>
    <citation>Roberts KE, Bonafide CP, Paine CW, Paciotti B, Tibbetts KM, Keren R, Barg FK, Holmes JH. Barriers to calling for urgent assistance despite a comprehensive pediatric rapid response system. Am J Crit Care. 2014 May;23(3):223-9. doi: 10.4037/ajcc2014594.</citation>
    <PMID>24786810</PMID>
  </results_reference>
  <results_reference>
    <citation>Ludikhuize J, Dongelmans DA, Smorenburg SM, Gans-Langelaar M, de Jonge E, de Rooij SE. How nurses and physicians judge their own quality of care for deteriorating patients on medical wards: self-assessment of quality of care is suboptimal*. Crit Care Med. 2012 Nov;40(11):2982-6. doi: 10.1097/CCM.0b013e31825fe2cb.</citation>
    <PMID>22890255</PMID>
  </results_reference>
  <results_reference>
    <citation>Ludikhuize J, Brunsveld-Reinders AH, Dijkgraaf MG, Smorenburg SM, de Rooij SE, Adams R, de Maaijer PF, Fikkers BG, Tangkau P, de Jonge E; Cost and Outcomes of Medical Emergency Teams Study Group. Outcomes Associated With the Nationwide Introduction of Rapid Response Systems in The Netherlands. Crit Care Med. 2015 Dec;43(12):2544-51. doi: 10.1097/CCM.0000000000001272.</citation>
    <PMID>26317569</PMID>
  </results_reference>
  <results_reference>
    <citation>Johnston M, Arora S, Anderson O, King D, Behar N, Darzi A. Escalation of care in surgery: a systematic risk assessment to prevent avoidable harm in hospitalized patients. Ann Surg. 2015 May;261(5):831-8. doi: 10.1097/SLA.0000000000000762.</citation>
    <PMID>24887972</PMID>
  </results_reference>
  <results_reference>
    <citation>Chrysochoou G, Gunn SR. Demonstrating the benefit of medical emergency teams (MET) proves more difficult than anticipated. Crit Care. 2006;10(2):306. doi: 10.1186/cc4865. No abstract available.</citation>
    <PMID>16542491</PMID>
  </results_reference>
  <results_reference>
    <citation>Arriaga AF, Bader AM, Wong JM, Lipsitz SR, Berry WR, Ziewacz JE, Hepner DL, Boorman DJ, Pozner CN, Smink DS, Gawande AA. Simulation-based trial of surgical-crisis checklists. N Engl J Med. 2013 Jan 17;368(3):246-53. doi: 10.1056/NEJMsa1204720.</citation>
    <PMID>23323901</PMID>
  </results_reference>
  <results_reference>
    <citation>Harrison TK, Manser T, Howard SK, Gaba DM. Use of cognitive aids in a simulated anesthetic crisis. Anesth Analg. 2006 Sep;103(3):551-6. doi: 10.1213/01.ane.0000229718.02478.c4.</citation>
    <PMID>16931660</PMID>
  </results_reference>
  <results_reference>
    <citation>Ziewacz JE, Arriaga AF, Bader AM, Berry WR, Edmondson L, Wong JM, Lipsitz SR, Hepner DL, Peyre S, Nelson S, Boorman DJ, Smink DS, Ashley SW, Gawande AA. Crisis checklists for the operating room: development and pilot testing. J Am Coll Surg. 2011 Aug;213(2):212-217.e10. doi: 10.1016/j.jamcollsurg.2011.04.031. Epub 2011 Jun 11. Erratum In: J Am Coll Surg. 2012 Aug;215(2):310. Dosage error in article text.</citation>
    <PMID>21658974</PMID>
  </results_reference>
  <results_reference>
    <citation>Neal JM, Hsiung RL, Mulroy MF, Halpern BB, Dragnich AD, Slee AE. ASRA checklist improves trainee performance during a simulated episode of local anesthetic systemic toxicity. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):8-15. doi: 10.1097/AAP.0b013e31823d825a.</citation>
    <PMID>22157743</PMID>
  </results_reference>
  <results_reference>
    <citation>Burden AR, Carr ZJ, Staman GW, Littman JJ, Torjman MC. Does every code need a &quot;reader?&quot; improvement of rare event management with a cognitive aid &quot;reader&quot; during a simulated emergency: a pilot study. Simul Healthc. 2012 Feb;7(1):1-9. doi: 10.1097/SIH.0b013e31822c0f20.</citation>
    <PMID>22113440</PMID>
  </results_reference>
  <results_reference>
    <citation>Koers L, Eveleens FM, Schlack WS, Preckel B. [Cognitive aid for emergencies in the OR--AMC bundle helps ensure that no steps are left out]. Ned Tijdschr Geneeskd. 2015;159:A8325. Dutch.</citation>
    <PMID>25784063</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>B Preckel</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>failure to rescue</keyword>
  <keyword>postoperative complications</keyword>
  <keyword>adherence to best practice</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03812861
org study id: W16_209
nct id: NCT03812861
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background and Goal of Study: Adherence to best practice management of emergencies improves
      through the use of cognitive aids. Aim of this study was to develop and validate cognitive
      aids for management of deteriorating surgical ward patients (CAMDS) in order to improve
      adherence to best practice and hereby reduce the likelihood of failure to rescue.

      Materials and Methods: Fifty surgical teams will be randomly assigned to manage 150
      standardised high fidelity simulation cases of deteriorating patients using the CAMDS or not.
      There are 10 standardised patient scenarios; pneumonia, pneumothorax, bradycardia, cardiac
      arrest shockable and non-shockable rhythm, bleeding, myocardial infarction, anaphylaxis,
      sepsis and loss of consciousness. Two independent observers will score the team's performance
      in adhering to all the management steps. To assess perceived usability of the CAMDS
      participants will be asked about eight aspects of the CAMDS. These items will be scored on a
      Likert scale (0= strongly disagree to 4= strongly agree).
INTRODUCTION AND RATIONALE

      The suboptimal management of deteriorating surgical patients is an important factor in
      preventable death and morbidity in hospitals. Several studies have shown that the mortality
      rate in different hospitals is not associated with different complication rates between these
      hospitals but with the ability to effectively rescue patients from these complications. This
      has been called failure to rescue. Misapplication of the early warning score, failure to
      recognize a deteriorating patient, delays in seeking senior advice and delays in adequate
      management or inadequate resuscitation are found to be important factors. Strategies focusing
      on the management of complications once they occur may be essential to improve outcomes.

      Recent publications emphasized human factors as a cause that contributed towards failure to
      rescue. Medical staff often fails to recognize a deteriorating patient. Partly because there
      is lack of insight in the development of a critically illness. Ludikhuize showed that
      care-providers mostly rate their care, provided to patients in the hours preceding a
      life-threatening adverse event, as good. However, independent experts felt that patients
      often could have been identified as deteriorating, much earlier. It does not, however, seem
      wholly unexpected that the assessment of a deteriorating patient by an experienced ICU
      consultant is superior to the assessment made by a ward nurse or junior surgical doctor.

      Another important cause of failure to rescue was the failure to react promptly tot a
      deterioration in care. It has been reported that the Rapid Response Team (RRT) was called in
      only 30% of cases when criteria for activating the RRT were fulfilled. Sometimes because of
      an unclear escalation policy, sometimes because of self-doubt and insecurity of the care
      provider or because of hierarchical barriers.

      It is known that the management of intraoperative emergencies improves through the use of
      cognitive aids.These cognitive aids remind practitioners to best practice management of these
      emergencies and hereby increase adherence to these practices. Because the CAMDS will assist
      surgical staff at the bedside in the assessment of deteriorating surgical patients and prompt
      best practice management of specific complications it is likely that failure to rescue will
      also decrease. The CAMDS can furthermore prompt a nurse or junior doctor to liaise with
      seniors and/or critical care staff. Because they can communicate a differential diagnosis and
      management steps taken so far from the CAMDS this might decrease self-doubt and insecurity in
      liaising with seniors or critical care staff. A, clear escalation policy on the CAMDS,
      embraced by the hospital can further assist in the timely escalation of care and breakdown of
      hierarchical barriers. This will result in a decrease of the likelihood of failure to rescue.

      OBJECTIVES

      Primary Objective is to answer the following research questions:

      Will the correct application of the CAMDS improve adherence (measured by the omission of
      critical steps) to best practice management of perioperative complications in surgical
      patients?

      Secondary Objective is to validate the CAMDS in terms of user perceived usability.

      STUDY DESIGN Randomized study comparing adherence rates to best practice management of
      patients with a perioperative complication in a high fidelity simulation session with and
      without the use of the CAMDS.

      The investigators will develop and validate cognitive aids for the assessment and management
      of deteriorating surgical patients (CAMDS). These CAMDS contain instructions for doctors and
      nursing staff to assess, manage and escalate care of deteriorating surgical patients. These
      management instructions will be derived from best practices that are linked with improved
      mortality and morbidity in surgical patients. The cognitive aids will be developed in an
      expert team of 2 surgical consultants, 2 surgical registrars (one junior and one senior), 3
      nurses from a surgical ward, 1 critical care consultant, 2 anaesthetic consultants and an
      anaesthetic registrar. The content of the CAMDS and accompanying evidence will be determined
      within this team. The design of the CAMDS will be done by adaptation of the local emergency
      manual, which is a bundle of cognitive aids for intraoperative emergencies adapted from the
      Stanford Emergency Manual (with permission). The design for this bundle has been thoroughly
      tested. The simulation scenarios will be based upon the 10 different conditions that are in
      the CAMDS. Scenarios will be tested and validated through a pilot study.

      STUDY POPULATION Population (base) Surgical doctors from the surgical departments of several
      Dutch hospitals will be included in the study. Doctors and nurses will be assigned to teams
      and randomised to a management scenario with the use of the CAMDS or without the use of the
      CAMDS. They will have to give individual consent to participate in the study and are only
      allowed to participate in the study once.

      Sample size calculation Sample size calculation is based on a cluster-randomized design. No
      previous data on the effectiveness of CAMDS is available, thus no formal power analysis was
      possible. Available data on the use of cognitive aids in simulated crisis scenarios in the
      operating theatre shows a baseline omission of critical steps of about 75%.The investigators
      therefore estimate that the correct application of the CAMDS will reduce the omission of
      critical steps with 50%. Each team will run through three scenarios and will randomised to
      complete the scenario with or without the CAMDS. Across these three scenarios participants
      will be measured on a total of 45 (15 per scenario) process measures for adherence. Based on
      this effect size and an estimated intra-cluster correlation coefficient within teams of 0.1
      and a mean cluster size of 45, with a two-sided alpha level of 0.05 and 80% power, 25
      surgical teams per study arm are needed.

      METHODS

      Main study parameter/endpoint:

      Failure to adhear to best practice (omission of critical management steps) for the given
      scenarios, as predefined by the team that developed the CAMDS.

      Secondary study parameters/endpoints (if applicable):

      Perceived utility, ease of use and user satisfaction of the CAMDS. Eight aspects of perceived
      usability; ease of use, logical order of described management steps, readability of the
      CAMDS, whether the CAMDS provided overview, interrupted treatment, improved treatment,
      recommendation to use and suitability for daily use, will be assessed through a survey. These
      items will be scored on a five-point Likert scale (strongly agree to strongly disagree).
      Completion of the questionnaires will be voluntary and no compensation of any kind will be
      provided.

      Randomisation, blinding and treatment allocation This is a prospective randomised,
      non-blinded study. Surgical teams will be randomised through a computer generated code in
      sealed opaque envelopes to the CAMDS group or non CAMDS group. Randomisation will take place
      only after the teams have been made familiar with the cognitive aid bundle and the high
      fidelity simulation laboratory, so during the introduction study staff and participants will
      be unaware of allocation.

      Study procedures Surgical teams will be asked to manage a simulated scenario of a
      deteriorating surgical patient. The simulated scenario will take place in the high fidelity
      simulator of the Academic Medical Centre Amsterdam and will be recorded on video. Two
      independent observers will score the key processes for managing the specific scenarios.
      Interrater reliability will be assessed with Cohen's Kappa. There are three independent EuSim
      trained simulation laboratory operators (CHSOS) who will run the simulated patient, the
      Laerdal SimMan 3G. Ten standardised patient cases- pneumonia, pneumothorax, bradycardia,
      cardiac arrest shockable and non-shockable rhythm, bleeding, myocardial infarction,
      anaphylaxis, sepsis and loss of consciousness- were preprogrammed for the study. So a correct
      action resulted in progression in the scenario.

      Withdrawal of individual subjects Not applicable.

      Premature termination of the study The study will be terminated after enclosure of the last
      participating surgical team (n=50)

      STATISTICAL ANALYSIS Will be performed using SPSS statistics. All data will be checked for
      normal distribution using the Kolmogorov-Smirnov test and histograms. For normal distributed,
      continuous variables, an independent Student´s t-test will be used and the variables will be
      presented as mean ± standard deviation (SD). A p-value <0.05 will be considered as
      statistically significant. For categorical variables, cross tabulation and the Pearson chi
      square test will be applied and variables will be allegorized as number and/or percentage of
      the total. Not normally distributed data will be compared using the Man-Whitney U-test where
      appropriate, and data will be presented by the median and the interquartile range. For the
      primary outcome measure univariate analysis to test failure rates (percentage omitted
      critical steps). Multivariate analysis will also be done to compare failure rates with and
      without the CAMDS. Descriptive statistics will be used to describe perceived usability.

      No interim analysis will be done

      Handling and storage of data and documents Video data from the simulated scenarios will be
      stored on a password protected folder in a computer drive only available by the
      investigators. All questionnaires will be anonymously collected and electronic copies of the
      files will be stored in the same folder as the video data. Participants will be asked to fill
      in a training grade to allow stratification of the data. The study staff will ensure that the
      participants' anonymity is maintained. All documents will be stored securely and only
      accessible by study staff. The trial will comply with the Data Protection Act, which requires
      data to be anonymised as soon as it is practical to do so.

      This study is funded by an Innovation Grant from the Academic Medical Centre, Amsterdam.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 50 surgical teams (1 doctor, 2 nurses) will be randomly allocated to intervention or control group
primary purpose: Treatment
masking: None (Open Label)
masking description: Study introduction and familiarisation of the simulation lab and cognitive aid bundle will be done blindly for both participant and study staff. Randomisation will be done after study introduction and familiarisation of the simulation lab and cognitive aid bundle by means of opening a opaque sealed envelope. The randomisation is done by a computer generated code for use of the CAMDS (intervention) or not (control) and 3 patient scenario's
measure: Failure to adhear to best practice (percentage of omitted critical management steps) for the given scenario
time frame: start to end of high fidelity simulation session (aprox. 10 min)
description: Every scenario consisted of 15 predefined critical management steps (for examle cardiac arrest with a shockable rhythm critical steps would be; start basic life support, open the airway, identify shockable rhythm, defibrillate with appropriate amount of Joules etc.) Primary outcome is the failure to adhear to best practice expressed as percentage of omitted predefined critical management steps.
measure: Perceived usability of the CAMDS
time frame: During debrief of high fidelity simulation session (aprox. 30 min)
description: Eight aspects of perceived usability; ease of use, logical order of described management steps, readability of the CAMDS, whether the CAMDS provided overview, interrupted treatment, improved treatment, recommendation to use and suitability for daily use, will be assessed through a survey. These items will be scored on a five-point Likert scale (strongly agree to strongly disagree).
arm group label: CAMDS bundle
arm group type: Experimental
description: 25 surgical teams will manage 10 standardised simulated deteriorating ward patients with the help of a cognitive aid bundle
arm group label: No bundle
arm group type: No Intervention
description: 25 surgical teams will manage 10 standardised simulated deteriorating ward patients without the help of a cognitive aid bundle
intervention type: Other
intervention name: CAMDS bundle
description: Cognitive aids for the assessment and management of deteriorating surgical patients (CAMDS). This bundle contains instructions for doctors and nursing staff to assess, manage and escalate care of deteriorating surgical patients. These management instructions will be derived from best practices that are linked with improved mortality and morbidity in surgical patients.
arm group label: CAMDS bundle
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Benedikt Preckel, M.D. P.h.D.
role: Principal Investigator
affiliation: Amsterdam UMC, location AMC
facility: 
country: Netherlands
citation: NCEPOD. Knowing the risk. A review of the peri-operative care of surgical patients 2011 (via: https://www.ncepod.org.uk/2011poc.html )
citation: Gaba DM, Howard SK, Fish KJ, Smith BE, Sowb YA. Simulation- based training in anesthesia crisis resource management (ACRM): a decade of experience. Simul Gaming 2001;32:175-93. ( via: http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.454.6344&rep=rep1&type=pdf )
citation: Ghaferi AA, Birkmeyer JD, Dimick JB. Hospital volume and failure to rescue with high-risk surgery. Med Care. 2011 Dec;49(12):1076-81. doi: 10.1097/MLR.0b013e3182329b97.
PMID: 22002649
citation: Ghaferi AA, Osborne NH, Birkmeyer JD, Dimick JB. Hospital characteristics associated with failure to rescue from complications after pancreatectomy. J Am Coll Surg. 2010 Sep;211(3):325-30. doi: 10.1016/j.jamcollsurg.2010.04.025. Epub 2010 Jul 14.
PMID: 20800188
citation: Symons NR, Almoudaris AM, Nagpal K, Vincent CA, Moorthy K. An observational study of the frequency, severity, and etiology of failures in postoperative care after major elective general surgery. Ann Surg. 2013 Jan;257(1):1-5. doi: 10.1097/SLA.0b013e31826d859b.
PMID: 23044786
citation: Garry DA, McKechnie SR, Culliford DJ, Ezra M, Garry PS, Loveland RC, Sharma VV, Walden AP, Keating LM; PREVENT group. A prospective multicentre observational study of adverse iatrogenic events and substandard care preceding intensive care unit admission (PREVENT). Anaesthesia. 2014 Feb;69(2):137-42. doi: 10.1111/anae.12535.
PMID: 24443852
citation: Johnston M, Arora S, King D, Stroman L, Darzi A. Escalation of care and failure to rescue: a multicenter, multiprofessional qualitative study. Surgery. 2014 Jun;155(6):989-94. doi: 10.1016/j.surg.2014.01.016. Epub 2014 Feb 7.
PMID: 24768480
citation: Roberts KE, Bonafide CP, Paine CW, Paciotti B, Tibbetts KM, Keren R, Barg FK, Holmes JH. Barriers to calling for urgent assistance despite a comprehensive pediatric rapid response system. Am J Crit Care. 2014 May;23(3):223-9. doi: 10.4037/ajcc2014594.
PMID: 24786810
citation: Ludikhuize J, Dongelmans DA, Smorenburg SM, Gans-Langelaar M, de Jonge E, de Rooij SE. How nurses and physicians judge their own quality of care for deteriorating patients on medical wards: self-assessment of quality of care is suboptimal*. Crit Care Med. 2012 Nov;40(11):2982-6. doi: 10.1097/CCM.0b013e31825fe2cb.
PMID: 22890255
citation: Ludikhuize J, Brunsveld-Reinders AH, Dijkgraaf MG, Smorenburg SM, de Rooij SE, Adams R, de Maaijer PF, Fikkers BG, Tangkau P, de Jonge E; Cost and Outcomes of Medical Emergency Teams Study Group. Outcomes Associated With the Nationwide Introduction of Rapid Response Systems in The Netherlands. Crit Care Med. 2015 Dec;43(12):2544-51. doi: 10.1097/CCM.0000000000001272.
PMID: 26317569
citation: Johnston M, Arora S, Anderson O, King D, Behar N, Darzi A. Escalation of care in surgery: a systematic risk assessment to prevent avoidable harm in hospitalized patients. Ann Surg. 2015 May;261(5):831-8. doi: 10.1097/SLA.0000000000000762.
PMID: 24887972
citation: Chrysochoou G, Gunn SR. Demonstrating the benefit of medical emergency teams (MET) proves more difficult than anticipated. Crit Care. 2006;10(2):306. doi: 10.1186/cc4865. No abstract available.
PMID: 16542491
citation: Arriaga AF, Bader AM, Wong JM, Lipsitz SR, Berry WR, Ziewacz JE, Hepner DL, Boorman DJ, Pozner CN, Smink DS, Gawande AA. Simulation-based trial of surgical-crisis checklists. N Engl J Med. 2013 Jan 17;368(3):246-53. doi: 10.1056/NEJMsa1204720.
PMID: 23323901
citation: Harrison TK, Manser T, Howard SK, Gaba DM. Use of cognitive aids in a simulated anesthetic crisis. Anesth Analg. 2006 Sep;103(3):551-6. doi: 10.1213/01.ane.0000229718.02478.c4.
PMID: 16931660
citation: Ziewacz JE, Arriaga AF, Bader AM, Berry WR, Edmondson L, Wong JM, Lipsitz SR, Hepner DL, Peyre S, Nelson S, Boorman DJ, Smink DS, Ashley SW, Gawande AA. Crisis checklists for the operating room: development and pilot testing. J Am Coll Surg. 2011 Aug;213(2):212-217.e10. doi: 10.1016/j.jamcollsurg.2011.04.031. Epub 2011 Jun 11. Erratum In: J Am Coll Surg. 2012 Aug;215(2):310. Dosage error in article text.
PMID: 21658974
citation: Neal JM, Hsiung RL, Mulroy MF, Halpern BB, Dragnich AD, Slee AE. ASRA checklist improves trainee performance during a simulated episode of local anesthetic systemic toxicity. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):8-15. doi: 10.1097/AAP.0b013e31823d825a.
PMID: 22157743
citation: Burden AR, Carr ZJ, Staman GW, Littman JJ, Torjman MC. Does every code need a "reader?" improvement of rare event management with a cognitive aid "reader" during a simulated emergency: a pilot study. Simul Healthc. 2012 Feb;7(1):1-9. doi: 10.1097/SIH.0b013e31822c0f20.
PMID: 22113440
citation: Koers L, Eveleens FM, Schlack WS, Preckel B. [Cognitive aid for emergencies in the OR--AMC bundle helps ensure that no steps are left out]. Ned Tijdschr Geneeskd. 2015;159:A8325. Dutch.
PMID: 25784063
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: B Preckel
investigator title: Principle Investigator
sharing ipd: No