Cognitive Aids for the Management of Deteriorating Surgical Patients

NCT03812861 | Completed

• 1 other identifier: W16_209
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Surgery--Complications

Keywords

failure to rescue; postoperative complications; adherence to best practice

Outcome Measures

Primary Outcomes (1)

• Failure to adhear to best practice (percentage of omitted critical management steps) for the given scenario

  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.

  start to end of high fidelity simulation session (aprox. 10 min)

Secondary Outcomes (1)

• Perceived usability of the CAMDS

  During debrief of high fidelity simulation session (aprox. 30 min)

Study Arms (2)

CAMDS bundle

EXPERIMENTAL

25 surgical teams will manage 10 standardised simulated deteriorating ward patients with the help of a cognitive aid bundle

Other: CAMDS bundle

No bundle

NO INTERVENTION

25 surgical teams will manage 10 standardised simulated deteriorating ward patients without the help of a cognitive aid bundle

Interventions

CAMDS bundle OTHER

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.

CAMDS bundle

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All hospital surgical staff is eligible

You may not qualify if:

• Surgical staff that is unwilling to give consent
• Staff that already has participated in the study

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, location: Academic Medical Centre

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (19)

• NCEPOD. Knowing the risk. A review of the peri-operative care of surgical patients 2011 (via: https://www.ncepod.org.uk/2011poc.html )

  BACKGROUND

• 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 )

  BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 21658974 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Koers L, van Haperen M, Meijer CGF, van Wandelen SBE, Waller E, Dongelmans D, Boermeester MA, Hermanides J, Preckel B. Effect of Cognitive Aids on Adherence to Best Practice in the Treatment of Deteriorating Surgical Patients: A Randomized Clinical Trial in a Simulation Setting. JAMA Surg. 2020 Jan 1;155(1):e194704. doi: 10.1001/jamasurg.2019.4704. Epub 2020 Jan 15.

  PMID: 31774483 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benedikt Preckel, M.D. P.h.D.

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 50 surgical teams (1 doctor, 2 nurses) will be randomly allocated to intervention or control group

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 23, 2019
• Study Start: February 7, 2017
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)