Simulation-based Stress Inoculation Training Study for UK Medical Professionals (SITS)

Preparing for the Stress of Resuscitation: A Randomised Control Trial of Simulation-based Stress Inoculation Training for UK Medical Professionals

This study is to assess for the effectiveness of a Simulation-Based Stress Inoculation Training (SIT) Programme for junior doctors and physicians associates. It was well known that clinical practice can be stressful, particularly resuscitation events. When practitioners are stressed, they become less clinically effective. However, this is little in the way of training on how to manage acute stress in the workplace.

Stress Inoculation Training is established in military and sports training but is yet to be researched fully in junior doctors or physicians associates. By integrating a SIT programme into regular simulation training, the study aims to assess whether it helps with managing stress and performing better resuscitation. This assessment will be via questionnaire, heart rate monitors and judgement of clinical performance.

The study will be open to junior doctors and physicians associates who are currently practicing at the Royal Cornwall Hospital Trust and will take place in the Simulation Suite over a 6 month period.

Results will be prepared for publication and circulated among participants

Study Overview

• Status: Enrolling by invitation
• Conditions: Stress; Stress, Psychological; Stress, Job
• Intervention / Treatment: Behavioral: Stress Inoculation Training; Behavioral: Alternative Training

Detailed Description

This study is a randomised control trial design. The study aim is to obtain 40 participants of varied roles, all healthcare professionals at the NHS RCHT. Participants will be asked to sign up to a session run in regular working hours at the RCHT simulation suite. If participants wish to take part in the study, after being consented to the project, they will be randomised to either the intervention arm or control arm.

Best practice/control is as follows

1. 30 minutes of teaching on management of a drowning patient (or similar topic, in order that both control and intervention perceive they have had teaching of the same length as the other group)
2. 1-2 resuscitation simulation events (same scenario and tasks as in the intervention group)

The SIT programme/intervention will involve

1. 30 minute educational phase of preparatory information to allow participants to conceptualise the types of stressors they are likely to face and the role of stress on performance
2. 30 minutes of skills acquisition which will involve teaching participants techniques to reduce stress in simulated resuscitation events
3. Inoculation through the application of acquired skills in 1-2 resuscitation scenarios

All participants will be asked to complete a State-Trait Anxiety Inventory (STAI) questionnaire both prior to and immediately after the end of each scenario All participants will have their heart rates monitored throughout the session with timings correlated against stressors and application of stress reduction techniques

All participants will have the same set of scenarios involving the same tasks. Performance at individual tasks (such as cannulation, guide wire fitting, ECG interpretation, ABG interpretation, recalling allergies, noticing equipment failure) and overall performance will be assessed by an independent, blinded assessors according to a pre-determined score scheme using video footage of each scenario

Scenarios will be facilitated by blinded researchers. These facilitators will be members of the simulation team. For the duration of the session, they will be based on the simulation room and not take part in the training modules. They will not be aware if simulation participants are part of the control or intervention group. They will be tasked with running the simulation scenario with consistency across participants.

Data analysis will include using MSExcel to test for statistically significant differences in biomarkers, self-reported scores and independent, blinded assessor scores. All results will be identified by using an anonymous code for each participant which will reference only their job role and whether they are in the intervention or control group* (badges will be worn by participants for identification).

*this may have to be done via a code so independent assessors watching the videos do not know

Data, including videos of the simulation session, photocopies of the STAI questionnaire and transcribed heart rate values will be stored anonymously on the RCHT server and not copied across to any personal or other devices. It will only be accessed my primary researchers. Videos will be stored in a separate folder which the independent assessor will have access to and photocopies of their mark schemes will be uploaded to the RCHT server also. All paper forms will be shredded using the hospital's existing system for disposal of confidential waste

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Post-Graduate Centre, Royal Cornwall Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Any medical professional (junior doctors or physicians associates) currently working part/full time at RCHT
• A current licence to practice
• Willing to consent to participate in the study

Exclusion Criteria:

• Anyone taking a medication which modifies heart rate (eg betablockers)
• Unwilling to consent to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress Inoculation Training; Intervention Arm	Behavioral: Stress Inoculation Training; The SIT programme/intervention will involve; 30 minute educational phase of preparatory information to allow participants to conceptualise the types of stressors they are likely to face and the role of stress on performance; 30 minutes of skills acquisition which will involve discussion of and teaching participants techniques to reduce stress in simulated resuscitation events; Inoculation through the application of acquired skills in 1-2 resuscitation scenarios
Active Comparator: Alternative Training; Best practice/control	Behavioral: Alternative Training; 30 minutes of teaching on management of a drowning patient (in order that both control and intervention perceive they have had teaching of the same length as the other group); 1-2 resuscitation simulation events (same scenario and tasks as in the intervention group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability	Difference in heart rate variability during simulated resuscitation events (objective measure)	10 minutes during simulation scenario
State-Trait Anxiety Inventory Difference	Difference in State-Trait Anxiety Inventory (STAI) scores before and after resuscitation events (subjective measure)	STAI takes about 1 minute to complete and participants will be asked to complete it 5 minutes before and 5 minutes after simulation event

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Task Capacity	Difference in time (seconds) taken to perform a fine motor task. This task will involve insertion of catheter onto guide wire during simulated resuscitation event	Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario
Cognitive Capacity	Difference in time (seconds) taken to perform a cognitive task. This task will involve interpreting an Electrocardiogram (ECG) or Arterial Blood Gas (ABG) during simulated resuscitation event	Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario
Situational Awareness Capacity	Difference in time (seconds) taken to demonstrate situational awareness. This task will involve participants recognising a device failure such as detachment of ECG leads and loss of ECG trace during simulated resuscitation event	Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario
Effectiveness of Resuscitation	Difference in overall performance as assessed by independent expert. The expert will be asked to rank the overall effectiveness of the resuscitation on a scale of 1 to 10 where 1 is entirely ineffective resuscitation and 10 is entirely effective resuscitation	An independent assessor will review the videos of simulation events within 2 months of the simulation event. Each simulation should last around 10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported stress in real resuscitation events	Difference in self reported stress at work after simulated resuscitation event. Participants will be asked to rank their level of stress/anxiety on a scale of 1 to 10 in three scenarios: anticipation of a real resuscitation event, during a real resuscitation event, after a real resuscitation event	5 minute questionnaire conducted between 1 and 3 months following training and simulation event

Collaborators and Investigators

• Sponsor: Royal Cornwall Hospitals Trust
• Investigators: Study Chair: Lewis Connolly, MBChB, FRSA, National Health Service (NHS)

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Medical Education; Simulation; Resuscitation; SIT; NHS; Stress Inoculation Training; Doctor
• Additional Relevant MeSH Terms: Behavioral Symptoms; Occupational Diseases; Stress, Psychological; Occupational Stress
• Other Study ID Numbers: 2021.RCHT.86

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate data will be shared generally. Individual level data will only be shared within the primary research team and only when strictly necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No