Simulation-based Stress Inoculation Training Study for UK Medical Professionals

Stress Clinical Trial

— SITS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05182710
• Other study ID #: 2021.RCHT.86
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: November 2023
• Source: Royal Cornwall Hospitals Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: August 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Occupational Stress
• Stress
• Stress, Psychological

Intervention

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
• 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)

Locations

Country	Name	City	State
United Kingdom	Post-Graduate Centre, Royal Cornwall Hospital NHS Trust	Truro	Cornwall

Sponsors (1)

Lead Sponsor	Collaborator
Royal Cornwall Hospitals Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Heart Rate Variability	Difference in heart rate variability during simulated resuscitation events (objective measure)	10 minutes during simulation scenario
Primary	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	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
Secondary	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
Secondary	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
Secondary	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