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Patient Care TeamNCT06257511

Developing an Intervention to Improve the Non-Technical Skills of the Cardiac Surgical Teams

A study testing Simulation-Based Mastery Learning of the Non-technical skills in people with Patient Care Team and Coronary Artery Disease, run by Northwestern University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Teams of several medical professionals conduct high-risk cardiac surgical procedures. These professionals work in complex, stressful operating room environments requiring effective communication and teamwork skills. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Simulation-Based Mastery Learning of the Non-technical skills
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2025to Jun 2030
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All members of the cardiac surgical teams will be eligible to participate in the study (cardiac surgeons, OR nurses, perfusionists, anesthetists...

Who cannot join

  • Clinicians who are not directly involved in intraoperative care of cardiac surgical patients ( for example nurses working only in the recovery room, ICU, floor)

About this study

Official title: Developing an Intervention to Improve the Non-Technical Skills of the Cardiac Surgical

Teams of several medical professionals conduct high-risk cardiac surgical procedures. These professionals work in complex, stressful operating room environments requiring effective communication and teamwork skills. Surgeons, anesthesiologists, perfusionists, nurses, and surgical technicians working in this environment are also vulnerable to human errors. Non-technical skills for surgeons (NOTSS), defined as cognitive skills (situation awareness, decision making) and social skills (leadership, communication, and teamwork) underpinning medical knowledge and technical skills, are essential contributors to better cardiac surgery outcomes. Yet most of the surgical education programs focus only on technical skills, and interventions to improve the non-technical skills of cardiac surgical teams are scarce. The proposed research will develop and pilot-test and evaluate the preliminary effectiveness of an intervention to improve the non-technical skills of cardiac surgical teams.

Read the detailed description

Over 290,000 Coronary Artery Bypass Graft (CABG) and valve replacement surgeries are performed in the US annually. Around 30% of patients undergoing CABG experience a complication. Notably, hospitals and surgeons with high CABG and valve surgery volumes are more likely to achieve better outcomes. In other surgical specialties, more than 50% of surgical complications are attributable to ineffective non-technical skills for surgeons (NOTSS), defined as cognitive skills (situation awareness, decision making) and social skills (leadership, communication, and teamwork) underpinning medical knowledge and technical skills. The previous work and others found that better non-technical skills were associated with improved risk-adjusted rates of any post-operative complication, mortality, return to the operating room, and intraoperative performance. The investigator have also reported that non-technical skills training programs for general surgeons can effectively improve NOTSS and are associated with improved Operating Room (OR) performance metrics, fewer unplanned reoperations, decreased length of hospital stay, and lower mortality rate. Given our prior work, it is likely that Non-Technical Skills for Cardiac Surgery (NOTSCS) are also important contributors to better cardiac surgery outcomes.

Cardiac surgery procedures are technically challenging for the surgeons and physiologically disruptive for patients, e.g. circulatory arrest, cardiopulmonary bypass, with very little physiologic reserve as a result of their cardiac disease. Cardiac surgeries are conducted by different teams each composed for specialized medical professionals working in concert and relieving each other to support creation of new anatomical structures in the heart (surgery team), cardiopulmonary function (anesthesia team), perfusion to vital organs (perfusionist team), transfusion (blood management team), provision of medicines (operating room pharmacy team) and provision of tools and implants (nursing team). The dramatic and unexpected physiologic changes that occur, large number of medical professionals, extreme sub-specialization of medical professionals, ad-hoc nature of the teams, steep hierarchy between medical professionals and participation of learners all make cardiac surgery operating rooms highly stressful environments. Individuals working in this stressful environment are highly vulnerable to human errors that lead to complications. Yet most of the surgical education programs focus only on technical skills, and interventions to improve the non-technical skills of cardiac surgical teams are scarce. Therefore, there is an urgent need to develop tailored, cardiac surgery-specific interventions to improve the NOTSCS and to assess their effect on patient outcomes.

The goal of this K99/R00 is to develop and test an intervention to improve the non-technical skills of cardiac surgical teams. The investigators will develop, pilot test, refine, and assess the effect of a NOTSCS intervention by applying principles of simulation-based mastery learning (SBML). SBML allows learners to deliberately practice skills until they achieve a mastery level. Most importantly, this application will allow for my development as an independent investigator focused on improving NOTSCS, with a long-term goal of improving cardiac surgery outcomes. The aims of this application are:

K99 Aim 1: To adapt existing non-technical skills performance metrics to cardiac surgical teams. The investigators will identify the behavioral markers required to enhance intraoperative non-technical skills performance for the cardiac surgery teams at academic and community hospitals.

K99 Aim 2: To adapt refine and pilot test an existing NOTSS improvement intervention for cardiac surgery-specific skills, environments, and teams, and assess barriers and facilitators to its implementation.

R00 Aim 1: To assess the preliminary effectiveness of NOTSCS on OR times and patient outcomes.

The research team will implement the NOTSCS intervention to cardiac surgical teams from two academic hospitals. The hypothesis is that a non-technical skills improvement program will be associated with increased NOTSS behaviors, decreased OR time, cardiopulmonary bypass time, time on/off pump, intraoperative bleeding requiring transfusion, and unplanned return to the operating room.

R00 Aim 2: To examine implementation acceptability, feasibility, appropriateness of a SBML NOTSCS intervention. Using quantitative and qualitative feedback, the investigators will map barriers and facilitators to an implementation framework to address barriers to the NOTSCS intervention.

Being tested
Simulation-Based Mastery Learning of the Non-technical skills
Medical subject headings
Coronary Artery Disease, Postoperative Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulation-Based Mastery Learning of the Non-technical skillsBehavioural

    Participants will participate in a simulation-based mastery learning of the non-technical skills.

Study groups in NCT06257511
Study groupRoleWhat they receive
Non Technical Skills for Cardiac Surgery (NOTSCS) intervention groupExperimentalThese are the members of the cardiac surgical teams who will be trained in the non-technical skills.
Receives: Behavioral: Simulation-Based Mastery Learning of the Non-technical skills
Control groupNo interventionThese are members of the cardiac surgical teams who will not participate in the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Non-technical skills behaviors of the members of the cardiac surgical teams

    Investigators will use the Non-Technical Skills for Surgery (NOTSS) rating tool to evaluate the effectiveness of the non-technical skills educational intervention on participants' intraoperative non-technical skills.

    Measured: Non-technical skills will be measured before the intervention, immediately after the intervention, and six months after the intervention

Secondary outcomes (2)
  1. Intraoperative performance of the cardiac surgical teams

    Investigators will measure the length of the operation, the length cardiopulmonary bypass time, time on/off pump.

    Measured: For each of the cardiac surgeons who will participate in the study, the investigators will compare baseline data (six months collected before implementing the NOTSCS intervention), with data collected after the NOTSCS intervention (six months data).

  2. Rate of patients with patients with intraoperative bleeding requiring transfusion, and unplanned return to the operating room

    intraoperative bleeding requiring transfusion, and unplanned return to the operating room. Investigators will conduct a quasi-experimental study. Investigators will compare baseline data (six months collected before implementing the NOTSCS intervention), with data collected after the NOTSCS intervention (six months data).

    Measured: Data for six months before and six months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study startJun 2025 (estimated)
  3. Primary completionJun 2030 (estimated)
  4. Study completionJun 2030 (estimated)

Why it stopped: Researcher left university before the start of recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The goal of this project is to develop and test an intervention to improve the non-technical skills of cardiac surgical teams. The Investigators will develop, pilot test, refine, and assess the preliminary effectiveness of Non-Technical Skills for cardiac Surgery (NOTSCS) intervention on the non-technical skills of participants, operating room (OR) time, and patient post-operative complications (intraoperative bleeding, and unplanned return to the OR. Investigators will compare the outcomes between the intervention and control groups, before and after the intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257511
Sponsor's protocol ID
K99_01
Status last verified
Jan 2024
First submitted
29 Jan 2024
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The findings from this study will be at national and international conferences. Additionally, the study team will publish findings from this study in the peer-reviewed scientific journals. Along with publication, cardiac surgery-specific non-technical skills assessment tools, simulation scenarios, and debriefing templates that will be developed in this study, will be shared with the scientific community so that they can understand the process of developing and implementing this project, and possibly replicate it if they are interested. The datasets and coding book, and STATA codes will be shared to the scientific community. Quantitative data generated from this project will be made available as soon as the article gets published online. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.

Questions about this trial

What is this clinical trial studying?

A study testing Simulation-Based Mastery Learning of the Non-technical skills in people with Patient Care Team and Coronary Artery Disease, run by Northwestern University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-technical skills behaviors of the members of the cardiac surgical teams (time frame: Non-technical skills will be measured before the intervention, immediately after the intervention, and six months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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