Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257511
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-29
Brief Title:
Developing an Intervention to Improve the Non-Technical Skills of the Cardiac Surgical Teams
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Developing an Intervention to Improve the Non-Technical Skills of the Cardiac Surgical
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
Detailed Description:
Over 290000 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 eg 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 K99R00 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 onoff 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
Cardiac surgery procedures are technically challenging for the surgeons and physiologically disruptive for patients eg 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 K99R00 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 onoff 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None