Patient Safety Training of Anaesthesiology Residents to Assess the Impact on the Knowledge and Attitudes Towards Patient Safety
- Conditions
- Anaesthesiology Residents and Anaesthesia Theatre In-Charges in Seth G.S. Medical College and K.E.M. Hospital
- Registration Number
- CTRI/2019/09/021259
- Lead Sponsor
- Dr Anita N Shetty
- Brief Summary
**INTRODUCTION**
PatientSafety has emerged as an essential healthcare discipline in medical curriculato reduce the rate and effect of adverse events. The level of errorin health care and lack of awareness of its significance draws the attention ofmedical educators to address the issue of Patient Safety. Several researchershave emphasized the importance of incorporating Patient Safety education inmedical education. The World HealthOrganization (WHO) also recognized the importance of Patient Safety and it’sintegration into medical education and published a Patient Safety curriculumguide for medical students. Patient safetytraining can create a positive impact on safety sensitisation and creation of apatient safety culture. However, the impact of any training programme must beassessed to see if the theoretical knowledge, has translated into betterpractices even on a day to day basis. Hence, we plan to train anaesthesiologyresidents with patient safety practices, sensitise them towards adopting saferpractices and promote voluntary reporting of critical events. We intend toasses the current level of knowledge, attitude and practices and see if thetraining can evoke a change both in the attitudes and the practice.
**PURPOSE OF STUDY**
Patient safety training is an important partof medical curriculum in the western countries.[1, 2,3, 4, 6] Regular trainingwith impact assessment, will help reduce the global burden due to medicalerrors. However, in India, this practice is not as widespread. The purpose ofthis study will be to assess knowledge, attitudes and safety practicesprevalent in our department and to study the impact of a training programme inpatient safety, on these practices. Assessing thisimpact will help us to make recommendations for future practice and thusimprove patient safety.
**AIM**
To assesscurrent levels of knowledge and attitudes towards patient safety amongAnaesthesiology residents and assess the impact of a Patient Safety TrainingWorkshop on their knowledge and attitudes.
**PRIMARY OBJECTIVE**
Assessmentof impact of Patient Safety Training Programme on the knowledge and attitudestowards patient safety.
**SECONDARY OBJECTIVES**
· To assessthe baseline knowledge and attitudes among residents towards patient safety.
· To assess the impact of patient safety training on thenumber of critical incidents that get reported.
· To assess the impact of patient safety training on thenature of critical incidents that get reported.
**MATERIALS AND METHODS:**
**Study Design:** It is a Prospective Observational study.
Self-administered questionnaires will beused to assess the students’ knowledge and attitudes regarding patient safetypractices, before they undergo patient safety training and one month after it. Theyalso be additionally assessed by their respective theatre in-charges, through self-administeredquestionnaires at the same time, to allow objective assessment of the impact ofthe training programme.
**Study Duration:** 2months
**Number of** **centres**: 1
**Principal Investigator**: DrAnita N. Shetty
**Co- Investigators**: Dr. Gauri R. Gangakhedkar
Dr. Pallavi Waghalkar
Dr. Amit M. Dalvi
**SampleSize:** Non-probability sampling willbe used. Our cohort will consist of 83 Anaesthesiologyresidents, and our theatre in-charges including 6 Professors, 6 AdditionalProfessors and 6 Associate Professors. Our sample size will be determinedby the number of participants giving consent for the study. We also assume thatwe will have a loss to follow up of 10%
**INCLUSION CRITERIA**
1) All the residents undergoing Anaesthesiology training foreither the M.D. or D.A. course.
2) All the Anaesthesia theatre in-charges, including 6Professors, 6 Additional Professors and 6 Associate Professors
**EXCLUSION CRITERIA**
Any residents or faculty refusing to participate.
**STUDY PROCEDURE**
Thisstudy will be conducted after Departmental, Administrative sanction, andHospital Ethics Committee approval. All the residents, currently undergoingAnaesthesiology training for either the M.D. or D.A. course will be recruitedfor the study to undergo a Patient Safety Training Programme.
The theatre in-charges will be recruited aweek prior to the resident training programme. Anaesthesiology residents followa monthly rotation schedule for each operation theatre, which begins on thefirst of every month. The residents will be recruited on the first three daysof the month.
The training willbe conducted in three batches, over three days to recruit as many residents aspossible. The programme will consist of, a three-hourlong teaching module consisting of lectures, videos and problem-baseddiscussions, which would cover Patient Safety topics consisting of, definitionof critical incidents, the importance of reporting them and the importance of debriefingafter a critical incident. In addition, creation of a Patient Safety Culture,Critical Incident Reporting Systems and Root Cause Analysis will also betaught.At the beginning of the training programme, the students will beasked if they would like to participate in in the study, which would consist ofthem filling out a questionnaire, once before the safety training and once atthe end of one month. The residents will be assured about the anonymity of thesurvey responses, non-punitive action against anything revealed in the workshopand the voluntary nature of participation in the programme. They will also beassured that their education, and the attitude towards them in the departmentwill not change, should they refuse to participate. To ensure a lack of bias,on the part of those providing the patient safety training, consent will beadministered by an impartial person, who is not an investigator. The trainers/investigators, will thus be blinded to knowledge who among the residents is aparticipant and who is not. After taking an informed written consent, theparticipants will be recruited in the study. The participants will be given 20minutes to fill the Pre- Test Form, the format of which is attached below. TheQuestionnaire consists of the standardized and validated, Attitudes TowardsPatient Safety (ASPQ-III) along with some basic demographic questions. TheASPQ-III was published by Carruthers et al in 2009. We have obtained permissionfor the use of this questionnaire from the corresponding authors via email. Theemail communication is attached below. Those who do not wish to participate inthe study, will be exempted from filling out the form, but still will betrained as a part of the Patient Safety Training programme.
Atthe end of the one-month rotation, the Post- Test will be administered to thestudents by distributing the forms. The proposed method to reduce the loss tofollow up, is by allowing them to return the forms over a period of a week. Atthis time, they will be asked additional questions with regards to impact ofthe Patient Safety Training programme. The theatre in-charges will also beasked to fill out the Post- Test, to assess if the training translated intoimplementation of safer clinical practices in the Operation Theatre.
**Following data will be collected from thePre-Test from the Students (In Addition to the PSQ-III)**
1. Age/Sex
2. Hoursof work per week
3. Yearsinto Anaesthesia Practice
4. Numberof Critical Incidents they reported in the last week
5. Numberof Near Misses they reported in the last week
6. Numberof Never Events they reported in the last week
7. Proportionthat they think could have been prevented
**Following data will be collected from thePre-Test from the Theatre In-Charges**
1. Age/Sex
2. Hoursof work per week
3. Yearsinto Anaesthesia Practice
4. Numberof Critical Incidents reported to them in the last week
5. Numberof Near Misses reported to them in the last week
6. Numberof Never Events reported to them in the last week
7. Numberof Events that were unreported by students but detected by faculty
8. Proportionthat they think could have been prevented
**Components of the PSQ-III (To be answeredon the Likert scale from 1-7, with one being highly disagree to 7 being highlyagree)**
1. Mytraining is preparing me to understand the causes of medical errors.
2. I havea good understanding of patient safety issues as a result of my undergraduatemedical training.
3. Mytraining is preparing me to prevent medical errors.
4. I wouldfeel comfortable reporting any errors I had made, no matter how serious theoutcome had been for the patient.
5. I wouldfeel comfortable reporting any errors other people had made, no matter howserious the outcome had been for the patient.
6. I amconfident I could talk openly to my supervisor about an error I had made if ithad resulted in potential or actual harm to my patient.
7. Shortershifts for doctors will reduce medical errors.
8. By nottaking regular breaks during shifts doctors are at an increased risk of makingerrors.
9. Thenumber of hours doctors work increases the likelihood of making medical errors.
10. Eventhe most experienced and competent doctors make errors.
11. A trueprofessional does not make mistakes or errors.
12. Humanerror is inevitable.
13. Mostmedical errors result from careless nurses.
14. Ifpeople paid more attention at work, medical errors would be avoided.
15. Mostmedical errors result from careless doctors.
16. Medicalerrors are a sign of incompetence.
17. It isnot necessary to report errors which do not result in adverse outcomes for thepatient.
18. Doctorshave a responsibility to disclose errors to patients only if they result inharm.
19. Allmedical errors should be reported.
20. Bettermulti-disciplinary teamwork will reduce medical errors.
21. Teachingteamwork skills will reduce medical errors.
22. Patientshave an important role in preventing medical errors.
23. Encouragingpatients to be more involved in their care can help to reduce the risk ofmedical errors occurring
24. Teachingstudents about patient safety should be an important priority in a medicalstudent’s training
25. Patientsafety issues cannot be taught and can only be learned by a clinical experiencewhen qualified.
26. Learningabout patient safety issues before I qualify will enable me to become a betterdoctor.
**Following data will be collected from thePost-Test from the Students**
1. Numberof Critical Incidents you reported in the last week
2. Numberof Near Misses you reported in the last week
3. Numberof Never Events you reported in the last week
4. Proportionthat they think could have been prevented
5. Thistraining has made a positive impact on patient safety (Assessed on Likert7-point Scale)
6. Iwas able to see a difference in my attitude towards patients (Assessed onLikert 7-point Scale)
7. Iwas able to influence other hospital caregivers to adopt safer patientpractices (Assessed on Likert 7-point Scale)
8. Iwould recommend repeating this training regularly (Assessed on Likert 7-pointScale)
**Following data will be collected from thePost-Test from the Theatre In-Charges**
1. Numberof Critical Incidents reported to them in the last week
2. Numberof Near Misses reported to them in the last week
3. Numberof Never Events reported to them in the last week
4. Numberof Events that were unreported by students but detected by faculty
5. Proportionthat they think could have been prevented
6. Thereis a positive change in the attitudes of the students. (Assessed on Likert7-point Scale)
7. Theproportion of critical incidents that students report has increased. (Assessedon Likert 7-point Scale)
8. Amongthe incidences that get reported, the proportion of near misses has increasedover the number of critical incidents. (Assessed on Likert 7-point Scale)
**Patient Safety Definitions:**
1. **CriticalIncident:** A critical incident will be defined as an eventadversely affecting, or potentially affecting, the perioperative anaestheticmanagement of a patient.
**2.****NearMiss Event:** A Near-Miss event will bedefined as a perioperative event which had the potential to lead to substantialnegative outcomes for the patient if left to progress without intervention.
**3.****NeverEvent:** A Never Event will be defined as serious, largelypreventable patient safety incidents that should not occur if the availablepreventative measures have been implemented by healthcare providers, whichresulted in serious harm or death and has existing guidelines or safetyrecommendations, which if followed, would have prevented the incident fromoccurring.
**STATISTICS**
1. Datawill be pooled.
2. Quantitativedata like Age, Sex and Hours of work per week will be represented as mean andStandard Deviation.
3. Independentsample t test will be used to find the difference of attitudes in two groupswith gender, age, prior experience and hours of work per week.
4. The preand post-test cohort will be compared using the Mann-Whitney U test. (p-valueof < 0.05 will be considered statistically significant)
5. Spearmanrank correlation coefficient will be used to explore the relationship betweenpatient safety and nominal variables, and one-way analysis of variance (ANOVA)to compare the mean scores of the students’ perceptions, knowledge andattitudes.
6. Qualitativedata will be represented as frequency and proportion.
7. Datawill be entered in Microsoft excel and analyzed with the help of statisticalsoftware SPSS.
8. A pvalue ≤ 0.05 will be considered statistically significant.
**REFERENCES**
1. 1. Ahmed M, Arora S, Tiew S, Hayden J, Sevdalis N, VincentC, Baker P. Building a safer foundation: the Lessons Learnt patient safety trainingprogramme. BMJ Qual Saf. 2014 Jan;23(1):78-86. doi: 10.1136/bmjqs-2012-001740.Epub 2013 Sep 3. PubMed PMID: 24003238.
2. 2. Kirkman MA,Sevdalis N, Arora S, Baker P, Vincent C, Ahmed M. The outcomes of recentpatient safety education interventions for trainee physicians and medicalstudents: a systematic review. BMJ Open. 2015 May 20;5(5):e007705. doi:10.1136/bmjopen-2015-007705. Review. PubMed PMID: 25995240; PubMed CentralPMCID: PMC4442206.
3. 3. Carruthers S,Lawton R, Sandars J, Howe A, Perry M. Attitudes to patient safety amongstmedical students and tutors: Developing a reliable and valid measure. MedTeach. 2009 Aug;31(8):e370-6. PubMed PMID: 19811201.
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4. Lee P, Allen K, Daly M. A ’Communication and Patient Safety’ training programme for all healthcare staff: can it make a difference? BMJ Qual Saf. 2012 Jan;21(1):84-8. doi: 10.1136/bmjqs-2011-000297. Epub 2011 Nov 18. PubMed PMID: 22101101.
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5. Kamran R, Bari A, Khan RA, Al-Eraky M. Patient safety awareness among Undergraduate Medical Students in Pakistani Medical School. Pak J Med Sci. 2018 Mar-Apr;34(2):305-309. doi: 10.12669/pjms.342.14563. PubMed PMID: 29805398; PubMed Central PMCID: PMC5954369.
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6. Wetzel AP, Dow AW, Mazmanian PE. Patient safety attitudes and behaviors of graduating medical students. Eval Health Prof. 2012 Jun;35(2):221-38. doi: 10.1177/0163278711414560. Epub 2011 Jul 25. PubMed PMID: 21788294.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 101
- 1)All the residents undergoing Anaesthesiology training for either the M.D. or D.A. course.
-
- All the Anaesthesia theatre in-charges, including 6 Professors, 6 Additional Professors and 6 Associate Professors.
Any residents or faculty refusing to participate.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of impact of Patient Safety Training Programme on the knowledge and attitudes towards patient safety One month after completion of Patient Safety Programme
- Secondary Outcome Measures
Name Time Method •To assess the baseline knowledge and attitudes among residents towards patient safety. One month after completion of Patient Safety Programme •To assess the impact of patient safety training on the number of critical incidents that get reported. One month after completion of Patient Safety Programme •To assess the impact of patient safety training on the nature of critical incidents that get reported. One month after completion of Patient Safety Programme
Trial Locations
- Locations (1)
Seth G.S. Medical College and K.E.M. Hospital, Mumbai
🇮🇳Mumbai, MAHARASHTRA, India
Seth G.S. Medical College and K.E.M. Hospital, Mumbai🇮🇳Mumbai, MAHARASHTRA, IndiaDr Gauri R GangakhedkarPrincipal investigator9096266328gauri2903@rediffmail.com