INTRODUCTION
Patient
Safety has emerged as an essential healthcare discipline in medical curricula
to reduce the rate and effect of adverse events. The level of error
in health care and lack of awareness of its significance draws the attention of
medical educators to address the issue of Patient Safety. Several researchers
have emphasized the importance of incorporating Patient Safety education in
medical education. The World Health
Organization (WHO) also recognized the importance of Patient Safety and it’s
integration into medical education and published a Patient Safety curriculum
guide for medical students. Patient safety
training can create a positive impact on safety sensitisation and creation of a
patient safety culture. However, the impact of any training programme must be
assessed to see if the theoretical knowledge, has translated into better
practices even on a day to day basis. Hence, we plan to train anaesthesiology
residents with patient safety practices, sensitise them towards adopting safer
practices and promote voluntary reporting of critical events. We intend to
asses the current level of knowledge, attitude and practices and see if the
training can evoke a change both in the attitudes and the practice.
PURPOSE OF STUDY
Patient safety training is an important part
of medical curriculum in the western countries. [1, 2,
3, 4, 6] Regular training
with impact assessment, will help reduce the global burden due to medical
errors. However, in India, this practice is not as widespread. The purpose of
this study will be to assess knowledge, attitudes and safety practices
prevalent in our department and to study the impact of a training programme in
patient safety, on these practices. Assessing this
impact will help us to make recommendations for future practice and thus
improve patient safety.
AIM
To assess
current levels of knowledge and attitudes towards patient safety among
Anaesthesiology residents and assess the impact of a Patient Safety Training
Workshop on their knowledge and attitudes.
PRIMARY OBJECTIVE
Assessment
of impact of Patient Safety Training Programme on the knowledge and attitudes
towards patient safety.
SECONDARY OBJECTIVES
· To assess
the baseline knowledge and attitudes among residents towards patient safety.
· To assess the impact of patient safety training on the
number of critical incidents that get reported.
· To assess the impact of patient safety training on the
nature of critical incidents that get reported.
MATERIALS AND METHODS:
Study Design: It is a Prospective Observational study.
Self-administered questionnaires will be
used to assess the students’ knowledge and attitudes regarding patient safety
practices, before they undergo patient safety training and one month after it. They
also be additionally assessed by their respective theatre in-charges, through self-administered
questionnaires at the same time, to allow objective assessment of the impact of
the training programme.
Study Duration: 2
months
Number of centres: 1
Principal Investigator: Dr
Anita N. Shetty
Co- Investigators: Dr. Gauri R. Gangakhedkar
Dr. Pallavi Waghalkar
Dr. Amit M. Dalvi
Sample
Size: Non-probability sampling will
be used. Our cohort will consist of 83 Anaesthesiology
residents, and our theatre in-charges including 6 Professors, 6 Additional
Professors and 6 Associate Professors. Our sample size will be determined
by the number of participants giving consent for the study. We also assume that
we will have a loss to follow up of 10%
INCLUSION CRITERIA
1) All the residents undergoing Anaesthesiology training for
either the M.D. or D.A. course.
2) All the Anaesthesia theatre in-charges, including 6
Professors, 6 Additional Professors and 6 Associate Professors
EXCLUSION CRITERIA
Any residents or faculty refusing to participate.
STUDY PROCEDURE
This
study will be conducted after Departmental, Administrative sanction, and
Hospital Ethics Committee approval. All the residents, currently undergoing
Anaesthesiology training for either the M.D. or D.A. course will be recruited
for the study to undergo a Patient Safety Training Programme.
The theatre in-charges will be recruited a
week prior to the resident training programme. Anaesthesiology residents follow
a monthly rotation schedule for each operation theatre, which begins on the
first of every month. The residents will be recruited on the first three days
of the month.
The training will
be conducted in three batches, over three days to recruit as many residents as
possible. The programme will consist of, a three-hour
long teaching module consisting of lectures, videos and problem-based
discussions, which would cover Patient Safety topics consisting of, definition
of critical incidents, the importance of reporting them and the importance of debriefing
after a critical incident. In addition, creation of a Patient Safety Culture,
Critical Incident Reporting Systems and Root Cause Analysis will also be
taught. At the beginning of the training programme, the students will be
asked if they would like to participate in in the study, which would consist of
them filling out a questionnaire, once before the safety training and once at
the end of one month. The residents will be assured about the anonymity of the
survey responses, non-punitive action against anything revealed in the workshop
and the voluntary nature of participation in the programme. They will also be
assured that their education, and the attitude towards them in the department
will 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 be
administered by an impartial person, who is not an investigator. The trainers/
investigators, will thus be blinded to knowledge who among the residents is a
participant and who is not. After taking an informed written consent, the
participants will be recruited in the study. The participants will be given 20
minutes to fill the Pre- Test Form, the format of which is attached below. The
Questionnaire consists of the standardized and validated, Attitudes Towards
Patient Safety (ASPQ-III) along with some basic demographic questions. The
ASPQ-III was published by Carruthers et al in 2009. We have obtained permission
for the use of this questionnaire from the corresponding authors via email. The
email communication is attached below. Those who do not wish to participate in
the study, will be exempted from filling out the form, but still will be
trained as a part of the Patient Safety Training programme.
At
the end of the one-month rotation, the Post- Test will be administered to the
students by distributing the forms. The proposed method to reduce the loss to
follow up, is by allowing them to return the forms over a period of a week. At
this time, they will be asked additional questions with regards to impact of
the Patient Safety Training programme. The theatre in-charges will also be
asked to fill out the Post- Test, to assess if the training translated into
implementation of safer clinical practices in the Operation Theatre.
Following data will be collected from the
Pre-Test from the Students (In Addition to the PSQ-III)
1. Age/Sex
2. Hours
of work per week
3. Years
into Anaesthesia Practice
4. Number
of Critical Incidents they reported in the last week
5. Number
of Near Misses they reported in the last week
6. Number
of Never Events they reported in the last week
7. Proportion
that they think could have been prevented
Following data will be collected from the
Pre-Test from the Theatre In-Charges
1. Age/Sex
2. Hours
of work per week
3. Years
into Anaesthesia Practice
4. Number
of Critical Incidents reported to them in the last week
5. Number
of Near Misses reported to them in the last week
6. Number
of Never Events reported to them in the last week
7. Number
of Events that were unreported by students but detected by faculty
8. Proportion
that they think could have been prevented
Components of the PSQ-III (To be answered
on the Likert scale from 1-7, with one being highly disagree to 7 being highly
agree)
1. My
training is preparing me to understand the causes of medical errors.
2. I have
a good understanding of patient safety issues as a result of my undergraduate
medical training.
3. My
training is preparing me to prevent medical errors.
4. I would
feel comfortable reporting any errors I had made, no matter how serious the
outcome had been for the patient.
5. I would
feel comfortable reporting any errors other people had made, no matter how
serious the outcome had been for the patient.
6. I am
confident I could talk openly to my supervisor about an error I had made if it
had resulted in potential or actual harm to my patient.
7. Shorter
shifts for doctors will reduce medical errors.
8. By not
taking regular breaks during shifts doctors are at an increased risk of making
errors.
9. The
number of hours doctors work increases the likelihood of making medical errors.
10. Even
the most experienced and competent doctors make errors.
11. A true
professional does not make mistakes or errors.
12. Human
error is inevitable.
13. Most
medical errors result from careless nurses.
14. If
people paid more attention at work, medical errors would be avoided.
15. Most
medical errors result from careless doctors.
16. Medical
errors are a sign of incompetence.
17. It is
not necessary to report errors which do not result in adverse outcomes for the
patient.
18. Doctors
have a responsibility to disclose errors to patients only if they result in
harm.
19. All
medical errors should be reported.
20. Better
multi-disciplinary teamwork will reduce medical errors.
21. Teaching
teamwork skills will reduce medical errors.
22. Patients
have an important role in preventing medical errors.
23. Encouraging
patients to be more involved in their care can help to reduce the risk of
medical errors occurring
24. Teaching
students about patient safety should be an important priority in a medical
student’s training
25. Patient
safety issues cannot be taught and can only be learned by a clinical experience
when qualified.
26. Learning
about patient safety issues before I qualify will enable me to become a better
doctor.
Following data will be collected from the
Post-Test from the Students
1. Number
of Critical Incidents you reported in the last week
2. Number
of Near Misses you reported in the last week
3. Number
of Never Events you reported in the last week
4. Proportion
that they think could have been prevented
5. This
training has made a positive impact on patient safety (Assessed on Likert
7-point Scale)
6. I
was able to see a difference in my attitude towards patients (Assessed on
Likert 7-point Scale)
7. I
was able to influence other hospital caregivers to adopt safer patient
practices (Assessed on Likert 7-point Scale)
8. I
would recommend repeating this training regularly (Assessed on Likert 7-point
Scale)
Following data will be collected from the
Post-Test from the Theatre In-Charges
1. Number
of Critical Incidents reported to them in the last week
2. Number
of Near Misses reported to them in the last week
3. Number
of Never Events reported to them in the last week
4. Number
of Events that were unreported by students but detected by faculty
5. Proportion
that they think could have been prevented
6. There
is a positive change in the attitudes of the students. (Assessed on Likert
7-point Scale)
7. The
proportion of critical incidents that students report has increased. (Assessed
on Likert 7-point Scale)
8. Among
the incidences that get reported, the proportion of near misses has increased
over the number of critical incidents. (Assessed on Likert 7-point Scale)
Patient Safety Definitions:
1.
Critical
Incident: A critical incident will be defined as an event
adversely affecting, or potentially affecting, the perioperative anaesthetic
management of a patient.
2.
Near
Miss Event: A Near-Miss event will be
defined as a perioperative event which had the potential to lead to substantial
negative outcomes for the patient if left to progress without intervention.
3.
Never
Event: A Never Event will be defined as serious, largely
preventable patient safety incidents that should not occur if the available
preventative measures have been implemented by healthcare providers, which
resulted in serious harm or death and has existing guidelines or safety
recommendations, which if followed, would have prevented the incident from
occurring.
STATISTICS
1. Data
will be pooled.
2. Quantitative
data like Age, Sex and Hours of work per week will be represented as mean and
Standard Deviation.
3. Independent
sample t test will be used to find the difference of attitudes in two groups
with gender, age, prior experience and hours of work per week.
4. The pre
and post-test cohort will be compared using the Mann-Whitney U test. (p-value
of < 0.05 will be considered statistically significant)
5. Spearman
rank correlation coefficient will be used to explore the relationship between
patient safety and nominal variables, and one-way analysis of variance (ANOVA)
to compare the mean scores of the students’ perceptions, knowledge and
attitudes.
6. Qualitative
data will be represented as frequency and proportion.
7. Data
will be entered in Microsoft excel and analyzed with the help of statistical
software SPSS.
8. A p
value ≤ 0.05 will be considered statistically significant.
REFERENCES
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