CTRI/2024/03/063399 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On:
25/02/2024
Post Graduate Thesis
Yes
Type of Trial
Observational
Type of Study
Cross Sectional Study
Study Design
Other
Public Title of Study
Exploring Patient Safety Culture in Hospitals-A Study on Measurement and Healthcare Employee Perspectives
Scientific Title of Study
Patient safety culture in hospital setting :measurement,
and the perception among healthcare employees.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Nibana p
Designation
Masters in Hospital Administration, Student
Affiliation
Prasanna School of Public Health, Manipal University
Address
Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka Udupi KARNATAKA 576104 India
Phone
6282944950
Fax
Email
nibana.psphmpl2022@learner.manipal.edu
Details of Contact Person Scientific Query
Name
DrSwathi KS
Designation
Associate Professor, Department of Social and Health Innovation
Affiliation
Prasanna School of Public Health, Manipal University
Address
Department of Social and Health Innovation, Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka Department of Social and Health Innovation, Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka Udupi KARNATAKA 576104 India
Phone
9481749911
Fax
Email
swathi.ks@manipal.edu
Details of Contact Person Public Query
Name
DrSwathi KS
Designation
Associate Professor, Department of Social and Health Innovation
Affiliation
Prasanna School of Public Health, Manipal University
Address
Department of Social and Health Innovation, Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka
Department of Social and Health Innovation, Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka Udupi KARNATAKA 576104 India
Phone
9481749911
Fax
Email
swathi.ks@manipal.edu
Source of Monetary or Material Support
Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka
Primary Sponsor
Name
Nibana p
Address
Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka
Type of Sponsor
Other [Self]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Swathi K S
Kasturba Hospital
Cabin no. 56 ,General Medicine Department ,Madhav Nagar, Manipal,Karnataka,576104. Udupi KARNATAKA
9481749911
swathi.ks@manipal.edu
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Not applicable
Intervention / Comparator Agent
Type
Name
Details
Intervention
NIL
NIL
Inclusion Criteria
Age From
20.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
The study includes all the participants comprising of doctors and nurses of all the different clinical departments who are willing to respond to the study.
ExclusionCriteria
Details
The interns of MBBS of the hospital are excluded from the study.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The researcher conducts the study to measure the patient safety culture and the perception among healthcare professionals on patient safety culture.
8 TO 10 WEEKS
Secondary Outcome
Outcome
TimePoints
NIL
NIL
Target Sample Size
Total Sample Size="325" Sample Size from India="325" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
09/03/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Protocol (Description of the Project) 1. Title of the project: Patient safety culture in hospital settings: measurement, and the perception among healthcare employees. 2. Type of Study: Prospective study- cross sectional study 3. Aims & objectives (hypotheses if applicable): AIM: The study aims to assess the perception of healthcare staff’s perception on patient safety culture. OBJECTIVE: I. To understand the patient safety culture in hospital. II. To analyze the perceptions among healthcare professionals towards patient safety culture. 4. Justification for study: Patient safety is a global concern and is the most important domains of healthcare quality. This study would help to assess the perception of patient safety culture among healthcare providers at a tertiary care hospital. Patient safety emphasizes reporting, analysis and prevention of medical errors that often lead to adverse events. This study will help to create awareness among employees of the importance of patient safety culture. Also The healthcare professional’s perception on patient safety culture. The findings of the study will be useful for the hospital administrator to improve patient safety culture in the hospital. 5. Departments involved: Healthcare professionals from all the clinical departments will be involved in this study. 6. Study period: The time required for the study is from September 2023 till May 2024. 7. Sample size: : The formula for finite population that is used is- n = �’��’� 2�’�(1�’�’�) �’’2(�’��’1)+�’�2�’�(1�’�’�) , (Daniel WW, 1999) n = 2093∗(1.96) 20.5(1�’0.5) (0.5) 2(2093�’1)+(1.96) 20.5(1�’0.5) substituting the valuesN=2093 d=0.05 Z=1.96 P=0.5 The value of n=324.7 which is rounded off to 325. 8. Materials and methods: a) Inclusion and exclusion criteria: Inclusion criteria- The study includes all the participants comprising of doctors and nurses of a tertiary care hospital in coastal Karnataka who are willing to respond to the study. Exclusion criteria- The interns of MBBS of the hospital are excluded from the study. b) Biological materials required (type - blood, tissue etc. and quantity): Yes ☠No �’ I. Biological material : nil II. Biosafety measures: nil c) Statistical methods: Descriptive statistics and advanced statistics like correlations and T-tests for independent samples will be used. d) Tools used: surveys on patient safety culture (SOPS)Is the validated questionnaire founded by the Agency for Healthcare Research and Quality (AHRQ), this questionnaire would be used for the data collection and Jamovi statistical software for analyzing data. 9. Detailed description of procedure / processes: The researcher would be conducting a crosssectional quantitative study in a tertiary care hospital to collect information regarding healthcare professional’s perceptions of patient safety culture in hospital settings. The study will be using (SOPS), which is a self-administered questionnaire developed by the Agency for Healthcare Research and Quality (AHRQ), the validated version of the “Surveys on Patient Safety Culture. Permission for use of the tool was obtained from AHRQ. A 5-point Likert scale would be used to measure the responses and the purposive sampling technique will be used for reaching the respondents in the hospital. The questionnaire consisting of two parts ,one is the demographic details of the respondents and the second part will be the HSOPSC scale. The items included in the HSOPSC scale will be used as in the questionnaire. The data analysis will be done by conducting t-test for independent samples. 10. Outcome measures: The researcher conducts the study to measure the patient safety culture and the perception among healthcare professionals on patient safety culture. Where, N=Population size Z=level of confidence P=expected proportion D=precision 11. Potential risks and benefits: Risks: There Is minimal risk to the study respondents. Benefit: The study reveals the perception among healthcare professionals on patient safety culture which would help the administrators and organization for the policymaking procedures and create awareness of importance of patient safety organization in hospital settings. 12. Ethical considerations and methods to address issues: The researcher seeks approval for the study from the Institutional Ethical Committee upon which the study will be conducted. 13. Budget (give details) and proposed funding source: Not applicable. 14. Review of literature (within 1000 words The researcher was able to identify the 10 relevant studies in relation to the research studies by using the keywords expanding “patient safetyâ€, “patient safety cultureâ€, “patient safety surveyâ€, “patient safety climateâ€. The data bases used were PubMed, Scopus. The studies were done in many middle east countries, Sweden, France, Malaysia, Ethiopia, etc. There are very few studies had happened in an Indian context. The research published only in English language are considered. In many of the studies researchers did a quantitative crosssectional studies and the data was collected by the questionnaire tools like Hospital Survey on Patient Safety Culture (HSPSC), the Safety Attitudes Questionnaire (SAQ).For qualitative studies peer observation, group discussions, analysis of the incident history of the organization and audits of the safety management system is recommended to explore the main dimensions that influence patient safety culture.so the researcher could find a validated version of the “Surveys on Patient Safety Culture†(SOPS), which is a self-administered questionnaire developed by the Agency for Healthcare Research and Quality (AHRQ).Permission for the tool was obtained from the AHRQ. The SOPS was developed to evaluate the culture of patient safety in a healthcare facility. It contains 42 items and measures 14 dimensions These 14 dimensions were organizational learning-continuous improvement, teamwork within units, hospital management support for patient safety, feedback and communication about errors, teamwork across hospital units, supervisor/manager expectations and actions promoting patient safety, frequency of events reported, overall perception of patient safety, hospital handoffs and transitions, communication openness, staffing, and non-punitive responses to errors. This tool has been used earlier for many country’s patient safety studies. The target population will be all physicians and nurses excluding interns. Also, there were many studies which used all the administrative bodies and healthcare workers as their target population. Most of the studies have used stratified random sampling for the participant selection to avoid the selection bias. The respondent’s response was measured in the 5-point Likert scale. The data was analyzed by independent t test, One-way ANOVA, chi square test, variance analysis in different studies. The study focuses on achieving quality and safety in hospital and teamwork within department†and “organizational learning†dimensions were area of highest average positive response rate. This indicates respondents are positive in supporting one another, working together as a team and doing things to improve patient safety. While in some studies communication openness, staffing and non-punitive response error were identified the area for improvement. In most of the studies dimensions were used in two levels like unit level safety culture and overall unit level that is hospital level safety culture. And there are two outcome variables like Overall perceptions of safety and Frequency of event reporting. The studies have shown that most of the patient safety culture dimensions score were significantly higher among nurses than physicians. The studies are giving the results like there are many positive score dimensions and negative score dimensions too, which reflects there are some areas or departments with the potential for improvement. This would benefit the organization as it can improve the patient safety culture in particular department and overall safety culture simultaneously. And many studies reveal that health care professionals should be trained or oriented for maintaining patient safety culture in hospitals. Also, findings of some studies include there should be a proper committee for the incident reporting, root causes and risk analysis.so, numerous studies shows that SOPSC by AHRQ is suitable for measuring patient safety culture and their perception by health care employees.so Management commitment towards patient safety improvement activities is vital in helping healthcare professionals’ positive culture. Based on this finding, a well-designed patient safety intervention can be addressed in hospitals to strengthen patient safety. And studies conclude that supporting and committed managers, teamwork and collaboration are important for patient safety improvement. Registered nurses have an important coordinating position in patient safety work, since they work near the patients, and in teams, where important decisions for patient safety are made. Based on this finding, well-designed patient safety interventions can be addressed in hospitals. The studies on Indian context had been given many recommendations like build responsive teams and rapid responsive system, train hospital staff to communicate effectively as a team, written communication should be there for patient treatment process, there will be a patient safety organization which take care of report and share patient information to avoid errors.so there are many studies which reflects these recommendations. The conceptual framework of a study is the relationship between the independent and dependent variables. The factors related to patient safety culture gives the independent variables like Organizational learning-and continuous improvement, Teamwork within units and across units, Communication openness, Feedback and communication about errors, staffing, non-punitive response to errors, management support and expectations, handoff and transitions. These factors contribute to the overall patient safety culture as outcome. And patient safety culture helps to improve the quality of healthcare. There were many countries that widely used this HSOPSC as their tool for patient safety culture studies. And the items in the HSOPSC scale would be used as questionnaire. The surveys can be used to raise awareness of and improve patient safety culture in organizations. The surveys are reliable, valid, and comprehensively tested. 15. References: • Alex Kim, R. J., Chin, Z. H., Sharlyn, P., Priscilla, B., & Josephine, S. (2019). Hospital survey on patient safety culture in Sarawak General Hospital: A cross sectional study. The Medical journal of Malaysia, 74(5), 385–388. • Ismail, A., & Khalid, S. N. M. (2022). Patient safety culture and its determinants among healthcare professionals at a cluster hospital in Malaysia: a cross-sectional study. BMJ open, 12(8), e060546. https://doi.org/10.1136/bmjopen-2021-060546 • Ahmed, F. A., Asif, F., Munir, T., Halim, M. S., Feroze Ali, Z., Belgaumi, A., Zafar, H., & Latif, A. (2023). Measuring the patient safety culture at a tertiary care hospital in Pakistan using the Hospital Survey on Patient Safety Culture (HSOPSC). BMJ open quality, 12(1), e002029. https://doi.org/10.1136/bmjoq-2022-002029 15 • Danielsson, M., Nilsen, P., Rutberg, H., & Ã…restedt, K. (2019). A National Study of Patient Safety Culture in Hospitals in Sweden. Journal of patient safety, 15(4), 328–333. https://doi.org/10.1097/PTS.0000000000000369 • Azyabi, A., Karwowski, W., & Davahli, M. R. (2021). Assessing Patient Safety Culture in Hospital Settings. International journal of environmental research and public health, 18(5), 2466. https://doi.org/10.3390/ijerph18052466 • Azyabi, A., Karwowski, W., & Davahli, M. R. (2021). Assessing Patient Safety Culture in Hospital Settings. International journal of environmental research and public health, 18(5), 2466. https://doi.org/10.3390/ijerph18052466 • Nordin, A. (2015). Patient safety culture in hospital settings : Measurements, health care staff perceptions and suggestions for improvement (PhD dissertation, Karlstads universitet). Retrieved from https://urn.kb.se/resolve?urn=urn:nbn:se:kau:diva-35424