| CTRI Number |
CTRI/2024/01/061031 [Registered on: 01/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Womens Healthcare: Patient Experiences and health knowledge in gynecology outpatient services |
|
Scientific Title of Study
|
Assessing Patient Experiences and health literacy in Gynaecology and
Obstetrics Outpatient Department in tertiary care teaching hospital |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debasmeeta Das |
| Designation |
Student of masters in hospital administration |
| Affiliation |
Prasanna School of public Health |
| Address |
student, room no-LH3, Department of social and health innovation ,Prasanna school of public health, manipal academy of higher education, Manipal,MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
7980078541 |
| Fax |
|
| Email |
debasmeeta.psphmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Rani |
| Designation |
Associate Professor |
| Affiliation |
Prassana School of Public Health |
| Address |
Department.of social and Health Innovation,Prasanna School of Public Health,MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310214742 |
| Fax |
|
| Email |
usha.rani@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shripad Hebbar |
| Designation |
professor |
| Affiliation |
KMC,Manipal |
| Address |
Head, Department of OBG, Kasturba Hospital, Manipal, Room no-7, Outpatient Department, Women and child block.
Udupi
KARNATAKA
576104
India |
| Phone |
9611786463 |
| Fax |
|
| Email |
shripad.hebbar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of social and health innovation, Prasanna School of Public Health, MAHE, Manipal, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
Debasmeeta Das |
| Address |
Prasanna school of public health ,MAHE |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shripad Hebbar |
Kasturba Hospital, Manipal |
Department of gynecology and obstetrics department, Outpatient Department (OPD), Womens and child block, ground floor
Udupi
KARNATAKA |
09611786463
shripad.hebbar@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Patients (18yrs and above) who are coming to get treatment in Gynaecology and
obstetrics outpatient department |
|
| ExclusionCriteria |
| Details |
Children, Adolescent &Patient with cognitive impairments or communication
barriers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Data will be obtained through questionnaires related to patient experience and health literacy among patients in gynaecology and obstetrics outpatient department.
|
8-10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
05/01/2024 |
| 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="2"
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
|
1. Title of the project: Assessing Patient Experiences and health literacy in Gynaecology and Obstetrics Outpatient Department in tertiary care teaching hospital 2. Type of Study: Prospective study- cross sectional study 3. Aims & objectives (hypotheses if applicable): Aims- Assessing Patient Experiences and health literacy in Gynaecology and Obstetrics Outpatient Department in tertiary care teaching hospital. Objective – â–ª To explore the patient experiences in the Gynaecology and Obstetrics department â–ª To assess and analyze the level of health literacy among Gynaecology and obstetrics patients â–ª To identify the factor that influences patient experience and health literacy level within the Gynaecology and obstetrics outpatient department. 4. Justification for study (whether of national significance with rationale): According to the Beryl Institute , Patient experience is defined as “ the sum of all interactions, shaped by an organization’s culture, that influence patient perceptions across the continuum of care. In other words, it describes how a person feels about their experience of receiving care. It is also an important outcome of medical care and a key component of quality of care. As we are talking about experience its the hospital’s responsibility to see whether all categories of a patient are getting equal treatment or not, whether all types of care or not, whether proper facilities are provided to the patient or not, how much time are taken in providing the appointment, whether there is enough space in waiting area for patient to wait, whether the surroundings are clean or not mainly washroom, whether the proper information are provided to the patient or not and most crucial proper communication should be there between staff, receptionist, nurses and patients. A proper patient feedback system needs to be there in healthcare, it helps us to understand their experiences, and what problems they are facing in the healthcare processing system, so that it will help us to improve the process. There are also different strategies to collect patient feedback like post appointment mail and SMS surveys for outpatients, post-discharge email surveys and SMS surveys for inpatients, questionnaires, feedback forms etc. As in this study I will going to assess and analyze the level of health literacy among gynaecology and obstetrics outpatient department, the basic definition of health literacy we have to know. Health literacy refers to an individual’s ability to access, understand and apply health-related information to make informed decisions about their health. In the context of the OB/GYN outpatient department, assessing health literacy is crucial to ensure that patients can understand their medical conditions, treatment options, and preventive measures. By assessing health literacy levels, healthcare providers can customize their communication strategies and educational materials to ensure that patients fully understand their conditions and treatment options. By implementing a comprehensive assessment of patient experiences and health literacy in the Obstetrics and Gynaecology outpatient department, healthcare providers can create a patient-centred care environment that supports informed decision-making, fosters open communication, and ultimately improves the overall health and well-being of women. Effectively assessing patient experiences and health literacy in this context promotes better communication, enhanced patient satisfaction, and improved health outcomes 5. Departments involved: Department of Gynaecology and Obstetrics, Kasturba Hospital, Manipal, Prasanna School of public Health (PSPH). 6. Study period: 6-8months 7. Sample size: Time-bound 8. Materials and methods: a) Inclusion criteria :Patients (18yrs and above) who are coming to get treatment in Gynaecology and obstetrics outpatient department. Exclusion Criteria: Children, Adolescent &Patient with cognitive impairments or communication barriers. b) Biological materials required (type - blood, tissue etc and quantity): Yes ☠No �’ c) Statistical methods: Descriptive statistics like mean and +/- SD, median, IQR will be reported for numerical data. Graphical and pictorial tools like table, pie chart and bar graph will be used to project participants Inferential statistical tools like chi-square test, multiple linear regression and parametric / nonparametric test will be used in analysis d) Tools used: Predesigned questionnaire, which was previously used for a similar kind of study will be used. We have email permission from the author to reuse the same questionnaire and use it by translating it into Indian local language. Conceptual-based short-form health literacy questionnaire (HLS-SF12) Validation of questionnaire has been done. 9. Detailed description of procedure / processes: This study will adopt a prospective-cross sectional study design. Through a questionnaire we will going to collect a experience feedback from patients in gynaecology and obstetrics outpatient department. Permission to use questionnaire has been sought from the author. The questionnaire is translated to Kanada language through the forward-backwardforward translation method. The English questionnaire will be translated back to English by another bilingual expert. The modified version of the English questionnaire will be sent to the original author for comments & suggestions. The Kanada version will be validated by experts. The modified & validated version of English and Kanada questionnaire will be used in a study. The participants’ information sheets outlining the objectives & methodology of the study will be given to the participants. Written informed consent will be obtained for the participants in the study. The participants will be requested to fill in the self-administered tool, which will take about 10-12minutes.The contents of the questionnaire will be explained to the participants additionally in case of need. Data will be assessed, and gaps identified as per the standards/criteria. And also, in this study I will going to use (HLS-SF 12) questionnaire to assess and analyze the health literacy level within Gynaecology and obstetrics outpatient department. 10. Outcome measures: Questionnaires related to basic questions like whether the healthcare staff are correctly communicating with patients or not, how the patient’s overall experience in the Gynaecology and obstetrics department etc. will be given to each participant, and the outcome will be derived based on the data collected from the questionnaire. 11. Potential risks and benefits: Minor increase over minimal risk 12. Ethical considerations and methods to address issues: The research protocol will be submitted to the Institutional Ethics Committee (IEC) for clearance. Confidentiality of the participants of the study will be strictly maintained. 13. Budget (give details) and proposed funding source: The project is self-funded 14. Review of literature (within 1000 words): Serife Didem Kaya et al. stated that patient satisfaction is one of the most essential parts to measure the quality of care. There are also variety of factors that could influence in the patient satisfaction process are patient demographics, health condition, health care provider qualities like technical expertise, waiting time etc. It is also mentioned that patient satisfaction has been research in various parts of the countries but satisfaction of those patients who are visiting Gynaecology and obstetrics along with its predictors has not been studied in teaching hospital within turkey Konya province. So, the goal of this study is to evaluate the patient satisfaction who receive care at obstetrics and Gynaecology clinics. The author was conducted a cross-sectional survey and questionnaire were used to collect feedback from patients who are attending in Gynaecology and Obstetrics department. Data were also analyzed using SPSS Program.1(1) Pankaj Kumar et al. stated that the healthcare services scenario in India is evolving into a more advanced stage. So, the priority should be given to patient satisfaction as this is an essential parameter for the evaluation of the healthcare services. The goal of the study to find out the patient satisfaction in relation to different parameter of healthcare quality in the OPD. Later in the study author find out that there was a lack of privacy in the OPD, waiting time was too lengthy, though hospital maintained a clean environment but the toilet was unhygienic. The author concluded that though majority of patients were satisfied with the services but still there is a improvement required to make in this field to lower the percentage of the patient who has faced issues with these aspect.2(2) Samdana Wahab et al. stated OPD is designed to be a first point of contact between the patient and the hospital staff. It serves the best, and quickest care for both administrative and medical care which makes the patient satisfied and happy. But at the same time patient satisfaction can be affected by many factors related to medical care like how well the doctor communicate with patients and treat their condition and also whether the hospital have a right facilities and good environment. The main goal of conducting this study is to assessing patient experiences like what they think about the medical and administrative services that they get in the OPD, so that it will also help to improve policies and suggest the same services to other patients who come to the hospital. The author concluded that to maintain the best OPD services, the government and hospital administration need to create effective health service policies.3(3) Mehr un-Nisa et al. conducted a descriptive study among the patients who are admitted to the Gynaecology and obstetrics department. A quantitative structured questionnaire was used to record information. The author found that there is a need to improve the infrastructure and architecture of the hospital, improvement needed in the waiting area as per the guideline of the healthcare, need to development of washroom, the lower staff needs in service training for improving their communication skills.4(4) Jawahar SK et al. conducted a cross-sectional descriptive study among patients who are attending OPD at AIIMS, Bhubaneswar. Systematic random sampling was used to select participants. The aim of this study is to assess the quality service of OPD based on standard indicator and find out the patients satisfaction level. The author found out that to enhance the OPD Services in hospital, its important to gather patient feedback and minimizes the waiting area. 5(5) Olfat A Salem et al, In this study a cross-sectional survey research design was used. It was mainly focuses on female outpatients. So the basic definition of health literacy by Institute of medicine is “ the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decision†. The study recommended that in Saudi arabia, the health and higher education ministers should focus on reducing the incidence rate by improving community awareness program.6(6) 15. References: 1. Kaya SD, Maimaiti N, Gorkemli H. Assessing patient satisfaction with obstetrics and gynaecology clinics/outpatient department in university hospital Konya, Turkey. Int J Res Med Sci. 2017 Aug 26;5(9):3794. 2. Kumar P, Adhikari A, Ray M, Indu R, Bhattacharya S, Das AK. Assessment of patient satisfaction in outpatient department of a tertiary care hospital in West Bengal, India: a questionnaire based study. Int J Community Med Public Health. 2018 Aug 24;5(9):3919. 3. Wahab S, Wahab A, Zahoor F, Razzaq A, Qazi Q, Zaib L. THE PATIENT EXPERIENCE IN GYNAE/OBSTETRICAL WALK IN SERVICES IN LADY READING HOSPITAL PESHAWAR. Journal of Medical Sciences [Internet]. 2022 Jun 29 [cited 2023 Aug 24];30(02):121–5. Available from: https://jmedsci.com/index.php/Jmedsci/article/view/1203 4. Patient satisfaction survey in an obstetric and gynaecology ward of a tertiary care hospital | Request PDF [Internet]. [cited 2023 Aug 27]. Available from: https://www.researchgate.net/publication/288788671_Patient_satisfaction_survey_in_an_obstetric_a nd_gynaecology_ward_of_a_tertiary_care_hospital 5. Jawaha SK. A Study on Out Patient Satisfaction at a Super Specialty Hospital in India. Internet Journal of Medical Update - EJOURNAL. 2007 Nov 1;2(2). 6. (PDF) Evaluation of Health Literacy among Females in Outpatient Clinics [Internet]. [cited 2023 Aug 27]. Available from: https://www.researchgate.net/publication/324952850_Evaluation_of_Health_Literacy_among_Female s_in_Outpatient_Clinics. |