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Study Protocol

A protocol to study the impact of implementation of National Accreditation Board for Hospitals & Healthcare Providers (NABH) standards among health care workers in a tertiary care hospital in India

[version 1; peer review: 1 approved, 3 not approved]
PUBLISHED 10 Nov 2023
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background: The healthcare system is now transforming widely with new technology including the introduction of a variety of medical gadgets, clinical trials, telemedicine, health insurance, health tourism, and outsourcing programs. Recent research focused on the quality of healthcare has proved useful for evaluating satisfaction and improvement of services in an organization. The World Medical Assembly asserts that in order to enhance patient outcomes on an individual level and community health, healthcare providers and organizations have an ethical and professional commitment to continuously improve the quality of services and patient safety. The National Accreditation Board for Hospitals & Healthcare Providers - Quality Council of India - (NABH) formed a constituent board to design and oversee an accreditation scheme for healthcare institutions to ensure the quality of care. Healthcare accreditation organizations and certification programs have progressed international efforts to raise the standard of healthcare since the 1970s. The accreditation process, which is carried out by qualified external peer reviewers, allows a healthcare organization to be officially recognized for achieving performance standards.
The objectives of this protocol are to understand the perception and impact of healthcare workers towards implementation of NABH standards and to study the impact of pre and post assessment of NABH with the help of 10 important key performance indicators in hospitals.
Methods: A descriptive cross-sectional design will be adopted in the study. It includes collection of data from the medical record department records for pre-assessment and direct questionnaire to the participants for post-assessment of NABH standards. The pre-assessment data of quality indicators will be collected from the previous records of NABH files from the quality assurance department.
Expected result: The expected result of the study will identify the different impacts of implementation of NABH standards after pre and post assessment in an organization.

Keywords

NABH, Healthcare, Implementation, Pre and post assessment, Quality, Satisfaction, Improvement, Healthcare workers, Gap analysis

Introduction

In light of the enormous social, financial, and technological changes of the 21st century, the Indian medical system is operating in a dynamic environment. Health care is now transforming widely with new technology. The healthcare system includes a variety of medical gadgets, clinical trials, health insurance, medical tourism, and outsourcing programs that have advanced to laudable levels which are more focused on the certification of accredited bodies to improve the services and productivity of the organization.1 Healthcare workers have an obligation and responsibility to save human lives for which they require skill in their professional aspects as a small error can have very serious consequences on human lives.

The NABH provide the standards and objective elements to improve the structure, process, and outcome of the organization which help to improve the healthcare quality and patient safety. Since the current healthcare system does not impose cost and quality standardization, certification is the only likely method of establishing the dependability and authenticity of a healthcare provider.1,2

Healthcare accreditation and certification programs have progressed international efforts to raise the standard of healthcare since the 1970s. The accreditation process, which is carried out by qualified external peer reviewers, allows a healthcare organization to be officially recognized for achieving performance standards.3,4 Accreditation may be considered a way to monitor quality preservation and enhancement, public security, legal protections, risk management, monitoring by the private sector, the adoption of new service settings, addressing issues with the healthcare system, and the creation of leading universities.5 It may encourage healthcare workers to be more accountable for their actions and to work collaboratively as a team, help in assessing the long-term impact of NABH accreditation, and help to identify areas where further training is needed, which will help participant development.

This cross sectional study will be conducted for assessing & evaluating the awareness among healthcare workers for NABH guidelines. Records for the assessment will be collected from medical record department (MRD) secondary source of information will be generated from ABVRH hospital Wardha. Ethical permission with hospital regularities will be taken from medical superintendent & medical record department in charge. Confidentiality of the data will be proofed for patient identification.

Questionnaire will be provided for assessment based on adopted questionnaire in use itself in ABVRH.

Post assessment survey will be conducted after 6 months of providing assistant over NABH guidelines among healthcare workers. Data will be gathered by data management team will be analyzed for objectives results considering per protocol basis on minimum sample size required for full analysis data set.

Protocol

Ethics and consent

The synopsis for this study has been approved by Datta Meghe Institute of Higher Education and Research ethical committee, ethical reference no. is DMIHER (DU)/IEC/2023/563 on 4th February 2023. Written informed consent will be obtained from the healthcare workers for this study. For collecting the data from medical records permission from the higher authority of the medical record department and chief medical superintendent has been granted for the collection of data. This article is reported in line with STROBE guidelines.12

Study design

This study will adopt a descriptive cross-sectional design consisting of two phases. The first phase is a collection of data from the previous patients health records of the medical record department to assess how well staff adhere to the quality check list of NABH guidelines where we have taken 10 quality indicators from the check list10 and a direct paper questionnaires to the healthcare workers to assess their knowledge (see Extended data11).

The second phase conducts a post-assessment survey with nursing staff, doctors, technicians and paramedical staff. The post assessment survey will be given by the 1st week of October to see the knowledge of the healthcare workers regarding the quality indicators. The same questionnaires will be used.

This study will be conducted in a tertiary care hospital in central India. The study duration will be three years (Aug 2023- Aug 2025).

Sample

Sample size calculation: The sample size for data collection is 280. Percentage regarding pre-implementation of NABH standards among healthcare professionals. This will be purposive selection of data records and trained doctors for NABH.

P = 0.500

D = estimated error (5 %) = 0.05

=20.50010.500/0.0025=280

The minimum sample size required is 280

Estimate value of awareness of NABH guidelines among healthcare workers.

Inclusion and exclusion criteria: The study will include nurses, technicians, paramedical staff and doctors. Excluded from the study will be the employees who are not willing to participate, class IV workers, and those who are on medical leave at the time of data collection.

Demographic variables: age, gender, experience, department, qualification/designation, training on NABH (Yes/No).

Outcome variables:

  • A) Research questions based on organization (Yes/no) total 7 questions

  • B) Quality Indicator

    • 1) Quality Indicator-1 No. of reporting errors per 1000 investigations

    • 2) Quality Indicator-2 Incidence of medication errors

    • 3) Quality Indicator-3 Percentage of unplanned return to OT

    • 4) Quality Indicator 4- Return to ICU within 48 hours

    • 5) Quality Indicator-5 Compliance of Hand Hygiene

    • 6) Quality Indicator 6- Time taken for discharge

    • 7) Quality Indicator 7-Incidence of patient fall

    • 8) Quality Indicator 8- Rate of needle stick Injuries

    • 9) Quality Indicator 9 – Percentage of near misses

    • 10) Quality Indicator 10 – Compliance rate to medication prescription in capitals

Research questions based on organization (Yes/no) total 7 questions will be evaluated for frequency & (%) basis. This indicators will be collection of 57 questionnaire each for 1 mark of correct answer total 57 marks, distributed amongst poor (0-19), Average (20-38), Good (39-57). Association with demographic variables will be tested at 5% l.o.s. (P<=0.05) using chi square analysis.

The perception and impact of healthcare workers towards implementation of NABH standards.

The impact of pre and post assessment of NABH with the help of 10 important key performance indicators in hospitals.

Confounders: The knowledge of the study participants and their previous exposure for NABH training can be a confounding factor.

Variables

For the post-assessment survey of 10 quality indicators, participants will be given a self-administered questionnaire that will be created with the assistance of the NABH checklist.

Pre-assessment information will be gathered from MRD records, and we will compare the progress and productivity of employees. The following indicators for pre and post assessing are:

  • 1. No. of reporting errors per 1000 investigations

  • 2. Incidence of medical errors

  • 3. Percentage of unplanned return to OT

  • 4. Return to ICU within 48 hours

  • 5. Compliance to hand hygiene

  • 6. Time taken for discharge

  • 7. Incidence of patient fall

  • 8. Rate of needle stick injuries

  • 9. Percentages of near misses

  • 10. Compliance rate to medication prescription in capital

Quantitative variables:

  • 1. Level of awareness and knowledge among the healthcare workers.

  • 2. Number of healthcare workers who attended the NABH training (provided by the Chief Medical superintendent).

Data analysis

The mean and standard deviation of the data for the outcome variables will be checked for normality, and the median statistics will be used to locate skewed distributions and the interquartile range (IQR). Descriptive statistics will be used to tabulate and describe the results for the outcome variables. Frequency and percentages for binary and categorical variables will be totaled for descriptive statistics. SPSS version 22.0 will be used for all statistical analysis. We'll look at the inferential statistics that correspond with the justification given below.

Primary outcome

The two groups' measurement scores (before versus post-assessment) and the major variable's mean change will be compared using inferential statistics. Participants will take a test to determine how the major variable changed from the baseline to the period measured during the study.

Fixed effects will be examined by taking into account the two-year follow-up period and will be assessed with the matching 95% confidence interval (CI) reported. The impacts of chance will be generalized to research participants.

The aforementioned linear mixed model effect on secondary outcomes (pre-analysis) will be used to predict how much the active and control groups' effects will differ from each other. The T-test (unpaired) will be used to evaluate whether there is a normal distribution-conforming difference in the means between the two groups if there is one. Chi square, Mann Whitney, and Wilcoxon test are additional non-parametric tests that we will use if the data for the principal variable are still distributed non-normally.

Results

In this study we will identify the different impacts of implementation of NABH standards after pre- and post-assessment of 280 staff working in a tertiary care hospital.

Discussion

A cross-sectional study on the effectiveness of implementation of NABH standards among healthcare workers in a tertiary care center in India concluded that more than 80% of participants believe that NABH accreditation has a positive impact on the hospital's services and operational procedures, which have since improved. 85% of participants reported that after post NABH accreditation, their level of job satisfaction had changed. Also, an average of 83.66% think that after NABH accreditation, hospital procedures have improved. It was found that 91.09% of participants believe that hospital processes have improved since NABH accreditation; 85.78% of participants believe that patient satisfaction has improved continuously since NABH accreditation; 82.61% of participants think the training they received on NABH accreditation was valuable; 83.66% believe that systems and processes have become more standardized since NABH accreditation; NABH accreditation; 84.28% of participants believed that following NABH accreditation, the organization provided them with enough support for their contributions to hospital procedures; 79.14% of participants thought that staff complaints were resolved more quickly; and overall, 87.27% of participants said they would refer their family members to this hospital for treatment. 85.55% of participants said it had a favorable effect on employees' morale and job satisfaction.2

A systematic review on Impact of Accreditation on the Quality of Healthcare Services conducted by Abdullah Alkhenizan et al. found that the majority of the 26 studies evaluating the effects of accreditation in their research exhibited broad accreditation for acute myocardial infarction (AMI), trauma, ambulatory surgical treatment, infection control, and pain management; and subspecialty accreditation programs to significantly improve the structure and organization of healthcare facilities. According to numerous studies, general accreditation programs considerably improve clinical outcomes and the level of care for these clinical disorders. Furthermore, they demonstrated a significant improvement in clinical outcomes across a number of subspecialties, including sleep medicine, chest pain management, and trauma management, as a result of subspecialty accreditation programs. The studies came to the conclusion that there is consistent evidence that accreditation programs enhance the process of care. Numerous studies revealed that general accreditation programs significantly enhance clinical outcomes and the standard of care for these clinical conditions, and they also demonstrated a significant positive impact of subspecialty accreditation programs in enhancing clinical outcomes in a variety of subspecialties, including sleep medicine, chest pain management, and trauma management. These studies came to the conclusion that there is resounding evidence that accreditation programs enhance the process of care. There is a lot of data to support the claim that accrediting programs enhance clinical outcomes for a variety of clinical diseases. As a tool to raise the caliber of healthcare services, accreditation programs should be encouraged.7

An observational study was carried out on every single patient admitted to the ICU for a period of five months (from April to August 2015) in a Hospital at Hubli, in order to know whether the effective application of NABH guidelines was able to control the number of new cases of hospital-acquired infections in their ICU. At first, they conducted an initial evaluation of infection control, and then consistently carried out an evaluation every month about infection control. This study concluded that there was a significantly lower number of new cases that occurred in their ICU which could be, accredited to the application of NABH guidelines.8

A cross-sectional, descriptive study conducted by Lallu Joseph et al., received 415 respondents from a conference of healthcare organizations. The survey was done to know the discernment of the frontline workers as well as the administrators of the hospital on accreditation. The study showed that the administrators of various hospitals and not the healthcare workers had a positive response in their perception. It also showed that the long years of experience in accreditation, the weaker their thought was about accreditation. This teaches us that the senior faculty of any hospital should especially be made aware of the benefits of the application of NABH guidelines.9

Generalizability

The outcome of the study will help in improving the quality of care and update the policies at institution level.

Dissemination

The study will be published in an institutional-indexed journal.

Study status

Data collection of the study will be started in the first week of July 2023.

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VERSION 1 PUBLISHED 10 Nov 2023
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how to cite this article
Kanyal D and Ghewade B. A protocol to study the impact of implementation of National Accreditation Board for Hospitals & Healthcare Providers (NABH) standards among health care workers in a tertiary care hospital in India [version 1; peer review: 1 approved, 3 not approved]. F1000Research 2023, 12:1454 (https://doi.org/10.12688/f1000research.141807.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 10 Nov 2023
Views
6
Cite
Reviewer Report 11 Jun 2024
Shahenaz Najjar, KU Leuven University, Leuven, Belgium 
Not Approved
VIEWS 6
Overall Comment
This protocol, as presented, lacks clarity and is incomplete, making it challenging to understand or replicate. The following are detailed comments and recommendations for improvement:

Introduction
  • Study objectives are unclear.
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Najjar S. Reviewer Report For: A protocol to study the impact of implementation of National Accreditation Board for Hospitals & Healthcare Providers (NABH) standards among health care workers in a tertiary care hospital in India [version 1; peer review: 1 approved, 3 not approved]. F1000Research 2023, 12:1454 (https://doi.org/10.5256/f1000research.155286.r275542)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
6
Cite
Reviewer Report 11 May 2024
Nidhi Yadav, Indian Institute of Health Management Research (IIHMR) University, Jaipur, India 
Not Approved
VIEWS 6
First, the study objectives are vague and unclear. 
The data collection from medical records is not specified. neither the sample size of medical records to be studied is drawn
Secondly, the staff of 280 needs to be further ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Yadav N. Reviewer Report For: A protocol to study the impact of implementation of National Accreditation Board for Hospitals & Healthcare Providers (NABH) standards among health care workers in a tertiary care hospital in India [version 1; peer review: 1 approved, 3 not approved]. F1000Research 2023, 12:1454 (https://doi.org/10.5256/f1000research.155286.r230123)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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3
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Reviewer Report 11 May 2024
Surianti Sukeri, Department of Community Medicine, Universiti Sains Malaysia, School of Medical Sciences, Kubang Kerian, Kelantan, Malaysia;  Department of Community Medicine, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia 
Not Approved
VIEWS 3
Overall comment:
The protocol was incomplete; it is confusing to read and even more difficult to understand, let alone replicate.

Study objective:
The study objective is confusing. Why pre and post-assessment? What assessment are the ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Sukeri S. Reviewer Report For: A protocol to study the impact of implementation of National Accreditation Board for Hospitals & Healthcare Providers (NABH) standards among health care workers in a tertiary care hospital in India [version 1; peer review: 1 approved, 3 not approved]. F1000Research 2023, 12:1454 (https://doi.org/10.5256/f1000research.155286.r225696)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
5
Cite
Reviewer Report 11 May 2024
Sharad Chand, Department of Pharmaceutical Sciences, Dr Vishwanath Karad MIT World Peace University, Pune, Maharashtra, India 
Approved
VIEWS 5
Abstract Can be improved. Background should be trimmed out and methodology needs to be explained.
Keywords can be arranged in alphabetical order.
Remaining sections looks fine as this is just a protocol rather than a research paper. The ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Chand S. Reviewer Report For: A protocol to study the impact of implementation of National Accreditation Board for Hospitals & Healthcare Providers (NABH) standards among health care workers in a tertiary care hospital in India [version 1; peer review: 1 approved, 3 not approved]. F1000Research 2023, 12:1454 (https://doi.org/10.5256/f1000research.155286.r230127)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 10 Nov 2023
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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