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CTRI Number  CTRI/2024/11/076365 [Registered on: 07/11/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Digitisation of clinical records with the help of AI]  
Study Design  Other 
Public Title of Study   A pilot study on improving the digitization of health records using ambient clinical intelligence solutions driven by AI 
Scientific Title of Study   Enhancing health record digitization using AI-powered ambient clinical intelligence solutions - a pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alok Shetty  
Designation  Assistant Professor Medical oncology adult hematology 
Affiliation  Tata Memorial Hospital 
Address  OPD 81, ground floor , Main Building , Tata memorial hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  22241770007211  
Fax    
Email  dralokshetty@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alok Shetty  
Designation  Assistant Professor Medical oncology adult hematology 
Affiliation  Tata Memorial Hospital 
Address  OPD 81, ground floor , Main Building , Tata memorial hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  22241770007211  
Fax    
Email  dralokshetty@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alok Shetty  
Designation  Assistant Professor Medical oncology adult hematology 
Affiliation  Tata Memorial Hospital 
Address  OPD 81, ground floor , Main Building , Tata memorial hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  22241770007211  
Fax    
Email  dralokshetty@gmail.com  
 
Source of Monetary or Material Support  
Material support-Oxalis Technology, Address 104, D-156, Akshat Spring, Durga Marg, Bani Park, Jaipur - 302016, Rajasthan, India Monetary support-National Cancer Grid, Office at Tata Memorial Hospital, Dr. e Borges Road, Parel, Mumbai, 400012 
 
Primary Sponsor  
Name  Oxalis Technology 
Address  104, D-156, Akshat Spring, Durga Marg, Bani Park, Jaipur - 302016, Rajasthan, India  
Type of Sponsor  Other [Incorporated & Registered under the Companies Act 2013 by Ministry of Company Affairs] 
 
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 Alok Shetty  Tata memorial hospital  Room No 81, Main Building, Ground Floor, Adult Hematolymphoid Unit, Department of Medical Oncology, Tata Memorial Hospital, Dr E. Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 
02224177000

dralokshetty@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: X||New Technology,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Use of AI to capture clinical records  Application will be used to capture the clinical records into electronic medical records. This application will capture the audio and records will be digitised. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All patients above the age of 14 who are willing to participate.
2. Patient knows to talk in Hindi or Marathi or Bengali language.
 
 
ExclusionCriteria 
Details  1. Patient below the age of 14 years.
2. Patient cannot talk in Hindi or Marathi or Bengali language.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the accuracy of the records digitized using AI-powered clinical intelligence solution as compared to the actual clinical notes.
To compare the time taken for record digitization using conventional method versus the AI-
powered clinical intelligence solution 
4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time taken for record digitization using conventional method versus the AIpowered clinical intelligence solution.
To assess the meaningfulness of the records digitized using AI-powered clinical intelligence as
assessed by the clinicians. 
4 weeks 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   02/12/2024 
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="1"
Months="0"
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  

The digitization of health records plays a crucial role in reducing errors, such as missing data commonly associated with paper records, standardizing care, and facilitating the adoption and monitoring of evidence-based management guidelines. However, the extent of digitization in the Indian healthcare system is limited, primarily due to the high patient volume managed by healthcare professionals. The disparity is evident in the number of physicians per 1,000 population—0.7 in India compared to 3.6 in the United States—resulting in limited time for detailed patient documentation. Thus, there is a pressing need for solutions that enable digitization of medical records without imposing additional manual effort on clinicians and nurses.

To address this, we propose the development of artificial intelligence (AI) models capable of executing speech processing and natural language understanding tasks to generate structured clinical notes based on ambient conversations between clinicians and patients. This study aims to create an AI-driven clinical intelligence solution for real-time digitization of healthcare records during interactions between healthcare professionals and patients.

The study will be conducted in four phases:

Phase I - Audio Capture: Establishing high-fidelity audio capture systems.

Phase II - Multilingual Transcription: Implementing technology for real-time transcription in multiple languages.

Phase III - Clinical Note and Template Generation: Developing AI models to convert transcriptions into structured clinical notes and customized templates.

Phase IV - Deployment and Trial: Integrating and testing the technology within existing healthcare infrastructure.

The proposed plan involves co-developing the application to align with the existing infrastructure and workflows at Tata Memorial Hospital. This will include the installation of robust audio capture systems, the integration of multilingual transcription capabilities, and the generation of clinical notes in preferred formats.

The study will also evaluate the impact of the co-developed technology in terms of its technical robustness and operational efficacy. Key stages of development include setting up audio capture infrastructure, developing technology for audio-to-English translation, creating AI-driven clinical note generation systems, ensuring data privacy and security, and designing custom form templates for clinical documentation.

 

 

 

 
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