| 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
|
|
|
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
|
|
|
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. |