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CTRI Number  CTRI/2024/11/077027 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 19/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Other 
Public Title of Study   Study to develop integrated mental health care model for surgical patients of North-east India 
Scientific Title of Study   Development and Implementation of Proactive Integrated Mental Health Care Model for Hospitalized Surgical Patients: Quasi-Experimental Trial from North-East India  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  kewithinwangbo Newme 
Designation  Assistant professor 
Affiliation  AIIMS GUWAHATI 
Address  Department of General Surgery AIIMS Guwahati Changsari

Kamrup
ASSAM
781101
India 
Phone  9101001330  
Fax    
Email  kewithinwangbonewme@aiimsguwahati.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  kewithinwangbo Newme 
Designation  Assistant professor 
Affiliation  AIIMS GUWAHATI 
Address  Department of General Surgery AIIMS Guwahati Changsari


ASSAM
781101
India 
Phone  9101001330  
Fax    
Email  kewithinwangbonewme@aiimsguwahati.ac.in  
 
Details of Contact Person
Public Query
 
Name  kewithinwangbo Newme 
Designation  Assistant professor 
Affiliation  AIIMS GUWAHATI 
Address  Department of General Surgery AIIMS Guwahati Changsari


ASSAM
781101
India 
Phone  9101001330  
Fax    
Email  kewithinwangbonewme@aiimsguwahati.ac.in  
 
Source of Monetary or Material Support  
Science and Engineering Research Board (SERB), 3rd &4th floor, block-ii,Technology bhawan, New Mehrauli Road,New Delhi-110016 
 
Primary Sponsor  
Name  Science and Engineering Research BoardSERB 
Address  Anusandhan National Research Foundation (ANRF) 4th Floor, AI Block, Technology Bhawan Complex, New Mehrauli Road, New Delhi-110016. 
Type of Sponsor  Government funding agency 
 
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 
drkewithinwangbo newme  AIIMS GUWAHATI  Department of Genral surgery,room no. 1096 AIIMS GUWAHATI Changsari-781101
Kamrup
ASSAM 
9101001330

kewithinwangbonewme@aiimsguwahati.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS GUWAHATI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients admitted for elective operation under general surgery. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Consultation as usual   The consultation or treatment as usual will be followed during this period /arm for 6 months. 
Intervention  Integrated mental heath Intervention delivered by Health workers  The Health care workers (Nurse, Medical doctors) will screen the surgical patients for mental disorders and will provide psychological first aid and referral services for 6 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  admitted in surgery ward (for any planned or
emergency operative procedure) with reliable informant or caregiver (staying with patient
or having knowledge about patient for at least 6 months) 
 
ExclusionCriteria 
Details  1) Pregnant or lactating woman, 2) not willing to provide informed
consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
the primary outcome measures (length of stay.
consultation latency, consultation rate)
 
2 weeks,6 weeks,8 weeks and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Objectives:
1. To evaluate the effectiveness of proactive integrated mental health care model for
screening (case detection rate), referral (consultation latency) , and monitoring
(readmission) of surgical inpatients with MHDs.
2. To investigate the feasibility, and usefulness of implementing a proactive integrated
mental health care model in surgical inpatients services of tertiary care teaching
hospital. 
3 years 
 
Target Sample Size   Total Sample Size="684"
Sample Size from India="684" 
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   Phase 4 
Date of First Enrollment (India)   01/12/2024 
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="3"
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  

Rationale of the research: Mental Health disorders (MHDs) have a significant impact on surgical

outcomes such as increased post-surgical pain, hospital length of stay, complications, readmissions, and

mortality. Western countries have developed a proactive consultation-liaison (C-L) psychiatry model for

the early detection and management of psychiatric issues among surgical inpatients. Despite the fact

that proactive C-L service models are superior to traditional care models, no model has been developed

and evaluated for its effectiveness, and feasibility in Indian healthcare settings. This study will be

planned to develop and Implement the Proactive Integrated Mental Health Care (PIMHC) Model for

Hospitalized Surgical Patients. Methods: The quasi-experimental study (A1-B-A2 design) study, will be

carried out in AIIMS Guwahati for a period of 2 years. After brief training, surgical nurses will screen

the patients admitted to surgical wards for psychiatric issues. The surgical inpatient with MHDs with

an age of more than 18 years, either gender will be intervened using a PIMHC model (intervention

period) or consultation as a usual model (CAU model). Outcomes (length of stay. consultation latency,

consultation rate, MERIT, ASSIST, and GHQ-28 score) will be assessed 2-3 weeks after the admission in

surgical wards (Primary end-point). The secondary endpoints will be changes in MERIT, ASSIST, and

GHQ-28 scores at 6 and 8 weeks. Expected outcome: The PIMHC model could be effective, feasible, and

promising for surgical inpatients with MHD in terms of early detection and prompt management.

Furthermore, the model may help to reduce hospital stays by addressing the existing barriers within

Indian settings. The effective model could be scaled-up in nonsurgical settings as well as secondary or

tertiary care settings in the future.

 
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