| 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
|
|
|
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
|
|
|
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. |