| CTRI Number |
CTRI/2018/08/015213 [Registered on: 07/08/2018] Trial Registered Prospectively |
| Last Modified On: |
06/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Innovative Approach to the Specialist Workforce Crisis in Rural Indian Hospitals |
|
Scientific Title of Study
|
Task-based Credentialing for Medical Officers in Spinal Anesthesia: an Innovative Approach to the Specialist Workforce Crisis in Rural Indian Hospitals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandakumar Menon |
| Designation |
Director / Pl |
| Affiliation |
ASHWINI, Gudalur Adivasi Hospital |
| Address |
ASHWINI - Gudalur Adivasi Hospital
PO Box - 20 , Kotheravayal
Gudalur - 643212
The Nilgiris
TAMIL NADU
643212
India |
| Phone |
9442633665 |
| Fax |
|
| Email |
nkshyla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandakumar Menon |
| Designation |
Director / Pl |
| Affiliation |
ASHWINI, Gudalur Adivasi Hospital |
| Address |
ASHWINI - Gudalur Adivasi Hospital
PO Box - 20 , Kotheravayal
Gudalur - 643212
The Nilgiris
TAMIL NADU
643212
India |
| Phone |
9442633665 |
| Fax |
|
| Email |
nkshyla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandakumar Menon |
| Designation |
Director / Pl |
| Affiliation |
ASHWINI, Gudalur Adivasi Hospital |
| Address |
ASHWINI - Gudalur Adivasi Hospital
PO Box - 20 , Kotheravayal
Gudalur - 643212
The Nilgiris
TAMIL NADU
643212
India |
| Phone |
9442633665 |
| Fax |
|
| Email |
nkshyla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Center for Global Health Delivery, Harvard Medical School
Building 14,Mohammed Bin Rashid Academic Medical Center، Dubai Healthcare City - Dubai - United Arab Emirates |
|
|
Primary Sponsor
|
| Name |
Harvard Medical School |
| Address |
Harvard University
Boston
USA |
| Type of Sponsor |
Research institution |
|
|
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 Nandakumar Menon |
ASHWINI |
PO BOX -20
KOTHERAVAYAL
GUDALUR
The Nilgiris
TAMIL NADU |
9442633665
nkshyla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ASHWINI ethics commitee |
Approved |
| ASHWINI IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
all patients undergoing spinal anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ANESTHETIST |
Existing curricula in India for spinal anesthesia are largely targeted at the postgraduate trainee and are typically written for relatively high-resource settings. These curricula will need to be adapted for medical officers who may have extensive practical experience but do not have formal training in the provision of anesthesia care. Moreover, the curriculum will need to consider the scarcity of resources in rural India and should be designed to be taught in a shorter timeframe. Ultimately, however, the curriculum must include teaching on processes to ensure safe provision of care and education on how to deal with complications that may arise from spinal anesthesia. To do so, the curriculum will require both comprehensive educational content as well as innovative educational methods including the use of online theoretical lessons and simulation with mannequins, both with regular assessments and feedback for trainees. The ability to achieve this objective will be measured by the production of a curriculum that has tri-institutional approval from anesthesiologists at Harvard Medical School, Karunya University, and Gudalur Adivasi Hospital. Additionally, advice from the Australian Northern Territory Alice Springs Hospital Anaesthesia department may be sought in the curriculum content and methodology, as these anesthesiologists are experienced in training doctors for task-sharing in anaesthesia. The curriculum could also demonstrate how task-based training modules can be adapted from existing curriculum areas of clinical need. This particular curriculum for spinal anaesthesia could be adopted for use for other rural Indian hospital settings |
| Intervention |
Conducting a non-inferiority study of medical officers versus anesthesiologist in provision of spinal anesthesia |
1) Development of curriculum: Designing a spinal anaesthesia curriculum for “trainees†(medical officers) for the rural Indian hospital context. Content will include spinal anesthesia technique and managing complications, and methods will include a theoretical online learning platform, hands-on mannequin simulators and practical training. Three sites will collaborate on this curriculum design; ASHWINI Gudalur Adivasi Hospital, SEESHA Karunya University, and Harvard Medical School.
2) Training: Preliminary theoretical training and then practical supervised training across three rural hospitals (see appendix 10).
3) Non-inferiority trial: A randomized, non-inferiority trial across the same facilities comparing trainees to anesthesiologists on parameters measuring safety and effectiveness outcomes.
We will not be using any new or experimental spinal anesthetic for the study. No new medical therapy or intervention is going to be used.
|
| Comparator Agent |
Medical Oficers |
Ascertain whether the educational curriculum results in training MOs to administer spinal anaesthesia as safely as anesthesiologists- i.e.g non-inferiority of intervention (educational curriculum) when comparing medical officers with anesthesiologist. Data collected pre-, peri- and 72 hours post-operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are posted for spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Refusal of consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Completion of a non-inferiority study comparing medical officers to anesthesiologists on outcomes of rates of inadequate analgesia, up to 72 hour complications, and adherence to a safety checklists
The time period depends on the number of patients needing surgical intervention under spinal anesthesia, who can enroll in the study. |
We anticipate that the requisite number of patients will be obtained by June 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Development of a curriculum on spinal anesthesia specific to rural Indian hospitals medical officers
2) A system for mannequin training/ simulation for medical officers
|
It will be only after the non-inferiority trial is over that we can come to a conclusion regarding the non-inferiority of the trainees as compared to the anesthesiologists. If the trainees are found to be non-inferior, the training modules, the mannequin training and the simulation can be recommended as valid training material for other rural Indian Hospitals. |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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 1 |
|
Date of First Enrollment (India)
|
16/08/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Rationale In rural
India, it is uncommon for hospitals to be staffed with both a surgeon and an
anesthesiologist, resulting in poor access to surgical care and patient
morbidity and mortality. “Task-based credentialing†of rural medical officers
in spinal anaesthesia is an innovative proposed solution to improve volume of
surgical procedures and thereby avert preventable morbidity and mortality. Objectives The
specific objectives of the project are; 1.
Development of a spinal anaesthesia
curriculum and recruitment of trainees 2.
Training of medical officers in
provision of spinal anesthesia, including theoretical, simulation and practical 3.
Conducting a noninferiority study of
medical officers versus anesthesiologist in provision of spinal anesthesia A
secondary objective includes the credentialing of trainees following successful
completion of the 3 part educational curriculum (theory, simulation and
practical) and proven non-inferiority Methods The study
consists of three phases: 1)
Development of curriculum:
Designing a spinal anaesthesia curriculum for “trainees†(medical officers) for
the rural Indian hospital context. Content will include spinal anesthesia
technique and managing complications, and methods will include a theoretical
online learning platform, hands-on mannequin simulators and practical training.
Three sites will collaborate on this curriculum design; ASHWINI Gudalur Adivasi
Hospital, SEESHA Karunya University, and Harvard Medical School. 2)
Training:
Preliminary theoretical training and then practical supervised training across
three rural hospitals (see appendix 10). 3)
Non-inferiority trial:
A randomized, non-inferiority trial across the same facilities comparing trainees to anesthesiologists on parameters
measuring safety and effectiveness outcomes. Expected Outcomes 1)
Development of a curriculum on
spinal anesthesia specific to rural Indian hospitals medical officers 2)
Training of five medical officers to
provide spinal anesthesia for surgery in rural Indian hospitals
3)
Completion of a non-inferiority
study comparing medical officers to anesthesiologists on outcomes of rates of
inadequate analgesia, up to 72 hour complications, and adherence to a safety
checklists |