Task-based Credentialing for Medical Officers in Spinal Anesthesia

April 28, 2021 updated by: Craig McClain, Harvard Medical School (HMS and HSDM)

Task-based Credentialing for Medical Officers in Spinal Anesthesia: An Innovative Approach to the Specialist Workforce Crisis in Rural Indian Hospitals Curriculum Training of Medical Officers

Test the safety and effectiveness of training medical officers in the provision of spinal anesthesia in a rural hospital context using a non-inferiority randomized trial.

The safety and effectiveness of the MOs will be evaluated through a non-inferiority trial in which patients are randomized to care by a trained MO or an anesthesiologist. The primary outcomes are safety (adherence to adapted anesthesia safety checklist- see supporting documents "Adapted Anesthesia Safety Checklist") and effectiveness (adequate analgesia) of spinal anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The vast majority of the world is without access to surgical and anesthesia care, and a severe workforce shortage is a major contributing factor. The Lancet Commission on Global Surgery (LCoGS) demonstrated that Africa and South Asia, home to over a third of the global population, lay claim to just 12% of surgeons, anesthesiologists and obstetricians. This workforce shortage may be particularly severe for anesthesia care given that anesthesiologist make up less than 20% of surgical care providers globally. In a series of qualitative interviews, providers across three continents noted that in rural and under-resourced areas, it was unlikely that there was a surgeon and an anesthesiologist in the same place.

In India, the concerns of under-provision of human resources in the rural area are especially severe. The Lancet commission on Global Surgery estimates that while 68% of Indians live in rural areas, only 22% of the health care workforce does. For specialist services, which are even more urbanized, the disparity is likely greater. The result is that, in South Asia, 95% of people are estimated to lack access to safe, affordable and timely surgical care.

In India, which is home to nearly 400 medical schools, it may be posited that the country is well positioned to close this gap. However, the number of postgraduate training seats - 14,000 countrywide - are entirely insufficient for the 50,000 doctors that graduate each year. With only 1500 postgraduate training seats for anesthesia, a graduate who may otherwise aspire to train in anesthesia instead remains generalist MO or seeks training elsewhere. The World Health Organization suggests that a presence of anesthesiologists in rural India may be so scarce it is "non-existent.". It has also been estimated that 43% of the Indian population lives more than 50km from their nearest health center, 76% of which do not have an anesthesiologist.

The result of these human resource limitations, is that rural Indian surgeons often administer anesthesia for their patient prior to performing necessary surgeries or medical officers with only ad hoc training provide anesthesia care. The de facto standard of care in rural India, ends up being the provision of anesthesia by a surgeon or untrained medical officer. While advocacy towards increasing post-graduate education must continue, it is also clear that interim measures are needed to improve upon current baseline practices.

One such measure suggested by the Disease Control Priorities 3 (DCP3), the LCoGS, and others is the concept of "task-based credentialing." In this model of credentialing, physicians are trained and credentialed in a limited set of procedures. Task sharing - a process by which non-specialists take on whole-sale the tasks typically performed by a specialist - is prevalent in the provision of anesthesia care worldwide. However, a recent meta-analysis evaluated outcomes for task-sharing in anesthesia in 15 LMIC and found that administration of anesthesia by a non-physician was a risk-factor for maternal mortality. To mitigate these concerns, task-based credentialing focuses on the training of non-specialist medical officers in a discrete, well-defined task and includes training to deal with the possible complications. This task-based training would serve as an improvement on the de facto standard of care in rural India by providing specific training in place of ad hoc learning.

The provision of spinal anesthesia is thought to be well-suited for this form of training. The procedure involves the injection of a local anesthetic agent into the subarachnoid space. This allows for analgesia and anesthesia below the level of injection. This procedure is widely used in general surgery, obstetric surgery, and orthopedic surgery. Moreover, the use of spinal anesthesia is particularly well-adapted to rural care as it is less expensive than general anesthesia and has a lower requirement of infrastructure and disposables when compared to general anesthesia.

Test the safety and effectiveness of training medical officers in the provision of spinal anesthesia in a rural hospital context using a non-inferiority randomized trial.

The safety and effectiveness of the MOs will be evaluated through a non-inferiority trial in which patients are randomized to care by a trained MO or an anesthesiologist. The primary outcomes are safety (adherence to adapted anesthesia safety checklist- see supporting documents "Adapted Anesthesia Safety Checklist") and effectiveness (adequate analgesia) of spinal anesthesia.

Study Type

Interventional

Enrollment (Actual)

486

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Chhattisgarh
      • Ganiyari, Chhattisgarh, India
        • JSS Hospital
    • Tamil Nadu
      • Gudalur, Tamil Nadu, India
        • Ashwini Hospital
      • Harur, Tamil Nadu, India
        • Sittilingi Tribal Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion criteria for MOs

  • Consent to participate in practical training and clinical trial (consent process will be repeated)
  • Successful completion of the theoretical and simulation training
  • Be deemed safe to continue to practical training by their supervising Anesthesiologist
  • Feel comfortable to proceed to practical training

Inclusion criteria for patients

  • Age 18-65

  • Undergoing one of the surgeries noted in supporting document "List of surgeries for patient inclusion criteria" or otherwise deemed appropriate for spinal anesthesia as determined by surgeon and supervising anesthesiologist

    • Willingness to provide informed consent
    • ASA (American Society of Anesthesiology Physical Status Classification System) grades I and II

Inclusion criteria for Consultant Anesthetists

  • Anesthetist licensed to practice independently with availability to provide care at one of the selected sites

Exclusion Criteria:

Exclusion criteria for MOs

  • Recent suspension from clinical practice
  • Due to change sites or retire before the expected end date of the trial

Exclusion criteria for patients

  • Obese (BMI > 35)
  • Refusal of consent to participate in trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Consultant Anesthetist
Patients who are randomized to this arm will receive their spinal anesthesia froma consultant anesthetist
Other: delivery of spinal anesthetic by a consultant anesthetist
The delivery of spinal anesthesia by the trained medical officers in 3 rural Indian hospitals will be compared to those delivered by consultant anesthetists in the same hospitals in a non-inferiority analysis.
OTHER: Medical Officer
Patients randomized to this arm will receive their spinal anesthetic from a medical officer. There will be a consultant anesthetist immediately available if needed but they will not be a direct participant in this arm. Any involvement by the consultant will result in the label of failure for this patient.
Other: delivery of the spinal anesthetic by a trained medical officer
The delivery of spinal anesthesia by the trained medical officers in 3 rural Indian hospitals will be compared to those delivered by consultant anesthetists in the same hospitals in a non-inferiority analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful delivery of spinal anaesthesia
Time Frame: Assessed pre-operatively following recruitment and consent (day 0 of the follow up period)
Delivery of spinal anaesthesia into the intrathecal space with three or less attempts and no intra-operative conversion to general anaesthesia due to spinal failure
Assessed pre-operatively following recruitment and consent (day 0 of the follow up period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Complications
Time Frame: Reviewed at two time points - on discharge from healthcare facility or day 3 post-operatively (whichever occurs first) and day 10-14 post-operatively
Incidence of post-dural puncture headache, epidural haematoma, spinal abscess and neurological deficit
Reviewed at two time points - on discharge from healthcare facility or day 3 post-operatively (whichever occurs first) and day 10-14 post-operatively
Patient experience measures
Time Frame: Reviewed at two time points - on discharge from healthcare facility or day 3 post-operatively (whichever occurs first) and day 10-14 post-operatively
Patient reported experience measures of clinical care and pain
Reviewed at two time points - on discharge from healthcare facility or day 3 post-operatively (whichever occurs first) and day 10-14 post-operatively
Intraoperative Complications
Time Frame: Assessed intraoperatively during surgical procedure
The incidence of hypotension, bradycardia, high spinal, apnoea and hypoxia
Assessed intraoperatively during surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Medical School (HMS and HSDM)

Collaborators

Boston Children's Hospital
Ashwini Health System, Gudalur, India
Harvard Center for Global Health, Dubai
Program in Global Surgery and Social Change, Harvard Medical School

Investigators

  • Principal Investigator: Craig D McClain, MD, MPH, Boston Children's Hospital, Harvard Medical School, Program in Global Surgery and Social Change

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

January 10, 2021

Study Completion (ACTUAL)

March 1, 2021

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (ACTUAL)

June 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB17-0624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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