Task-based Credentialing for Medical Officers in Spinal Anesthesia

• ClinicalTrials.gov Identifier: NCT04438811
• Recruitment Status: Completed
• First Posted: June 19, 2020
• Last Update Posted: April 29, 2021
• Sponsor: Harvard Medical School (HMS and HSDM)
• Collaborators: Ashwini Health System, Gudalur, India; Harvard Center for Global Health, Dubai; Boston Children's Hospital; Program in Global Surgery and Social Change, Harvard Medical School
• Information provided by (Responsible Party): Craig McClain, Harvard Medical School (HMS and HSDM)

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Spinal Anesthesia; Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care	Other: delivery of the spinal anesthetic by a trained medical officer; Other: delivery of spinal anesthetic by a consultant anesthetist	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 486 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a non-inferiority, randomized trial. Patients will be randomized to receive a protocolized spinal anesthetic from a consultant anesthetist or a trained medical officer. Failure rates and need for rescue will be assessed as primary outcomes.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: January 10, 2021
• Actual Study Completion Date: March 1, 2021

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. Intraoperative Complications [ Time Frame: Assessed intraoperatively during surgical procedure ]
   The incidence of hypotension, bradycardia, high spinal, apnoea and hypoxia

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

India

JSS Hospital

Ganiyari, Chhattisgarh, India

Ashwini Hospital

Gudalur, Tamil Nadu, India

Sittilingi Tribal Hospital

Harur, Tamil Nadu, India

Sponsors and Collaborators

Harvard Medical School (HMS and HSDM)

Ashwini Health System, Gudalur, India

Harvard Center for Global Health, Dubai

Boston Children's Hospital

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

More Information

Publications:

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Grimes CE, Bowman KG, Dodgion CM, Lavy CB. Systematic review of barriers to surgical care in low-income and middle-income countries. World J Surg. 2011 May;35(5):941-50. doi: 10.1007/s00268-011-1010-1.

Hoyler M, Finlayson SR, McClain CD, Meara JG, Hagander L. Shortage of doctors, shortage of data: a review of the global surgery, obstetrics, and anesthesia workforce literature. World J Surg. 2014 Feb;38(2):269-80. doi: 10.1007/s00268-013-2324-y.

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Ng-Kamstra JS, Greenberg SLM, Abdullah F, Amado V, Anderson GA, Cossa M, Costas-Chavarri A, Davies J, Debas HT, Dyer GSM, Erdene S, Farmer PE, Gaumnitz A, Hagander L, Haider A, Leather AJM, Lin Y, Marten R, Marvin JT, McClain CD, Meara JG, Mehes M, Mock C, Mukhopadhyay S, Orgoi S, Prestero T, Price RR, Raykar NP, Riesel JN, Riviello R, Rudy SM, Saluja S, Sullivan R, Tarpley JL, Taylor RH, Telemaque LF, Toma G, Varghese A, Walker M, Yamey G, Shrime MG. Global Surgery 2030: a roadmap for high income country actors. BMJ Glob Health. 2016 Apr 6;1(1):e000011. doi: 10.1136/bmjgh-2015-000011. eCollection 2016.

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• Responsible Party: Craig McClain, Principle Investigator, Harvard Medical School (HMS and HSDM)
• ClinicalTrials.gov Identifier: NCT04438811
• Other Study ID Numbers: IRB17-0624
• First Posted: June 19, 2020
• Last Update Posted: April 29, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Craig McClain, Harvard Medical School (HMS and HSDM):

global health

Additional relevant MeSH terms:

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs