Task-based Credentialing for Medical Officers in Spinal Anesthesia
Condition: Spinal Anesthesia; Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care
Study type: Interventional

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.
    

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.
    

Intervention name(s): delivery of the spinal anesthetic by a trained medical officer; delivery of spinal anesthetic by a consultant anesthetist
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Intervention MeSH terms: Anesthetics
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
Keywords: global health