<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04438811</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-0624</org_study_id>
    <nct_id>NCT04438811</nct_id>
  </id_info>
  <brief_title>Task-based Credentialing for Medical Officers in Spinal Anesthesia</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ashwini Health System, Gudalur, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Center for Global Health, Dubai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Program in Global Surgery and Social Change, Harvard Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Harvard Medical School (HMS and HSDM)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Test the safety and effectiveness of training medical officers in the provision of spinal&#xD;
      anesthesia in a rural hospital context using a non-inferiority randomized trial.&#xD;
&#xD;
      The safety and effectiveness of the MOs will be evaluated through a non-inferiority trial in&#xD;
      which patients are randomized to care by a trained MO or an anesthesiologist. The primary&#xD;
      outcomes are safety (adherence to adapted anesthesia safety checklist- see supporting&#xD;
      documents &quot;Adapted Anesthesia Safety Checklist&quot;) and effectiveness (adequate analgesia) of&#xD;
      spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The vast majority of the world is without access to surgical and anesthesia care, and a&#xD;
      severe workforce shortage is a major contributing factor. The Lancet Commission on Global&#xD;
      Surgery (LCoGS) demonstrated that Africa and South Asia, home to over a third of the global&#xD;
      population, lay claim to just 12% of surgeons, anesthesiologists and obstetricians. This&#xD;
      workforce shortage may be particularly severe for anesthesia care given that anesthesiologist&#xD;
      make up less than 20% of surgical care providers globally. In a series of qualitative&#xD;
      interviews, providers across three continents noted that in rural and under-resourced areas,&#xD;
      it was unlikely that there was a surgeon and an anesthesiologist in the same place.&#xD;
&#xD;
      In India, the concerns of under-provision of human resources in the rural area are especially&#xD;
      severe. The Lancet commission on Global Surgery estimates that while 68% of Indians live in&#xD;
      rural areas, only 22% of the health care workforce does. For specialist services, which are&#xD;
      even more urbanized, the disparity is likely greater. The result is that, in South Asia, 95%&#xD;
      of people are estimated to lack access to safe, affordable and timely surgical care.&#xD;
&#xD;
      In India, which is home to nearly 400 medical schools, it may be posited that the country is&#xD;
      well positioned to close this gap. However, the number of postgraduate training seats -&#xD;
      14,000 countrywide - are entirely insufficient for the 50,000 doctors that graduate each&#xD;
      year. With only 1500 postgraduate training seats for anesthesia, a graduate who may otherwise&#xD;
      aspire to train in anesthesia instead remains generalist MO or seeks training elsewhere. The&#xD;
      World Health Organization suggests that a presence of anesthesiologists in rural India may be&#xD;
      so scarce it is &quot;non-existent.&quot;. It has also been estimated that 43% of the Indian population&#xD;
      lives more than 50km from their nearest health center, 76% of which do not have an&#xD;
      anesthesiologist.&#xD;
&#xD;
      The result of these human resource limitations, is that rural Indian surgeons often&#xD;
      administer anesthesia for their patient prior to performing necessary surgeries or medical&#xD;
      officers with only ad hoc training provide anesthesia care. The de facto standard of care in&#xD;
      rural India, ends up being the provision of anesthesia by a surgeon or untrained medical&#xD;
      officer. While advocacy towards increasing post-graduate education must continue, it is also&#xD;
      clear that interim measures are needed to improve upon current baseline practices.&#xD;
&#xD;
      One such measure suggested by the Disease Control Priorities 3 (DCP3), the LCoGS, and others&#xD;
      is the concept of &quot;task-based credentialing.&quot; In this model of credentialing, physicians are&#xD;
      trained and credentialed in a limited set of procedures. Task sharing - a process by which&#xD;
      non-specialists take on whole-sale the tasks typically performed by a specialist - is&#xD;
      prevalent in the provision of anesthesia care worldwide. However, a recent meta-analysis&#xD;
      evaluated outcomes for task-sharing in anesthesia in 15 LMIC and found that administration of&#xD;
      anesthesia by a non-physician was a risk-factor for maternal mortality. To mitigate these&#xD;
      concerns, task-based credentialing focuses on the training of non-specialist medical officers&#xD;
      in a discrete, well-defined task and includes training to deal with the possible&#xD;
      complications. This task-based training would serve as an improvement on the de facto&#xD;
      standard of care in rural India by providing specific training in place of ad hoc learning.&#xD;
&#xD;
      The provision of spinal anesthesia is thought to be well-suited for this form of training.&#xD;
      The procedure involves the injection of a local anesthetic agent into the subarachnoid space.&#xD;
      This allows for analgesia and anesthesia below the level of injection. This procedure is&#xD;
      widely used in general surgery, obstetric surgery, and orthopedic surgery. Moreover, the use&#xD;
      of spinal anesthesia is particularly well-adapted to rural care as it is less expensive than&#xD;
      general anesthesia and has a lower requirement of infrastructure and disposables when&#xD;
      compared to general anesthesia.&#xD;
&#xD;
      Test the safety and effectiveness of training medical officers in the provision of spinal&#xD;
      anesthesia in a rural hospital context using a non-inferiority randomized trial.&#xD;
&#xD;
      The safety and effectiveness of the MOs will be evaluated through a non-inferiority trial in&#xD;
      which patients are randomized to care by a trained MO or an anesthesiologist. The primary&#xD;
      outcomes are safety (adherence to adapted anesthesia safety checklist- see supporting&#xD;
      documents &quot;Adapted Anesthesia Safety Checklist&quot;) and effectiveness (adequate analgesia) of&#xD;
      spinal anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 10, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful delivery of spinal anaesthesia</measure>
    <time_frame>Assessed pre-operatively following recruitment and consent (day 0 of the follow up period)</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative Complications</measure>
    <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</time_frame>
    <description>Incidence of post-dural puncture headache, epidural haematoma, spinal abscess and neurological deficit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experience measures</measure>
    <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</time_frame>
    <description>Patient reported experience measures of clinical care and pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Complications</measure>
    <time_frame>Assessed intraoperatively during surgical procedure</time_frame>
    <description>The incidence of hypotension, bradycardia, high spinal, apnoea and hypoxia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">486</enrollment>
  <condition>Spinal Anesthesia</condition>
  <condition>Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care</condition>
  <arm_group>
    <arm_group_label>Consultant Anesthetist</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who are randomized to this arm will receive their spinal anesthesia froma consultant anesthetist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Officer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>delivery of the spinal anesthetic by a trained medical officer</intervention_name>
    <description>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.</description>
    <arm_group_label>Medical Officer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>delivery of spinal anesthetic by a consultant anesthetist</intervention_name>
    <description>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.</description>
    <arm_group_label>Consultant Anesthetist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria for MOs&#xD;
&#xD;
          -  Consent to participate in practical training and clinical trial (consent process will&#xD;
             be repeated)&#xD;
&#xD;
          -  Successful completion of the theoretical and simulation training&#xD;
&#xD;
          -  Be deemed safe to continue to practical training by their supervising Anesthesiologist&#xD;
&#xD;
          -  Feel comfortable to proceed to practical training&#xD;
&#xD;
        Inclusion criteria for patients&#xD;
&#xD;
          -  Age 18-65&#xD;
&#xD;
          -  Undergoing one of the surgeries noted in supporting document &quot;List of surgeries for&#xD;
             patient inclusion criteria&quot; or otherwise deemed appropriate for spinal anesthesia as&#xD;
             determined by surgeon and supervising anesthesiologist&#xD;
&#xD;
               -  Willingness to provide informed consent&#xD;
&#xD;
               -  ASA (American Society of Anesthesiology Physical Status Classification System)&#xD;
                  grades I and II&#xD;
&#xD;
        Inclusion criteria for Consultant Anesthetists&#xD;
&#xD;
          -  Anesthetist licensed to practice independently with availability to provide care at&#xD;
             one of the selected sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria for MOs&#xD;
&#xD;
          -  Recent suspension from clinical practice&#xD;
&#xD;
          -  Due to change sites or retire before the expected end date of the trial&#xD;
&#xD;
        Exclusion criteria for patients&#xD;
&#xD;
          -  Obese (BMI &gt; 35)&#xD;
&#xD;
          -  Refusal of consent to participate in trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Craig D McClain, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital, Harvard Medical School, Program in Global Surgery and Social Change</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JSS Hospital</name>
      <address>
        <city>Ganiyari</city>
        <state>Chhattisgarh</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashwini Hospital</name>
      <address>
        <city>Gudalur</city>
        <state>Tamil Nadu</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sittilingi Tribal Hospital</name>
      <address>
        <city>Harur</city>
        <state>Tamil Nadu</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Meara JG, Leather AJ, Hagander L, Alkire BC, Alonso N, Ameh EA, Bickler SW, Conteh L, Dare AJ, Davies J, Merisier ED, El-Halabi S, Farmer PE, Gawande A, Gillies R, Greenberg SL, Grimes CE, Gruen RL, Ismail EA, Kamara TB, Lavy C, Lundeg G, Mkandawire NC, Raykar NP, Riesel JN, Rodas E, Rose J, Roy N, Shrime MG, Sullivan R, Verguet S, Watters D, Weiser TG, Wilson IH, Yamey G, Yip W. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015 Aug 8;386(9993):569-624. doi: 10.1016/S0140-6736(15)60160-X. Epub 2015 Apr 26. No abstract available.</citation>
    <PMID>25924834</PMID>
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    <citation>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.</citation>
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    <citation>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.</citation>
    <PMID>24218153</PMID>
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  <reference>
    <citation>Bergstrom S, McPake B, Pereira C, Dovlo D. Workforce Innovations to Expand the Capacity for Surgical Services. In: Debas HT, Donkor P, Gawande A, Jamison DT, Kruk ME, Mock CN, editors. Essential Surgery: Disease Control Priorities, Third Edition (Volume 1). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2015 Apr 2. Chapter 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK333504/</citation>
    <PMID>26741003</PMID>
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    <citation>Holmer H, Lantz A, Kunjumen T, Finlayson S, Hoyler M, Siyam A, Montenegro H, Kelley ET, Campbell J, Cherian MN, Hagander L. Global distribution of surgeons, anaesthesiologists, and obstetricians. Lancet Glob Health. 2015 Apr 27;3 Suppl 2:S9-11. doi: 10.1016/S2214-109X(14)70349-3. No abstract available.</citation>
    <PMID>25926323</PMID>
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  <reference>
    <citation>Dubowitz G, Detlefs S, McQueen KA. Global anesthesia workforce crisis: a preliminary survey revealing shortages contributing to undesirable outcomes and unsafe practices. World J Surg. 2010 Mar;34(3):438-44. doi: 10.1007/s00268-009-0229-6.</citation>
    <PMID>19795163</PMID>
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    <citation>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.</citation>
    <PMID>28588908</PMID>
  </reference>
  <reference>
    <citation>Raykar NP, Yorlets RR, Liu C, Greenberg SL, Kotagal M, Goldman R, Roy N, Meara JG, Gillies RD. A qualitative study exploring contextual challenges to surgical care provision in 21 LMICs. Lancet. 2015 Apr 27;385 Suppl 2(Suppl 2):S15. doi: 10.1016/S0140-6736(15)60810-8. Epub 2015 Apr 26.</citation>
    <PMID>26313061</PMID>
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  <reference>
    <citation>Alkire BC, Raykar NP, Shrime MG, Weiser TG, Bickler SW, Rose JA, Nutt CT, Greenberg SL, Kotagal M, Riesel JN, Esquivel M, Uribe-Leitz T, Molina G, Roy N, Meara JG, Farmer PE. Global access to surgical care: a modelling study. Lancet Glob Health. 2015 Jun;3(6):e316-23. doi: 10.1016/S2214-109X(15)70115-4. Epub 2015 Apr 27.</citation>
    <PMID>25926087</PMID>
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  <reference>
    <citation>MUZAFFARNAGAR, I. Special Report: Why India's medical schools are plagued with fraud. Available from: http://www.reuters.com/article/us-india-medicine-education- specialrepor-idUSKBN0OW1NM20150617.</citation>
  </reference>
  <reference>
    <citation>Shetty, D., Reform medical education, transform healthcare, in The Times of India. 2015.</citation>
  </reference>
  <reference>
    <citation>Cherian M, Choo S, Wilson I, Noel L, Sheikh M, Dayrit M, Groth S. Building and retaining the neglected anaesthesia health workforce: is it crucial for health systems strengthening through primary health care? Bull World Health Organ. 2010 Aug 1;88(8):637-9. doi: 10.2471/BLT.09.072371. Epub 2010 May 10. No abstract available.</citation>
    <PMID>20680130</PMID>
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    <citation>Dare AJ, Ng-Kamstra JS, Patra J, Fu SH, Rodriguez PS, Hsiao M, Jotkar RM, Thakur JS, Sheth J, Jha P; Million Death Study Collaborators. Deaths from acute abdominal conditions and geographical access to surgical care in India: a nationally representative spatial analysis. Lancet Glob Health. 2015 Oct;3(10):e646-53. doi: 10.1016/S2214-109X(15)00079-0. Epub 2015 Aug 13. Erratum In: Lancet Glob Health. 2015 Nov;3(11):e680.</citation>
    <PMID>26278186</PMID>
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    <citation>Gnanaraj J, Jason LY, Khiangte H. High quality surgical care at low cost: the diagnostic camp model of Burrows Memorial Christian Hospital (BMCH). Indian J Surg. 2007 Dec;69(6):243-7. doi: 10.1007/s12262-007-0034-0. Epub 2008 Jan 28.</citation>
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    <citation>Federspiel F, Mukhopadhyay S, Milsom P, Scott JW, Riesel JN, Meara JG. Global surgical and anaesthetic task shifting: a systematic literature review and survey. Lancet. 2015 Apr 27;385 Suppl 2:S46. doi: 10.1016/S0140-6736(15)60841-8. Epub 2015 Apr 26.</citation>
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    <citation>Sobhy S, Zamora J, Dharmarajah K, Arroyo-Manzano D, Wilson M, Navaratnarajah R, Coomarasamy A, Khan KS, Thangaratinam S. Anaesthesia-related maternal mortality in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Glob Health. 2016 May;4(5):e320-7. doi: 10.1016/S2214-109X(16)30003-1.</citation>
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  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard Medical School (HMS and HSDM)</investigator_affiliation>
    <investigator_full_name>Craig McClain</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>global health</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04438811
org study id: IRB17-0624
nct id: NCT04438811
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Successful delivery of spinal anaesthesia
time frame: Assessed pre-operatively following recruitment and consent (day 0 of the follow up period)
description: 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
measure: 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
description: Incidence of post-dural puncture headache, epidural haematoma, spinal abscess and neurological deficit
measure: 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
description: Patient reported experience measures of clinical care and pain
measure: Intraoperative Complications
time frame: Assessed intraoperatively during surgical procedure
description: The incidence of hypotension, bradycardia, high spinal, apnoea and hypoxia
arm group label: Consultant Anesthetist
arm group type: Other
description: Patients who are randomized to this arm will receive their spinal anesthesia froma consultant anesthetist
arm group label: Medical Officer
arm group type: Other
description: 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.
intervention type: Other
intervention name: delivery of the spinal anesthetic by a trained medical officer
description: 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.
arm group label: Medical Officer
intervention type: Other
intervention name: delivery of spinal anesthetic by a consultant anesthetist
description: 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.
arm group label: Consultant Anesthetist
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Craig D McClain, MD, MPH
role: Principal Investigator
affiliation: Boston Children's Hospital, Harvard Medical School, Program in Global Surgery and Social Change
facility: 
facility: 
facility: 
facility: 
country: India
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Harvard Medical School (HMS and HSDM)
investigator full name: Craig McClain
investigator title: Principle Investigator
mesh term: Anesthetics