Task-based Credentialing for Medical Officers in Spinal Anesthesia: an Innovative Approach to the Specialist Workforce Crisis in Rural Indian Hospitals
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- The time period depends on the number of patients needing surgical intervention under spinal anesthesia, who can enroll in the study.
研究概览
简要总结
Rationale
In ruralIndia, it is uncommon for hospitals to be staffed with both a surgeon and ananesthesiologist, resulting in poor access to surgical care and patientmorbidity and mortality. “Task-based credentialing†of rural medical officersin spinal anaesthesia is an innovative proposed solution to improve volume ofsurgical procedures and thereby avert preventable morbidity and mortality.
Objectives
Thespecific objectives of the project are;
1. Development of a spinal anaesthesiacurriculum and recruitment of trainees
2. Training of medical officers inprovision of spinal anesthesia, including theoretical, simulation and practical
3. Conducting a noninferiority study ofmedical officers versus anesthesiologist in provision of spinal anesthesia
Asecondary objective includes the credentialing of trainees following successfulcompletion of the 3 part educational curriculum (theory, simulation andpractical) and proven non-inferiority
Methods
The studyconsists of three phases:
1) *Development of curriculum:*Designing a spinal anaesthesia curriculum for “trainees†(medical officers) forthe rural Indian hospital context. Content will include spinal anesthesiatechnique and managing complications, and methods will include a theoreticalonline learning platform, hands-on mannequin simulators and practical training.Three sites will collaborate on this curriculum design; ASHWINI Gudalur AdivasiHospital, SEESHA Karunya University, and Harvard Medical School.
2) *Training:*Preliminary theoretical training and then practical supervised training acrossthree rural hospitals (see appendix 10).
3) Non-inferiority trial:A randomized, non-inferiority trial across the same facilities comparing trainees to anesthesiologists on parametersmeasuring safety and effectiveness outcomes.
Expected Outcomes
1) Development of a curriculum onspinal anesthesia specific to rural Indian hospitals medical officers
2) Training of five medical officers toprovide spinal anesthesia for surgery in rural Indian hospitals
3) Completion of a non-inferioritystudy comparing medical officers to anesthesiologists on outcomes of rates ofinadequate analgesia, up to 72 hour complications, and adherence to a safetychecklists
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are posted for spinal anaesthesia.
排除标准
- •Refusal of consent.
结局指标
主要结局
The time period depends on the number of patients needing surgical intervention under spinal anesthesia, who can enroll in the study.
时间窗: We anticipate that the requisite number of patients will be obtained by June 2019
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
时间窗: We anticipate that the requisite number of patients will be obtained by June 2019
次要结局
- 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)