The Effect of Long-Term HEAD START Training on Surgical Skill Levels
Condition: Trichiasis; Surgery
MeSH terms: Trichiasis
Study type: Interventional

Summary: 
      The research group developed a surgical simulation device, the Human Eyelid Analogue Device
      for Surgical Training And skill Reinforcement in Trachoma (HEAD START), to bridge the gap
      between classroom and live-surgery training specifically for trichiasis surgery. In most
      settings, HEAD START is utilized once during training, then surgeons move on to live surgery
      and typically do not return to the simulator. The research team is interested in determining
      whether HEAD START provides benefit for long-term trichiasis surgery training, since many
      surgeons operate seasonally, with long periods of downtime between surgical camps and with
      little field supervision.

      Participating surgeons will practice on HEAD START weekly, with monthly feedback from a
      senior supervisor. Researchers will assess their skill level at the start of HEAD START
      training and again at the start of the new surgical season in the fall of 2017. Researchers
      will also administer questionnaires to elicit feedback on the HEAD START training and
      supervision process.
    

Detailed description: 
      Eliminating blinding trachoma by 2020 is a key goal of the World Health Organization (WHO).
      Nearly 8 million individuals worldwide are in need of trichiasis surgery to prevent
      blindness.1 Currently, many trichiasis surgery programs experience poor outcomes in 10-50% of
      patients.2-11 High-quality surgery with minimal post-operative trichiasis is critical for
      success of the WHO goals. Typically, non-physician "surgeons" perform the procedure.
      Historically, they have been provided with one-week of classroom training and then begin live
      surgery training.

      The research group developed a surgical simulation device, the Human Eyelid Analogue Device
      for Surgical Training And skill Reinforcement in Trachoma (HEAD START), to bridge the gap
      between classroom and live-surgery training specifically for trichiasis surgery. Based on
      this work, the WHO now recommends that all trainees receive training with a surgical
      simulation device before performing live surgery and that any refresher training should
      include simulation training as well.

      In most settings, HEAD START is utilized once during training, meaning that once individuals
      are trained on HEAD START, they move on to live surgery and typically do not return to the
      simulator. In surgical sub-specialties with ready access to simulation devices, regular
      surgical simulation practice is utilized for skills maintenance and enhancement. The research
      team is interested in determining whether HEAD START provides benefit for long-term
      trichiasis surgery training, since many surgeons operate seasonally, with long periods of
      downtime between surgical camps and with little field supervision.

      This project will compare skills of surgical trainees who continued with HEAD START practice
      and feedback throughout a 6-month break in surgery with those who did not. Study subjects
      will be selected based on their participation in an ORBIS-sponsored trichiasis surgery
      training program (either new training or refresher/conversion training). At the end of the
      standard training, the trainees who successfully complete training are ranked according to
      their scores on a classroom-based test and the WHO certification/assessment form. All
      individuals who successfully complete the training session and are scheduled to begin
      independent trichiasis surgery practice through the National Eye Care Program will be invited
      to participate in the study until we have reached 30 participants. Fifteen trainees will be
      invited to participate in long-term HEAD START practice in addition to performing regular
      live surgery. An additional 15 individuals will be selected for the trainer to assess their
      skill levels on live surgery at the end of training and again at the start of the surgical
      season this fall.
    

Intervention name(s): Long-Term HEAD START Training; Standard of Care
Intervention type(s): Other; Other
Intervention description(s): The Human Eyelid Analogue Device for Surgical Training And skill Reinforcement in Trachoma (HEAD START) is a surgical simulation device used to bridge the gap between classroom and live-surgery training specifically for trichiasis surgery. Long-term HEAD START practice will involve the following components, after completion of standard training (as described in the standard of care arm). Each week the participant will complete 2 surgeries on the HEAD START device. Monthly, the participant will send the accumulated cartridges to Addis Ababa for review by a senior trichiasis surgery trainer. The trainer will evaluate the cartridges and then will discuss his impression of the surgeries with the participant during a regular monthly call and note the findings. Practice will continue for 4-6 months, depending on the length of the rainy season and time of enrollment. At the end of the rainy season, an external examiner will evaluate the first 2 surgeries that the participant completes.; All participants will receive trichiasis surgery training following Orbis' standard training approach, with the inclusion of HEAD START training between classroom and live surgery training. At the end of the surgical training session, an independent examiner will evaluate all trainees using the World Health Organization's Final Assessment of Surgeons form, as part of standard practice. The examiner also will complete a standard questionnaire focusing on the specific skill level achieved for each of the critical aspects of TT surgery. This form will be completed for all trainees undergoing training this spring, regardless of whether they are part of the long-term HEAD START assessment program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All study participants will have their skill levels on live surgery evaluated at the end of surgical training and again at the start of the surgical season, approximately 6 months later. Fifteen trainees will participate in long-term HEAD START practice and receive feedback throughout this break during the rainy season when surgical activity is low. An additional 15 individuals will be selected for the trainer to assess their skill levels on live surgery at the end of training and again at the start of the surgical season this fall but will not receive additional surgical practice.
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research