Clinical trial NCT03135080: The Effect of Long-Term HEAD START Training on Surgical Skill Levels
Official title: The Effect of Long-Term HEAD START Training on Surgical Skill Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichiasis
Surgery
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: International Agency for the Prevention of Blindness
First posted: 2017-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Individuals who have been selected to complete either

  1. new trichiasis surgery training through the Orbis Ethiopia of FHF training program OR
  2. refresher training for transitioning from bilamellar tarsal rotation surgery to posterior lamellar tarsal rotation surgery.
* Plans to continue practicing as a trichiasis surgeon throughout 2017.

Exclusion Criteria:

* Experienced surgeons who are retiring from surgical practice.

Primary outcomes:
measure: Number of participants who feel long-term HEAD START use is beneficial for their surgical practice.
timeFrame: 6 months
Secondary outcomes:
measure: Change in overall live-surgery training assessment scores between baseline and follow up
timeFrame: 6 months
measure: Change in individual criterion scores for live surgery skills
timeFrame: 6 months
measure: Change in individual criterion scores for live surgery skills among long-term HEAD START participants, comparing those who were the most highly active surgeons versus those who were the least active
timeFrame: 6 months
Other outcomes:
Locations:
city: Gama Goffa
country: Ethiopia
facility: Arbaminch Health Center
state: Southern Nations, Nationalities, And Peoples Region
city: Wolaita
country: Ethiopia
facility: Sodo Health Center
state: Southern Nations, Nationalities, And Peoples Region
city: Gurage
country: Ethiopia
facility: Wolkite Health Center
state: Southerns Nations, Nationalities, And Peoples Region
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Emily W Gower
role: PRINCIPAL_INVESTIGATOR
References: