The Effect of Long-Term HEAD START Training on Surgical Skill Levels

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Trichiasis
• Intervention / Treatment: Other: Long-Term HEAD START Training; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Southern Nations, Nationalities, And Peoples Region
    • Gama Goffa, Southern Nations, Nationalities, And Peoples Region, Ethiopia, 41042
      • Arbaminch Health Center
    • Wolaita, Southern Nations, Nationalities, And Peoples Region, Ethiopia
      • Sodo Health Center
  • Southerns Nations, Nationalities, And Peoples Region
    • Gurage, Southerns Nations, Nationalities, And Peoples Region, Ethiopia
      • Wolkite Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Long-term HEAD START Training; Fifteen surgeons will participate in long-term HEAD START practice once live surgical training is complete. Each week the participant will complete 2 surgeries on the HEAD START device and mark the surgery number on the cartridge. Monthly, the participant will send the accumulated cartridges to Addis for review by a senior trichiasis surgery trainer. The trainer will evaluate the cartridges and then will discuss his/her impression of the surgeries with the participant during a regular monthly call. He/she will also note the findings on a standardized form. Practice will continue for approximately 4-6 months, depending on the length of the rainy season and time of enrollment.	Other: Long-Term HEAD START Training; 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.
ACTIVE_COMPARATOR: Standard of Care; Once live surgical training is complete, fifteen surgeons will commence live surgery without supervision until the rainy season begins. Then they will break for the rainy season, per the typical practice. The trainer will assess their skill levels on live surgery at the end of training and again at the start of the surgical season in the fall.	Other: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who feel long-term HEAD START use is beneficial for their surgical practice.	All participants and the senior trainers who conducted the monthly evaluations will be asked to complete an end of project questionnaire documenting their experience with HEAD START regarding the usefulness of regular surgical simulation practice, value of the monthly calls, and any recommendations for changes to the approach. Trainee and trainer responses to an end-of-project questionnaire regarding the utility of incorporating regular HEAD START practice will be analyzed to understand the benefit of regular HEAD START practice.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in overall live-surgery training assessment scores between baseline and follow up	At the end of initial surgical trainings and again at the end of the rainy season, an independent examiner (not involved in the HEAD START evaluations) will assess the first 1-2 surgeries of the season of all study participants and all surgeons who successfully completed training in the spring but were not part of the long-term HEAD START assessment program. This assessment includes standard rankings of trainee skill.	6 months
Change in individual criterion scores for live surgery skills	At the end of initial surgical trainings and again at the end of the rainy season, an independent examiner (not involved in the HEAD START evaluations) will assess the first 1-2 surgeries of the season of all study participants and all surgeons who successfully completed training in the spring but were not part of the long-term HEAD START assessment program. This assessment includes standard rankings of trainee skill. Individual criterion scores for live surgery skills include incision placement and suturing placement, spacing and alignment	6 months
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	Comparison in change in scores for individuals who were the most highly active surgeons versus those who were the least active but followed the HEAD START protocol. Surgeons will provide a record of the number of surgeries they completed each month (as part of standard practice). Criterion scores described in outcome 3 will be used to compare rates of change across level of surgical productivity (the number of surgeries performed).	6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: International Agency for the Prevention of Blindness
• Investigators: Principal Investigator: Emily W Gower, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2017
• Primary Completion (ACTUAL): February 26, 2018
• Study Completion (ACTUAL): February 26, 2018

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (ACTUAL): May 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Trichiasis
• Other Study ID Numbers: 17-0423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No