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

NCT ID: NCT03135080

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2018-02-26

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.

Conditions

Trichiasis; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Long-Term HEAD START Training

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Agency for the Prevention of Blindness

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily W Gower

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Arbaminch Health Center

Gama Goffa, Southern Nations, Nationalities, and Peoples Region, Ethiopia

Sodo Health Center

Wolaita, Southern Nations, Nationalities, and Peoples Region, Ethiopia

Wolkite Health Center

Guragē, Southerns Nations, Nationalities, and Peoples Region, Ethiopia

Countries

Ethiopia

Other Identifiers

17-0423

Identifier Type: -

Identifier Source: org_study_id