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

NCT03135080 | Completed

• 1 other identifier: 17-0423
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Trichiasis; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in overall live-surgery training assessment scores between baseline and follow up

  6 months

• Change in individual criterion scores for live surgery skills

  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

  6 months

Study Arms (2)

Long-term HEAD START Training

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Long-Term HEAD START Training 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.

Long-term HEAD START Training

Standard of Care 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.

Standard of Care

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who have been selected to complete either
• new trichiasis surgery training through the Orbis Ethiopia of FHF training program OR
• 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.

You may not qualify if:

• Experienced surgeons who are retiring from surgical practice.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• International Agency for the Prevention of Blindness: collaborator

Study Sites (3)

Arbaminch Health Center

Gama Goffa, Southern Nations, Nationalities, and Peoples Region, 41042, Ethiopia

Location

Sodo Health Center

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

Location

Wolkite Health Center

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

Location

MeSH Terms

Conditions

Trichiasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Emily W Gower

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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. The assessor will not know whether surgeons had participated in the long-term HEAD START training over the rainy season.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: May 1, 2017
• Study Start: May 17, 2017
• Primary Completion: February 26, 2018
• Study Completion: February 26, 2018
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ET (3)