TrichiasisNCT03135080
The Effect of Long-Term HEAD START Training on Surgical Skill Levels
A study testing Long-Term HEAD START Training in people with Trichiasis and Surgery, run by University of North Carolina, Chapel Hill at 3 sites in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Trichiasis, Surgery
- What is being tested?
- Long-Term HEAD START Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesEthiopia
- Study dates
- 17 May 2017to 26 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Experienced surgeons who are retiring from surgical practice.
Trial locations and contacts
3 sites in 1 country.
Ethiopia3 sites
Arbaminch Health Center
Gama Goffa, Southern Nations, Nationalities, and Peoples Region, 41042
Wolkite Health Center
Guragē, Southerns Nations, Nationalities, and Peoples Region
Sodo Health Center
Wolaita, Southern Nations, Nationalities, and Peoples Region
About this study
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.
Read the 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
- Being tested
- Long-Term HEAD START Training, Standard of Care
- Medical subject headings
- Trichiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-Term HEAD START TrainingOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start17 May 2017
- Primary completion26 Feb 2018
- Study completion26 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrichiasisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- International Agency for the Prevention of Blindness
- Responsible party
- Sponsor
- Investigators
- Emily W Gower, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135080
- Sponsor's protocol ID
- 17-0423
- Status last verified
- Mar 2018
- First submitted
- 11 Apr 2017
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-Term HEAD START Training on Surgical Skill Levels
- ClinicalTrials.gov ID
- NCT03135080
- Acronym / sponsor ID
- 17-0423
- Conditions
- Trichiasis, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- International Agency for the Prevention of Blindness
- Study start
- 17 May 2017 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Long-term HEAD START Training | Experimental | Other: Long-Term HEAD START TrainingFifteen 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. |
| Standard of Care | Active comparator | Other: Standard of CareOnce 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who have been selected to complete either
- Plans to continue practicing as a trichiasis surgeon throughout 2017.
Key exclusion criteria (1 listed)
- Experienced surgeons who are retiring from surgical practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-Term HEAD START TrainingThe 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. | Other | Long-term HEAD START Training |
| Standard of CareAll 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. | Other | Standard of Care |
Primary outcome
Number of participants who feel long-term HEAD START use is beneficial for their surgical practice.
Time frame: 6 months
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.
3 secondary outcomes
Change in overall live-surgery training assessment scores between baseline and follow up
Time frame: 6 months
Change in individual criterion scores for live surgery skills
Time frame: 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
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Trichiasis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily W Gower principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-Term HEAD START Training in people with Trichiasis and Surgery, run by University of North Carolina, Chapel Hill at 3 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who feel long-term HEAD START use is beneficial for their surgical practice. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.