CataractNCT02621840
A Proposed Intervention to Decrease Resident-Performed Cataract Surgery Cancellation
A study testing Mandatory On-Site Pre-Admission Testing in people with Cataract, run by Wills Eye at 1 site in United States.
Trial summary
The investigators aim to investigate the impact of mandating on-site pre-admission testing on cataract cancellation rates in a randomized, prospective, intervention study. Cataract extraction is the most commonly performed ocular surgery making surgical training an integral component of ophthalmology residency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Mandatory On-Site Pre-Admission Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient scheduled for cataract surgery in the resident CPEC clinic at Wills Eye Hospital from the time period of 1/5/15 to 11/30/15.
Who cannot join
- All prisoners, nursing home, dialysis patients, and patients under 18 years of age will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
The investigators aim to investigate the impact of mandating on-site pre-admission testing on cataract cancellation rates in a randomized, prospective, intervention study. Cataract extraction is the most commonly performed ocular surgery making surgical training an integral component of ophthalmology residency. Patient cancellation of surgery results in a financial burden to the institution and a loss of essential educational experiences for the residents. An earlier study explored variables impacting cancellation rates and identified incomplete pre-admission testing as a major contributing factor to surgery cancellation.
Patients will be randomized to either 1) the intervention group where on-site pre-admission testing will be mandated or 2) the control group, where on-site pre-admission testing will be offered but not mandated. Cancellation rates will be collected prospectively and statistical analysis utilized to evaluate the significance of intervention.
Read the detailed description
Cataract surgery is the most commonly performed eye surgery in the US, and it is vital for ophthalmology residents to have a high quality cataract surgery experience during their supervised training years. This allows trainees to feel comfortable performing ocular surgery and managing associated complications in a variety of clinical settings. Aspiring ophthalmologists desire a high level of surgical comfort and competence, and often times, prospective applicants to residency programs use the surgical volume and quality of training, particularly cataract surgery, as a surrogate measure for the overall quality of the residency program. This encourages residency programs to provide the most robust surgical experience possible.
Residency programs provide various levels of exposure to cataract surgery during training, from providing surgical stimulators to wet labs, where residents can practice surgical maneuvers on pig or cow eyes. These studies show that using such devices improve a resident's operative skill level, translating to greater efficiency and lower intra-operative complication rates. While practice through wet labs and surgical stimulation are clearly beneficial, there is no substitute for direct experience performing cataract surgery in the operating room. Complication rates in resident-performed cataract surgery were found to drop 50% after the resident's first 40 cases. A study evaluating the first 3000 phacoemulsification procedures of an experienced surgeon found a substantial decrease in the rate of major complications after the first 100 procedures. Another study investigating the first 1000 phacoemulsification cases performed by an experienced surgeon found an 8.4% decrease in both major and minor complications after the first 150 cases (9.3% to 0.9%).
Therefore, it is critical that ophthalmology residency programs provide a robust clinical cataract curriculum that affords residents the ability to maximize their surgical exposure and experience. Substantial exposure however, is prevented by the high rates of cancellation of cataract surgeries. This is a widespread phenomenon seen at various eye care institutions. A study of all eye surgeries cancelled at an ambulatory surgicenter in Boston found a 5.3% cancellation rate within 24 hours of the procedure, leading to a loss of at least $100,000 per year with 41% of cancellations considered preventable. Case cancellation data for 123 Veterans Administration (VA) facilities throughout 2006 showed a 9% cancellation rate for ophthalmic surgeries, with 35% of cancellations being due to "patient factors" followed by 28% due to "work up/medical condition change".
A prior study at Wills Eye Hospital found that out of the 1,083 surgeries scheduled through the Cataract and Primary Eye Care Clinic (CPEC) from 7/1/11 through 6/3/0/12, 319 (29.5%) were canceled. Of these cancellations, 72% were cancelled within 7 days of the procedure, not permitting enough time to reassign the operating room slot. Internal economic analysis at Wills has estimated lost reimbursement of these cancellations was $607,946, with $391,884 of the lost revenue from facility fees. Additionally, this is a relative loss of 230 resident surgical experiences or 28.75 surgeries missed per resident. Considered together, these findings mean that Wills Eye Hospital is not reaching its full clinical and economic potential in providing cataract surgery experience; more specifically, the institution is functioning at 86% of its capacity for cataract surgery procedures. It is apparent that the high rate of cataract surgery cancellation affects this teaching hospital both academically and economically. There is a cost to the residents who are losing valuable experience, the attending staff, and the institution as a whole.
The prior study also revealed that the most common reason for cataract surgery cancellation is patients' failure to complete pre-admission testing (PAT). While routine pre-operative testing is not supported in otherwise healthy patients undergoing elective non-cardiac surgeries, these tests are used to provide a baseline, elicit preventative measures and minimize post-operative risk. Improvement of the pre-admission testing process is modifiable and therefore presents an opportunity for intervention. Other modifiable reasons for cancellation include lack of transportation, and failure to remember not to eat the night before the procedure.
Past experience at Wills indicates that there are roughly 1100 resident cataract surgeries scheduled each year. The cancellation rate for a similar period of time determined from Assessing Cancellation Rates and Barriers to Completion of Resident Performed Cataract Surgery at Wills Eye Hospital was 29.45%, or approximately 320 cancellations per year. The investigators propose to test an intervention to address these modifiable reasons for cancellation.
Patients will be randomized to either 1) the intervention group where on-site pre-admission testing will be mandated or 2) the control group, where on-site pre-admission testing will be offered but not mandated. The intervention will be coupled with personalized patient communication appropriately timed before the scheduled procedure. Multiple studies have shown that scheduled pre-operative visitation and assessment and enhanced communication between the physician and the patient contribute to decreased cancellation of surgeries. It has been found that anesthesia-run pre-operative clinic visits significantly decrease cancellations and delays of same-day surgeries. Additionally, older patients were found to have the greatest decrease in cancellation rates after preoperative anesthesia clinic visits. At VA facilities throughout America, surgeons at low cancellation rate sites reported higher use of written preoperative instructions and pre-operative clinic visits. Cancellation rates will be collected prospectively and statistical analysis utilized to evaluate the significance of intervention.
- Conditions
- Cataract
- Being tested
- Mandatory On-Site Pre-Admission Testing
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandatory On-Site Pre-Admission TestingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients in the intervention group will be mandated to complete the PAT with Dr. Koka. After scheduling the surgery with the surgical coordinator, intervention patients will be required to go directly to Dr. Koka's office, to complete all necessary pre-operative steps. Receives: Behavioral: Mandatory On-Site Pre-Admission Testing |
| Usual Care | No intervention | Patients in the usual care group will be treated with the standard protocol that is currently utilized in the Wills Eye Hospital Cataract and Primary Eye Care (CPEC) Service. After scheduling the surgery with the surgical coordinator, the patient will be given pre-admission testing (PAT) paperwork to be completed. The patient schedules the PAT on his or her own with the primary care physician.The patient will be given the information for Dr. Koka's cardiology office if he or she has any problem getting the PAT done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cataract Surgery Adherence Rate
The adherence rate to cataract surgery will be assessed in the usual care and intervention groups and compared.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Correlation between Cataract Surgery Adherence and Demographic/Clinical Characteristics
The relationship between patients' demographic/clinical characteristics and patients' adherence rates will be assessed.
Measured: Through study completion, an average of 1 year
Cost Analysis
A cost analysis will be performed to estimate revenue losses from cancelled surgical procedures and compare costs to the previous CPEC Innovation grant, "Assessing Cancellation Rates and Barriers to Completion of Resident Performed Cataract Surgery".
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bailey, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621840
- Sponsor's protocol ID
- IRB 14-414
- Other IDs
- 15072
- Status last verified
- Dec 2015
- First submitted
- 30 Nov 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript is under development.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proposed Intervention to Decrease Resident-Performed Cataract Surgery Cancellation
- ClinicalTrials.gov ID
- NCT02621840
- Acronym / sponsor ID
- IRB 14-414
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Dec 2015 (estimated)
- 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 investigators aim to investigate the impact of mandating on-site pre-admission testing on cataract cancellation rates in a randomized, prospective, intervention study. Cataract extraction is the most commonly performed ocular surgery making surgical training an integral component of ophthalmology residency. Patient cancellation of surgery results in a financial burden to the institution and a loss of essential educational experiences for the residents. An earlier study explored variables impacting cancellation rates and identified incomplete pre-admission testing as a major contributing factor to surgery cancellation.
Patients will be randomized to either 1) the intervention group where on-site pre-admission testing will be mandated or 2) the control group, where on-site pre-admission testing will be offered but not mandated. Cancellation rates will be collected prospectively and statistical analysis utilized to evaluate the significance of intervention.
Detailed description
Cataract surgery is the most commonly performed eye surgery in the US, and it is vital for ophthalmology residents to have a high quality cataract surgery experience during their supervised training years. This allows trainees to feel comfortable performing ocular surgery and managing associated complications in a variety of clinical settings. Aspiring ophthalmologists desire a high level of surgical comfort and competence, and often times, prospective applicants to residency programs use the surgical volume and quality of training, particularly cataract surgery, as a surrogate measure for the overall quality of the residency program. This encourages residency programs to provide the most robust surgical experience possible.
Residency programs provide various levels of exposure to cataract surgery during training, from providing surgical stimulators to wet labs, where residents can practice surgical maneuvers on pig or cow eyes. These studies show that using such devices improve a resident's operative skill level, translating to greater efficiency and lower intra-operative complication rates. While practice through wet labs and surgical stimulation are clearly beneficial, there is no substitute for direct experience performing cataract surgery in the operating room. Complication rates in resident-performed cataract surgery were found to drop 50% after the resident's first 40 cases. A study evaluating the first 3000 phacoemulsification procedures of an experienced surgeon found a substantial decrease in the rate of major complications after the first 100 procedures. Another study investigating the first 1000 phacoemulsification cases performed by an experienced surgeon found an 8.4% decrease in both major and minor complications after the first 150 cases (9.3% to 0.9%).
Therefore, it is critical that ophthalmology residency programs provide a robust clinical cataract curriculum that affords residents the ability to maximize their surgical exposure and experience. Substantial exposure however, is prevented by the high rates of cancellation of cataract surgeries. This is a widespread phenomenon seen at various eye care institutions. A study of all eye surgeries cancelled at an ambulatory surgicenter in Boston found a 5.3% cancellation rate within 24 hours of the procedure, leading to a loss of at least $100,000 per year with 41% of cancellations considered preventable. Case cancellation data for 123 Veterans Administration (VA) facilities throughout 2006 showed a 9% cancellation rate for ophthalmic surgeries, with 35% of cancellations being due to "patient factors" followed by 28% due to "work up/medical condition change".
A prior study at Wills Eye Hospital found that out of the 1,083 surgeries scheduled through the Cataract and Primary Eye Care Clinic (CPEC) from 7/1/11 through 6/3/0/12, 319 (29.5%) were canceled. Of these cancellations, 72% were cancelled within 7 days of the procedure, not permitting enough time to reassign the operating room slot. Internal economic analysis at Wills has estimated lost reimbursement of these cancellations was $607,946, with $391,884 of the lost revenue from facility fees. Additionally, this is a relative loss of 230 resident surgical experiences or 28.75 surgeries missed per resident. Considered together, these findings mean that Wills Eye Hospital is not reaching its full clinical and economic potential in providing cataract surgery experience; more specifically, the institution is functioning at 86% of its capacity for cataract surgery procedures. It is apparent that the high rate of cataract surgery cancellation affects this teaching hospital both academically and economically. There is a cost to the residents who are losing valuable experience, the attending staff, and the institution as a whole.
The prior study also revealed that the most common reason for cataract surgery cancellation is patients' failure to complete pre-admission testing (PAT). While routine pre-operative testing is not supported in otherwise healthy patients undergoing elective non-cardiac surgeries, these tests are used to provide a baseline, elicit preventative measures and minimize post-operative risk. Improvement of the pre-admission testing process is modifiable and therefore presents an opportunity for intervention. Other modifiable reasons for cancellation include lack of transportation, and failure to remember not to eat the night before the procedure.
Past experience at Wills indicates that there are roughly 1100 resident cataract surgeries scheduled each year. The cancellation rate for a similar period of time determined from Assessing Cancellation Rates and Barriers to Completion of Resident Performed Cataract Surgery at Wills Eye Hospital was 29.45%, or approximately 320 cancellations per year. The investigators propose to test an intervention to address these modifiable reasons for cancellation.
Patients will be randomized to either 1) the intervention group where on-site pre-admission testing will be mandated or 2) the control group, where on-site pre-admission testing will be offered but not mandated. The intervention will be coupled with personalized patient communication appropriately timed before the scheduled procedure. Multiple studies have shown that scheduled pre-operative visitation and assessment and enhanced communication between the physician and the patient contribute to decreased cancellation of surgeries. It has been found that anesthesia-run pre-operative clinic visits significantly decrease cancellations and delays of same-day surgeries. Additionally, older patients were found to have the greatest decrease in cancellation rates after preoperative anesthesia clinic visits. At VA facilities throughout America, surgeons at low cancellation rate sites reported higher use of written preoperative instructions and pre-operative clinic visits. Cancellation rates will be collected prospectively and statistical analysis utilized to evaluate the significance of intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mandatory On-Site Pre-Admission TestingPatients in the intervention group will be mandated to complete the PAT with Dr. Koka. After scheduling the surgery with the surgical coordinator, intervention patients will be required to go directly to Dr. Koka's office, to complete all necessary pre-operative steps. |
| Usual Care | No intervention | –Patients in the usual care group will be treated with the standard protocol that is currently utilized in the Wills Eye Hospital Cataract and Primary Eye Care (CPEC) Service. After scheduling the surgery with the surgical coordinator, the patient will be given pre-admission testing (PAT) paperwork to be completed. The patient schedules the PAT on his or her own with the primary care physician.The patient will be given the information for Dr. Koka's cardiology office if he or she has any problem getting the PAT done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient scheduled for cataract surgery in the resident CPEC clinic at Wills Eye Hospital from the time period of 1/5/15 to 11/30/15.
Key exclusion criteria (1 listed)
- All prisoners, nursing home, dialysis patients, and patients under 18 years of age will be excluded from the study.
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 |
|---|---|---|
| Mandatory On-Site Pre-Admission Testing | Behavioural | Intervention |
Primary outcome
Cataract Surgery Adherence Rate
Time frame: Through study completion, an average of 1 year
The adherence rate to cataract surgery will be assessed in the usual care and intervention groups and compared.
2 secondary outcomes
Correlation between Cataract Surgery Adherence and Demographic/Clinical Characteristics
Time frame: Through study completion, an average of 1 year
Cost Analysis
Time frame: Through study completion, an average of 1 year
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 9 May 2017.
- Individual participant dataSharing planned: Yes. A manuscript is under development.
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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.
Robert Bailey, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandatory On-Site Pre-Admission Testing in people with Cataract, run by Wills Eye at 1 site in United States.
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 1 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Cataract Surgery Adherence Rate (time frame: Through study completion, an average of 1 year). 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 9 May 2017; AzTrials last refreshed its copy on 4 Nov 2026.