Improving Outpatient Colonoscopy Bowel Prep With the Orton Score

Study Overview
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Brief Summary
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Colonoscopy is a common endoscopic procedure which the UVA Gastroenterology & Hepatology department performs on a daily basis for both screening/surveillance and diagnostic/therapeutic intent. As a safety net hospital, the institution also offers open access colonoscopy as a means of allowing outside primary care and urgent care providers a way to have patients receive necessary endoscopy services. However, these patients are not all seen in clinic prior to their procedure but are all prescribed a specific bowel prep by a medical professional who screens the referrals. Given that the patient population described above are often not well-known to UVA providers, they may be prescribed prep regimens that are not ideal for their comorbidities. Not infrequently, these patients show up to their colonoscopies with an inadequate bowel prep, leading to either cancelled or incomplete procedures, increased healthcare and personal financial costs (such as missed wages from taking off work), suboptimal endoscopy resource utilization, and delay in or missed polyp (or potentially cancer) detection. The investigators seek to use a novel scoring system designed to predict patients at risk for suboptimal preps (and hence patients that would benefit from an extended prep) and apply it in uniform fashion to a patient population most at risk for suboptimal preps. Because obtaining written consent is not practical given that these patients may not be seen by a UVA provider prior to their endoscopic procedure, the investigators will plan to verbally consent via the telephone in an all-inclusive manner; there will be no randomization but rather the selection of prep to be determined by the novel scoring system. Subjects be prescribed either a standard split-dose GoLytely prep (or SuPrep) or an extended split-dose GoLytely prep. The investigators predict that utilizing this new system will lead to a decreased number of inadequate bowel preps and will increase polyp detection. The investigators will work with a UVA biostatistician to analyze the data and use Chi Square, student's T tests, and logistic regression models to assess significance and help validate the model.

Official Title
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Validation of a Novel Clinical Prediction Scoring System for Improved Bowel Preparation Prior to Outpatient Colonoscopy

Conditions
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Colonic Polyp, Colon Cancer

Intervention / Treatment
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* Other: Orton Score
* Other: Typical Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older (up to 100 years) Referred for open access colonoscopy from an outside provider/UVA provider Able to provide informed consent Exclusion Criteria: Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients will be assessed for the most appropriate bowel preparation prior to colonoscopy (standard vs. extended) based on a novel scoring tool that accounts for various clinical conditions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orton Score Cohort - High<br>Patients will be scored using the Orton Score, a novel clinical prediction tool to determine which patients are at risk for poor bowel preps and may benefit from an extended prep. If they score highly, they will receive an extended GoLytely bowel prep. | Other: Orton Score<br>* Significant a priori predictors of poor prep included: male gender, COPD, diabetes with end-organ damage, severe neurologic disease, constipation medication use, and tricyclic antidepressant use. Proprietary web-based weighted scoring model allows screening clinician to predict which bowel prep would be best for patient depending on which risk factors patients have.<br>|
| Placebo Comparator: Prospective Orton Score Cohort - Low<br>Patients will be scored using the Orton Score, a novel clinical prediction tool to determine which patients are at risk for poor bowel preps and may benefit from an extended prep. If they do not score highly, they will receive a standard GoLytely (or Suprep) bowel prep. | Other: Orton Score<br>* Significant a priori predictors of poor prep included: male gender, COPD, diabetes with end-organ damage, severe neurologic disease, constipation medication use, and tricyclic antidepressant use. Proprietary web-based weighted scoring model allows screening clinician to predict which bowel prep would be best for patient depending on which risk factors patients have.<br>|
| Other: Retrospective Cohort (before Orton Score)<br> | Other: Typical Standard of Care<br>* Clinician usual practice of prescribing bowel preps to patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inadequate prep rate | Percentage of colonoscopies where performing endoscopist rates the prep as inadequate for intended purpose (screening/surveillance) | Through study duration, approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate (ADR) | Percentage of colonoscopies with detection of at least 1 adenoma | Through study duration, approximately 1 year | 
| Polyp burden | Mean # of polyps found per colonoscopy | Through study duration, approximately 1 year | 
| Advanced adenoma / adenocarcinoma detection rate | Percentage of colonoscopies with detection of an adenoma with high-grade dysplasia, tubulovillous adenoma, or adenocarcinoma | Through study duration, approximately 1 year | 
| Incomplete colonoscopy rate | Percentage of colonoscopies that are unable to be completed secondary to inadequate prep or technical difficulty | Through study duration, approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, bowel prep, screening