The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations

Study Overview
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Brief Summary
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The investigators developed a smartphone app that guides pediatric patients and their families through colonoscopy prep in an attempt to see if an app could improve the colonoscopy process.

Detailed Description
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The investigators created a smartphone app designed for pediatric patients and their families that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite. The investigators designed a study to determine if this app will yield improved colonoscopy cleanouts, better patient understanding of the procedure, fewer calls to the GI service and more punctual arrival times to the endoscopy suite compared to patients who receive written instructions that do not actively interact with the patient before, during or after their colonoscopy prep.

Official Title
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The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations

Conditions
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Pediatric ALL

Intervention / Treatment
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* Device: Smartphone App SB Colonoscopy Prep
* Other: Written Instruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Aged 5-18 years scheduled to undergo a diagnostic and/or therapeutic colonoscopy Exclusion Criteria: Patients who had undergone a colonoscopy within the past one year Patients admitted for a nasogastric (NG) cleanout Patients requiring colonoscopy preparation medication other than Polyethylene Glycol Patients with poor understanding of English.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects were randomly assigned via block randomization to receive either written or software-based prep instructions.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App Subject<br>Users who were assigned to use a smartphone app downloaded a free app from the iOS App or Google Play stores titled SB Colonoscopy Prep. The app informed subjects about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite. | Device: Smartphone App SB Colonoscopy Prep<br>* We created a smartphone app that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite.<br>|
| Active Comparator: Written Instruction Subjects<br>Subjects in the control group were given a three-page document that described the procedure and instructed users on how to take the preparation medications. The written instructions had a list of frequently asked questions about colonoscopies and the URL of a website where users could view the animated video that was included in the app. The written instructions also contained the time and date of the procedure. All subjects were instructed to arrive one hour before their scheduled procedure. | Other: Written Instruction<br>* Written Instruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smartphone application use was associated with increased number of excellent colonoscopy preps. | Prep quality was measured with the validated Boston Scoring Scale. A score of 0, 1, 2 or 3 is given to the right, transverse and left colon based on the amount and consistency of stool visualized as well as the ease or difficulty of guiding endoscopic instrumentation during a colonoscopy. Higher scores indicate a cleaner colon and as per Lai, a Boston Score of 7 or above indicates an excellent prep. To eliminate bias, the four grading gastroenterologists did not know whether subjects had used written or app instructions. | Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects. Subjects were scored on their colonoscopies immediately following the procedure once the patient was stable | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the number of calls to the gastroenterology service between app users and controls. | Calls to the GI service were recorded by the GI staff. | Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects | 
| The difference between app users and controls regarding patient arrival time. | Patient arrival time was taken from the patients arrival time in the endoscopy suite. | Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects | 
| The significant difference between app users and controls regarding patient knowledge about the procedure. | A questionnaire with validated questions determined whether subjects improvement their knowledge before and after receiving colonoscopy information. | Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects |