Enhanced Recovery Pathway for Endoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare an Enhanced Recovery Pathway to the current pre-operative/recovery practices of the endoscopy department on patient post-procedure outcomes.

Detailed Description
-----------------
Every 4th to 5th patient that checks in to the endoscopy department for their procedure will be screened for eligibility requirements. If eligible for the study, the patient will be informed about the study and potential risks. All patients giving written informed consent will be enrolled into the enhanced recovery protocol (ERP) [nursing managed ERP: goal-directed fluid management (Lactated Ringer's Solution at 5mL/kg/hr), PONV prophylaxis for an apfel score of 2 or greater (ondansetron 4 mg IV), early mobilization up to chair (within 5-30 minutes of admission to the recovery room), and early PO intake within 15-30 minutes of admission to the recovery room post-procedure] for their procedure.

Official Title
-----------------
Evaluation of an Enhanced Recovery Pathway for Endoscopy Patients Receiving Moderate Sedation

Conditions
-----------------
Endoscopy, Enhanced Recovery Pathway

Intervention / Treatment
-----------------
* Drug: Ondansetron 4 MG
* Drug: Lactated Ringers, Intravenous
* Other: Early Mobilization
* Other: Early PO Intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient colonoscopy under moderate sedation Colonoscopy Indications: Screening Exclusion Criteria: More than one sedation procedure scheduled same day Allergy to ondansetron Past PONV requiring scopolamine patches Diagnoses: ESRD, heart failure, cirrhosis, long QT syndrome Patients requiring fluid restrictions, such as dialysis patients Post-procedure NPO requirements, such as procedure-related NPO status (stent placement, pneumatic dilation, etc.) or second procedure in another location High Fall Risk Patients Adults unable to consent Pregnant patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective Experimental Group<br>For the experimental group, we will recruit 200 participants who will receive the Enhanced Recovery Pathway, which will be ordered as a standing order set by the attending provider and managed by their peri-procedural nurses. The modified ERP for this study includes the following interventions: nursing managed order sets with ERP instructions to receive goal-directed fluid management within anesthesia approved parameters utilizing the NMH Colorectal ERAS protocol for IV fluid administration, PONV prophylaxis for participants with an apfel score of 2 or greater (ondansetron 4 mg IV), an additional dose of ondansetron 4mg IV will be available in recovery if the patient has nausea/vomiting despite prophylaxis, early mobilization up to chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters, and early PO intake within 15-30 minutes of admission to the recovery room post-procedure based on nursing parameters. | Drug: Ondansetron 4 MG<br>* PONV prophylaxis for participants with an apfel score of 2 or greater (ondansetron 4 mg IV), an additional dose of ondansetron 4mg IV will be available in recovery if the patient has nausea/vomiting despite prophylaxis.<br>* Other names: Post-operative Nausea & Vomiting Prophylaxis;Drug: Lactated Ringers, Intravenous<br>* Goal directed IV fluids to be administered starting preop per the NMH Colorectal ERAS protocol (LR @ 5mL/kg/hr).<br>* Other names: Intravenous Hydration;Other: Early Mobilization<br>* Patient transferred up to the chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters and patient safety.<br>Other: Early PO Intake<br>* Patient will be offered PO intake within 15-30 minutes of admission to the recovery room post-procedure based on nursing parameters and patient safety.<br>|
| No Intervention: Retrospective Control Group<br>The retrospective group will consist of 200 randomly selected medical records of patients who had colonoscopy procedures for a 6 month period prior to study implementation (between 10/1/2019 to 4/1/2020). The retrospective control group will have received the current standard of care including: IV fluids for management of intra-procedural hypotension as indicated/ordered by the physician, PO intake at 30-45 minutes, up to a chair at 60 minutes, and all procedure related complications will have been treated (e.g. PONV) per physician order as is the current standard of practice in the GI Lab recovery area. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare recovery time stamps before and after implementing a modified ERAs for endoscopy patients in the recovery period. | We will compare mean recovery times between control and intervention groups using analysis of variance (ANOVA). | 1-2 hours | 
| To compare the incidence of postoperative nausea and vomiting before and after implementing a modified ERAs for endoscopy patients in the recovery period. | We will perform a Chi-square analysis for presence or absence of nausea and/or vomiting in the recovery period (measured by: administration of anti-emetic, documentation on N/V flowchart, and/or documentation in nursing narrative note) between control and intervention groups. | 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare patient satisfaction scores before and after implementing a modified ERAs for endoscopy patients in the recovery period. | We will perform a t-test of patient satisfaction scores (Press Ganey scores) between control and intervention groups. | 15 minutes |