The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy

December 25, 2014 updated by: Kim Eun Soo, Keimyung University Dongsan Medical Center

The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy; Randomized Single Blinded Study

Effective bowel preparation is important for examination of the entire colon adequately and for identifying colonic lesions during colonoscopy. However, it is well known that bowel preparation of inpatients is much poorer than that of outpatients. Our goal is to improve bowel preparations with reinforcement of nurse education that explains the steps required for bowel preparation for inpatients undergoing colonoscopies. The education will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative. Patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a explanation from reinforcement-educated nurse. The investigators hypothesize that patients received a explanation from reinforcement-educated nurses will lead to improved patient compliance and a better bowel preparation. In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and patients' satisfaction for colonoscopy.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all inpatients
  • age >18
  • referred and scheduled for an elective screening colonoscopy

Exclusion Criteria:

  • outpatients
  • pregnancy
  • breast feeding
  • prior history of surgical large bowel resection
  • patients allergic to PEG-ELS based laxatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus interventional instructions from reinforcement educated nurse such as 'Reinforcement Nurse Education'
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions from reinforcement educated nurse
No Intervention: Standard preparation instructions
The control arm will receive written instructions on preparing for a colonoscopy per standard of care at Keimyung University Dongsan Medical Center

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of bowel preparation
Time Frame: day 1
The primary outcome will be the endoscopist's assessment of the quality of preparation using Boston and Ottawa bowel preparation scale
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient compliance
Time Frame: baseline
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
baseline
Colonoscope insertion and withdrawal times
Time Frame: day 1
Time from insertion to cecum and time from cecum to anus
day 1
Patient's willingness to do bowel preparation next time
Time Frame: baseline
Patient's willingness to do bowel preparation next time self-reported on a pre-procedure questionnaire
baseline
Preparation associated side effects
Time Frame: baseline
Presence and severity of preparation associated side effects including: bloating, abdominal pain, and nausea/vomiting
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eun Soo Kim, Professor, Keimyung University Dongsan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 22, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 25, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2013-05-049-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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