Evaluation of a Preoperative Education Class for Colorectal Surgery Patients

The purpose of the study is to evaluate the value and effectiveness of a newly-implemented preoperative education class for patients undergoing colorectal surgery.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Surgery
• Intervention / Treatment: Behavioral: Preoperative education class; Behavioral: Pedometer

Detailed Description

This is a non-randomized study to be conducted in a cohort of patients who are scheduled to undergo colorectal surgical procedures at Carolinas Medical Center (CMC)-Main. The primary objective of this study is to determine the effect of preoperative education classes on postoperative compliance with mobilization guidelines. Secondary objectives of this study are to evaluate the effect of the preoperative education class on patient knowledge, anxiety, and satisfaction, and postoperative outcomes such as inpatient length of stay, postoperative complications, and 30-day readmission rates. Data will be compared between patients who are scheduled to attend the class and attend and those who are scheduled to attend the class and do not.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include only patients scheduled to undergo colorectal surgical procedures at CMC-Main.

Description

Inclusion Criteria:

• Scheduled to undergo surgical operations of the colon or rectum at Carolinas Medical Center Main

Exclusion Criteria:

• A medical condition, laboratory finding, or physical exam finding that precludes participation
• Develop a significant intra- or postoperative complication that precludes or delays participation for longer than 4 weeks; or
• Have anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Class attendees; A cohort of patients who are scheduled to undergo colorectal surgical procedures and attend the preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge.	Behavioral: Preoperative education class; The preoperative enhanced recovery after surgery education class will be offered twice a week in coordination with anesthesia preoperative appointments to minimize inconvenience for patients. Patients will need to attend only one class. All participants will be offered the class. This class will be one hour in duration and will be taught by a surgical advanced care practitioner familiar with the details of colorectal surgery. The class will include detailed information about preoperative care, intraoperative care, and postoperative care.; Behavioral: Pedometer; A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge
Class non-attendees; A cohort of patients who are scheduled to undergo colorectal surgical procedures and do not attend the scheduled preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge.	Behavioral: Pedometer; A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ambulation	time to first ambulation following surgery measured by pedometer and notations made by nursing staff in the patient records prior to patient discharge.	from time of surgery until the time of first documented ambulation, assessed up to 90 days
Mean number of steps	mean number of steps taken daily as measured by pedometer	from time of surgery until the time of discharge, up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge level	Knowledge level assessed by knowledge survey administered to patients	date of preoperative education class (up to 2 weeks prior to time of surgery) and date of first postoperative follow-up appointment (up to 90 days following surgery)
Patient anxiety level	Patient anxiety level assessed by anxiety survey administered to patients	date of enrollment and date of discharge, up to 90 days following surgery
Patient satisfaction score	Patient satisfaction score assessed by satisfaction survey administered to patients	date of first postoperative follow-up appointment, up to 90 days following surgery
30-day readmission rate		30 days following surgery
Inpatient length of stay	Inpatient length of stay measured in number of days	from date of surgery until the date of discharge, up to 90 days

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Caroline E Reinke, MD, Carolinas Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: September 23, 2016
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: ERAS; Enhanced recovery after surgery
• Other Study ID Numbers: 07-16-05E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No