Evaluation of a Preoperative Education Class for Colorectal Surgery Patients

NCT03237897 | Withdrawn

• 1 other identifier: 07-16-05E
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colorectal Surgery

Keywords

ERAS; Enhanced recovery after surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Knowledge level

  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

  date of enrollment and date of discharge, up to 90 days following surgery

• Patient satisfaction score

  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

  from date of surgery until the date of discharge, up to 90 days

Study Arms (2)

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; Behavioral: Pedometer

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

Interventions

Preoperative education class BEHAVIORAL

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.

Class attendees

Pedometer BEHAVIORAL

A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge

Class attendees; Class non-attendees

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Officials

• Caroline E Reinke, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: August 3, 2017
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 27, 2022

Record last verified: 2018-03