Evaluation of a Preoperative Education Class for Colorectal Surgery Patients

April 20, 2022 updated by: Wake Forest University Health Sciences
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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to ambulation
Time Frame: from time of surgery until the time of first documented ambulation, assessed up to 90 days
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
Time Frame: from time of surgery until the time of discharge, up to 90 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge level
Time Frame: 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)
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
Time Frame: date of enrollment and date of discharge, up to 90 days following surgery
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
Time Frame: date of first postoperative follow-up appointment, up to 90 days following surgery
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
Time Frame: 30 days following surgery
30 days following surgery
Inpatient length of stay
Time Frame: from date of surgery until the date of discharge, up to 90 days
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caroline E Reinke, MD, Carolinas 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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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