TrialReader


Evaluation of a Preoperative Education Class for Colorectal Surgery Patients

NCT03237897 — Withdrawn, Wake Forest University Health Sciences

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03237897
StatusWithdrawn - Study withdrawn due to staff unavailability and limited resources
Study typeObservational
SponsorWake Forest University Health Sciences (Other)
ConditionsColorectal Surgery
InterventionsPreoperative education class, Pedometer (Behavioral)
Datesstart 2018-04-01 (estimated), primary completion 2019-04-01 (estimated), completion 2019-11-01 (estimated), first posted 2017-08-03, last updated 2022-04-27

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Colorectal Surgery All trials of Preoperative education class All trials of Pedometer

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Class attendeesBehavioral: Preoperative education class; Behavioral: PedometerA 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.
Class non-attendeesBehavioral: PedometerA 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.
  • 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.
  • Pedometer (Behavioral): A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge

+Outcome measures

Primary outcomes

  • Time to ambulation [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.
  • Mean number of steps [from time of surgery until the time of discharge, up to 90 days]: mean number of steps taken daily as measured by pedometer

Secondary outcomes

  • 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)]: Knowledge level assessed by knowledge survey administered to patients
  • Patient anxiety level [date of enrollment and date of discharge, up to 90 days following surgery]: Patient anxiety level assessed by anxiety survey administered to patients
  • Patient satisfaction score [date of first postoperative follow-up appointment, up to 90 days following surgery]: Patient satisfaction score assessed by satisfaction survey administered to patients
  • 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]: Inpatient length of stay measured in number of days

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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.

+Investigators

My Notes