Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery

Colorectal Surgery Clinical Trial

Official title:

An Educational Mobile Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients Enrolled in an Enhanced Recovery After Surgery (ERAS) Pathway for Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06350916
• Other study ID #: IRB00082594
• Secondary ID: LCI-GI-CRC-SEAML
• Status: Completed
• Start date: January 28, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery.

Description:

To analyze the impact of implementation of patient-centered educational material delivered the SeamlessMD® mobile application on perioperative Enhanced Recovery After Surgery (ERAS) metric completion rates among patients undergoing elective colorectal surgery. This is a non-interventional, prospective feasibility study. The planned study period will encompass adult patients (>18 years) scheduled to undergo an elective colorectal surgery procedure at CMC-Main during the six-month period of December 2020 to May 2021. Patients enrolling in SeamlessMD will be prompted by the mobile app to electronically complete a validated quality-of-life assessment, the Quality of Recovery (QoR-15) evaluation, five days prior to surgery, three days postoperatively, and 30 days postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 1, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (>18 years old)
• Scheduled to undergo an elective colorectal surgery procedure (for benign or malignant colon or rectal pathology) at CMC-Main by one of the 5 participating colorectal surgeons (Davis, Hill, Kasten, Salo, Squires)
• Ability to provide informed consent

Exclusion Criteria:

• Emergent, non-elective colorectal procedures
• Non-English speaking

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Behavioral:
• SeamlessMD® Mobile Application
Mobile cloud-based applications (apps), such as SeamlessMD®, are readily accessible on smart phones and offer an innovative strategy to encourage and track patient adherence to recommended ERAS components pre- and postoperatively.

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Atrium Health Levine Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative ERAS metric completion rate	Completion rate for perioperative ERAS metrics	30 Days Following Hospital Discharge
Primary	Postoperative hospital length of stay	Postoperative hospital length of stay	30 Days Following Hospital Discharge
Primary	Postoperative complications	Occurrence of postoperative complications within 30 days, classified as Clavien-Dindo Grade I-V	30 Days Following Hospital Discharge
Primary	30-day readmission	Readmission to any hospital facility as inpatient within 30 days of surgery	30 Days Following Hospital Discharge
Secondary	Postoperative Opioid Consumption	Postoperative opioid consumption in morphine equivalent daily doses (MEDDs) as extracted from the medical administration record (MAR) for the inpatient hospitalization period	30 Days Following Hospital Discharge