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

NCT06350916 | Completed

• 2 other identifiers: IRB00082594LCI-GI-CRC-SEAMLESS-2020
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Surgery

Outcome Measures

Primary Outcomes (4)

• Perioperative ERAS metric completion rate

  Completion rate for perioperative ERAS metrics

  30 Days Following Hospital Discharge

• Postoperative hospital length of stay

  Postoperative hospital length of stay

  30 Days Following Hospital Discharge

• Postoperative complications

  Occurrence of postoperative complications within 30 days, classified as Clavien-Dindo Grade I-V

  30 Days Following Hospital Discharge

• 30-day readmission

  Readmission to any hospital facility as inpatient within 30 days of surgery

  30 Days Following Hospital Discharge

Secondary Outcomes (1)

• Postoperative Opioid Consumption

  30 Days Following Hospital Discharge

Study Arms (2)

SeamlessMD Mobile Application

Participants 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 over 30 days. Participants will also be prompted by the app to record their daily narcotic consumption via an "Opioid Tracker" page that requests participants enter the number of doses taken for each narcotic medication in the last 24 hours.

Behavioral: SeamlessMD® Mobile Application

Non-App User Study Participant

Participants will receive on postoperative day one (POD1) in the hospital a one-page paper survey of the same questions prompted by the SeamlessMD app regarding completion of preoperative ERAS metrics.

Interventions

SeamlessMD® Mobile Application BEHAVIORAL

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.

SeamlessMD Mobile Application

Eligibility Criteria

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

Study Population

Adult patients scheduled to undergo an elective colorectal surgery procedure at Carolinas Medical Center-Main during a six-month period (December, 2020 through May, 2021).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Study Officials

• Malcolm H Squires, MD

  Wake Forest University Health Sciences

  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: March 18, 2024
• First Posted: April 8, 2024
• Study Start: January 28, 2021
• Primary Completion: July 30, 2021
• Study Completion: October 1, 2021
• Last Updated: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)