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Completed

NCT Number: NCT06350916

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

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.

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Key information

Conditions

Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Perioperative ERAS metric completion rate

    Time frame: 30 Days Following Hospital Discharge

    Completion rate for perioperative ERAS metrics

  2. Postoperative hospital length of stay

    Time frame: 30 Days Following Hospital Discharge

    Postoperative hospital length of stay

  3. Postoperative complications

    Time frame: 30 Days Following Hospital Discharge

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

  4. 30-day readmission

    Time frame: 30 Days Following Hospital Discharge

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

Secondary outcomes

  1. Postoperative Opioid Consumption

    Time frame: 30 Days Following Hospital Discharge

    Postoperative opioid consumption in morphine equivalent daily doses (MEDDs) as extracted from the medical administration record (MAR) for the inpatient hospitalization period

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Levine Cancer Institute

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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