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

NCT ID: NCT06350916

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-28

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

SeamlessMD® Mobile Application

Intervention Type 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.

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atrium Health Levine Cancer Institute

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malcolm H Squires, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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LCI-GI-CRC-SEAMLESS-2020

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00082594

Identifier Type: -

Identifier Source: org_study_id

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