Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LCI-GI-CRC-SEAMLESS-2020 | Other Identifier | Atrium Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Malcolm H Squires, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
Releasing the Individual Participant Data (IPD) is not required to meet the study objectives, and therefore is not planned to be released. Additionally, there is no plan to share data, particularly individual participant data, with anyone who is not already involved in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided