Clinical trial NCT06350916: Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2024-04-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative ERAS metric completion rate
timeFrame: 30 Days Following Hospital Discharge
measure: Postoperative hospital length of stay
timeFrame: 30 Days Following Hospital Discharge
measure: Postoperative complications
timeFrame: 30 Days Following Hospital Discharge
measure: 30-day readmission
timeFrame: 30 Days Following Hospital Discharge
Secondary outcomes:
measure: Postoperative Opioid Consumption
timeFrame: 30 Days Following Hospital Discharge
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Malcolm H Squires, MD
role: PRINCIPAL_INVESTIGATOR
References: