Colorectal SurgeryNCT06350916
Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery
An observational study of Colorectal Surgery, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- SeamlessMD® Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Emergent, non-elective colorectal procedures
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Surgery
- Being tested
- SeamlessMD® Mobile Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeamlessMD® Mobile ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative ERAS metric completion rate
Completion rate for perioperative ERAS metrics
Measured: 30 Days Following Hospital Discharge
Postoperative hospital length of stay
Postoperative hospital length of stay
Measured: 30 Days Following Hospital Discharge
Postoperative complications
Occurrence of postoperative complications within 30 days, classified as Clavien-Dindo Grade I-V
Measured: 30 Days Following Hospital Discharge
30-day readmission
Readmission to any hospital facility as inpatient within 30 days of surgery
Measured: 30 Days Following Hospital Discharge
Secondary outcomes (1)
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
Measured: 30 Days Following Hospital Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start28 Jan 2021
- Primary completion30 Jul 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Malcolm H Squires, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350916
- Sponsor's protocol ID
- IRB00082594
- Other IDs
- LCI-GI-CRC-SEAMLESS-2020
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06350916
- Acronym / sponsor ID
- IRB00082594
- Conditions
- Colorectal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SeamlessMD Mobile Application | – | Behavioral: SeamlessMD® Mobile ApplicationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Emergent, non-elective colorectal procedures
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeamlessMD® Mobile ApplicationMobile 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. | Behavioural | SeamlessMD Mobile Application |
Primary outcome
Perioperative ERAS metric completion rate
Time frame: 30 Days Following Hospital Discharge
Completion rate for perioperative ERAS metrics
Postoperative hospital length of stay
Time frame: 30 Days Following Hospital Discharge
Postoperative hospital length of stay
Postoperative complications
Time frame: 30 Days Following Hospital Discharge
Occurrence of postoperative complications within 30 days, classified as Clavien-Dindo Grade I-V
30-day readmission
Time frame: 30 Days Following Hospital Discharge
Readmission to any hospital facility as inpatient within 30 days of surgery
1 secondary outcome
Postoperative Opioid Consumption
Time frame: 30 Days Following Hospital Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm H Squires, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative ERAS metric completion rate (time frame: 30 Days Following Hospital Discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.