- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424954
The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy
April 2, 2019 updated by: Grace Montenegro, MD, St. Louis University
Each year a large number of patients undergo ileostomy surgery, a procedure in which a portion of the small intestine is attached to a hole in the abdominal wall, allowing for digested material to pass into a disposable bag worn attached to the skin.
Ileostomies are performed for the treatment of a variety of diseases of the intestinal tract, such as inflammatory bowel disease, intestinal trauma, and gastrointestinal malignancy.
Of the patients that undergo ileostomy surgery, 36% will require urgent medical care within the first 30 days of surgery.
Most frequently, this is a result of dehydration due to excessive ostomy output.
Thus, there is potential for significant improvement of the post-operative outcomes of ileostomy patients.
Implementation of an automated text messaging system, EpxOstomy, can provide a way of monitoring patient's daily ostomy output and allow for timely intervention if output is outside normal limits, providing an effective way of improving patient outcomes while simultaneously reducing healthcare costs.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Each year thousands of patients undergo ostomy surgery in the treatment of diseases such as colorectal cancer, Crohn's disease, diverticulitis, and ulcerative colitis.
During the 30-day post-operative period, patients that undergo ileostomy have a 36.1% rate of acute healthcare encounter compared to 16.2% of patients undergoing similar surgery but with primary anastomosis.
The 30-day hospital readmission rate for ileostomy patients due to dehydration and renal failure is 17%, with the median cost per colorectal surgery readmission being $8,885.
Thus, there is substantial room for post-operative improvement in the care of ileostomy patients, both to reduce healthcare costs and improve patient quality of life.
An automated text messaging system can provide a way to consistently monitor patients' ileostomy output, ensuring that patients are measuring their daily output as instructed and allowing for timely preemptive intervention should output be outside normal limits.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- SSM Health Saint Louis University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients between 18-90 years of age with phone or text receiving device access.
- English speaking
- Patients undergoing ileostomy surgery
Exclusion Criteria:
- Patients who do not have phone or text receiving device access
- Patients mentally unable to provide consent for the study
- Patients who do not speak English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EpxOstomy
Post-operative ileostomy patients will receive the study intervention for 30 days following discharge from the hospital.
|
A 30-day post-operative automated text-messaging intervention for home monitoring of ileostomy output
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital-based acute health care encounters (HBAC)
Time Frame: 30 days following discharge
|
The percentage of patients that require a HBAC (HBAC = readmissions + emergency department visits) due to post-op complications following ileostomy surgery.
Medical records will be reviewed for readmissions or ED visits within 30-days following discharge.
Additionally, the final message of the automated text-message intervention asks patients if they required readmission or ED care at any non-Saint Louis University Hospital facility(s).
|
30 days following discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient response rates
Time Frame: throughout the 30 days of the intervention
|
Automated message response data
|
throughout the 30 days of the intervention
|
Patient satisfaction survey results
Time Frame: One time, on day 30 of the intervention.
|
Results of a patient survey administered via automated text-message after completion of the intervention.
|
One time, on day 30 of the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Grace Montenegro, MD, Saint Louis University, Dept. of Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wick EC, Shore AD, Hirose K, Ibrahim AM, Gearhart SL, Efron J, Weiner JP, Makary MA. Readmission rates and cost following colorectal surgery. Dis Colon Rectum. 2011 Dec;54(12):1475-9. doi: 10.1097/DCR.0b013e31822ff8f0.
- Tyler JA, Fox JP, Dharmarajan S, Silviera ML, Hunt SR, Wise PE, Mutch MG. Acute health care resource utilization for ileostomy patients is higher than expected. Dis Colon Rectum. 2014 Dec;57(12):1412-20. doi: 10.1097/DCR.0000000000000246.
- Paquette IM, Solan P, Rafferty JF, Ferguson MA, Davis BR. Readmission for dehydration or renal failure after ileostomy creation. Dis Colon Rectum. 2013 Aug;56(8):974-9. doi: 10.1097/DCR.0b013e31828d02ba.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Actual)
March 31, 2019
Study Completion (Actual)
March 31, 2019
Study Registration Dates
First Submitted
January 16, 2018
First Submitted That Met QC Criteria
February 6, 2018
First Posted (Actual)
February 7, 2018
Study Record Updates
Last Update Posted (Actual)
April 4, 2019
Last Update Submitted That Met QC Criteria
April 2, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 28262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no IPD sharing plan.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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