The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy

Conditions
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Ileostomy; Complications, Ileostomy - Stoma, Ileostomy Malfunction, Ileostomy Underactive, Complication of Surgical Procedure

Intervention / Treatment
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* Behavioral: EpxOstomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All patients undergoing ileostomy surgery will receive the study intervention. We will compare to a historical control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EpxOstomy<br>Post-operative ileostomy patients will receive the study intervention for 30 days following discharge from the hospital. | Behavioral: EpxOstomy<br>* A 30-day post-operative automated text-messaging intervention for home monitoring of ileostomy output<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital-based acute health care encounters (HBAC) | 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 | Automated message response data | throughout the 30 days of the intervention | 
| Patient satisfaction survey results | Results of a patient survey administered via automated text-message after completion of the intervention. | One time, on day 30 of the intervention. |