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

Not Applicable

Terminated

• Conditions: Ileostomy; Complications; Ileostomy - Stoma; Ileostomy Malfunction; Ileostomy Underactive; Complication of Surgical Procedure
• Interventions: Behavioral: EpxOstomy

• Registration Number: NCT03424954
• Lead Sponsor: St. Louis University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Study Start: 2018-03-01
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EpxOstomy	EpxOstomy	Post-operative ileostomy patients will receive the study intervention for 30 days following discharge from the hospital.

Primary Outcome Measures

Name	Time	Method
Hospital-based acute health care encounters (HBAC)	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).

Secondary Outcome Measures

Name	Time	Method
Patient response rates	throughout the 30 days of the intervention	Automated message response data
Patient satisfaction survey results	One time, on day 30 of the intervention.	Results of a patient survey administered via automated text-message after completion of the intervention.

Trial Locations

Locations (1)

SSM Health Saint Louis University Hospital; 🇺🇸 Saint Louis, Missouri, United States