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

• ClinicalTrials.gov Identifier: NCT03424954
• Recruitment Status: Terminated
• First Posted: February 7, 2018
• Last Update Posted: April 4, 2019
• Sponsor: St. Louis University
• Collaborator: Epharmix, Inc.
• Information provided by (Responsible Party): Grace Montenegro, MD, St. Louis University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ileostomy; Complications; Ileostomy - Stoma; Ileostomy Malfunction; Ileostomy Underactive; Complication of Surgical Procedure	Behavioral: EpxOstomy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All patients undergoing ileostomy surgery will receive the study intervention. We will compare to a historical control.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: March 31, 2019
• Actual Study Completion Date: March 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: EpxOstomy; Post-operative ileostomy patients will receive the study intervention for 30 days following discharge from the hospital.	Behavioral: EpxOstomy; A 30-day post-operative automated text-messaging intervention for home monitoring of ileostomy output

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Patient response rates [ Time Frame: throughout the 30 days of the intervention ]
   Automated message response data
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Missouri

SSM Health Saint Louis University Hospital

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

St. Louis University

Epharmix, Inc.

Investigators

• Principal Investigator: Grace Montenegro, MD; Saint Louis University, Dept. of Surgery

More Information

Publications:

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.

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.

• Responsible Party: Grace Montenegro, MD, Assistant Professor, Department of Surgery, Division of General Surgery, St. Louis University
• ClinicalTrials.gov Identifier: NCT03424954
• Other Study ID Numbers: 28262
• First Posted: February 7, 2018
• Last Update Posted: April 4, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no IPD sharing plan.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No