Clinical trial NCT03424954: The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy
Official title: The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ileostomy; Complications
Ileostomy - Stoma
Ileostomy Malfunction
Ileostomy Underactive
Complication of Surgical Procedure
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: Epharmix, Inc.
First posted: 2018-02-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients undergoing ileostomy surgery will receive the study intervention. We will compare to a historical control.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Hospital-based acute health care encounters (HBAC)
timeFrame: 30 days following discharge
Secondary outcomes:
measure: Patient response rates
timeFrame: throughout the 30 days of the intervention
measure: Patient satisfaction survey results
timeFrame: One time, on day 30 of the intervention.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital
state: Missouri
Study officials:
affiliation: Saint Louis University, Dept. of Surgery
name: Grace Montenegro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.