NCT03424954

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

January 16, 2018

Last Update Submit

April 2, 2019

Conditions

Ileostomy; ComplicationsIleostomy - StomaIleostomy MalfunctionIleostomy UnderactiveComplication of Surgical Procedure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patient response rates

    throughout the 30 days of the intervention

  • Patient satisfaction survey results

    One time, on day 30 of the intervention.

Study Arms (1)

EpxOstomy

EXPERIMENTAL

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

Behavioral: EpxOstomy

Interventions

EpxOstomyBEHAVIORAL

A 30-day post-operative automated text-messaging intervention for home monitoring of ileostomy output

EpxOstomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18-90 years of age with phone or text receiving device access.
  • English speaking
  • Patients undergoing ileostomy surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • 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.

    PMID: 25380008BACKGROUND

  • 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.

    PMID: 23838866BACKGROUND

  • 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.

    PMID: 22067174BACKGROUND

Study Officials

  • Grace Montenegro, MD

    Saint Louis University, Dept. of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All patients undergoing ileostomy surgery will receive the study intervention. We will compare to a historical control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Surgery, Division of General Surgery

Study Record Dates

First Submitted

January 16, 2018

First Posted

February 7, 2018

Study Start

March 1, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

There is no IPD sharing plan.

Locations

US(1)