Ileostomy; ComplicationsNCT03424954
The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy
A study testing EpxOstomy in people with Ileostomy; Complications and Ileostomy - Stoma, run by St. Louis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ileostomy; Complications, Ileostomy - Stoma, Ileostomy Malfunction
- What is being tested?
- EpxOstomy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18-90 years of age with phone or text receiving device access.
- English speaking
- Patients undergoing ileostomy surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Ileostomy; Complications, Ileostomy - Stoma, Ileostomy Malfunction, Ileostomy Underactive, Complication of Surgical Procedure
- Being tested
- EpxOstomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpxOstomyBehavioural
A 30-day post-operative automated text-messaging intervention for home monitoring of ileostomy output
| Study group | Role | What they receive |
|---|---|---|
| EpxOstomy | Experimental | Post-operative ileostomy patients will receive the study intervention for 30 days following discharge from the hospital. Receives: Behavioral: EpxOstomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days following discharge
Secondary outcomes (2)
Patient response rates
Automated message response data
Measured: 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.
Measured: One time, on day 30 of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 Mar 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Why it stopped: IRB request IRB request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ileostomy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients undergoing ileostomy surgery will receive the study intervention. We will compare to a historical control.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- Epharmix, Inc.
- Responsible party
- Principal investigator, Grace Montenegro, MD, St. Louis University
- Investigators
- Grace Montenegro, MD, Principal investigator, Saint Louis University, Dept. of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424954
- Sponsor's protocol ID
- 28262
- Status last verified
- Apr 2019
- First submitted
- 16 Jan 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD sharing plan.
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.
PubMed 25380008Paquette 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.
PubMed 23838866Wick 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.
PubMed 22067174
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy
- ClinicalTrials.gov ID
- NCT03424954
- Acronym / sponsor ID
- 28262
- Conditions
- Ileostomy; Complications, Ileostomy - Stoma, Ileostomy Malfunction, Ileostomy Underactive, Complication of Surgical Procedure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB request IRB request
- Enrolment
- 9 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- Epharmix, Inc.
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients undergoing ileostomy surgery will receive the study intervention. We will compare to a historical control.
| Arm | Type | Receives |
|---|---|---|
| EpxOstomy | Experimental | Behavioral: EpxOstomyPost-operative ileostomy patients will receive the study intervention for 30 days following discharge from the hospital. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 18-90 years of age with phone or text receiving device access.
- English speaking
- Patients undergoing ileostomy surgery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpxOstomyA 30-day post-operative automated text-messaging intervention for home monitoring of ileostomy output | Behavioural | EpxOstomy |
Primary outcome
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).
2 secondary outcomes
Patient response rates
Time frame: throughout the 30 days of the intervention
Patient satisfaction survey results
Time frame: One time, on day 30 of the intervention.
Results and safety
The study was stopped early (reason given: IRB request IRB request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Background: PubMed 25380008Tyler 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.
- Background: PubMed 23838866Paquette 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.
- Background: PubMed 22067174Wick 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.
- Individual participant dataSharing planned: No. There is no IPD sharing plan.
Related trials for Ileostomy; Complications
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Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
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Phasix Mesh Underlay During Loop Ileostomy Closure
Incisional Hernia of Anterior Abdominal Wall
Recruiting
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
Colorectal Surgery, Colorectal Cancer
Active, not recruiting
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
Rectal Cancer, Low Anterior Resection Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Montenegro, MD principal investigator
Saint Louis University, Dept. of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpxOstomy in people with Ileostomy; Complications and Ileostomy - Stoma, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: IRB request IRB request). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-based acute health care encounters (HBAC) (time frame: 30 days following discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03424954, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.