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| Name | Class |
|---|---|
| Epharmix, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EpxOstomy | Experimental | Post-operative ileostomy patients will receive the study intervention for 30 days following discharge from the hospital. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpxOstomy | Behavioral | A 30-day post-operative automated text-messaging intervention for home monitoring of ileostomy output |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient response rates | Automated message response data | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace Montenegro, MD | Saint Louis University, Dept. of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SSM Health Saint Louis University Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25380008 | Background | 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. | |
| 23838866 | Background | 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. |
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There is no IPD sharing plan.
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All patients undergoing ileostomy surgery will receive the study intervention. We will compare to a historical control.
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| One time, on day 30 of the intervention. |
| 22067174 | Background | 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. |