Clinical Trials Logo

Clinical Trial Summary

The investigators will be using a text messaging intervention to identify potentially dangerous and re- admission causing symptoms in patients with Short Bowel Syndrome (SBS) on Total Parenteral Nutrition (TPN). Each consented patient will receive weekly text messages inquiring about potentially harmful symptoms identified by a team of physicians. If the patient screens positive via text message, an alert will be sent to the medical team. All patients with SBS on TPN will receive text messages. The investigators will be monitoring response rates to text messages screening for potentially harmful symptoms and compare the text- message response rate to historical rates of successful calls by nurses.

All patients with SBS on TPN will receive text messages instead of weekly phone calls from a nurse. If the patient does not respond to the text messages or the text message responses suggest that the patient may be presenting with potentially harmful symptoms, the nurse will call the patient to inquire about more information.


Clinical Trial Description

Short Bowel Syndrome (SBS) is a condition that results from a host of different conditions, the most common of which is Necrotizing Enterocolitis. Patients who have SBS are often Total Parenteral Nutrition (TPN) dependent. TPN is a carefully formulated intravenous nutrition that is utilized either alone or in conjunction with gastrointestinal feeds in patients who fail to achieve adequate caloric intake enterally. According to the American Society of Parenteral and Enteral Nutrition, 360,000 hospital visits required usage of TPN in 2009. Short and long-term use of TPN is associated with catheter infections, cholestasis, liver failure, refeeding-syndrome, hyperglycemia, bone demineralization, and death (1). Thus careful and comprehensive monitoring of patients on TPN, especially after hospital discharge is essential (1-3). Some hospitals have introduced resource intensive support teams consisting of various health care professionals to manage these costly patients (1).

Using a variety of definitions, the incidence of SBS has been estimated at approximately 0.02 to 0.1 percent among all live births (4, 5), 0.5 to 2.0 percent among neonatal intensive care unit (NICU) admissions (4, 5), and 0.7 percent among very low birthweight infants (6). Approximately 80 percent of pediatric SBS cases develop during the neonatal period.

The average cost of care in the US for a single pediatric patient with SBS is $550,250 +/- $248, 398 for the first year of care alone (7). These costs were attributable to prolonged requirements for intensive care resources, numerous surgical procedures, multiple readmissions, TPN and home care during the first year of diagnosis. Interestingly, Spencer et al. suggested that hospital-based costs steadily declined in subsequent years, but home-care services increased every year for the first 5 y of diagnosis (7). This increasing cost was attributable to increasing complications of TPN, especially infectious complications (something our application will specifically try to identify). The mean total cost of care per child over a 5-y period was US$1,619,851 +/- US$1,028,985 (7).

At Cardinal Glenon, a significant amount of time (about 10 hours per week) is spent by nurses calling these patients. This automated system will allow nurses to spend a portion of these 10 hours performing other activities, significantly reducing the costs attributed to SBS patients. Also, most of the mothers of patients who have SBS are between the ages of 15-30. This generation of millennials often have an aversion to phone calls and prefer texts [8]. Text- messages can be answered at a convenient time for the parent while the parent must be present and available to answer a phone call. Multiple prior text message or application intervention studies have reported high response rates, high satisfaction, and improvement in outcomes (9-12). For example, Devitto et al. reported that the estimated odds of reporting critical care symptoms of application group was 8.9 times that of control and showed slightly higher adherence to the prescribed regimen (OR 1.64, 95% CI [1.01, 2.66]) (9). Martinez et al. reported that 16 patients would have returned to the hospital without photos of surgical sites prompting health care team intervention (12). Our automated texting system may improve response rates from these young parents.

For this project, the investigators will be examining the effect of an Epharmix text messaging intervention on identifying potentially dangerous and re-admission causing symptoms with SBS patients on TPN. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03419156
Study type Interventional
Source St. Louis University
Contact
Status Terminated
Phase N/A
Start date February 20, 2018
Completion date March 21, 2019

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05635747 - A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB
Completed NCT01891279 - Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition? N/A
Completed NCT00930644 - Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS) Phase 3
Completed NCT01696656 - Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency N/A
Completed NCT00910104 - Cholestasis Reversal: Efficacy of IV Fish Oil Phase 2/Phase 3
Recruiting NCT04981262 - Improved Quality of Life in Children With Intestinal Failure N/A
Completed NCT01930539 - Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp N/A
Recruiting NCT05023382 - A Study of Teduglutide in Japanese People With Short Bowel Syndrome
Recruiting NCT04733066 - Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis
Terminated NCT00742157 - Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS) Phase 4
Completed NCT04743960 - Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition N/A
Completed NCT03690206 - Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) Phase 3
Terminated NCT02266849 - Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study Phase 3
Completed NCT01306838 - Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy Early Phase 1
Completed NCT01380366 - rHGH and Intestinal Permeability in Intestinal Failure Phase 4
Completed NCT00248573 - Mechanisms of Adaptation in Human Short Bowel Syndrome Phase 1/Phase 2
Withdrawn NCT03371862 - Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS) Phase 2
Completed NCT04474743 - Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study
Completed NCT00067860 - Diet/Growth Factor Mechanisms of Gut Adaptation Phase 2
Terminated NCT04046328 - Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome Phase 2