Clinical trial NCT03419156: Effect of a Short Message Service Intervention on Patients With Short Bowel Syndrome
Official title: Effect of a Short Message Service Intervention on Patients With Short Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Short Bowel Syndrome
Keywords: text message
telemedicine
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: Epharmix, Inc.
First posted: 2018-02-01
Enrollment: 5
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients with SBS on TPN at Cardinal Glennon will receive text messages inquiring about their symptoms instead of weekly phone calls from a nurse. There will be no randomization. All patients will be sent text-messages from the automated system for 6 months to assess response rates and the amount of time saved by the nurse staff. 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.The text messages are designed to help target calls made by the nursing staff.
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients under the age of 18
* Patients with a diagnosis of short bowel syndrome and who are treated with total parenteral nutrition
* Patients able to understand English or have a caregiver who understands English.
* Patients must have caregiver who has access to a phone (landline or cell phone)

Exclusion Criteria:

* Patients who do not have access to a phone (landline or cell phone), and patients who are not mentally able to consent to the study.
* Patients who are not treated with total parenteral nutrition.
* Patients who do no have a short bowel syndrome diagnosis

Primary outcomes:
measure: Response rate
timeFrame: 6 months
Secondary outcomes:
measure: Specificity and Sensitivity
timeFrame: 6 months
measure: Cost savings
timeFrame: 6 months
measure: Clinic visits
timeFrame: 6 months
measure: Readmissions
timeFrame: 6 months
measure: Days spent in the hospital
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Medical Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Josef Greenspon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartl WH, Jauch KW, Parhofer K, Rittler P; Working group for developing the guidelines for parenteral nutrition of The German Association for Nutritional Medicine. Complications and monitoring - Guidelines on Parenteral Nutrition, Chapter 11. Ger Med Sci. 2009 Nov 18;7:Doc17. doi: 10.3205/000076.
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citation: Cole CR, Hansen NI, Higgins RD, Ziegler TR, Stoll BJ; Eunice Kennedy Shriver NICHD Neonatal Research Network. Very low birth weight preterm infants with surgical short bowel syndrome: incidence, morbidity and mortality, and growth outcomes at 18 to 22 months. Pediatrics. 2008 Sep;122(3):e573-82. doi: 10.1542/peds.2007-3449.
citation: Spencer AU, Kovacevich D, McKinney-Barnett M, Hair D, Canham J, Maksym C, Teitelbaum DH. Pediatric short-bowel syndrome: the cost of comprehensive care. Am J Clin Nutr. 2008 Dec;88(6):1552-9. doi: 10.3945/ajcn.2008.26007.
citation: https://www.forbes.com/sites/larryalton/2017/05/11/how-do-millennials-prefer-to- communicate/#58cc85d16d6f
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citation: Cleeland CS, Wang XS, Shi Q, Mendoza TR, Wright SL, Berry MD, Malveaux D, Shah PK, Gning I, Hofstetter WL, Putnam JB Jr, Vaporciyan AA. Automated symptom alerts reduce postoperative symptom severity after cancer surgery: a randomized controlled clinical trial. J Clin Oncol. 2011 Mar 10;29(8):994-1000. doi: 10.1200/JCO.2010.29.8315. Epub 2011 Jan 31.
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