Effect of a Short Message Service Intervention on Patients With Short Bowel Syndrome

March 27, 2019 updated by: Yosef Greenspon, MD, St. Louis University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Cardinal Glennon Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Text Message Arm
Patients in the Text Message Arm will receive a weekly set of text messages inquiring about the patients' symptoms instead of a weekly phone call from the nurse team (standard of care). Potentially harmful symptoms identified by the automated system will generate an alert that will be sent to the medical team. The alert will be immediately sent via email to the nursing team. The nurse will be able to contact the patient to decide the best further treatment. The nurses will check patient response rates daily. If a patient does not respond to their weekly message, then the patient will be called.
Other: Text Message Arm Intervention
Patients in the Text Message Arm will receive a weekly set of text messages inquiring about the patients' symptoms instead of a weekly phone call from the nurse team (standard of care). Potentially harmful symptoms identified by the automated system will generate an alert that will be sent to the medical team. The alert will be immediately sent via email to the nursing team. The nurse will be able to contact the patient to decide the best further treatment. The nurses will check patient response rates daily. If a patient does not respond to their weekly message, then the patient will be called.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 6 months
The primary outcome for this study will be comparing response rates to automated text messages vs historical weekly nurse call success rates. The investigators will compare these values using a chi-square.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity and Sensitivity
Time Frame: 6 months
Specificity and sensitivity of the alerts generated by the automated system
6 months
Cost savings
Time Frame: 6 months
Cost saved in terms of nurse time required without automated text message intervention
6 months
Clinic visits
Time Frame: 6 months
Number of clinic visits by SBS patients
6 months
Readmissions
Time Frame: 6 months
30 day readmission of SBS patients
6 months
Days spent in the hospital
Time Frame: 6 months
Number of days spent in the hospital
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Collaborators

Epharmix, Inc.

Investigators

  • Principal Investigator: Josef Greenspon, MD, St. Louis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2018

Primary Completion (Actual)

December 24, 2018

Study Completion (Actual)

March 21, 2019

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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