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

NCT03419156 | Terminated

• 1 other identifier: 28143
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Bowel Syndrome

Keywords

text message; telemedicine

Outcome Measures

Primary Outcomes (1)

• Response rate

  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 Outcomes (5)

• Specificity and Sensitivity

  6 months

• Cost savings

  6 months

• Clinic visits

  6 months

• Readmissions

  6 months

• Days spent in the hospital

  6 months

Study Arms (1)

Text Message Arm

EXPERIMENTAL

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

Interventions

Text Message Arm Intervention OTHER

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.

Text Message Arm

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead
• Epharmix, Inc.: collaborator

Study Sites (1)

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Related Publications (12)

• 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.

  PMID: 20049074 BACKGROUND

• Duro D, Kamin D, Duggan C. Overview of pediatric short bowel syndrome. J Pediatr Gastroenterol Nutr. 2008 Aug;47 Suppl 1:S33-6. doi: 10.1097/MPG.0b013e3181819007.

  PMID: 18667916 BACKGROUND

• Uko V, Radhakrishnan K, Alkhouri N. Short bowel syndrome in children: current and potential therapies. Paediatr Drugs. 2012 Jun 1;14(3):179-88. doi: 10.2165/11594880-000000000-00000.

  PMID: 22452596 BACKGROUND

• Salvia G, Guarino A, Terrin G, Cascioli C, Paludetto R, Indrio F, Lega L, Fanaro S, Stronati M, Corvaglia L, Tagliabue P, De Curtis M; Working Group on Neonatal Gastroenterology of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition. Neonatal onset intestinal failure: an Italian Multicenter Study. J Pediatr. 2008 Nov;153(5):674-6, 676.e1-2. doi: 10.1016/j.jpeds.2008.05.017. Epub 2008 Jun 27.

  PMID: 18589446 BACKGROUND

• Wales PW, de Silva N, Kim J, Lecce L, To T, Moore A. Neonatal short bowel syndrome: population-based estimates of incidence and mortality rates. J Pediatr Surg. 2004 May;39(5):690-5. doi: 10.1016/j.jpedsurg.2004.01.036.

  PMID: 15137001 BACKGROUND

• 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.

  PMID: 18762491 BACKGROUND

• 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.

  PMID: 19064515 BACKGROUND

• https://www.forbes.com/sites/larryalton/2017/05/11/how-do-millennials-prefer-to- communicate/#58cc85d16d6f

  BACKGROUND

• DeVito Dabbs A, Song MK, Myers BA, Li R, Hawkins RP, Pilewski JM, Bermudez CA, Aubrecht J, Begey A, Connolly M, Alrawashdeh M, Dew MA. A Randomized Controlled Trial of a Mobile Health Intervention to Promote Self-Management After Lung Transplantation. Am J Transplant. 2016 Jul;16(7):2172-80. doi: 10.1111/ajt.13701. Epub 2016 Mar 14.

  PMID: 26729617 BACKGROUND

• Carrier G, Cotte E, Beyer-Berjot L, Faucheron JL, Joris J, Slim K; Groupe Francophone de Rehabilitation Amelioree apres Chirurgie (GRACE). Post-discharge follow-up using text messaging within an enhanced recovery program after colorectal surgery. J Visc Surg. 2016 Aug;153(4):249-52. doi: 10.1016/j.jviscsurg.2016.05.016. Epub 2016 Aug 8.

  PMID: 27423211 BACKGROUND

• 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.

  PMID: 21282546 BACKGROUND

• Martinez-Ramos C, Cerdan MT, Lopez RS. Mobile phone-based telemedicine system for the home follow-up of patients undergoing ambulatory surgery. Telemed J E Health. 2009 Jul-Aug;15(6):531-7. doi: 10.1089/tmj.2009.0003.

  PMID: 19566396 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josef Greenspon, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery; Pediatric Surgery

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 1, 2018
• Study Start: February 20, 2018
• Primary Completion: December 24, 2018
• Study Completion: March 21, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)