Protocol for the MobiMD trial: A randomized controlled trial to evaluate the effect of a self-monitoring mobile app on hospital readmissions for complex surgical patients

• Published in: Contemporary clinical trials Vol. 113; p. 106658
• Main Authors: Diehl, Thomas M., Barrett, James R., Abbott, Daniel E., Cherney Stafford, Linda M., Hanlon, Bret M., Yang, Qiuyu, Van Doorn, Rachel, Weber, Sharon M., Voils, Corrine I.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-02-2022
• Subjects: Emergency Service, Hospital; Health services research; Humans; Mobile app; Mobile Applications; Mobile health; Patient Readmission; Randomized Controlled Trials as Topic; Readmissions; Telemedicine; Transitional Care; Transitional care; Telemedicine; Mobile app; Mobile health; Readmissions; Health services research
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2021.106658

Hospital readmissions are estimated to cost $17.4 billion per year in the Medicare population alone, with readmission rates as high as 30% for patients undergoing complex abdominal surgery. Improved transitional care and self-monitoring may reduce preventable readmissions for such high-risk populations. In this study, we will conduct a single-institution randomized controlled trial (RCT) to assess the effect of a novel transitional care mobile app, MobiMD, on hospital readmission in complex abdominal surgery patients.
Three hundred patients will be randomized 1:1 to standard of care (SOC) versus SOC plus MobiMD app in a parallel, single-blinded, two-arm RCT. Eligible patients are those who undergo complex abdominal surgery in the division of Surgical Oncology, Colorectal Surgery or Transplant Surgery. The MobiMD app provides push notification reminders directly to the patient's smart device, prompting them to enter clinical data and patient-reported outcomes. Clinical data collected via the MobiMD app include vital signs, red flag symptoms, daily wound and surgical drain images, ostomy output, drain output, medication compliance, and wound care compliance. These data are reviewed daily by a physician. The primary outcome is the proportion of participants readmitted to the hospital within 30 days of surgery. Secondary outcomes are 90-day hospital readmission, emergency department and urgent care visits, complication severity, and total readmission cost.
If effective, mobile health apps such as MobiMD could be routinely integrated into surgical transitional care programs to minimize unnecessary hospital readmissions, emergency department visits and healthcare resource utilization.
Clinical trials identifier: NCT04540315