This randomized trial will study the effect of a mobile app that facilitates patient engagement (patients undergoing complex abdominal surgery will track metrics of interest to the surgeon, submit reports on their symptoms/pain/physical function, and upload wound images) on readmission to the hospital. This trial will also assess whether the app can impact surgical complication severity, number of emergency department visits, and readmission costs. 300 participants will be enrolled and can expect to be on study for 6 months.
Hospital readmissions are estimated to cost $17.4 billion per year in the Medicare population alone. Readmission rates may be as high as 30% for patients undergoing complex abdominal surgery. In this study, investigators will conduct a randomized controlled trial (RCT) to assess the effect of a novel mobile technology platform, MobiMD, on hospital readmission in complex abdominal surgery patients. Data from a 50-patient MobiMD pilot study supports the RCT design and mobile platform's feasibility in this study population. Investigators hypothesize that the MobiMD app can facilitate better information transfer between surgeons and patients in the high-risk postoperative time period, thereby reducing hospital readmissions, emergency department visits, complication severity, and overall resource utilization. Investigators will conduct a parallel, single-blinded, 2-arm randomized controlled trial investigating the effect of a novel mobile health app on hospital readmissions for adults undergoing complex abdominal surgery. Three hundred participants (150 patients per arm) will be randomized to compare standard postoperative care alone versus plus MobiMD app. This study is powered to detect a clinically meaningful difference of 11% in readmissions. Participants will be eligible if they undergo any of the following procedures: pancreaticoduodenectomy, cytoreductive surgery/ hyperthermic intraperitoneal chemotherapy (HIPEC), gastrectomy, distal pancreatectomy, liver transplant, pancreas transplant, simultaneous kidney and pancreas transplant, low anterior resection, and any bowel resection requiring an ostomy. The MobiMD app collects important clinical data points and patient-reported outcomes with associated push notifications sent directly to the patient's smart device. 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. The primary outcome of the RCT will be 30-day hospital readmission. The secondary outcomes will include 90-day readmission, emergency department and urgent care visits, complication severity, and total readmission cost. Exploratory outcomes will include length of stay and patient-reported outcomes in patient satisfaction, pain, and physical function. All participants will be followed for 6 months.
MobiMD is a mobile app. This is an app available to IOS and Android devices only. The app provides a digitized version of the discharge instructions and provides push notifications to remind the participant of important instructions. In addition, the app allows participants (and their care teams) to record and track relevant clinical data.
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Proportion of participants readmitted within 30 days of surgery
The primary aim of the study is to determine if using MobiMD app changes the proportion of participants readmitted to the hospital within 30 days of surgery. Readmission will be counted as "1" event and no readmission will be counted as "0" event. In concordance with the standards of Centers for Medicare and Medicaid services, multiple readmissions for the same participant within a 30-day period will be measured as one event.
Time frame: 30 days postoperative
Proportion of participants readmitted within 90 days of surgery
Readmission will be counted as "1" event and no readmission will be counted as "0" event. In concordance with the standards of Centers for Medicare and Medicaid services, multiple readmissions for the same participant within a 90-day period will be measured as one event.
Time frame: 90 days post-operative
30 day postoperative complication severity as measured by Clavien-Dindo Score
Complications and their associated severity as measured by the Clavien-Dindo score will be reported at 30 days postoperatively. The Clavien-Dindo score ranges from 1 to 5, with higher score indicating more severe complication. This score will be obtained and scored from chart review.
Time frame: 30 days postoperative
90 day postoperative complication severity as measured by Clavien-Dindo Score
Complications and their associated severity as measured by the Clavien-Dindo score will be reported at 90 days postoperatively. The Clavien-Dindo score ranges from 1 to 5, with higher score indicating more severe complication. This score will be obtained and scored from chart review.
Time frame: 90 days postoperative
Total number of emergency department visits at 30 days postoperative
The total number of emergency department and urgent care visits will be reported at 30 days postoperatively. This data will be obtained from chart review.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
300
Time frame: 30 days postoperative
Total number of emergency department visits at 90 days postoperative
The total number of emergency department and urgent care visits will be reported at 90 days postoperatively. This data will be obtained from chart review.
Time frame: 90 days postoperative
Total readmission cost
The total readmission hospital cost will be calculated using fiscal data harvested form Clarity (Epic). Clarity includes direct/indirect and fixed/variable hospital cost and reimbursement for professional fees. These variables can be accessed in very short timeframes (1 week). The two trial arms will be compared with respect to total healthcare-associated readmission costs.
Time frame: Up to 90 days postoperative