Reducing Surgical Readmissions Through Mobile Technology

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reducing Surgical Readmissions Through Mobile Technology: A Randomized Controlled Trial

Conditions
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Readmission, Perioperative Care

Intervention / Treatment
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* Behavioral: MobiMD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study English speaking Able to pass a cognitive screening test Patient or caregiver has access to a device capable of running the MobiMD app (tablet or smartphone). Undergoing complex abdominal surgery in the departments of surgical oncology, colorectal surgery, or transplant surgery, (Complex abdominal surgery is interpreted as whipple procedure, hyperthermic intraperitoneal chemotherapy (HIPEC), gastrectomy, distal pancreatectomy, liver transplant, pancreas transplant, simultaneous kidney and pancreas transplant, low anterior resection, and all bowel resections requiring an ostomy). Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - MobiMD app<br>Intervention group will receive notifications to their smart device through MobiMD app. Participants will be asked to fill out reports and upload all clinically relevant data using the app. Engaging with the app will be in addition to the standard of care follow-up. | Behavioral: MobiMD<br>* 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.<br>|
| No Intervention: Standard of Care<br>The standard of care control group will receive conventional postoperative care. Participants will receive reported outcome survey by email. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Up to 90 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile app, readmission