Clinical trial NCT04540315: Reducing Surgical Readmissions Through Mobile Technology
Official title: Reducing Surgical Readmissions Through Mobile Technology: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Readmission
Perioperative Care
Keywords: mobile app
readmission
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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:

Primary outcomes:
measure: Proportion of participants readmitted within 30 days of surgery
timeFrame: 30 days postoperative
Secondary outcomes:
measure: Proportion of participants readmitted within 90 days of surgery
timeFrame: 90 days post-operative
measure: 30 day postoperative complication severity as measured by Clavien-Dindo Score
timeFrame: 30 days postoperative
measure: 90 day postoperative complication severity as measured by Clavien-Dindo Score
timeFrame: 90 days postoperative
measure: Total number of emergency department visits at 30 days postoperative
timeFrame: 30 days postoperative
measure: Total number of emergency department visits at 90 days postoperative
timeFrame: 90 days postoperative
measure: Total readmission cost
timeFrame: Up to 90 days postoperative
Other outcomes:
measure: 30-day participant satisfaction measured by Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey
timeFrame: 30 days postoperative
measure: 90-day participant satisfaction measured by Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey
timeFrame: 90 days postoperative
measure: 180-day participant satisfaction measured by Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey
timeFrame: 180 days postoperative
measure: 30-day physical function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form score
timeFrame: 30 days postoperative
measure: 90-day physical function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form score
timeFrame: 90 days postoperative
measure: 180-day physical function as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form score
timeFrame: 180 days postoperative
measure: 30-day pain intensity as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form pain intensity scale
timeFrame: 30 days postoperative
measure: 90-day pain intensity as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form pain intensity scale
timeFrame: 90 days postoperative
measure: 180-day pain intensity as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) short form pain intensity scale
timeFrame: 180 days postoperative
measure: Total number of days spent in-hospital for the readmission event
timeFrame: Up to 90 days
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Corrine I Voils, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diehl TM, Barrett JR, Abbott DE, Cherney Stafford LM, Hanlon BM, Yang Q, Van Doorn R, Weber SM, Voils CI. 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. Contemp Clin Trials. 2022 Feb;113:106658. doi: 10.1016/j.cct.2021.106658. Epub 2021 Dec 22.