Reducing Surgical Readmissions Through Mobile Technology

NCT04540315 | Completed DMC

• 5 other identifiers: 2020-0739MSN225549A539722SMPH/SURGERYProtocol Version 9/20/2021
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Readmission; Perioperative Care

Keywords

mobile app; readmission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of participants readmitted within 90 days of surgery

  90 days post-operative

• 30 day postoperative complication severity as measured by Clavien-Dindo Score

  30 days postoperative

• 90 day postoperative complication severity as measured by Clavien-Dindo Score

  90 days postoperative

• Total number of emergency department visits at 30 days postoperative

  30 days postoperative

• Total number of emergency department visits at 90 days postoperative

  90 days postoperative

Other Outcomes (10)

• 30-day participant satisfaction measured by Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey

  30 days postoperative

• 90-day participant satisfaction measured by Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey

  90 days postoperative

• 180-day participant satisfaction measured by Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey

  180 days postoperative

Study Arms (2)

Intervention - MobiMD app

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

The standard of care control group will receive conventional postoperative care. Participants will receive reported outcome survey by email.

Interventions

MobiMD BEHAVIORAL

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.

Intervention - MobiMD app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 34954099 DERIVED

Study Officials

• Corrine I Voils, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: October 2, 2020
• Primary Completion: February 4, 2022
• Study Completion: August 10, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)