Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay (RPM)

The investigators believe that hospital readmissions for intermediate- to high-complexity surgeries can be reduced by remote patient monitoring follow-up post-discharge, which involves daily touchpoints with a clinical nurse, vital sign evaluation and a symptom directed communication escalation process.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Remote Monitoring

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults (over 18 years of age)
• Undergoing one of the following inpatient elective surgery procedures: abdominal wall reconstruction, bariatrics, hepatectomy, pancreatectomy, aortic surgery, lower extremity bypass, esophagectomy and colectomy at Mayo Clinic Rochester.
• Must be willing to actively work with RPM nurses with vital sign capturing.

Exclusion Criteria:

• Have uncontrolled mental illness and/or drug or alcohol abuse
• Reside in a long-term care facility
• Are being actively followed by dialysis or transplant services
• Pregnant
• Are being actively treated for cancer, receiving chemo or radiation therapy during the remote monitoring
• Are identified as end-of-life by provider
• Have dementia, cognitive impairment, or physical condition that limits ability to use home remote monitoring equipment independently or interact with remote patient monitoring staff (unless a caregiver commits to assisting daily).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Current Care Group; The current care group will receive the standard of care currently in place within the subspecialty practices in the Department of Surgery, Mayo Clinic Rochester. This includes postoperative inpatient care directed by the surgical team, including timing of discharge and follow-up.
Active Comparator: Remote Care Group; Patients randomized to the remote monitoring arm will engage in a Connected Care Remote Patient Monitoring (RPM) Complex Care program. RPM Complex Care programs utilize established and standardized equipment, logistics/reverse logistic, engagement methods, and nursing clinical practice. Use of RPM Complex Care programs in this manner, is considered standard practice. Patients will be monitored for 30 days by the Connected Care nursing team as is standard for surgical RPM Complex Care programs.	Device: Remote Monitoring; Subjects assigned to the Remote Care group will receive education from a clinical nurse from Mayo Clinic's Department of Connected Care on use of the equipment as part of Remote Monitoring. The equipment will be shipped along with instructions and Welcome Letter describing the Mayo Clinic Remote Patient Monitoring program. The Remote Patient Monitoring kit includes a digital tablet, a blood pressure cuff, a thermometer, a pulse oximeter, and a weight scale. Subjects will be contacted by phone at the end of the study to be instructed how to return the kit by mail.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Track the length of hospital stay in each group and compare.	Until hospital discharge, typically 3 to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day readmission rates	Evaluate the number of patients that are readmitted to the hospital in each group and compare.	30 day

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21-000817

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No