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

NCT04881708 | Completed

• 1 other identifier: 21-000817
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  Track the length of hospital stay in each group and compare.

  Until hospital discharge, typically 3 to 7 days

Secondary Outcomes (1)

• 30-day readmission rates

  30 day

Study Arms (2)

Current Care Group

NO INTERVENTION

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.

Remote Care Group

ACTIVE COMPARATOR

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

Interventions

Remote Monitoring DEVICE

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.

Remote Care Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Janani Reisenauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery, College of Medicine

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 11, 2021
• Study Start: April 19, 2021
• Primary Completion: January 17, 2022
• Study Completion: January 18, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

US (1)