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

NCT ID: NCT04881708

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2022-01-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Remote Monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Janani S. Reisenauer

Assistant Professor of Surgery, College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janani Reisenauer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

21-000817

Identifier Type: -

Identifier Source: org_study_id