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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04881708
Other study ID # 21-000817
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2021
Est. completion date January 18, 2022

Study information

Verified date July 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 18, 2022
Est. primary completion date January 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of Stay Track the length of hospital stay in each group and compare. Until hospital discharge, typically 3 to 7 days
Secondary 30-day readmission rates Evaluate the number of patients that are readmitted to the hospital in each group and compare. 30 day
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