Home Telemonitoring in Patients at High Risk for Readmission

Inpatients Clinical Trial

Official title:

Home Telemonitoring in Patients at High Risk for Readmission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136186
• Other study ID #: 13-003548
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy of home telemonitoring as an intervention to decrease hospital readmissions in patients at high risk for readmission. The overall readmission rate for high-risk MCF hospital patients is approximately 20%. Currently a system is in place to identify and score all MCF patients for their risk of readmission. This score is based on multiple variables including but not limited to: co-morbid conditions, patient's health literacy, whether they are a Medicare/Medicaid patient, their in-home social support, and whether they have had prior hospital admissions within the previous year. The literature shows that home telemonitoring of patients has had mixed results for effectiveness at preventing hospitalizations and emergency department visits. Many of these reports have restricted studies to patients with specific diseases or general characteristics; some have shown improved results while others have not. No study has examined patients who are high risk for readmission to determine if home telemonitoring for 30 days post-discharge reduces the risk for 30-day readmission.

Description:

We hope to enroll a total of 1900 participants, 950 in each arm, over the next 2 years. One arm will be the telemonitoring group and one arm will be the standard of care group. Participants will be in the study for 30 days. Participants in the telemonitoring group will receive a Telestation, blood pressure monitor, and pulse oximeter. If the participant also has congestive heart failure, they will receive a scale. All of these vital measurements are to be taken on a daily basis along with survey questions on how the patient feels. If set parameters are out of the normal range, a flag will trigger that requires follow up/intervention from a nurse by telephone. In some cases, the participant might need to come back in to see a physician through the outpatient clinic. The participant in the standard of care group will be contacted via phone 30 days after discharge to learn if they were readmitted to any hospitals or had any emergency room visits during the past 30 days. This data will be collected via Philips software and also entered into the RedCap database here at Mayo Clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1380
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1) readmission risk score of 11 or higher 2) may be from any service in the hospital 3) patient discharged home or 4) patient discharged to skilled nursing/rehabilitation

Exclusion Criteria:

1. international

2. under age 18

3. discharged to hospice

4. discharged to a sub-acute care hospital

5. transferred to an acute care hospital or

6. if the patient has a planned readmission within the next 30 days

Related Conditions & MeSH terms

• Inpatients

Intervention

Device:
• Philips Telehealth
patients will be provided with a philips home telemonitoring system post hospital discharge

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Brooks Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Readmissions into Hospital	Compare 30-day readmission rates between high-risk patients who are home monitored using technology and high-risk patients who receive the current standard care.	30 days
Secondary	Changes in Readmissions in the Emergency Room	Compare 30-day emergency department visit rates between high-risk patients who are home monitored using technology and high-risk patients who receive current standard care.	30 days

External Links

•   Mayo Clinic Clinical Trials