Home Telemonitoring in Patients at High Risk for Readmission

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.

Study Overview

• Status: Completed
• Conditions: Inpatients
• Intervention / Treatment: Device: Philips Telehealth

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; patients will receive standard of care discharge instructions
Active Comparator: Philips Telehealth; patients will be discharged with a telemonitoring device for 30 days	Device: Philips Telehealth; patients will be provided with a philips home telemonitoring system post hospital discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Brooks Health System
• Investigators: Principal Investigator: Nancy Dawson, MD, Mayo Clinic

Publications and helpful links

General Publications

• Dawson NL, Hull BP, Vijapura P, Dumitrascu AG, Ball CT, Thiemann KM, Maniaci MJ, Burton MC. Home Telemonitoring to Reduce Readmission of High-Risk Patients: a Modified Intention-to-Treat Randomized Clinical Trial. J Gen Intern Med. 2021 Nov;36(11):3395-3401. doi: 10.1007/s11606-020-06589-1. Epub 2021 Jan 27.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 8, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: high risk; readmission; home telemonitoring
• Other Study ID Numbers: 13-003548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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