Home Telemonitoring in Patients at High Risk for Readmission

NCT02136186 | Completed

• 1 other identifier: 13-003548
• Study Type: interventional
• Target: 1,380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inpatients

Keywords

home telemonitoring; readmission; high risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Readmissions in the Emergency Room

  30 days

Study Arms (2)

Standard of care

NO INTERVENTION

patients will receive standard of care discharge instructions

Philips Telehealth

ACTIVE COMPARATOR

patients will be discharged with a telemonitoring device for 30 days

Device: Philips Telehealth

Interventions

Philips Telehealth DEVICE

patients will be provided with a philips home telemonitoring system post hospital discharge

Philips Telehealth

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• international
• under age 18
• discharged to hospice
• discharged to a sub-acute care hospital
• transferred to an acute care hospital or
• if the patient has a planned readmission within the next 30 days

Sponsors & Collaborators

• Mayo Clinic: lead
• Brooks Health System: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• 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.

  PMID: 33506388 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Nancy Dawson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients deidentified
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: May 12, 2014
• Study Start: October 1, 2014
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)