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OpenTrials
Completed

NCT Number: NCT02136186

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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

Treatment and study plan

Philips Telehealth

Device

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

Primary outcomes

  1. Changes in Readmissions into Hospital

    Time frame: 30 days

    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.

Secondary outcomes

  1. Changes in Readmissions in the Emergency Room

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Brooks Health System

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 12, 2014
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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