Home Telemonitoring in Patients at High Risk for Readmission

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Home Telemonitoring in Patients at High Risk for Readmission

Conditions
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Inpatients

Intervention / Treatment
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* Device: Philips Telehealth


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home telemonitoring, readmission, high risk