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Home Telemonitoring in Patients at High Risk for Readmission

NCT ID: NCT02136186

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-07-31

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.

Conditions

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Inpatients

Keywords

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home telemonitoring readmission high risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
patients deidentified

Study Groups

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Standard of care

patients will receive standard of care discharge instructions

Group Type NO_INTERVENTION

No interventions assigned to this group

Philips Telehealth

patients will be discharged with a telemonitoring device for 30 days

Group Type ACTIVE_COMPARATOR

Philips Telehealth

Intervention Type DEVICE

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

Interventions

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Philips Telehealth

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

Intervention Type DEVICE

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brooks Health System

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Nancy L. Dawson, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Dawson, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33506388 (View on PubMed)

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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13-003548

Identifier Type: -

Identifier Source: org_study_id