Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02136186 |
Other study ID # |
13-003548 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 2014 |
Est. completion date |
July 31, 2020 |
Study information
Verified date |
November 2020 |
Source |
Mayo Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.