Home Telemonitoring in Patients at High Risk for Readmission

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02136186

Collaborator

Brooks Health System (Other)

1,380

Enrollment

Location

Arms

Actual Duration (Months)

19.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inpatients	Device: Philips Telehealth	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

patients deidentified

Primary Purpose:

Prevention

Official Title:

Home Telemonitoring in Patients at High Risk for Readmission

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Standard of care

patients will receive standard of care discharge instructions

Active Comparator: Philips Telehealth

patients will be discharged with a telemonitoring device for 30 days

Device: Philips Telehealth

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

Outcome Measures

Primary Outcome Measures

Changes in Readmissions into Hospital [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 Outcome Measures

Changes in Readmissions in the Emergency Room [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Mayo Clinic
Brooks Health System

Investigators

Principal Investigator: Nancy Dawson, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Nancy L. Dawson, M.D., PI, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT02136186

Other Study ID Numbers:

13-003548

First Posted:

May 12, 2014

Last Update Posted:

Nov 10, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nancy L. Dawson, M.D., PI, Mayo Clinic

home telemonitoring

readmission

high risk

Study Results

No Results Posted as of Nov 10, 2020