Clinical trial NCT02136186: Home Telemonitoring in Patients at High Risk for Readmission
Official title: Home Telemonitoring in Patients at High Risk for Readmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inpatients
Keywords: home telemonitoring
readmission
high risk
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Brooks Health System
First posted: 2014-05-12
Enrollment: 1380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Readmissions into Hospital
timeFrame: 30 days
Secondary outcomes:
measure: Changes in Readmissions in the Emergency Room
timeFrame: 30 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Nancy Dawson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.