Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 2:41 PM
Study NCT ID:
NCT03528850
Status:
UNKNOWN
Last Update Posted:
2018-05-18
First Post:
2018-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stony Brook Telehealth Study
Sponsor:
Stony Brook University
Organization:
Study Overview
Official Title:
Stony Brook Telehealth Study. Tele-transitions of Care. An Approach to Reduce 30-day Readmission Using Tele-Health Technology; A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study evaluates the feasibility of providing tele-transition of care, using risk stratification, novel data tools, remote patient monitoring and virtual visits. A new communication tool for relaying tele-communication among providers caring for the virtual patient is introduced. The primary endpoint is 30-day readmissions.
Detailed Description:
The objective is to evaluate the feasibility and effectiveness of a patient-centered, physician led, transition of care, telehealth intervention. The intervention begins at the bedside prior to hospital discharge and involves remote patient monitoring of daily vitals, weekly virtual visits, detailed Electronic Medical Record (EMR) documentation and use of risk stratification as well as data from the Health Information Exchange (HIE).
The hypothesis is that in comparison to standard care:
1. Preventable hospital readmissions will be reduced through patient-centered virtual visits, daily biometric surveillance, and increased data access.
2. Patient satisfaction during the transition of care period will be improved
3. Adverse healthcare outcomes leading to ED visits or death will be reduced The primary aim of the study is to determine the effect of telehealth on unplanned hospital readmissions within 30 days of the index hospitalization discharge. In addition, data is collected in order to provide secondary analyses on the effect of telehealth on emergency department utilization, patient satisfaction, qualitative patient experience, patient self-management and self-efficacy attitudes.
The Telehealth patient is provided with a smart phone device and Bluetooth-enabled blood pressure monitoring cuff, weighing scale, and pulse oximeter. Telehealth patients measure their vitals daily and have weekly virtual visits with a transition of care physician (teledoc). The teledoc in this trial, is a senior resident physician in preventive medicine or family medicine.
Patient enrollment and randomization occurs at the bedside prior to hospital discharge. All patients are consented for the HIE in addition to the trial, and are risk stratified though an EMR data, based validated algorithm. The care management team is notified of all study participants in order to communicate to the telehealth team the date and time of hospital discharge. An introduction is made in person with the teledoc to evaluate the patient in person prior to virtual visits. Upon hospital discharge the patient receives the telehealth equipment by a vendor service to their home within 48 hours.
Risk stratification is done by an internally and externally validated High Risk Readmission Tool across many different hospital systems.
The patient follows prompts from the smart phone to register vitals daily, using a blood pressure cuff, pulse oximeter and digital scale. The teledoc determines the safety range parameters of the vitals depending on the patient clinical history and status. The telehealth vendor, notifies the teledoc of any abnormal values.
Weekly telehealth visits are conducted for the first 30 days after a hospitalization.
The hypothesis is that in comparison to standard care:
1. Preventable hospital readmissions will be reduced through patient-centered virtual visits, daily biometric surveillance, and increased data access.
2. Patient satisfaction during the transition of care period will be improved
3. Adverse healthcare outcomes leading to ED visits or death will be reduced The primary aim of the study is to determine the effect of telehealth on unplanned hospital readmissions within 30 days of the index hospitalization discharge. In addition, data is collected in order to provide secondary analyses on the effect of telehealth on emergency department utilization, patient satisfaction, qualitative patient experience, patient self-management and self-efficacy attitudes.
The Telehealth patient is provided with a smart phone device and Bluetooth-enabled blood pressure monitoring cuff, weighing scale, and pulse oximeter. Telehealth patients measure their vitals daily and have weekly virtual visits with a transition of care physician (teledoc). The teledoc in this trial, is a senior resident physician in preventive medicine or family medicine.
Patient enrollment and randomization occurs at the bedside prior to hospital discharge. All patients are consented for the HIE in addition to the trial, and are risk stratified though an EMR data, based validated algorithm. The care management team is notified of all study participants in order to communicate to the telehealth team the date and time of hospital discharge. An introduction is made in person with the teledoc to evaluate the patient in person prior to virtual visits. Upon hospital discharge the patient receives the telehealth equipment by a vendor service to their home within 48 hours.
Risk stratification is done by an internally and externally validated High Risk Readmission Tool across many different hospital systems.
The patient follows prompts from the smart phone to register vitals daily, using a blood pressure cuff, pulse oximeter and digital scale. The teledoc determines the safety range parameters of the vitals depending on the patient clinical history and status. The telehealth vendor, notifies the teledoc of any abnormal values.
Weekly telehealth visits are conducted for the first 30 days after a hospitalization.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: