Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stony Brook Telehealth Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528850
Recruitment Status : Unknown
Verified May 2018 by Stony Brook University.
Recruitment status was:  Recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Stony Brook University

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.

Condition or disease Intervention/treatment Phase
Telemedicine Patient Readmission Other: Telemedicine evaluation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2018

Arm Intervention/treatment
Experimental: Telehealth
The Telehealth arm will receive daily biometric measurement of blood pressure, heart rate, oxygen saturation and weight. The Telehealth arm will also have weekly virtual visits for the first month after hospital discharge. The Telehealth arm will answer surveys weekly for the first 30 days.
Other: Telemedicine evaluation
Weekly virtual visits and daily biometric readings of blood pressure, weight, oxygen saturation and pulse

No Intervention: Standard of Care
The Standard of Care will receive no interventions but will conduct surveys at enrollment and at the end of 30 days.



Primary Outcome Measures :
  1. Hospital Readmission [ Time Frame: 30 Days ]
    Hospital Readmission is calculated by data abstracted from the Electronic Medical Record and by surveys. Study data is collected and managed using REDCap (16) electronic data capture tools hosted at Stony Brook Medicine. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. REDCap software allows the team to incorporate a randomization schema to include it in the process of enrollment seamlessly. After meeting inclusion criteria, the software follows a schema unknown to the researchers to randomly select consented participants into appropriate arms of trial.


Secondary Outcome Measures :
  1. Emergency Room Utilization [ Time Frame: 30 Days ]
    Emergency Room Utilization is calculated by data abstracted from the Electronic Medical Record and by surveys. Study data is collected and managed using REDCap (16) electronic data capture tools hosted at Stony Brook Medicine. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. REDCap software allows the team to incorporate a randomization schema to include it in the process of enrollment seamlessly. After meeting inclusion criteria, the software follows a schema unknown to the researchers to randomly select consented participants into appropriate arms of trial.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Family Medicine Patients who are:

    • Age 30 years or older
    • Able to provide consent for their own care
    • English speakers (able to comprehend and speak English)
    • Patients with good cognitive function (as evidence by ability to answer a mild cognitive screen (age, telephone, current date, name of facility)
    • Living within reasonable commute to the Family Medical Group clinics
    • Patients with a life expectancy greater than 6 months
    • Patients with a clinical disposition to home after hospital discharge
    • Patients that are able to turn on the telehealth technology and follow prompts

Exclusion Criteria:

  • Uninsured patients who are not currently seen by the Family Medicine Practice
  • Patients whose physical limitations prohibit the use of the telehealth equipment
  • Patients involved in another research study
  • Pregnant patients (patients actively trying to conceive)
  • Admission for a psychiatric primary diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528850


Contacts
Layout table for location contacts
Contact: Kimberly Noel, MD MPH 6314442032 kimberly.noel@stonybrookmedicine.edu

Locations
Layout table for location information
United States, New York
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Kimberly Noel, MD MPH    631-444-2032    kimberly.noel@stonybrookmedicine.edu   
Sponsors and Collaborators
Stony Brook University
Investigators
Layout table for investigator information
Study Director: Kimberly Noel, MD MPH Stony Brook Medicine Telehealth Director
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT03528850    
Other Study ID Numbers: 970227
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study Protocol and supporting data will be shared with other similar academic centers upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data will be available within 1 year of publication and will be available for 5 years.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No