NCT03528850

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

February 1, 2018

Last Update Submit

May 16, 2018

Conditions

TelemedicinePatient Readmission

Outcome Measures

Primary Outcomes (1)

  • Hospital Readmission

    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.

    30 Days

Secondary Outcomes (1)

  • Emergency Room Utilization

    30 Days

Study Arms (2)

Telehealth

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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

Interventions

Telemedicine evaluationOTHER

Weekly virtual visits and daily biometric readings of blood pressure, weight, oxygen saturation and pulse

Telehealth

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (1)

  • Noel K, Messina C, Hou W, Schoenfeld E, Kelly G. Tele-transitions of care (TTOC): a 12-month, randomized controlled trial evaluating the use of Telehealth to achieve triple aim objectives. BMC Fam Pract. 2020 Feb 7;21(1):27. doi: 10.1186/s12875-020-1094-5.

    PMID: 32033535DERIVED

Study Officials

  • Kimberly Noel, MD MPH

    Stony Brook Medicine Telehealth Director

    STUDY DIRECTOR

Central Study Contacts

Kimberly Noel, MD MPH

CONTACT

6314442032kimberly.noel@stonybrookmedicine.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

May 18, 2018

Study Start

June 1, 2017

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Study Protocol and supporting data will be shared with other similar academic centers upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The data will be available within 1 year of publication and will be available for 5 years.

Locations

US(1)