NCT05166603

Brief Summary

The overall objective of the TeleGRACE project is to improve the care and outcomes of older Veterans with a recent inpatient stay by expanding access to the evidence-based GRACE program, by evaluating a telehealth implementation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

October 18, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 4, 2023

Completed
Last Updated

January 22, 2024

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

December 8, 2021

Results QC Date

February 24, 2023

Last Update Submit

December 21, 2023

Conditions

Keywords

comprehensive geriatrics assessmenttelehealthhome visit

Outcome Measures

Primary Outcomes (1)

  • 90-day All-cause Mortality

    The primary outcome is 90-day all-cause mortality measured from the date of discharge from the index hospitalization.

    90-days from discharge from the index hospitalization

Study Arms (2)

TeleGRACE

EXPERIMENTAL

Patients receive a virtual home visit and care from the GRACE team

Other: TeleGRACE

Usual Care

NO INTERVENTION

Patients receive usual care

Interventions

Patients receive a virtual home visit and care from the GRACE team

TeleGRACE

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Veterans discharged from the Indianapolis VA medical center (VAMC) for an medical/surgical diagnosis (excludes substance use disorder-related admissions; excludes planned admissions) within the prior week
  • Age 70 years
  • Not enrolled in home-based primary care (HBPC)
  • Not enrolled in hospice
  • Not in dialysis
  • Primary care visit within VA in the prior 2 years
  • Not residing in nursing home, skilled nursing facility, or CLC.
  • Living \>20 miles but \<60 miles from the Indianapolis VAMC facility
  • CAN score 95th percentile for mortality or missing CAN score
  • Discharged from the hospital alive

You may not qualify if:

  • Patients who have been randomized to the control arm after their index hospitalization who become readmitted to the hospital may not be re-randomized.
  • By definition, GRACE patients are not eligible for TeleGRACE due to the drive distance \>20 miles from the Indianapolis VAMC
  • Enrolled in home-based primary care (HBPC)
  • Enrolled in hospice
  • Dialysis (hemodialysis or peritoneal dialysis)
  • Residing in nursing home, skilled nursing facility, or CLC.
  • Living \<20 miles or 60 miles from the Indianapolis VAMC facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Results Point of Contact

Title
Dawn M. Bravata, MD
Organization
US Department of Veterans Affairs

Study Officials

  • Dawn M. Bravata, MD

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 22, 2021

Study Start

October 18, 2021

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

January 22, 2024

Results First Posted

December 4, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations