Expanding Access to Comprehensive Geriatrics Care Via Telehealth (TeleGRACE)

December 21, 2023 updated by: VA Office of Research and Development

Expanding Access to Comprehensive Geriatrics Care Via Telehealth (QUE 20-010)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The TeleGRACE evaluation will focus on three primary aims and a secondary aim:

Primary Aim 1: To examine the effectiveness of the TeleGRACE program, the investigators designed a randomized controlled implementation trial (RCT) powered for the primary outcome of 90-day all-cause mortality. The investigators will also examine its effectiveness for the secondary outcomes including 90-day readmissions, 1-year ED utilization (VA and non-VA), 1-year all-cause readmissions, 1-year mortality, as well as patient, caregiver, and staff satisfaction. The investigators hypothesize that patients who receive TeleGRACE will have lower 90-day mortality than patients in usual care.

Primary Aim 2: to examine the implementation of the TeleGRACE program. The implementation strategy is reflecting & evaluating. Implementation outcomes are based on the REAIM framework and include reach, efficacy (Aim 1), and implementation (total number of Veterans served, fidelity).

Primary Aim 3: to conduct a business-case analysis (BCA). The business case analysis will calculate the net financial savings or loss for TeleGRACE as the difference in the overall intervention costs and savings due to downstream benefits for patients receiving TeleGRACE versus usual care controls.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TeleGRACE
Patients receive a virtual home visit and care from the GRACE team
Patients receive a virtual home visit and care from the GRACE team
No Intervention: Usual Care
Patients receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day All-cause Mortality
Time Frame: 90-days from discharge from the index hospitalization
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dawn M. Bravata, MD, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2021

Primary Completion (Actual)

April 29, 2022

Study Completion (Actual)

April 29, 2022

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • QUX 21-007
  • QUE HX0003205-01 (Other Grant/Funding Number: VA HSRD QUERI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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