Expanding Access to Comprehensive Geriatrics Care Via Telehealth

Geriatric Syndrome Clinical Trial

— TeleGRACE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05166603
• Other study ID #: QUX 21-007
• Secondary ID: QUE HX0003205-01
• Status: Terminated
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: April 29, 2022

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatric Syndrome

Intervention

Other:
• TeleGRACE
Patients receive a virtual home visit and care from the GRACE team

Locations

Country	Name	City	State
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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