- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05166603
Expanding Access to Comprehensive Geriatrics Care Via Telehealth (TeleGRACE)
Expanding Access to Comprehensive Geriatrics Care Via Telehealth (QUE 20-010)
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Dawn M. Bravata, MD, Richard L. Roudebush VA Medical Center, Indianapolis, IN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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