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| ID | Type | Description | Link |
|---|---|---|---|
| QUE HX0003205-01 | Other Grant/Funding Number | VA HSRD QUERI |
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Inadequate recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TeleGRACE | Experimental | Patients receive a virtual home visit and care from the GRACE team |
|
| Usual Care | No Intervention | Patients receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TeleGRACE | Other | Patients receive a virtual home visit and care from the GRACE team |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn M. Bravata, MD | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TeleGRACE | Patients receive a virtual home visit and care from the GRACE team TeleGRACE: Patients receive a virtual home visit and care from the GRACE team |
| FG001 | Usual Care | Patients receive usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TeleGRACE | Patients receive a virtual home visit and care from the GRACE team TeleGRACE: Patients receive a virtual home visit and care from the GRACE team |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 90-days from discharge from the index hospitalization |
|
90-days
All unexpected, serious adverse events will be recorded
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TeleGRACE | Patients receive a virtual home visit and care from the GRACE team TeleGRACE: Patients receive a virtual home visit and care from the GRACE team |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn M. Bravata, MD | US Department of Veterans Affairs | 3179882676 | dawn.bravata2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2021 | Feb 24, 2023 | Prot_SAP_000.pdf |
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Patients receive usual care
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Usual Care | Patients receive usual care | 0 | 38 | 0 | 38 | 0 | 38 |
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