Geriatric SyndromeTeleGRACENCT05166603
Expanding Access to Comprehensive Geriatrics Care Via Telehealth
A study testing TeleGRACE in people with Geriatric Syndrome, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Geriatric Syndrome
- What is being tested?
- TeleGRACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
Official title: 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.
Read the 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.
- Conditions
- Geriatric Syndrome
- Being tested
- TeleGRACE
- Keywords
- comprehensive geriatrics assessment, telehealth, home visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleGRACEOther
Patients receive a virtual home visit and care from the GRACE team
| Study group | Role | What they receive |
|---|---|---|
| TeleGRACE | Experimental | Patients receive a virtual home visit and care from the GRACE team Receives: Other: TeleGRACE |
| Usual Care | No intervention | Patients receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day All-cause Mortality
The primary outcome is 90-day all-cause mortality measured from the date of discharge from the index hospitalization.
Measured: 90-days from discharge from the index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start18 Oct 2021
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Geriatric SyndromeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dawn M. Bravata, MD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166603
- Sponsor's protocol ID
- QUX 21-007
- Other IDs
- QUE HX0003205-01
- Acronym
- TeleGRACE
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2021
- Last updated
- 22 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Access to Comprehensive Geriatrics Care Via Telehealth (QUE 20-010)
- ClinicalTrials.gov ID
- NCT05166603
- Acronym / sponsor ID
- TeleGRACE / QUX 21-007
- Conditions
- Geriatric Syndrome
- Keywords
- comprehensive geriatrics assessment, telehealth, home visit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 111 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Posted 4 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TeleGRACE | Experimental | Other: TeleGRACEPatients receive a virtual home visit and care from the GRACE team |
| Usual Care | No intervention | –Patients receive usual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleGRACEPatients receive a virtual home visit and care from the GRACE team | Other | TeleGRACE |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn M. Bravata, MD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeleGRACE in people with Geriatric Syndrome, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day All-cause Mortality (time frame: 90-days from discharge from the index hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.