Expanding Access to Comprehensive Geriatrics Care Via Telehealth

NCT ID: NCT05166603

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2022-04-29

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TeleGRACE

Patients receive a virtual home visit and care from the GRACE team

Group Type: EXPERIMENTAL

TeleGRACE

Intervention Type: OTHER

Patients receive a virtual home visit and care from the GRACE team

Usual Care

Patients receive usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TeleGRACE

Patients receive a virtual home visit and care from the GRACE team

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn M. Bravata, MD

Role: PRINCIPAL_INVESTIGATOR

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Locations

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

QUE HX0003205-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

QUX 21-007

Identifier Type: -

Identifier Source: org_study_id