NCT04846049: C4

Inter-Disciplinary Outpatient Care Model Providing Comprehensive Geriatric Assessment, Care-Coordination & Co-management

Completed Last updated 23 August 2024

What this trial tests

trial testing Comprehensive Care in Veterans in 206 participants. Completed in 31 March 2022.

Timeline

16 April 2018

Primary endpoint
31 March 2022

31 March 2022

Quick facts

Lead sponsor	Miami VA Healthcare System
Status	Completed
Study type	OBSERVATIONAL
Enrollment	206
Start date	16 April 2018
Primary completion	31 March 2022
Estimated completion	31 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Comprehensive Care
• Standard Care — full drug profile →

Conditions studied

• Veterans — all drugs for Veterans →
• Geriatric Assessment — all drugs for Geriatric Assessment →
• Care-Coordination — all drugs for Care-Coordination →
• Outpatient Care — all drugs for Outpatient Care →

Sponsor

Miami VA Healthcare System — full company profile →

Who can join

65 and older, any sex, with Veterans or Geriatric Assessment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Department of Veterans Affairs' (VA) Home Based Primary Care (HBPC) program provides comprehensive care to its sickest, frailest Veterans with multiple complex chronic diseases. The HBPC program is a resource intensive non-institutional care program where Veterans, who are not able to receive primary care at the VA, are closely monitored and care is provided using an interdisciplinary team that coordinates the care through multi-professional home visits.

The Geriatric Extended Care recommended that Miami Veteran Affairs Healthcare System (VAHS) HBPC enroll from a list of over 2,000 pre-identified High Need High Risk (HNHR) Miami Veterans for whom HBPC enrollment would have a high likelihood of clinical and economic benefits. HNHR Veterans have the greatest need for care but face the steepest challenges with access. However, despite best of intentions, the Miami HBPC program does not have the capacity to enroll the large numbers of Veterans on this new HNHR list. Therefore, innovative strategies are needed to provide appropriate needed care for this HNHR Veteran population.

Goal: Maintain older Veterans in their homes for as long as possible.

Aims: Design and pilot test an evidence-based, outpatient, Comprehensive geriatric assessment, Care plan based, Care-coordination, Co-management (C4) model, for 100 HBPC eligible HNHR older Veterans who are not enrolled in the HBPC program.

The investigators will develop, implement and evaluate a VA model to provide a comprehensive geriatric assessment of HNHR Veterans, design a structured care plan that includes care coordination to link their needs to appropriate referrals, home and community based services, monitor and coach patients and caregivers, and coordinate their care across VA and non-VA providers and settings.

Objectives:

1. Characterize the needs of the HNHR group of Veterans
2. Evaluate the feasibility and processes of the Geri C4 model
3. Evaluate the impact of the model on patient, healthcare utilization, and other Geriatric Extended Care (GEC) outcomes
4. Determine the facilitators and barriers for implementing the intervention

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gap in Willingness and Access to Video Visit Use Among Older High-risk Veterans: Cross-sectional Study.
   Dang S, Muralidhar K, Li S, Tang F, et al · · 2022 · cited 17× · PMID 35394440 · DOI 10.2196/32570
2. Differences in Challenges to Using Telehealth Among Older Adult Video and Telephone Users With Frailty: Retrospective Observational Study.
   Lamba S, Li S, Lamba A, Tang F, et al · · 2025 · cited 1× · PMID 40882213 · DOI 10.2196/69437