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

Veterans Clinical Trial

— C4  

Official title:

An Inter-Disciplinary Outpatient Care Model Providing Comprehensive Geriatric Assessment, Care-Coordination and Co-management to High Need High Risk Veterans Meeting HBPC Criteria

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04846049
• Other study ID #: 1208331-1
• Status: Enrolling by invitation
• Start date: April 16, 2018
• Est. completion date: September 2023

Study information

• Verified date: April 2021
• Source: Miami VA Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The intervention will consist of the following components: 1. Comprehensive Geriatric Assessment: A complete geriatric assessment using an interdisciplinary team (geriatrician, psychologist, social worker, dietitian, and nurse). The investigators will increase the number of geriatrician and interdisciplinary team visits to every other month interspersed with their primary care visits. 2. Care Planning: The investigators will review and discuss each participant during the interdisciplinary team meeting. The team will jointly generate a care plan for the implementation of the interventions. The care plan will be shared with the respective primary care provider. 3. Care Coordination: Participant/caregiver will be regularly contacted to confirm that the care plan is being implemented and to allow the participant/caregiver to discuss issues related to the management. 4. Co-management: Primary care provider and project Geriatricians will share responsibility and decision making for participants aiming to prevent and treat geriatric complications.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Hospitalization in prior 12-months
• Received post-acute care in prior 12-months (skilled nursing facility or skilled home health care)
• Two or more chronic conditions
• Two or more activity of daily living impairments or greater or equal to six Frailty Index score
• Less than or equal to 60 minutes of closest VA primary care site.

Exclusion Criteria:

• Enrolled in Home Based Primary Care
• Using hospice Care
• Using palliative care
• In a foster home
• In a nursing home

Related Conditions & MeSH terms

• Care-Coordination
• Geriatric Assessment
• Outpatient Care
• Veterans

Intervention

Other:
• Comprehensive Care
Comprehensive Geriatric Assessment (3 visits with a geriatrician alternating with 3 primary provider visits over 6 months) Care Planning with Interdisciplinary Team Care coordination Co-management with Primary care Social work needs assessment Patient-centered telehealth using phone, home telehealth, patient portal, Video Transportation provided for all visits Referral to Geriatric primary care clinic and mental health per Veteran need Goals of Care and Veteran preferences conversation Educate primary care providers about HNHR population, home and community based services, collaboration
• Standard Care
No intervention or treatment will be provided.

Locations

Country	Name	City	State
United States	Miami VA Healthcare System	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Miami VA Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in FRAIL score	The FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight) is a simple questionnaire of frailty syndrome for older adults. If a patient scores 3-5 points over a total score of 5 points in the FRAIL, the patient is considered as frail. Change from baseline score and 6 months.	5 minutes
Primary	Change in Montreal Cognitive Assessment (MOCA)	Rapid screen of cognitive abilities designed to detect mild cognitive dysfunction consisting of 16 items and 11 categories assessing multiple cognitive domains. No cognitive impairment >=25 Mild cognitive impairment = 20-24 Severe cognitive impairment < 20. Change from baseline score and 6 months.	10 minutes
Secondary	Katz Index of Independence in Activities of Daily Living	Assessment of activities of daily living. Change from baseline score and 6 months.	10 minutes
Secondary	Lawton-Brody Instrumental Activities of Daily Living Scale	Instrumental activities of daily living assessment. Change from baseline score and 6 months.	10 minutes
Secondary	Detection of symptoms of depression	Patient Health Questionnaire (PHQ-2 and PHQ-9) for depression. The PHQ 2 is a preliminary screening tool administered before the PHQ 9. If a patient responds 'yes´ to one or both questions on the PHQ-2, the PHQ-9 questions are administered. Cut-off is set to a score of = 2 PHQ-2. PHQ-9 scoring: 0-4 none-minimal; 5-9 mild;10-14 moderate; 15-19 moderately severe; 20-27 severe.	5 minutes
Secondary	Change in number of clinic visits	Changes in pre intervention number of clinic visits. This will be measure by survey and chart review.	6-months
Secondary	Change in number of hospital admissions	Changes in pre intervention number of hospital admissions. This will be measure by survey and chart review.	6-months
Secondary	Change in healthcare utilization	Changes in pre intervention number of Home and Community Based services in place. This will be measure by survey and chart review.	6-months