Inter-Disciplinary Outpatient Care Model Providing Comprehensive Geriatric Assessment, Care-Coordination & Co-management (C4)

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Geriatric Assessment; Veterans; Care-Coordination; Outpatient Care
• Intervention / Treatment: Other: Comprehensive Care; Other: Standard Care

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • Miami VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

High Need High Risk Veterans in Miami Medical Center area

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Comprehensive Care; Veterans with complex medical conditions that may need more help. This intervention will provide extra care coordination after a complete assessment of their health. Research team will assess veteran's memory, physical function, strength, balance, and from there, find the areas they need the most help with and coordinate services at home. This is in addition to their regular primary care provider.	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; Veterans receiving standard of care	Other: Standard Care; No intervention or treatment will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Katz Index of Independence in Activities of Daily Living	Assessment of activities of daily living. Change from baseline score and 6 months.	10 minutes
Lawton-Brody Instrumental Activities of Daily Living Scale	Instrumental activities of daily living assessment. Change from baseline score and 6 months.	10 minutes
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
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
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
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

Collaborators and Investigators

• Sponsor: Miami VA Healthcare System
• Investigators: Principal Investigator: Stuti Dang, MD,MPH, Miami VA Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: High Need High Risk; Home Based Primary Care
• Other Study ID Numbers: 1208331-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No