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NCT Number: NCT04846049

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

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

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Key information

Conditions

Veterans Care-Coordination Geriatric Assessment Outpatient Care

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Miami VA Healthcare System

Miami, Florida, 33125, United States

About this study

The intervention will consist of the following components:

  • 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.
  • 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.
  • 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.
  • Co-management: Primary care provider and project Geriatricians will share responsibility and decision making for participants aiming to prevent and treat geriatric complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive care

Other
  • 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

Other

No intervention or treatment will be provided.

Primary outcomes

  1. Changes in FRAIL score

    Time frame: 5 minutes

    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.

  2. Change in Montreal Cognitive Assessment (MOCA)

    Time frame: 10 minutes

    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.

Secondary outcomes

  1. Katz Index of Independence in Activities of Daily Living

    Time frame: 10 minutes

    Assessment of activities of daily living. Change from baseline score and 6 months.

  2. Lawton-Brody Instrumental Activities of Daily Living Scale

    Time frame: 10 minutes

    Instrumental activities of daily living assessment. Change from baseline score and 6 months.

  3. Detection of symptoms of depression

    Time frame: 5 minutes

    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.

  4. Change in number of clinic visits

    Time frame: 6-months

    Changes in pre intervention number of clinic visits. This will be measure by survey and chart review.

  5. Change in number of hospital admissions

    Time frame: 6-months

    Changes in pre intervention number of hospital admissions. This will be measure by survey and chart review.

  6. Change in healthcare utilization

    Time frame: 6-months

    Changes in pre intervention number of Home and Community Based services in place. This will be measure by survey and chart review.

Sponsors and collaborators

Lead sponsor

Miami VA Healthcare System

Fed

Registry information

Official study 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

Acronym: C4

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2021
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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