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

12. april 2021 opdateret af: Stuti Dang, Miami VA Healthcare System

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

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33125
        • Miami VA Healthcare System

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

High Need High Risk Veterans in Miami Medical Center area

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: Comprehensive Care
  1. Comprehensive Geriatric Assessment (3 visits with a geriatrician alternating with 3 primary provider visits over 6 months)
  2. Care Planning with Interdisciplinary Team
  3. Care coordination
  4. Co-management with Primary care
  5. Social work needs assessment
  6. Patient-centered telehealth using phone, home telehealth, patient portal, Video
  7. Transportation provided for all visits
  8. Referral to Geriatric primary care clinic and mental health per Veteran need
  9. Goals of Care and Veteran preferences conversation
  10. Educate primary care providers about HNHR population, home and community based services, collaboration
Standard Care
Veterans receiving standard of care
Andet: Standard Care
No intervention or treatment will be provided.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in FRAIL score
Tidsramme: 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.
5 minutes
Change in Montreal Cognitive Assessment (MOCA)
Tidsramme: 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.
10 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Katz Index of Independence in Activities of Daily Living
Tidsramme: 10 minutes
Assessment of activities of daily living. Change from baseline score and 6 months.
10 minutes
Lawton-Brody Instrumental Activities of Daily Living Scale
Tidsramme: 10 minutes
Instrumental activities of daily living assessment. Change from baseline score and 6 months.
10 minutes
Detection of symptoms of depression
Tidsramme: 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.
5 minutes
Change in number of clinic visits
Tidsramme: 6-months
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
Tidsramme: 6-months
Changes in pre intervention number of hospital admissions. This will be measure by survey and chart review.
6-months
Change in healthcare utilization
Tidsramme: 6-months
Changes in pre intervention number of Home and Community Based services in place. This will be measure by survey and chart review.
6-months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Miami VA Healthcare System

Efterforskere

  • Ledende efterforsker: Stuti Dang, MD,MPH, Miami VA Healthcare System

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. april 2018

Primær færdiggørelse (Forventet)

1. september 2023

Studieafslutning (Forventet)

1. september 2023

Datoer for studieregistrering

Først indsendt

5. marts 2019

Først indsendt, der opfyldte QC-kriterier

12. april 2021

Først opslået (Faktiske)

15. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1208331-1

Plan for individuelle deltagerdata (IPD)

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Geriatrisk vurdering

Kliniske forsøg med Comprehensive Care

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Placeringer

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