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

12. April 2021 aktualisiert von: 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

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Florida
      • Miami, Florida, Vereinigte Staaten, 33125
        • Miami VA Healthcare System

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

65 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

High Need High Risk Veterans in Miami Medical Center area

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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
Sonstiges: Standard Care
No intervention or treatment will be provided.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in FRAIL score
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Katz Index of Independence in Activities of Daily Living
Zeitfenster: 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
Zeitfenster: 10 minutes
Instrumental activities of daily living assessment. Change from baseline score and 6 months.
10 minutes
Detection of symptoms of depression
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Miami VA Healthcare System

Ermittler

  • Hauptermittler: Stuti Dang, MD,MPH, Miami VA Healthcare System

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. April 2018

Primärer Abschluss (Voraussichtlich)

1. September 2023

Studienabschluss (Voraussichtlich)

1. September 2023

Studienanmeldedaten

Zuerst eingereicht

5. März 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. April 2021

Zuerst gepostet (Tatsächlich)

15. April 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. April 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. April 2021

Zuletzt verifiziert

1. April 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 1208331-1

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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