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

12 avril 2021 mis à jour par: 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

Aperçu de l'étude

Statut

Inscription sur invitation

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Florida
      • Miami, Florida, États-Unis, 33125
        • Miami VA Healthcare System

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

High Need High Risk Veterans in Miami Medical Center area

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: 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
Autre: Standard Care
No intervention or treatment will be provided.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in FRAIL score
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Katz Index of Independence in Activities of Daily Living
Délai: 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
Délai: 10 minutes
Instrumental activities of daily living assessment. Change from baseline score and 6 months.
10 minutes
Detection of symptoms of depression
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Miami VA Healthcare System

Les enquêteurs

  • Chercheur principal: Stuti Dang, MD,MPH, Miami VA Healthcare System

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 avril 2018

Achèvement primaire (Anticipé)

1 septembre 2023

Achèvement de l'étude (Anticipé)

1 septembre 2023

Dates d'inscription aux études

Première soumission

5 mars 2019

Première soumission répondant aux critères de contrôle qualité

12 avril 2021

Première publication (Réel)

15 avril 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 avril 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 avril 2021

Dernière vérification

1 avril 2021

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 1208331-1

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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