NCT04846049

Brief Summary

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. 1.Characterize the needs of the HNHR group of Veterans
  2. 2.Evaluate the feasibility and processes of the Geri C4 model
  3. 3.Evaluate the impact of the model on patient, healthcare utilization, and other Geriatric Extended Care (GEC) outcomes
  4. 4.Determine the facilitators and barriers for implementing the intervention

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

4 years

First QC Date

March 5, 2019

Last Update Submit

August 21, 2024

Conditions

Keywords

High Need High RiskHome Based Primary Care

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Katz Index of Independence in Activities of Daily Living

    10 minutes

  • Lawton-Brody Instrumental Activities of Daily Living Scale

    10 minutes

  • Detection of symptoms of depression

    5 minutes

  • Change in number of clinic visits

    6-months

  • Change in number of hospital admissions

    6-months

  • +1 more secondary outcomes

Study Arms (2)

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

Standard Care

Veterans receiving standard of care

Other: Standard Care

Interventions

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

Comprehensive Care

No intervention or treatment will be provided.

Standard Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

High Need High Risk Veterans in Miami Medical Center area

You may qualify if:

  • 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.

You may not qualify if:

  • Enrolled in Home Based Primary Care
  • Using hospice Care
  • Using palliative care
  • In a foster home
  • In a nursing home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami VA Healthcare System

Miami, Florida, 33125, United States

Location

MeSH Terms

Interventions

Comprehensive Health CareStandard of Care

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services AdministrationQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Stuti Dang, MD,MPH

    Miami VA Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

March 5, 2019

First Posted

April 15, 2021

Study Start

April 16, 2018

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations