VeteransC4NCT04846049
Inter-Disciplinary Outpatient Care Model Providing Comprehensive Geriatric Assessment, Care-Coordination & Co-management
An observational study of Veterans and Geriatric Assessment, run by Miami VA Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Veterans, Geriatric Assessment, Care-Coordination
- What is being tested?
- Comprehensive Care
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: High Need High Risk Veterans in Miami Medical Center area
Who may be able to join
- 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.
Who cannot join
- Enrolled in Home Based Primary Care
- Using hospice Care
- Using palliative care
- In a foster home
- In a nursing home
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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:
- Characterize the needs of the HNHR group of Veterans
- Evaluate the feasibility and processes of the Geri C4 model
- Evaluate the impact of the model on patient, healthcare utilization, and other Geriatric Extended Care (GEC) outcomes
- Determine the facilitators and barriers for implementing the intervention
Read the detailed description
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.
- Conditions
- Veterans, Geriatric Assessment, Care-Coordination, Outpatient Care
- Being tested
- Comprehensive Care, Standard Care
- Keywords
- High Need High Risk, Home Based Primary Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive CareOther
- 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 CareOther
No intervention or treatment will be provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Comprehensive Care | |
| Standard Care | Veterans receiving standard of care Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 minutes
Secondary outcomes (6)
Katz Index of Independence in Activities of Daily Living
Assessment of activities of daily living. Change from baseline score and 6 months.
Measured: 10 minutes
Lawton-Brody Instrumental Activities of Daily Living Scale
Instrumental activities of daily living assessment. Change from baseline score and 6 months.
Measured: 10 minutes
Detection of symptoms of depression
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.
Measured: 5 minutes
Change in number of clinic visits
Changes in pre intervention number of clinic visits. This will be measure by survey and chart review.
Measured: 6-months
Change in number of hospital admissions
Changes in pre intervention number of hospital admissions. This will be measure by survey and chart review.
Measured: 6-months
Change in healthcare utilization
Changes in pre intervention number of Home and Community Based services in place. This will be measure by survey and chart review.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start16 Apr 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VeteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami VA Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Stuti Dang, Miami VA Healthcare System
- Investigators
- Stuti Dang, MD,MPH, Principal investigator, Miami VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846049
- Sponsor's protocol ID
- 1208331-1
- Acronym
- C4
- Status last verified
- Aug 2024
- First submitted
- 5 Mar 2019
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04846049
- Acronym / sponsor ID
- C4 / 1208331-1
- Conditions
- Veterans, Geriatric Assessment, Care-Coordination, Outpatient Care
- Keywords
- High Need High Risk, Home Based Primary Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Miami VA Healthcare SystemUS federal agency
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Characterize the needs of the HNHR group of Veterans
- Evaluate the feasibility and processes of the Geri C4 model
- Evaluate the impact of the model on patient, healthcare utilization, and other Geriatric Extended Care (GEC) outcomes
- Determine the facilitators and barriers for implementing the intervention
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Care | – | Other: Comprehensive CareVeterans 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. |
| Standard Care | – | Other: Standard CareVeterans receiving standard of care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- High Need High Risk Veterans in Miami Medical Center area
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Enrolled in Home Based Primary Care
- Using hospice Care
- Using palliative care
- In a foster home
- In a nursing home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Care1. 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 | Other | Comprehensive Care |
| Standard CareNo intervention or treatment will be provided. | Other | Standard Care |
Primary outcome
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.
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.
6 secondary outcomes
Katz Index of Independence in Activities of Daily Living
Time frame: 10 minutes
Lawton-Brody Instrumental Activities of Daily Living Scale
Time frame: 10 minutes
Detection of symptoms of depression
Time frame: 5 minutes
Change in number of clinic visits
Time frame: 6-months
Change in number of hospital admissions
Time frame: 6-months
Change in healthcare utilization
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuti Dang, MD,MPH principal investigator
Miami VA Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Veterans and Geriatric Assessment, run by Miami VA Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FRAIL score (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.