Functional ImpairmentNCT06404970
A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings
A study testing Screening intervention, Standard bundle of implementation strategies and Enhanced bundle of implementation strategies in people with Functional Impairment and Frailty, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Maintaining functional status, or the ability to perform daily activities, is central to older adults' quality of life, health, and ability to remain independent. Identifying functional impairments is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Functional Impairment, Frailty
- What is being tested?
- Screening intervention, Standard bundle of implementation strategies and Enhanced bundle of implementation strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- >60 years old
- Seen in Veterans Health Administration primary care after implementation begins
Who cannot join
- Non-Veteran
- <60 years old
- Not seen in Veterans Health Administration primary care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
Tonia C Reynolds-Hendricks, BA MA, (215) 823-5800 ext. 206080, Tonia.Reynolds-Hendricks@va.gov
Johann Ochoa, MS, (215) 823-5821, johann.ochoa2@va.gov
About this study
Official title: A Partnered Evaluation to Improve Identification and Management of Functional Impairment and Frailty for Older Veterans in VA Primary Care
Maintaining functional status, or the ability to perform daily activities, is central to older adults' quality of life, health, and ability to remain independent. Identifying functional impairments is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into patient care has been slow and inconsistent due to the burden posed by current tools. The purpose of the proposed QUERI Partnered Evaluation Initiative is to implement and evaluate a patient-centered, low-burden intervention to improve measurement of functional status in VA primary care settings nationally. The investigators hypothesize that implementing this intervention will increase identification and improve management of functional impairment among older Veterans while providing key data to inform VHA strategic planning related to long-term services and supports.
Read the detailed description
Background: Maintaining functional status, or the ability to perform daily activities such as bathing, dressing, and preparing meals, is central to older adults' quality of life, health, and ability to remain independent. Identifying functional impairments - defined as having difficulty or needing help performing these activities - is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into routine patient care has been slow and inconsistent due to the burden posed by current tools. The purpose of the proposed QUERI Partnered Evaluation Initiative is to implement and evaluate the Patient-Aligned Care Team (PACT) Functional Status Screening Initiative (hereafter "PACT Function Initiative"), a patient-centered, low-burden intervention to improve measurement of functional status in VA primary care settings nationally.
Significance/Impact: Implementing routine measurement of functional status in primary care has the potential to improve identification and management of functional impairment for older Veterans. Improved management includes increasing access to services and supports, reducing potentially preventable acute care utilization, and allowing Veterans to live in the least restrictive setting for as long as possible. The proposed QUERI Partnered Evaluation Initiative is directly aligned with national VA strategic priorities including VA's Aging in Place and Aging and Frail Veterans initiatives (Objective 2.2) and developing Data as a Strategic Asset (Objective 4.2) to inform evidence-based decisions.
Innovation: The PACT Function Initiative is novel because it addresses prior barriers to functional status measurement. It incorporates Veteran and caregiver preferences while minimizing burden for primary care teams and maximizing clinical effectiveness. Implementing this intervention will provide functional status data that is directly actionable for patient care while creating a repository of data to inform VA strategic planning.
Specific Aims: (1) Measure clinician- and organization-level reach, adoption, implementation, and sustainment of the PACT Function Initiative; (2) Compare the effectiveness of a standard versus enhanced implementation bundle to improve adoption; (3) Measure patient-level clinical effectiveness of the intervention; and (4) To inform future GEC initiatives, test the effectiveness of EHR-based frailty screening for identifying Veterans at risk for functional impairment. The investigators hypothesize that implementing the PACT Function Initiative will result in increased identification and improved management of functional impairment among older Veterans while providing key data to inform VHA strategic planning related to long-term services and supports.
Methodology: In partnership with GEC and Primary Care, the investigators will implement and evaluate the PACT Function Initiative using a hybrid type 2 implementation-effectiveness cluster-randomized adaptive trial design with three phases: pre-implementation, implementation, and sustainment. The investigators will use the Practical, Robust Implementation and Sustainability Model (PRISM) to guide implementation and evaluation. During pre-implementation, the investigators will engage stakeholders and develop local adaptations to maximize intervention-setting fit. During implementation, the investigators will launch a standard bundle of implementation strategies (champions, system-level audit and feedback), identify sites with low uptake, and randomize those sites to receive continued standard vs. enhanced strategies (technical assistance, clinician-level audit and feedback).
Next Steps/Implementation: Establishing routine, standardized measurement of functional status and frailty among older Veterans will provide data to inform the delivery of proactive interventions to prevent and delay the development of functional impairment and improve quality of life, health, and independence.
- Conditions
- Functional Impairment, Frailty
- Being tested
- Screening intervention, Standard bundle of implementation strategies, Enhanced bundle of implementation strategies
- Keywords
- adult, aged, adult, middle aged, primary health care, functional status, frailty, patient reported outcome measures
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening interventionOther
Also called PACT Functional Status Screening Initiative
Intervention to improve identification and management of functional impairment among older Veterans in VA primary care settings. Intervention includes 5 components: (1) routine, standardized functional status measurement; (2) nursing screening followed by follow-up primary care provider assessment; (3) electronic tools and templates to facilitate screening, assessment, and documentation; (4) interprofessional educational session; (5) tailored reports on functional status
Standard bundle of implementation strategiesOther
Standard strategies include champions plus system-level audit and feedback
Enhanced bundle of implementation strategiesOther
Enhanced strategies include technical assistance plus clinician-level audit and feedback
| Study group | Role | What they receive |
|---|---|---|
| Functional status screening initiative plus standard bundle of implementation strategies | Active comparator | During an initial 3 month run-in period, the investigators will implement the intervention at all sites using the standard implementation strategy bundle (implementation champions, system-level audit and feedback). After run-in, the investigators will identify sites with inadequate Reach, defined as <80% of eligible Veterans receiving screening and/or assessment. Sites with >80% Reach at the end of run-in will receive standard implementation for all phases of implementation. For sites with <80% Reach, the investigators will randomize 1:1 by medical center to 3 additional months of a standard vs. enhanced implementation bundle. The enhanced implementation bundle will include technical assistance plus clinician-level audit and feedback. After 3 months' implementation, the investigators will then perform 3 months of crossover allocation. After crossover allocation, both arms will receive 3 months of standard implementation. Receives: Other: Screening intervention; Other: Standard bundle of implementation strategies |
| Functional status screening initiative plus enhanced bundle of implementation strategies | Experimental | During an initial 3 month run-in period, the investigators will implement the intervention at all sites using the standard implementation strategy bundle (implementation champions, system-level audit and feedback). After run-in, the investigators will identify sites with inadequate Reach, defined as <80% of eligible Veterans receiving screening and/or assessment. Sites with >80% Reach at the end of run-in will receive standard implementation for all phases of implementation. For sites with <80% Reach, the investigators will randomize 1:1 by medical center to 3 additional months of a standard vs. enhanced implementation bundle. The enhanced implementation bundle will include technical assistance plus clinician-level audit and feedback. After 3 months' implementation, the investigators will then perform 3 months of crossover allocation. After crossover allocation, both arms will receive 3 months of standard implementation. Receives: Other: Screening intervention; Other: Enhanced bundle of implementation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reach
Reach is defined as the proportion of eligible Veterans who receive LVN screening and PCP assessment at each center. The investigators will identify eligible Veterans (i.e., 60 years old, seen in primary care after implementation begins) and use Health Factors to identify completed screening, defined as an LVN completing the electronic tool, and assessment, defined as a PCP reviewing screening results and either (a) documenting via checkbox that further referral is not needed or (b) placing a referral to address impairments.
Measured: 9 months, 12 months, 15 months, 18 months, 24 months
Change in clinical effectiveness
The primary outcome is proportion of Veterans with impairments who receive appropriate referrals. Appropriate referrals will be defined as the PCP reviewing the LVN screening results and either (1) documenting via checkbox that further referral is not needed or (2) placing a referral to address identified impairments.
Measured: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in association of electronic health record frailty indices with functional status
Frailty will be measured using the validated VA Frailty Index (VA-FI), calculated using the cumulative deficit method. The VA-FI includes up to 31 age-related health deficits based on VA EHR diagnostic and procedure codes. Categories include non-frail (0-0.1), pre-frail (0.11-0.2), and frail (>0.2). Functional status will be measured from Health Factors. In sensitivity analyses, the investigators will examine other EHR frailty indices (e.g., JEN Index100)
Measured: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Secondary outcomes (10)
Change in adoption
Adoption is defined as (1) the proportion of LVNsat each medical center who regularly complete screening; and (2) the proportion of PCPs at each medical center who regularly complete assessment. Adequate adoption for each clinician-type is defined as 80%.
Measured: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in adoption in clinician notes
The investigators will review a subset of charts at the 6 sampled centers to examine if clinician notes for the visit when screening was completed have content related to functional status and type of content.
Measured: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in fidelity
Fidelity to implementation strategies will be measured using Managerial Champion attendance at VISN-level monthly meetings (standard strategy) or technical assistance calls (enhanced strategy). Fidelity to intervention core components will be measured at the 6-site subsample to determine if core components were implemented as intended, accounting for adaptations and modifications that were consistent vs. inconsistent with intent.
Measured: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Recipient experience
Recipient experience will be assessed using interviews for Veterans and periodic reflections and interviews for clinicians and will be used to inform adaptations to intervention components and implementation strategies. To operationalize processes within PRISM's Adoption, Implementation, and Maintenance domains, the investigators will use Normalization Process Theory (NPT) to guide qualitative data collection.
Measured: Through study completion, from 0 to 24 months
Change in Maintenance/sustainability
Maintenance/Sustainability will be measured as continued LVN screening and PCP assessment. The investigators will define adequate maintenance as 80% at 6 months after beginning Sustainment (i.e., at 24 months overall).
Measured: 24 months
Change in clinician capacity for implementation and sustainment
To assess clinician capacity for implementation and sustainment, the investigators will use 3 validated survey measures: the Clinical Sustainability Assessment Tool (CSAT), Normalization MeAsurement Development (NoMAD) items, and Primary Care Team Dynamics (PC-TD) survey. CSAT assesses 7 domains: engaged leadership; engaged stakeholders; organizational readiness; workflow integration; implementation and training; monitoring and evaluation; and outcomes and effectiveness (35 items, Likert scale; higher scores indicate greater capacity for sustainability). NoMAD uses NPT constructs to identify patterns across individual factors: for example, the intervention makes sense to staff (coherence) but is failing due to low engagement (cognitive participation; 23 items, Likert scale, higher scores reflect higher normalization). The PC-TD subscales measure shared understanding and communication (11 items, Likert scale, higher scores reflect more optimal team dynamics).
Measured: 9 months, 12 months, 15 months, 18 months, 24 months
Change in facility-free days
Facility-free days measures the number of days a Veteran is alive and outside a hospital or SNF, calculated from GECDAC residential history files (RHF).
Measured: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in number of emergency department visits
Measured using GECDAC Core Files.
Measured: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in number of hospitalizations
Measured using GECDAC Core Files.
Measured: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in functional status
Scored using screener for difficulty/need for help with each of 6 ADLs/7 IADLs. No difficulty scored as 0, difficulty as 1, need for help as 2. Score ranges from 0-26 with higher scores indicating more severe functional impairment.
Measured: 9 months, 12 months, 15 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start3 Mar 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Hybrid type 2 implementation-effectiveness cluster-randomized adaptive trial
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rebecca T. Brown, MD MPH, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAFrancesca M Nicosia, PhD MA, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404970
- Sponsor's protocol ID
- PEX 24-001
- Other IDs
- PEC 23-072
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nicosia FM, Zamora K, Ashcraft L, Krautner G, Groot M, Kinosian B, Schubert CC, Chhatre S, Moriarty H, Intrator O, Schwartz AW, Orkaby AR, Prigge J, Brown RT. Study protocol: type II hybrid effectiveness-implementation study of routine functional status screening in VA primary care. Implement Sci Commun. 2025 Jan 31;6(1):15. doi: 10.1186/s43058-025-00698-w.
PubMed 39891277
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partnered Evaluation to Improve Identification and Management of Functional Impairment and Frailty for Older Veterans in VA Primary Care
- ClinicalTrials.gov ID
- NCT06404970
- Acronym / sponsor ID
- PEX 24-001
- Conditions
- Functional Impairment, Frailty
- Keywords
- adult, aged, adult, middle aged, primary health care, functional status, frailty, patient reported outcome measures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 May 2024 (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.
Maintaining functional status, or the ability to perform daily activities, is central to older adults' quality of life, health, and ability to remain independent. Identifying functional impairments is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into patient care has been slow and inconsistent due to the burden posed by current tools. The purpose of the proposed QUERI Partnered Evaluation Initiative is to implement and evaluate a patient-centered, low-burden intervention to improve measurement of functional status in VA primary care settings nationally. The investigators hypothesize that implementing this intervention will increase identification and improve management of functional impairment among older Veterans while providing key data to inform VHA strategic planning related to long-term services and supports.
Detailed description
Background: Maintaining functional status, or the ability to perform daily activities such as bathing, dressing, and preparing meals, is central to older adults' quality of life, health, and ability to remain independent. Identifying functional impairments - defined as having difficulty or needing help performing these activities - is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into routine patient care has been slow and inconsistent due to the burden posed by current tools. The purpose of the proposed QUERI Partnered Evaluation Initiative is to implement and evaluate the Patient-Aligned Care Team (PACT) Functional Status Screening Initiative (hereafter "PACT Function Initiative"), a patient-centered, low-burden intervention to improve measurement of functional status in VA primary care settings nationally.
Significance/Impact: Implementing routine measurement of functional status in primary care has the potential to improve identification and management of functional impairment for older Veterans. Improved management includes increasing access to services and supports, reducing potentially preventable acute care utilization, and allowing Veterans to live in the least restrictive setting for as long as possible. The proposed QUERI Partnered Evaluation Initiative is directly aligned with national VA strategic priorities including VA's Aging in Place and Aging and Frail Veterans initiatives (Objective 2.2) and developing Data as a Strategic Asset (Objective 4.2) to inform evidence-based decisions.
Innovation: The PACT Function Initiative is novel because it addresses prior barriers to functional status measurement. It incorporates Veteran and caregiver preferences while minimizing burden for primary care teams and maximizing clinical effectiveness. Implementing this intervention will provide functional status data that is directly actionable for patient care while creating a repository of data to inform VA strategic planning.
Specific Aims: (1) Measure clinician- and organization-level reach, adoption, implementation, and sustainment of the PACT Function Initiative; (2) Compare the effectiveness of a standard versus enhanced implementation bundle to improve adoption; (3) Measure patient-level clinical effectiveness of the intervention; and (4) To inform future GEC initiatives, test the effectiveness of EHR-based frailty screening for identifying Veterans at risk for functional impairment. The investigators hypothesize that implementing the PACT Function Initiative will result in increased identification and improved management of functional impairment among older Veterans while providing key data to inform VHA strategic planning related to long-term services and supports.
Methodology: In partnership with GEC and Primary Care, the investigators will implement and evaluate the PACT Function Initiative using a hybrid type 2 implementation-effectiveness cluster-randomized adaptive trial design with three phases: pre-implementation, implementation, and sustainment. The investigators will use the Practical, Robust Implementation and Sustainability Model (PRISM) to guide implementation and evaluation. During pre-implementation, the investigators will engage stakeholders and develop local adaptations to maximize intervention-setting fit. During implementation, the investigators will launch a standard bundle of implementation strategies (champions, system-level audit and feedback), identify sites with low uptake, and randomize those sites to receive continued standard vs. enhanced strategies (technical assistance, clinician-level audit and feedback).
Next Steps/Implementation: Establishing routine, standardized measurement of functional status and frailty among older Veterans will provide data to inform the delivery of proactive interventions to prevent and delay the development of functional impairment and improve quality of life, health, and independence.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid type 2 implementation-effectiveness cluster-randomized adaptive trial
| Arm | Type | Receives |
|---|---|---|
| Functional status screening initiative plus standard bundle of implementation strategies | Active comparator | Other: Screening intervention, Other: Standard bundle of implementation strategiesDuring an initial 3 month run-in period, the investigators will implement the intervention at all sites using the standard implementation strategy bundle (implementation champions, system-level audit and feedback). After run-in, the investigators will identify sites with inadequate Reach, defined as <80% of eligible Veterans receiving screening and/or assessment. Sites with >80% Reach at the end of run-in will receive standard implementation for all phases of implementation. For sites with <80% Reach, the investigators will randomize 1:1 by medical center to 3 additional months of a standard vs. enhanced implementation bundle. The enhanced implementation bundle will include technical assistance plus clinician-level audit and feedback. After 3 months' implementation, the investigators will then perform 3 months of crossover allocation. After crossover allocation, both arms will receive 3 months of standard implementation. |
| Functional status screening initiative plus enhanced bundle of implementation strategies | Experimental | Other: Screening intervention, Other: Enhanced bundle of implementation strategiesDuring an initial 3 month run-in period, the investigators will implement the intervention at all sites using the standard implementation strategy bundle (implementation champions, system-level audit and feedback). After run-in, the investigators will identify sites with inadequate Reach, defined as <80% of eligible Veterans receiving screening and/or assessment. Sites with >80% Reach at the end of run-in will receive standard implementation for all phases of implementation. For sites with <80% Reach, the investigators will randomize 1:1 by medical center to 3 additional months of a standard vs. enhanced implementation bundle. The enhanced implementation bundle will include technical assistance plus clinician-level audit and feedback. After 3 months' implementation, the investigators will then perform 3 months of crossover allocation. After crossover allocation, both arms will receive 3 months of standard implementation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veteran
- >60 years old
- Seen in Veterans Health Administration primary care after implementation begins
Key exclusion criteria (3 listed)
- Non-Veteran
- <60 years old
- Not seen in Veterans Health Administration primary care
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 |
|---|---|---|
| Screening interventionAlso: PACT Functional Status Screening InitiativeIntervention to improve identification and management of functional impairment among older Veterans in VA primary care settings. Intervention includes 5 components: (1) routine, standardized functional status measurement; (2) nursing screening followed by follow-up primary care provider assessment; (3) electronic tools and templates to facilitate screening, assessment, and documentation; (4) interprofessional educational session; (5) tailored reports on functional status | Other | Functional status screening initiative plus enhanced bundle of implementation strategies, Functional status screening initiative plus standard bundle of implementation strategies |
| Standard bundle of implementation strategiesStandard strategies include champions plus system-level audit and feedback | Other | Functional status screening initiative plus standard bundle of implementation strategies |
| Enhanced bundle of implementation strategiesEnhanced strategies include technical assistance plus clinician-level audit and feedback | Other | Functional status screening initiative plus enhanced bundle of implementation strategies |
Primary outcome
Change in reach
Time frame: 9 months, 12 months, 15 months, 18 months, 24 months
Reach is defined as the proportion of eligible Veterans who receive LVN screening and PCP assessment at each center. The investigators will identify eligible Veterans (i.e., 60 years old, seen in primary care after implementation begins) and use Health Factors to identify completed screening, defined as an LVN completing the electronic tool, and assessment, defined as a PCP reviewing screening results and either (a) documenting via checkbox that further referral is not needed or (b) placing a referral to address impairments.
Change in clinical effectiveness
Time frame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
The primary outcome is proportion of Veterans with impairments who receive appropriate referrals. Appropriate referrals will be defined as the PCP reviewing the LVN screening results and either (1) documenting via checkbox that further referral is not needed or (2) placing a referral to address identified impairments.
Change in association of electronic health record frailty indices with functional status
Time frame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Frailty will be measured using the validated VA Frailty Index (VA-FI), calculated using the cumulative deficit method. The VA-FI includes up to 31 age-related health deficits based on VA EHR diagnostic and procedure codes. Categories include non-frail (0-0.1), pre-frail (0.11-0.2), and frail (>0.2). Functional status will be measured from Health Factors. In sensitivity analyses, the investigators will examine other EHR frailty indices (e.g., JEN Index100)
10 secondary outcomes
Change in adoption
Time frame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in adoption in clinician notes
Time frame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in fidelity
Time frame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Recipient experience
Time frame: Through study completion, from 0 to 24 months
Change in Maintenance/sustainability
Time frame: 24 months
Change in clinician capacity for implementation and sustainment
Time frame: 9 months, 12 months, 15 months, 18 months, 24 months
Change in facility-free days
Time frame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in number of emergency department visits
Time frame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in number of hospitalizations
Time frame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Change in functional status
Time frame: 9 months, 12 months, 15 months, 18 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 39891277Nicosia FM, Zamora K, Ashcraft L, Krautner G, Groot M, Kinosian B, Schubert CC, Chhatre S, Moriarty H, Intrator O, Schwartz AW, Orkaby AR, Prigge J, Brown RT. Study protocol: type II hybrid effectiveness-implementation study of routine functional status screening in VA primary care. Implement Sci Commun. 2025 Jan 31;6(1):15. doi: 10.1186/s43058-025-00698-w.
- Related InfoLink provided by the sponsor.
- 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.
Rebecca T. Brown, MD MPH principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Francesca M Nicosia, PhD MA principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening intervention, Standard bundle of implementation strategies and Enhanced bundle of implementation strategies in people with Functional Impairment and Frailty, run by VA Office of Research and Development 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca T Brown, MD MPH ((215) 823-5800, rebecca.brown@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reach (time frame: 9 months, 12 months, 15 months, 18 months, 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06404970, which also lists 1 linked publication.
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 18 Jun 2026.