A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings
NCT ID: NCT06404970
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
10000 participants
INTERVENTIONAL
2024-04-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Frailty Outcomes And Risk With Alzheimer's Related Dementia
NCT06570109
Multifactorial Intervention on Frailty in Vulnerable Older Adults
NCT02554994
A Casefinding and Referral System for Older Veterans Within Primary Care
NCT00012740
Clinical Intervention in Frail Older People (FRAILCLINIC)
NCT02643069
Assessing Frailty in Older Adults With Functional Mental Illness
NCT03018951
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Functional status screening initiative plus standard bundle of implementation strategies
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.
Screening intervention
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 strategies
Standard strategies include champions plus system-level audit and feedback
Functional status screening initiative plus enhanced bundle of implementation strategies
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.
Screening intervention
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
Enhanced bundle of implementation strategies
Enhanced strategies include technical assistance plus clinician-level audit and feedback
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Screening intervention
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 strategies
Standard strategies include champions plus system-level audit and feedback
Enhanced bundle of implementation strategies
Enhanced strategies include technical assistance plus clinician-level audit and feedback
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \>60 years old
* Seen in Veterans Health Administration primary care after implementation begins
Exclusion Criteria
* \<60 years old
* Not seen in Veterans Health Administration primary care
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rebecca T. Brown, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Francesca M Nicosia, PhD MA
Role: PRINCIPAL_INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PEC 23-072
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PEX 24-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.