A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings

NCT06404970 | Recruiting

• 2 other identifiers: PEX 24-001PEC 23-072
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Functional Impairment; Frailty

Keywords

adult, aged; adult, middle aged; primary health care; functional status; frailty; patient reported outcome measures

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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)

  0 months, 9 months, 12 months, 15 months, 18 months, 24 months

Secondary Outcomes (10)

• Change in adoption

  0 months, 9 months, 12 months, 15 months, 18 months, 24 months

• Change in adoption in clinician notes

  0 months, 9 months, 12 months, 15 months, 18 months, 24 months

• Change in fidelity

  0 months, 9 months, 12 months, 15 months, 18 months, 24 months

• Recipient experience

  Through study completion, from 0 to 24 months

• Change in Maintenance/sustainability

  24 months

Study Arms (2)

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.

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.

Other: Screening intervention; Other: Enhanced bundle of implementation strategies

Interventions

Standard bundle of implementation strategies OTHER

Standard strategies include champions plus system-level audit and feedback

Functional status screening initiative plus standard bundle of implementation strategies

Screening intervention OTHER

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

Also known as: PACT Functional Status Screening Initiative

Functional status screening initiative plus enhanced bundle of implementation strategies; Functional status screening initiative plus standard bundle of implementation strategies

Enhanced bundle of implementation strategies OTHER

Enhanced strategies include technical assistance plus clinician-level audit and feedback

Functional status screening initiative plus enhanced bundle of implementation strategies

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran
• \>60 years old
• Seen in Veterans Health Administration primary care after implementation begins

You may not qualify if:

• Non-Veteran
• \<60 years old
• Not seen in Veterans Health Administration primary care

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39891277 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Frailty

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Rebecca T. Brown, MD MPH

  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

• Francesca M Nicosia, PhD MA

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca T Brown, MD MPH

CONTACT

(215) 823-5800; rebecca.brown@va.gov

Jason Prigge, BS MS

CONTACT

(215) 823-5800; Jason.Prigge@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Hybrid type 2 implementation-effectiveness cluster-randomized adaptive trial

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: May 8, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)