Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT06404970

Conditions

Functional Impairment

Frailty

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Screening intervention

Standard bundle of implementation strategies

Enhanced bundle of implementation strategies

Study Details

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

Study ID

NCT06404970

Start date

Mar 3, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

10000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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

Primary outcome measure

  • Change in reach [ Time Frame: 9 months, 12 months, 15 months, 18 months, 24 months ]
  • Change in clinical effectiveness [ Time Frame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months ]
  • 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 ]

Central Contacts and Locations

Central contacts

Rebecca T Brown, MD MPH

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

Jason Prigge, BS MS

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

Locations

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

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4551

Contacts

Tonia C Reynolds-Hendricks, BA MA

(215) 823-5800Tonia.Reynolds-Hendricks@va.gov

Johann Ochoa, MS

(215) 823-5821johann.ochoa2@va.gov

Principal Investigator:

Rebecca T. Brown, MD MPH

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-18.