Clinical trial NCT06404970: A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings
Official title: A Partnered Evaluation to Improve Identification and Management of Functional Impairment and Frailty for Older Veterans in VA Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Impairment
Frailty
Keywords: adult, aged
adult, middle aged
primary health care
functional status
frailty
patient reported outcome measures
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-05-08
Enrollment: 10000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Hybrid type 2 implementation-effectiveness cluster-randomized adaptive trial
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in reach
timeFrame: 9 months, 12 months, 15 months, 18 months, 24 months
measure: Change in clinical effectiveness
timeFrame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
measure: Change in association of electronic health record frailty indices with functional status
timeFrame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
Secondary outcomes:
measure: Change in adoption
timeFrame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
measure: Change in adoption in clinician notes
timeFrame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
measure: Change in fidelity
timeFrame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
measure: Recipient experience
timeFrame: Through study completion, from 0 to 24 months
measure: Change in Maintenance/sustainability
timeFrame: 24 months
measure: Change in clinician capacity for implementation and sustainment
timeFrame: 9 months, 12 months, 15 months, 18 months, 24 months
measure: Change in facility-free days
timeFrame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
measure: Change in number of emergency department visits
timeFrame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
measure: Change in number of hospitalizations
timeFrame: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
measure: Change in functional status
timeFrame: 9 months, 12 months, 15 months, 18 months, 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Rebecca T. Brown, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Francesca M Nicosia, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: