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

Frailty Clinical Trial

Official title:

A Partnered Evaluation to Improve Identification and Management of Functional Impairment and Frailty for Older Veterans in VA Primary Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404970
• Other study ID #: PEX 24-001
• Secondary ID: PEC 23-072
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Rebecca T Brown, MD MPH
• Phone: (215) 823-5800
• Email: rebecca.brown[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Functional Impairment

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 15 months, 18 months
Primary	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.	9 months, 15 months, 18 months, 24 months
Primary	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)	9 months, 15 months, 18 months, 24 months
Secondary	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%.	9 months, 15 months, 18 months, 24 months
Secondary	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.	9 months, 15 months, 18 months, 24 months
Secondary	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.	9 months, 15 months, 18 months, 24 months
Secondary	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.	Through study completion, from 0 to 24 months
Secondary	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).	24 months
Secondary	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).	9 months, 15 months, 18 months, 24 months
Secondary	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).	9 months, 15 months, 18 months, 24 months
Secondary	Change in number of emergency department visits	Measured using GECDAC Core Files.	9 months, 15 months, 18 months, 24 months
Secondary	Change in number of hospitalizations	Measured using GECDAC Core Files.	9 months, 15 months, 18 months, 24 months
Secondary	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.	9 months, 15 months, 18 months, 24 months