A Partnered Evaluation to Improve Identification and Management of Functional Impairment and Frailty for Older Veterans in VA Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Change in reach
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>60 years old
- •Seen in Veterans Health Administration primary care after implementation begins
排除标准
- •Non-Veteran
- •<60 years old
- •Not seen in Veterans Health Administration primary care
研究组 & 干预措施
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.
干预措施: Screening intervention (Other)
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.
干预措施: Standard bundle of implementation strategies (Other)
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.
干预措施: Screening intervention (Other)
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.
干预措施: Enhanced bundle of implementation strategies (Other)
结局指标
主要结局
Change in reach
时间窗: 9 months, 12 months, 15 months, 18 months, 24 months
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.
Change in clinical effectiveness
时间窗: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
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.
Change in association of electronic health record frailty indices with functional status
时间窗: 0 months, 9 months, 12 months, 15 months, 18 months, 24 months
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)
次要结局
- Recipient experience(Through study completion, from 0 to 24 months)
- Change in clinician capacity for implementation and sustainment(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 facility-free days(0 months, 9 months, 12 months, 15 months, 18 months, 24 months)
- Change in adoption(0 months, 9 months, 12 months, 15 months, 18 months, 24 months)
- Change in number of emergency department visits(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)
- Change in number of hospitalizations(0 months, 9 months, 12 months, 15 months, 18 months, 24 months)
- Change in Maintenance/sustainability(24 months)
- Change in functional status(9 months, 12 months, 15 months, 18 months, 24 months)