Screening Strategies for Frailty

Overseen By Jason Prigge, BS MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-veteran, Under 60, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Screening intervention, Functional Status Screening, Frailty Screening Intervention for frailty?

Research suggests that early identification of frailty can help prevent or delay negative health outcomes like dependency and hospitalization. However, more evidence is needed to guide care for frail patients, as they are often excluded from studies, and few large trials have been conducted specifically on frail populations. ^{1 2 3 4 5}

Is frailty screening safe for humans?

The research on frailty screening in older adults does not report any safety concerns, suggesting it is generally safe for use in humans. ^{2 6 7 8 9}

How is the Screening intervention treatment for frailty different from other treatments?

The Screening intervention for frailty is unique because it focuses on identifying frailty through various screening tools rather than treating it directly. This approach aims to detect frailty early, allowing for preventive measures before serious health issues arise, unlike other treatments that may address frailty after it has already led to complications. ^{2 9 10 11 12}

Research Team

Rebecca T. Brown, MD MPH

Principal Investigator

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

Francesca M Nicosia, PhD MA

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

This trial is for Veterans who are 60 years or older and have been seen in Veterans Health Administration primary care after the start of the study. It aims to help those experiencing difficulty with daily activities due to functional impairments or frailty.

Inclusion Criteria

I am 60 years old or older.

Veteran

Seen in Veterans Health Administration primary care after implementation begins

Exclusion Criteria

Non-Veteran

Not seen in Veterans Health Administration primary care

I am younger than 60 years old.

Timeline

Pre-implementation

Engage stakeholders and develop local adaptations to maximize intervention-setting fit

3 months

Implementation

Launch standard bundle of implementation strategies and randomize sites with low uptake to receive standard vs. enhanced strategies

6 months

Sustainment

Continue LVN screening and PCP assessment to maintain 80% reach

15 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

6 months

Treatment Details

Interventions

• Screening intervention

Trial Overview The study tests a new low-burden intervention against standard practices, aiming to better identify and manage functional impairment in older adults. The effectiveness of standard versus enhanced strategies will be compared.

Participant Groups

Group I: Functional status screening initiative plus enhanced bundle of implementation strategies Experimental Treatment 2 Interventions

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.

Group II: Functional status screening initiative plus standard bundle of implementation strategies Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

This systematic review aims to analyze randomized control trials (RCTs) involving frail populations, highlighting the need for standardized definitions and outcome measures, as frail individuals are often excluded from research.

By identifying how frailty is measured and the outcomes reported in these trials, the review seeks to improve clinical decision-making and guide future research efforts in treating frail patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty measurement and outcomes in interventional studies: protocol for a systematic review of randomised control trials. Shears, M., McGolrick, D., Waters, B., et al.[2019]

In a study of 993 participants aged 70 and older, 16.9% were identified as frail, highlighting the prevalence of frailty in this age group.

The Timed Up and Go test, gait speed, and the Short Physical Performance Battery (SPPB) were found to be the most effective performance tests for identifying frailty, while the Short Form-Late Life Function and Disability Instrument (SF-LLFDI) was the best questionnaire for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Functional Assessment Instruments and Frailty in Older Adults: The FRADEA Study. Abizanda, P., Romero, L., Sánchez-Jurado, PM., et al.[2016]

In a study of 243 hospitalized patients aged 70 and older, the Frailty Index (FI) demonstrated superior reproducibility and responsiveness compared to the Frailty Phenotype (FP), making it a more reliable tool for measuring changes in frailty over time.

The FI showed high intra-class correlation coefficients (ICC) of 0.85 and 0.84 at three and twelve months, respectively, indicating strong consistency in measurements, while the FP had lower ICC values, suggesting it may be less effective for tracking frailty changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproducibility and responsiveness of the Frailty Index and Frailty Phenotype in older hospitalized patients. Feenstra, M., Oud, FMM., Jansen, CJ., et al.[2021]

In a study of 996 older adults (average age 82.2 years), the 35-item Frailty Index (FI-35) and the 5-item Frailty Trait Scale (FTS-5) were found to be the most effective instruments for predicting adverse outcomes like mortality and worsening of basic activities of daily living (BADL) in various healthcare settings, particularly in geriatric wards and nursing homes.

No single frailty assessment tool was effective across all settings, with the FI-35 and FTS-5 showing good sensitivity for predicting adverse outcomes in hospitalized patients, but none performing well in primary care, highlighting the need for tailored approaches in frailty assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ability of eight frailty instruments to identify adverse outcomes across different settings: the FRAILTOOLS project. Oviedo-Briones, M., Rodríguez-Laso, Á., Carnicero, JA., et al.[2022]

A review of 12 trials involving frail older inpatients found that while many studies reported significant outcomes, there was a high risk of bias and a lack of standardized measures for frailty, which limits the reliability of the findings.

The study highlights the need for using validated frailty measurement tools and consistent health outcome reporting to improve the quality and generalizability of future research in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for frail older inpatients: A systematic review of frailty measures and reported outcomes in randomised controlled trials. King, SJ., Raine, KA., Peel, NM., et al.[2021]

The study identified the VMS-tool combined with age as the most effective screening method for frailty in hospitalized older adults, classifying 34% of patients as frail with a sensitivity of 68% and specificity of 74%.

Among 883 patients aged 70 and older, all screening tools showed similar predictive power for adverse outcomes, but the VMS-tool was highlighted for its efficiency in identifying those at risk, emphasizing the need to balance screening costs and benefits in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal screening for increased risk for adverse outcomes in hospitalised older adults. Heim, N., van Fenema, EM., Weverling-Rijnsburger, AW., et al.[2022]

The brief Dutch National Safety Management Program (VMS) identified a higher proportion of frail patients (53.2%) compared to the Maastricht Frailty Screening Tool for Hospitalised Patients (MFST-HP), which identified only 16.1%, indicating that VMS may overestimate frailty in older hospitalized patients.

Both screening tools showed poor to moderate predictive properties for assessing frailty, with low specificity for VMS and low sensitivity for MFST-HP, suggesting that neither tool is highly effective for clinical decision-making regarding frailty in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty screening in hospitalised older adults: How does the brief Dutch National Safety Management Program perform compared to a more extensive approach? Warnier, RMJ., van Rossum, E., van Kuijk, SMJ., et al.[2020]

In a study of 116 older adults over 65 applying for public home care in Norway, 62.1% were found to be frail, highlighting the need for earlier screening for frailty before such applications.

Gait speed was identified as a potentially effective screening tool for frailty, with a sensitivity of 99% and specificity of 68% at a cut-off of 0.8 m/s, suggesting it could help identify frailty in the general population over 70 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty assessment of older adults, first-time applicants of public home care service in Norway. Laukli, I., Sandvik, L., Ormstad, H.[2022]

The study evaluated three frailty screening instruments (GFI, TFI, SPQ) among 687 older adults (70+) and found that the GFI and TFI had the highest agreement and internal consistency, making them effective tools for identifying frailty.

The prevalence of frailty in the sample ranged from 40% to 59%, indicating a significant portion of older adults may be at risk, highlighting the importance of reliable screening methods for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The psychometric properties of three self-report screening instruments for identifying frail older people in the community]. Metzelthin, SF., Daniels, R., van Rossum, E., et al.[2019]

Recent reviews highlight that while there are two main models for frailty screening—the phenotype model and the deficit model—both have limitations that hinder their widespread clinical use despite their strengths.

Current frailty screening tools are largely based on these models, with the phenotype model focusing on physical function declines and the deficit model assessing functional impairments across various domains, indicating a need for tailored approaches in different clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of frailty screening in clinical practice. Satake, S., Arai, H.[2022]

The Frailty Phenotype Questionnaire (FPQ) was developed as a screening tool for frailty in older adults, demonstrating a strong correlation with the established Fried frailty scale, making it a reliable method for assessing frailty.

With a diagnostic accuracy of 89%, the FPQ effectively identifies frailty in community-dwelling older adults, showing high sensitivity (81.7%) and specificity (82.5%), which suggests it can be a valuable tool for early detection and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Frailty Phenotype Questionnaire for Use in Screening Community-Dwelling Older Adults. Kim, S., Kim, M., Jung, HW., et al.[2022]

The FiND questionnaire effectively identifies frail older adults without mobility disabilities, showing substantial agreement with established reference tools in a study of 45 community-dwelling individuals aged 60 and older.

With a high agreement rate (Cohen's kappa = 0.748) and excellent correlation with mobility assessments (kappa = 0.920), the FiND tool could enhance awareness and preventive strategies for frailty in the elderly population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A self-reported screening tool for detecting community-dwelling older persons with frailty syndrome in the absence of mobility disability: the FiND questionnaire. Cesari, M., Demougeot, L., Boccalon, H., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Frailty measurement and outcomes in interventional studies: protocol for a systematic review of randomised control trials. [2019]

2. France pubmed.ncbi.nlm.nih.gov

Association between Functional Assessment Instruments and Frailty in Older Adults: The FRADEA Study. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Reproducibility and responsiveness of the Frailty Index and Frailty Phenotype in older hospitalized patients. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

The ability of eight frailty instruments to identify adverse outcomes across different settings: the FRAILTOOLS project. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Interventions for frail older inpatients: A systematic review of frailty measures and reported outcomes in randomised controlled trials. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Optimal screening for increased risk for adverse outcomes in hospitalised older adults. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Frailty screening in hospitalised older adults: How does the brief Dutch National Safety Management Program perform compared to a more extensive approach? [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Frailty assessment of older adults, first-time applicants of public home care service in Norway. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[The psychometric properties of three self-report screening instruments for identifying frail older people in the community]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Implications of frailty screening in clinical practice. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Development of a Frailty Phenotype Questionnaire for Use in Screening Community-Dwelling Older Adults. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

A self-reported screening tool for detecting community-dwelling older persons with frailty syndrome in the absence of mobility disability: the FiND questionnaire. [2022]