CLINICAL TRIAL

PAUSE Intervention for Frailty

EnrollingByInvitation · 18+ · All Sexes · Palo Alto, CA

This study is evaluating whether a multidisciplinary team approach can improve quality and outcomes for veterans with frailty.

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About the trial for Frailty

Treatment Groups

This trial involves 2 different treatments. PAUSE Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
PAUSE Intervention
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
One must be the Surgery Service Line chief or appointed designee in order to receive the Surgery Service Line Chief Clinical Excellence Award. show original
The individual must be a Section Chief of a qualifying surgical specialty or appointed designee. show original
Must work at either VA Palo Alto, VA Houston, or VA Nashville. show original
The surgical team member must have a surgical specialty such as general surgery, vascular surgery, orthopedics surgery, or heart surgery. show original
You must work at the VA Palo Alto, VA Houston, or VA Nashville. show original
Patient must have elective surgery within the intervention period
Surgery is only allowed if it is done by a doctor with a qualifying specialty show original
Surgery must be at either the VA Palo Alto, VA Houston, or VA Nashville
The person must have planned or had prior experience participating in PAUSE Board meetings. show original
The provider must be a high- or low-referring provider to the PAUSE Board. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through study completion, an average of 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Through study completion, an average of 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through study completion, an average of 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether PAUSE Intervention will improve 1 primary outcome, 5 secondary outcomes, and 10 other outcomes in patients with Frailty. Measurement will happen over the course of 1 day after surgery discharge.

Non-home discharge
1 DAY AFTER SURGERY DISCHARGE
The percent of non-home discharge dispositions
1 DAY AFTER SURGERY DISCHARGE
30-day rehospitalization
UP TO 30-DAYS AFTER DISCHARGE
The percent of rehospitalizations at or within 30 days after the elective surgery
UP TO 30-DAYS AFTER DISCHARGE
30-day mortality
UP TO 30-DAYS AFTER DISCHARGE
The rate of mortality at or within 30 days after the elective surgery
UP TO 30-DAYS AFTER DISCHARGE
Care Assessment Need
UP TO 90 DAYS BEFORE SURGERY
A predictive analytic tool for hospitalization and death at 90 days and one year, generated from electronic health records to assist Patient Aligned Care Teams in patient management and care coordination. Percentile score calculated where higher percentile indicates higher risk [0=lowest risk, 99=highest risk].
UP TO 90 DAYS BEFORE SURGERY
Risk Analysis Index
UP TO 90 DAYS BEFORE SURGERY
Frailty assessment where higher scores indicates higher frailty [0=lowest frailty, 81=highest frailty].
UP TO 90 DAYS BEFORE SURGERY
180-day home-time
UP TO 180-DAYS AFTER DISCHARGE
The percent of time spent at home (vs. non-home environment) in the 180 days after elective surgery
UP TO 180-DAYS AFTER DISCHARGE
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can frailty be cured?

Frailty cannot be cured; however, many frail persons can be made less frail or, if already frail, can be made more robust by careful management.

Anonymous Patient Answer

What are the signs of frailty?

Data from a recent study, frailty status was strongly associated with health-related and social-demographic factors. The findings are useful when formulating and designing strategies to evaluate and manage frail elderly out patients.

Anonymous Patient Answer

What causes frailty?

Healthy ageing could be one of the underlying reasons for the association between frailty and all-cause mortality; however, further prospective analyses are required to clarify its mechanism.

Anonymous Patient Answer

What is frailty?

In this cross sectional study the relationship between frailty and health care utilization was explored. Results from a recent paper suggest that frailty is not a good predictor of increased health care utilization which further points to the need to further consider frailty as a proxy for age rather than for a specific disability status.

Anonymous Patient Answer

How many people get frailty a year in the United States?

There are many older adults living in the United States living at what is considered low risk for frailty (physical weakness, impaired mobility or sensory impairment).

Anonymous Patient Answer

What are common treatments for frailty?

Clinicians often find that a wide range of treatment options are available for frail elderly patients such as home-based or home-care services. For patients suffering from frailty, treatment is often tailored towards those who are more susceptible to deterioration and adverse outcomes such as hospitalizations.

Anonymous Patient Answer

What is the average age someone gets frailty?

For individuals with frailty, it often takes a long time to achieve frailty criteria, and for those who do, they are often frail for an extended period. Additionally, an older frailty definition is associated with a high prevalence of physical limitation and adverse effects of frailty in adults.

Anonymous Patient Answer

What does pause intervention usually treat?

Most patients who received a 2-month hiatus intervention reported a more favorable health-related perception in all measured domains at follow-up compared to those who did not. In a recent study, findings may reflect improvements in perceived physical function, mental health, and self-perception as a result of the 2-month hiatus intervention. This is the first study to provide estimates on the effects of the 2-month hiatus intervention on these important outcomes following a long-term PA intervention.

Anonymous Patient Answer

Does frailty run in families?

Parents' perceptions of physical/mental health and cognitive decline are significantly associated with objectively ascertained indices of frailty that do not differ on their associations with other clinical indicators. Furthermore, the family history of frailty is a powerful predictor of age-adjusted mortality risk.

Anonymous Patient Answer

What is the latest research for frailty?

frailty varies in different populations with many sub-populations. Older persons are at risk for frailty. Recent research indicates the possibility of frailty at all ages, but especially in old age. The impact of frailty is very large, influencing overall health, daily functioning, psychological and social well-being. It is associated with increased healthcare use and institutionalization.

Anonymous Patient Answer

Have there been other clinical trials involving pause intervention?

The study's results were similar to previous research on the subject, and indicate the need for additional research on this specific intervention. Future studies may address the long-term maintenance of benefits. Other randomized controlled trials on the subject may also examine the effects of more intensive intervention or the initiation of treatment at earlier stages.

Anonymous Patient Answer

Who should consider clinical trials for frailty?

Physicians with experience in evaluating older patients of frailty can identify the patients most likely to benefit from a clinical trial. These patients can be identified as recipients of the smallest sample sizes in an intervention group and most likely to perceive the intervention as being most helpful. Physicians should consider offering clinical trials tailored specifically for frail patients, who might benefit more from the intervention than might most or any more frail patients.

Anonymous Patient Answer
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