Multidisciplinary Care Planning for Surgery in Veterans with Frailty

(PAUSE Trial)

Not currently recruiting at 2 trial locations

Overseen By Shipra Arya, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-veteran, refusal, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a team-based approach can improve care for Veterans identified as frail and scheduled for elective surgery. Specialists from various fields, such as surgery and nutrition, will collaborate to create personalized care plans that align with the patient's goals. Participants will either receive this specialized care, known as the PAUSE Intervention, or continue with usual care. Veterans suitable for this trial have been identified as frail and are planning surgery in specialties like general or orthopedic surgery at VA hospitals in Palo Alto, Houston, or Nashville. As an unphased trial, this study offers Veterans the chance to contribute to innovative care strategies that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this multidisciplinary care planning is safe for veterans with frailty?

Research has shown that the PAUSE Intervention, also known as the Surgical Pause, can enhance surgical safety for frail patients. This method involves assessing frailty and adjusting care plans, which has lowered death rates among high-risk Veterans.

The program employs a risk assessment tool to better plan surgeries and improve outcomes. It has received praise for enhancing surgical care for frail individuals, indicating it is safe and well-received. No major negative effects have been reported, making the PAUSE Intervention a potentially safer way to manage surgical risks in frail patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PAUSE Intervention because it offers a comprehensive approach to surgery in frail veterans by incorporating a multidisciplinary team. Unlike standard care, where perioperative management is handled by individual clinical teams, the PAUSE Board brings together experts from surgery, anesthesia, geriatrics, palliative care, and more, ensuring a holistic evaluation and tailored care plan. This team-based strategy aims to improve surgical outcomes by addressing the unique needs of frail patients, potentially reducing complications and enhancing recovery.

What evidence suggests that the PAUSE Intervention is effective for improving surgical outcomes in frail veterans?

Research has shown that the PAUSE intervention, which participants in this trial may receive, could greatly improve outcomes for frail veterans undergoing planned surgeries. Studies have found that similar methods can reduce the risk of death within 30 and 180 days post-surgery. This intervention also aims to decrease hospital readmissions and increase the likelihood of patients returning home rather than to another care facility. The approach includes a team-based discussion to ensure care aligns with patient preferences, which has previously led to better health outcomes. Overall, early findings suggest that involving a multidisciplinary team in care planning may enhance patients' quality of life and recovery. ^{1 2 6 7 8}

Who Is on the Research Team?

Shipra Arya, MD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

The PAUSE Trial is for Veterans at VA facilities in Palo Alto, Houston, and Nashville who are scheduled for elective surgery in specialties like general, vascular, orthopedics, cardio-thoracic, urology or neurosurgery. Participants include frail patients referred to the PAUSE Board and healthcare providers involved with the board.

Inclusion Criteria

Must have planned or prior experience participating in PAUSE Board meetings

My surgery will be at VA Palo Alto, VA Houston, or VA Nashville.

My surgery was performed by a specialist in areas such as general, vascular, or orthopedics.

Exclusion Criteria

Refusal or inability to participate during site visits

Non-Veteran (USA)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 90 days

Pre-surgical PAUSE

Veterans identified as frail are referred to a multidisciplinary PAUSE Board for care recommendations

Varies

Surgery and Immediate Post-operative Care

Veterans undergo elective surgery and receive immediate post-operative care

1 day after surgery discharge

Follow-up

Participants are monitored for safety and effectiveness after surgery, including 30-day and 180-day mortality and rehospitalization rates

Up to 180 days

What Are the Treatments Tested in This Trial?

Interventions

• PAUSE Intervention

Trial Overview This trial tests a multidisciplinary approach called the 'PAUSE Intervention' where specialists from various fields collaborate to tailor care plans for frail veterans undergoing elective surgery. The goal is to align treatment with patient goals using evidence-based recommendations.

How Is the Trial Designed?

Group I: PAUSE Experimental Treatment 1 Intervention

Surgical specialty clinics that completed an "onboarding" training for team members to use the standardized frailty screening incorporated in Veterans' medical records. Veterans identified as frail upon screening will be referred to a multidisciplinary "PAUSE Board" comprised of members from surgery, anesthesia, geriatrics, palliative care, case management, rehabilitation, nutrition.

Group II: Usual Care Active Control 1 Intervention

Surgical specialty clinics that have not yet implemented the PAUSE Intervention. Veterans at these clinics will receive usual perioperative assessment and management by the clinical team.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A survey of 168 emergency surgeons revealed that while 98.2% recognized the importance of frailty in surgical patients, only 2.4% actually performed comprehensive geriatric assessments, indicating a significant gap between awareness and practice.

Key barriers to implementing effective frailty management included a lack of knowledge about assessment tools, unclear responsibilities for screening, and insufficiently trained staff, suggesting that improved training and guidelines could enhance frailty care in emergency surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions and practices surrounding the perioperative management of frail emergency surgery patients: a WSES-endorsed cross-sectional qualitative survey. Viswanath, M., Clinch, D., Ceresoli, M., et al.[2023]

Frailty significantly increases the risk of adverse outcomes in general surgical patients, with a 30-day mortality rate of 8% for frail patients compared to just 1% for non-frail patients, based on a systematic review of 2,281 participants from nine studies.

Frail patients also experience higher rates of surgical complications (24%) and longer hospital stays (average of 9.6 days) compared to non-frail patients (5% complications and 6.4 days stay), highlighting the need for careful management of frail individuals undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of frailty and its association with clinical outcomes in general surgery: a systematic review and meta-analysis. Hewitt, J., Long, S., Carter, B., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05037292

PAtient-centered mUltidiSciplinary Care for vEterans ... The investigators hypothesize that the PAUSE intervention will decrease 30- and 180-day mortality, rehospitalizations, and non-home discharge and increase home- ...

2. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141707586

IIR 20-077 – HSR Study - VA Health Systems Research We hypothesize that the PAUSE intervention will lead to a decrease in 30- and 180-day mortality, rehospitalizations, non-home discharge and increase home-time ...

3. jointcommission.org jointcommission.org/en-us/knowledge-library/blogs/dateline-tjc-2024-05-vas-surgical-pause-initiative

VA's Surgical Pause Initiative Found to Reduce Mortality ... ... Pause initiative for its innovative efforts resulting in improved healthcare outcomes of frail veterans considering elective surgery.

4. hsrd.research.va.gov hsrd.research.va.gov/impacts/surgical-pause.cfm

The Surgical Pause Practice Adopted as National Program Daniel Hall and colleagues developed the Surgical Pause Practice, which screens frail Veterans before surgery so that their care plan can be ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039606025005288

Preimplementation expectations and perceptions of a ... Patients with frailty face greater postoperative mortality and adverse outcomes. However, evidence regarding interventions for mitigating the risks ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553725024003684

The Surgical Pause: The Importance of Measuring Frailty ... The Surgical Pause is a strategy to optimize outcomes for frail patients by screening for frailty and taking action to improve outcomes.

7. hsrd.research.va.gov hsrd.research.va.gov/impacts/surgical-pause-practice.cfm

The Surgical Pause Practice is Saving Veterans' Lives The Surgical Pause screens frail veterans before surgery using the RAI, identifying high-risk patients, and has reduced mortality rates from 25 ...

8. moaa.org moaa.org/content/publications-and-media/news-articles/2024-news-articles/advocacy/va-recognized-for-improving-surgical-care-for-frail-veterans/

VA Recognized for Improving Surgical Care for Frail ... The VA's "Surgical Pause" screens high-risk veterans for frailty, reviews care options, and uses a risk analysis index to improve outcomes.