Multidisciplinary Care Planning for Surgery in Veterans with Frailty

(PAUSE Trial)

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

35015 Participants Needed

Trial Summary

What is the purpose of this trial?

The PAUSE Trial is a pragmatic, randomized clinical trial for Veterans scheduled for elective surgery at 3 large VA facilities (Palo Alto, Houston, and Nashville). The PAUSE Trial focuses on cooperation between providers of various disciplines in order to provide better care. Veterans identified as frail upon standardized will be referred to a multidisciplinary "PAUSE Board" comprised of members from surgery, anesthesia, geriatrics, palliative care, case management, rehabilitation, and nutrition. Diverse specialists will come together in a team environment to discuss care options, scientific evidence, and patient goals and expectations, creating individual patient recommendations. The investigators hypothesize that the PAUSE Board model will improve quality and outcomes by promoting guidelines and evidence-based care recommendations as well as constructive team-based discussions to align care with patient goals and expectations.

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 data supports the effectiveness of the PAUSE Intervention treatment for frail veterans undergoing surgery?

Research suggests that multidisciplinary care, which is part of the PAUSE Intervention, can improve outcomes for frail patients undergoing surgery by providing a holistic approach to care. This type of care helps in assessing risks, modifying frailty, and planning the surgical pathway, which can lead to better recovery and reduced complications. ^{1 2 3 4 5}

Is the PAUSE Intervention safe for humans?

The research does not provide specific safety data for the PAUSE Intervention, but it suggests that multidisciplinary management can improve care for frail patients, which may imply a focus on safety and risk reduction. ^{2 6 7 8 9}

How is the PAUSE Intervention treatment different from other treatments for frailty in surgical patients?

The PAUSE Intervention is unique because it involves a multidisciplinary care planning approach specifically designed for veterans with frailty undergoing surgery. This treatment focuses on a holistic model of care, which means it considers the whole person, not just the medical condition, and involves collaboration among different healthcare professionals to improve surgical outcomes for frail patients. ^{1 2 4 7 10}

Research Team

Shipra Arya, MD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Interventions to improve the outcomes of frail people having surgery: A systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Frailty in the perioperative setting. [2020]

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

The association between preoperative multidisciplinary team care and patient outcome in frail patients undergoing cardiac surgery. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Perceptions and practices surrounding the perioperative management of frail emergency surgery patients: a WSES-endorsed cross-sectional qualitative survey. [2023]

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

Frailty for Perioperative Clinicians: A Narrative Review. [2020]

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

Impact of Frailty on Clinical Outcomes and Hospitalization Costs Following Elective Colectomy. [2021]

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

The prevalence of frailty and its association with clinical outcomes in general surgery: a systematic review and meta-analysis. [2019]

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

Incidence of Frailty in Community-Dwelling United States Older Veterans. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

Multidisciplinary management and optimization of frail or high surgical risk patients in colorectal cancer surgery: Prospective observational analysis. [2021]

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

Effects of a Multicomponent Frailty Prevention Program in Prefrail Community-Dwelling Older Persons: A Randomized Controlled Trial. [2021]