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Multidisciplinary Care Planning for Surgery in Veterans with Frailty (PAUSE Trial)

N/A

Waitlist Available

Led By Shipra Arya, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgery must be at either the VA Palo Alto, VA Houston, or VA Nashville

Surgery must be with a qualifying specialty (general, vascular, orthopedics, cardio-thoracic, urology, neurosurgery, and others [e.g., Plastics/ENT])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

PAUSE Trial Summary

This trial is testing a new way of giving care to veterans who are scheduled for surgery. A group of specialists will meet to discuss the care options, scientific evidence, and patient goals and expectations for each individual patient. The investigators hope that this will improve quality and outcomes by creating better care recommendations and team-based discussions.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on improving care coordination rather than testing a new medication or medical device, it does not have typical side effects. However, changes in care plans could affect recovery times and overall patient satisfaction.

PAUSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am scheduled for elective surgery during the study period.

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I am a surgeon specialized in one of the required fields.

PAUSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

180-day mortality

Secondary outcome measures

180-day home-time

180-day rehospitalization

30-day mortality

+2 more

Other outcome measures

Activities of Daily Living--long form

Activities of Daily Living--short form

Care Assessment Need

+7 more

PAUSE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PAUSEExperimental Treatment1 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 CareActive Control1 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,276,453 Total Patients Enrolled

9 Trials studying Frailty

714 Patients Enrolled for Frailty

Shipra Arya, MDPrincipal InvestigatorVA Palo Alto Health Care System, Palo Alto, CA

Media Library

PAUSE Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05037292 — N/A

Frailty Research Study Groups: PAUSE, Usual Care

Frailty Clinical Trial 2023: PAUSE Intervention Highlights & Side Effects. Trial Name: NCT05037292 — N/A

PAUSE Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05037292 — N/A

Frequently Asked Questions

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

Are more participants being admitted to this research program?

"Data from clinicaltrials.gov denotes that this medical experiment is no longer actively recruiting participants; the study was first introduced on October 26th, 2021 and its most recent amendment was conducted on October 19th, 2022. In spite of this fact, there are 146 other trials which remain open to applicants at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PAtient-centered mUltidiSciplinary Care for vEterans Undergoing Surgery (PAUSE)

2021. "PAtient-centered mUltidiSciplinary Care for vEterans Undergoing Surgery (PAUSE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05037292.