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

NCT05037292 | Active Not Recruiting DMC

• 2 other identifiers: IIR 20-0771I01HX003215-01A1
• Study Type: interventional
• Target: 35,015
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Frailty

Keywords

Surgery; Multidisciplinary care model; Implementation science; Pragmatic clinical trial; Qualitative research; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 180-day mortality

  The rate of mortality at or within 180 days after the elective surgery

  Up to 180-days after discharge

Secondary Outcomes (5)

• 30-day mortality

  Up to 30-days after discharge

• 30-day rehospitalization

  Up to 30-days after discharge

• 180-day rehospitalization

  Up to 180-days after discharge

• Non-home discharge

  1 day after surgery discharge

• 180-day home-time

  Up to 180-days after discharge

Other Outcomes (10)

• Risk Analysis Index

  Up to 90 days before surgery

• Care Assessment Need

  Up to 90 days before surgery

• Operative Stress Score

  Through study completion, an average of 1 year

Study Arms (2)

PAUSE

EXPERIMENTAL

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.

Other: PAUSE Intervention

Usual Care

NO 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.

Interventions

PAUSE Intervention OTHER

Standardized frailty screening and utilization of a frailty review board (PAUSE Board)

Also known as: frailty screening; utilization of frailty review board

PAUSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chart/Database Review:
• Patient must have elective surgery within the intervention period
• Surgery must be with a qualifying specialty (general, vascular, orthopedics, cardio-thoracic, urology, neurosurgery, and others \[e.g., Plastics/ENT\])
• Surgery must be at either the VA Palo Alto, VA Houston, or VA Nashville
• VA Providers:
• Service and Section Chief Interviews:
• Must be the Surgery Service Line chief (or appointed designee).
• Must be Section Chief (or appointed designee) of a qualifying surgical specialty (general, vascular, orthopedics, cardio-thoracic, urology, neurosurgery, and others \[e.g., Plastics/ENT\]).
• Must serve at the VA Palo Alto, VA Houston, or VA Nashville.
• Focus Groups:
• Must be a healthcare provider at VA Palo Alto, VA Houston, or VA Nashville.
• Must have planned or prior experience participating in PAUSE Board meetings.
• Referral Frequency Interviews:
• Must be a member of the surgical team with one of the qualifying surgical specialties (general, vascular, orthopedics, cardio-thoracic, urology, neurosurgery, and others \[e.g., Plastics/ENT\]).
• Must be one of the high- or low-referring providers to the PAUSE Board.

You may not qualify if:

• Chart/Database Review:
• Non-Veteran (USA)
• VA Providers:
• Refusal or inability to participate during site visits.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shipra Arya, MD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Onboarding, training, and implementation of surgical subspecialties into a standardized frailty screening index and the utilization of a frailty review board by surgical specialty.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 8, 2021
• Study Start: October 26, 2021
• Primary Completion: January 13, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)