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

NCT ID: NCT05037292

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35015 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2026-09-30

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.

Detailed Description

Background: Frailty is a syndrome of reduced physiologic reserve associated with higher postoperative mortality and adverse outcomes. The investigators' preliminary work shows that institution-wide frailty screening and introducing a "pre-surgical pause" reduces 6-month mortality threefold. However, a knowledge gap exists in the nature of the intervention and which stakeholders should be involved in the "pre-surgical pause". Multidisciplinary care models for complex patients are highly effective in oncology, wound care and primary care. The investigators propose a new care delivery model, i.e. PAtient-centered mUltidiSciplinary care for vEterans undergoing surgery (PAUSE), where experts from diverse fields contribute to surgical decision-making and optimize outcomes for high-risk Veterans.

Impact: Veterans above 65 years-of-age are a fast-growing population with significant need for high-quality surgical care. This study builds a structured multidisciplinary workflow to improve clinical and quality outcomes and provides high-value care for frail and high-risk Veterans that aligns with VA priorities and patient goals and expectations.

Innovation: This is the first study in the VA to implement a multidisciplinary care model for surgical care. The intervention employs an innovative hybrid-1 clinical effectiveness-implementation design to evaluate novel Veteran-centric outcomes of 30- and 180-day mortality, non-home discharge, rehospitalizations and home-time. A detailed formative evaluation (FE) evaluates provider and system factors that impact PAUSE intervention uptake. Further, the study has support from three national operational partners: National Surgery Office, Office of Geriatrics and Extended Care, and Palliative Care and Hospice Program.

Specific Aims: The goals for this project are to: (1) test the effectiveness of the PAUSE trial intervention vs usual care in improving 30- and 180-day mortality, non-home discharge, rehospitalizations and home-time for patients undergoing surgical evaluation; (2) test moderators of the PAUSE intervention effectiveness (treatment effect heterogeneity), especially specialty, frailty severity and risk status; and (3) use a mixed-method FE to understand the factors that influence fidelity, adaptation, and implementation of the PAUSE intervention. The investigators hypothesize that the PAUSE intervention will decrease 30- and 180-day mortality, rehospitalizations, and non-home discharge and increase home-time for all Veterans (Aim 1). The effect size for the outcomes will be greater for frail patients in certain specialties (Aim 2). The concurrent FE will highlight key barriers/facilitators for future implementation (Aim 3).

Methodology: The PAUSE trial is a pragmatic, stepped-wedge randomized clinical trial designed to capture a cohort of 25,000 Veterans scheduled for elective surgery at 3 large tertiary care VAMCs (Palo Alto, Houston and Nashville) and 7 specialty groups in each center: general, vascular, orthopedics, cardio-thoracic, urology, neurosurgery and others (e.g., plastics and ENT). The intervention includes standardized frailty screening and referral to a "multidisciplinary PAUSE Board" (surgery, anesthesia, geriatrics, palliative care, case management, rehabilitation and nutrition) for recommendations. Each 'step' is a randomly chosen specialty transitioning from usual care to the PAUSE intervention. Outcomes include 30- and 180-day mortality, non-home discharge, rehospitalizations and home-time. The Consolidated Framework for Implementation Research is used to guide FE and analysis of factors that influence implementation. The study spans across 4-years for pre-intervention FE (Y1), PAUSE intervention (Y1-3), post-intervention FE (Y3) and analysis (Y4).

Conditions

Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PAUSE

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 Type: EXPERIMENTAL

PAUSE Intervention

Intervention Type: OTHER

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

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PAUSE Intervention

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

Intervention Type: OTHER

Other Intervention Names

frailty screening; utilization of frailty review board

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

Chart/Database Review:

-Non-Veteran (USA)

VA Providers:

-Refusal or inability to participate during site visits.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shipra Arya, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1I01HX003215-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IIR 20-077

Identifier Type: -

Identifier Source: org_study_id