PAtient-centered mUltidiSciplinary care for vEterans undergoing surgery (PAUSE): a hybrid 1 clinical effectiveness-implementation intervention trial

Background: Frailty is a syndrome of reduced physiologic reserve associated with higher postoperative
mortality and adverse outcomes. Our preliminary work shows that institution-wide frailty screening and
introducing a “pre-surgical pause” reduces 6-month mortality by 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. We propose a new intervention i.e. PAtient-centered mUltidiSciplinary care for vEterans undergoing
surgery (PAUSE), where experts from diverse fields will contribute to surgical decision-making and
optimization of outcomes for high-risk Veterans.
Impact: Aging Veterans are a fast-growing population with significant need for high-quality surgical care. This
study will build a structured multidisciplinary workflow to improve clinical and quality outcomes and provide
high-value care per VA priorities for frail and high-risk Veterans that aligns with their 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) will evaluate provider and system factors that impact uptake of the
PAUSE intervention. Further, the study has support from three national operational partners: National Surgery
Office (NSO), Office of Geriatrics and Extended Care, and Palliative Care and Hospice Program.
Specific Aims: Our goals for this project are three-fold: (1) to 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) to test moderators of the PAUSE intervention
effectiveness (treatment effect heterogeneity), especially specialty, frailty severity and risk status; and (3) to
use a mixed-method formative evaluation to understand the factors that influence fidelity, adaptation, and
implementation of the PAUSE intervention. 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 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: general, vascular, orthopedics, cardio-thoracic, urology, neurosurgery
and others (e.g., plastics and ENT). The intervention will be frailty screening and referral to a “multidisciplinary
PAUSE board” (surgery, anesthesia, geriatrics, palliative care, case management, rehabilitation and nutrition)
for recommendations. Each ‘step’ will be a randomly chosen specialty group 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 (CFIR) will be 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).
Next Steps: The PAUSE intervention will result in development of an “Implementation Guide” for wider
dissemination and future implementation at other sites through larger funding mechanisms or operational
support. Future steps include formal budget impact analysis and study of health care utilization pre- and post-
PAUSE intervention in the VA system.

Grant Number: 5I01HX003215-05
NIH Institute/Center: VA
Principal Investigator: Shipra Arya