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

NIH RePORTER · VA · I01 · · view on reporter.nih.gov ↗

Abstract

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, orthopedi...

Key facts

NIH application ID
10641759
Project number
5I01HX003215-03
Recipient
VETERANS ADMIN PALO ALTO HEALTH CARE SYS
Principal Investigator
Shipra Arya
Activity code
I01
Funding institute
VA
Fiscal year
2023
Award amount
Award type
5
Project period
2021-05-01 → 2025-12-31