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

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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.