PAUSE Intervention
OtherStandardized frailty screening and utilization of a frailty review board (PAUSE Board)
Other names: frailty screening; utilization of frailty review board
NCT Number: NCT05037292
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Chart/Database Review:
VA Providers:
Exclusion criteria
Chart/Database Review:
-Non-Veteran (USA)
VA Providers:
-Refusal or inability to participate during site visits.
Standardized frailty screening and utilization of a frailty review board (PAUSE Board)
Other names: frailty screening; utilization of frailty review board
Time frame: Up to 180-days after discharge
The rate of mortality at or within 180 days after the elective surgery
Time frame: Up to 30-days after discharge
The rate of mortality at or within 30 days after the elective surgery
Time frame: Up to 30-days after discharge
The percent of rehospitalizations at or within 30 days after the elective surgery
Time frame: Up to 180-days after discharge
The percent of rehospitalizations at or within 180 days after the elective surgery
Time frame: 1 day after surgery discharge
The percent of non-home discharge dispositions
Time frame: Up to 180-days after discharge
The percent of time spent at home (vs. non-home environment) in the 180 days after elective surgery
Time frame: Up to 90 days before surgery
Frailty assessment where higher scores indicates higher frailty [0=lowest frailty, 81=highest frailty].
Time frame: Up to 90 days before surgery
A predictive analytic tool for hospitalization and death at 90 days and one year, generated from electronic health records to assist Patient Aligned Care Teams in patient management and care coordination. Percentile score calculated where higher percentile indicates higher risk [0=lowest risk, 99=highest risk].
Time frame: Through study completion, an average of 1 year
Score indicates the physiological stress of a surgery using CPT codes in the electronic health records [1=very low stress, 5=very high stress].
Time frame: Through study completion, an average of 1 year
Total score reflects an individual's ability to complete basic self-care activities independently on 7 items (e.g., locomotion, eating) [0=completely independent, 28=completely dependent].
Time frame: Through study completion, an average of 1 year
Total score reflects an individual's ability to complete basic self-care activities independently on 4 items (e.g., locomotion, ) [0=completely independent, 16=completely dependent].
Time frame: Through study completion, an average of 1 year
Total score reflects an individual's ability to accomplish tasks needed for self-maintenance and independence on 3 items [0=independent, 6=dependent].
Time frame: Through study completion, an average of 1 year
Score reflects an individual's ability to accomplish tasks needed for self-maintenance and independence on 3 items [0=independent, 21=dependent].
Time frame: Through study completion, an average of 1 year
Percent of "Always" (4=Always) responses where scores on 3 items reflect satisfaction with care coordination; each item 1=Never, 2=Sometimes, 3=Usually, 4=Always. Higher percent indicates better care coordination.
Time frame: Through study completion, an average of 1 year
Percent of "Strongly Agree" responses where scores on 3 items reflect satisfaction with care coordination; each item 1=Strongly Disagree, 2=Disagree, 3=Agree, 4=Strongly Agree. Higher percent indicates better care transition.
Time frame: Through study completion, an average of 1 year
Facility level scores of patient satisfaction with hospitalization where higher scores indicate higher patient satisfaction.
VA Office of Research and Development
Fed
PAtient-centered mUltidiSciplinary Care for vEterans Undergoing Surgery (PAUSE): a Hybrid 1 Clinical Effectiveness-implementation Intervention Trial
Acronym: PAUSE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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