Clinical trial NCT05037292: PAtient-centered mUltidiSciplinary Care for vEterans Undergoing Surgery (PAUSE)
Official title: PAtient-centered mUltidiSciplinary Care for vEterans Undergoing Surgery (PAUSE): a Hybrid 1 Clinical Effectiveness-implementation Intervention Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Frailty
Keywords: Surgery
Multidisciplinary care model
Implementation science
Pragmatic clinical trial
Qualitative research
Randomized Controlled Trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-09-08
Enrollment: 35015
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Onboarding, training, and implementation of surgical subspecialties into a standardized frailty screening index and the utilization of a frailty review board by surgical specialty.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: 180-day mortality
timeFrame: Up to 180-days after discharge
Secondary outcomes:
measure: 30-day mortality
timeFrame: Up to 30-days after discharge
measure: 30-day rehospitalization
timeFrame: Up to 30-days after discharge
measure: 180-day rehospitalization
timeFrame: Up to 180-days after discharge
measure: Non-home discharge
timeFrame: 1 day after surgery discharge
measure: 180-day home-time
timeFrame: Up to 180-days after discharge
Other outcomes:
measure: Risk Analysis Index
timeFrame: Up to 90 days before surgery
measure: Care Assessment Need
timeFrame: Up to 90 days before surgery
measure: Operative Stress Score
timeFrame: Through study completion, an average of 1 year
measure: Activities of Daily Living--long form
timeFrame: Through study completion, an average of 1 year
measure: Activities of Daily Living--short form
timeFrame: Through study completion, an average of 1 year
measure: Instrumental Activities of Daily Living--Difficulty Scale
timeFrame: Through study completion, an average of 1 year
measure: Instrumental Activities of Daily Living--Involvement Scale
timeFrame: Through study completion, an average of 1 year
measure: Survey of Healthcare Experiences of Patients Care Coordination
timeFrame: Through study completion, an average of 1 year
measure: Survey of Healthcare Experiences of Patients Care Transition
timeFrame: Through study completion, an average of 1 year
measure: Survey of Healthcare Experiences of Patients--Inpatient
timeFrame: Through study completion, an average of 1 year
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
state: Tennessee
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Shipra Arya, MD
role: PRINCIPAL_INVESTIGATOR
References: