Clinical trial NCT04606264: Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data
Official title: Randomized, Embedded, Multifactorial Adaptive Platform for Perioperative Medicine at UPMC (UPMC REMAP): Core Protocol - Enhanced Recovery Protocols (ERP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Perioperative Optimization
Keywords: perioperative
enhanced recovery
patient-directed care
randomized embedded multifactorial adaptive platform
REMAP
ERP
90-day hospital free days
length of stay
perioperative optimization
oral morphine equivalents
postoperative nausea and vomiting
readmission
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Berry Consultants
First posted: 2020-10-28
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This REMAP Periop ERP domain study falls under the Periop Core Protocol, which compares the different recommended strategies for enhancing recovery through the use of various standard of care treatments before, during and after surgery in all patients with elective surgical encounters at UPMC who meet eligibility criteria.

The ERP domain seeks to enhance recovery by optimizing strategies of perioperative care through evaluating combinations of perioperative treatment, which consists of preoperative, intraoperative and postoperative care. Optimal combinations of perioperative care will be generated and analyzed to determine the best outcomes for patients as defined by reduction in hospital free days, reduction in postoperative nausea and vomiting, and improved pain control.

Detailed description: The Periop Core Protocol is an administration structure designed to provide appropriate management of all aspects of the study, taking into account multiple factors including representation from clinics and hospitals that are participating in the trial, availability of skills and expertise related to trial conduct and statistical analysis, and content knowledge regarding acute illness, elective surgery, and the interventions that are being evaluated. Eligible patients will be randomized to a recommended set of standard of care treatments related to their surgery to identify those that improve outcomes as defined by hospital free days at 30 days from the date of the surgical encounter. The administration model is designed to provide effective operational and strategic management of the REMAP that operates in multiple UPMC facilities, is supported by multiple funding bodies and sponsors, and will evolve with addition of domains and interventions that are being evaluated.

The ERP domain under the Periop Core Protocol will evaluate the varying recommended combinations of perioperative treatments, in hopes to determine the optimal strategies for perioperative care based on surgery type and patient specific factors. In this study, patient care components within the preoperative, perioperative, and postoperative domains will be randomized with a machine learning REMAP technique. Optimal strategies combining the entire perioperative process will be analyzed that determine best outcomes for patients including hospital free days, reductions in postoperative nausea and vomiting, and improved pain control.

Eligibility criteria: Inclusion Criteria

1. Patient is seen in preoperative appointment prior to surgery
2. ≥ 18 years of age
3. Anticipated overnight hospital stay
4. Scheduled for elective abdominal surgery that utilizes ERP PowerPlans - placed into the patient's electronic chart at least one night before surgery
5. ERP Abdominal Complex Pathway PowerPlan (used for colorectal and gastrointestinal surgery)
6. ERP Bariatric Surgery Pathway PowerPlan
7. ERP Gynecology Oncology Pathway PowerPlan
8. ERP Whipple/Pancreas Pathway PowerPlan
9. ERP Open Liver Resection Pathway PowerPlan
10. Surgery is scheduled for one of the following UPMC sites:
11. UPMC Presbyterian Hospital
12. UPMC Passavant Hospital
13. UPMC Magee-Women's Hospital

Exclusion Critera

1. Death is deemed to be imminent or inevitable
2. Patient is pregnant \< 18 years of age
3. Patients undergoing emergent/urgent surgery
4. Patients that are pregnant
5. Patients that have an eligible PowerPlan ordered less than one night before surgery

Primary outcomes:
measure: 30 day hospital free days
timeFrame: Day 0 - Day 30
Secondary outcomes:
measure: Change in postoperative nausea and vomiting (PONV) by measurement incidences of emesis within 24 hours post surgery
timeFrame: 0 - 24 hours surgery
measure: Change in the rate of postoperative opioid use by measurement of oral morphine equivalents (OME) postoperative day 0 to postoperative day 1
timeFrame: Day 0 - Day 1
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee-Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Passavant
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Stephen Esper, MD, MBA
role: STUDY_CHAIR
References: