Clinical trial NCT04060303: ENhanced Recovery in CHildren Undergoing Surgery
Official title: Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: Pediatric Surgery
Implementation
Quality Improvement
Enhanced Recovery Protocols
Gastrointestinal Surgery
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-08-19
Enrollment: 599
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A stepped-wedge, cluster-randomized study design will be used in which the participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The institution of perioperative Enhanced Recovery Protocols (ERPs) has been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but data in pediatric populations are lacking. The Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery, which has the short title "ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US)," study is a multicenter, pragmatic, prospective study, using a stepped wedge cluster randomized controlled trial design. The study is designed to test the adoption, effectiveness, and generalizability of a newly developed, 21-element ERP for children undergoing elective gastrointestinal surgery.

Detailed description: The purpose of this study is to learn more about the clinical effectiveness and to examine obstacles to implementing a Perioperative Enhanced Recovery Protocol (ERP) in pediatric surgery. ERPs are evidence-based interventions that have been developed among adult surgical populations, but implementation of ERPs and data in pediatric populations are lacking. To address this need, we have designed a multicenter, prospective study entitled ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US). This study is designed to test the adoption, effectiveness, and generalizability of a pediatric specific 21-element ERP intervention for children recovering from surgery compared with usual care. All other peri-operative care in this study will not be modified from usual care pathways, including medications.

The basic elements of the ENRICH-US intervention are very similar to the elements of most adult ERPs and include perioperative counseling and education, mindfulness training, maintenance of euvolumia through limited perioperative fasting and limited intraoperative fluid resuscitation, early enteral intake, early mobilization, limited opioid use, and non-routine use of surgical drains and tubes. Elements span the preadmission and pre-, intra-, and post-operative phases of care. The concurrent use of these integrative healthcare interventions results in a markedly improved patient care experience that minimizes the physiologic stress of surgery and hastens recovery. These ERPs have been found to decrease hospital length of stay, in-hospital costs, complications, and help patients recover sooner after surgery. Though each ERP element is independently simple, implementation of the combined elements likely will require substantial redesign of the systems and processes of care to assure a high level of coordination among surgery, anesthesia, and nursing clinicians.

This prospective study involves multiple sites and uses a stepped-wedge, cluster-randomized, controlled study design of the ENRICH protocol in pediatric patients undergoing elective GI surgery. The cluster-randomized trial design is ideally suited for pragmatic intervention implementation. A hybrid, type 2 study design will be used with equal focus on evaluating the effectiveness and the implementation. The study will optimize implementation using the National Implementation Research Network's five Active Implementation Frameworks (AIFs), which identify competency, organization, and leadership as drivers of implementation and empower team collaboration and facilitate rapid-cycle evaluation. The five AIFs used as key tools to achieve high-fidelity and sustainable implementation will include patient-stakeholder input in all steps of the improvement process and a Learning Collaborative (LC) with rapid-cycle data feedback.

The study, by taking place in the setting where patients receive usual clinical care by usual clinicians, using data primarily from existing data sources (e.g., EHR), having minimal eligibility criteria, and recruiting all eligible pediatric patients undergoing GI surgery delivery, fulfills most of the pragmatic qualities to understand the real-world performance and implications of the intervention. The nature of this trial does not allow for subjects (patients or clinicians) to be blinded.

The study will enroll patients at 18 US hospitals ("sites") that participate in the Pediatric Surgery Research Collaborative (PedSRC), a cooperative group of pediatric surgeons and researchers committed to performing clinical research in pediatric surgery. All sites offer comprehensive, inpatient, pediatric services, including surgical services. The PedSRC represents one of the largest pediatric surgical networks for collaboration and research.

The 18 sites will be randomly assigned to one of three clusters for the stepped wedge design with each cluster, in turn, being randomly assigned to an intervention start period. Given that many sites have already initiated some ERP elements, a study design that randomizes sites or patients to a control arm without any ERP elements is not feasible. The stepped-wedge design was selected, in part, to ease the practical challenges of concurrently coordinating training and data collection across the 18 sites.

The ENRICH-US study provides a unique opportunity to accelerate, yet evaluate the adoption of ERP elements for pediatric GI patients, thus improving surgical care for this high-risk population by rapidly incorporating ERPs into practice, using the five AIFs. This study will serve as a model for future pediatric surgical quality improvement implementation efforts.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients ages 10-18
* Undergoing elective (non-emergency) gastrointestinal/colorectal surgical procedures

Exclusion Criteria:

* Children undergoing emergent/urgent gastrointestinal/colorectal surgical procedures
* Patients/families who cannot read and write English or Spanish

Primary outcomes:
measure: Length of stay (LOS)
timeFrame: Up to 30 days after surgery
Secondary outcomes:
measure: Intraoperative fluid use
timeFrame: Intraoperative
measure: Surgical Complications
timeFrame: Up to 30 days after surgery
measure: Hospital readmission
timeFrame: Up to 30 days after surgery
measure: Intraoperative opioid use
timeFrame: Intraoperative
measure: Postoperative opioid use
timeFrame: Up to 30 days after surgery
measure: Post-discharge opioid prescribed
timeFrame: Up to 30 days after surgery
measure: Time to regular diet
timeFrame: Up to 30 days after surgery
measure: Preoperative Quality of Life assessment
timeFrame: Baseline (prior to surgery)
measure: Immediate post-operative Quality of Life assessment
timeFrame: 48 hours after surgery
measure: Long-term post-operative Quality of Life assessment
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
citation: Raval MV, Wymore E, Ingram ME, Tian Y, Johnson JK, Holl JL. Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial. Trials. 2020 Nov 16;21(1):926. doi: 10.1186/s13063-020-04851-9.