ENhanced Recovery in CHildren Undergoing Surgery

Ulcerative Colitis Clinical Trial

— ENRICH-US  

Official title:

Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04060303
• Other study ID #: Pro00039201
• Secondary ID: R01HD099344
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Northwestern University
• Contact: Mehul Raval, MD, MS
• Phone: 3122274210
• Email: mraval[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1260
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Procedure:
• Perioperative surgical care
The ENRICH-US Protocol includes perioperative counseling and education, maintaining euvolumia through limited perioperative fasting and limited intraoperative fluid resuscitation, early enteral intake and mobilization, limited use of opioids, and non-routine use of surgical drains and tubes. Elements span the pre-, intra-, and post-operative experience for patients and involve care coordination among surgery, anesthesia, and nursing providers. Though individually simple, the concomitant implementation of the combined elements results in a markedly improved patient care experience that mitigates the physiologic stress of surgery and hastens recovery.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay (LOS)	Measured in days from surgery to discharge.	Up to 30 days after surgery
Secondary	Intraoperative fluid use	intravenous fluids given during surgery (measured in mL/kg)	Intraoperative
Secondary	Surgical Complications	wound infections, pneumonia, urinary tract infections within 30 days of surgery	Up to 30 days after surgery
Secondary	Hospital readmission	Post discharge hospital readmission within 30 days of surgery.	Up to 30 days after surgery
Secondary	Intraoperative opioid use	opioids used during surgery measured in morphine equivalents mg/kg	Intraoperative
Secondary	Postoperative opioid use	opioids from surgery until discharge measured in morphine equivalents mg/kg	Up to 30 days after surgery
Secondary	Post-discharge opioid prescribed	Opioids prescribed at discharge measured in morphine equivalents mg/kg	Up to 30 days after surgery
Secondary	Time to regular diet	Time from intestinal surgery to resumption of regular diet (measured in days)	Up to 30 days after surgery
Secondary	Preoperative Quality of Life assessment	Health Related Quality of Life assessment using Pediatric Quality of Life (PedsQL) inventory. Total scores spanning all domains (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning). Scores total to 100. Scores >90 considered normal. This measurement will be collected prior to surgery.	Baseline (prior to surgery)
Secondary	Immediate post-operative Quality of Life assessment	Health Related Quality of Life assessments: Pediatric Quality of Life (PedsQL) inventory. Total scores spanning all domains (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning). Scores total to 100. Scores >90 considered normal. This measurement will be collected within 48 hours after surgery	48 hours after surgery
Secondary	Long-term post-operative Quality of Life assessment	Health Related Quality of Life assessments: Pediatric Quality of Life (PedsQL) inventory. Total scores spanning all domains (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning). Scores total to 100. Scores >90 considered normal. This measurement will be collected 2 weeks after surgery.	2 weeks after surgery