ENhanced Recovery in CHildren Undergoing Surgery

NCT04060303 | Completed Phase 3 DMC

• 2 other identifiers: Pro00039201R01HD099344
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Keywords

Pediatric Surgery; Implementation; Quality Improvement; Enhanced Recovery Protocols; Gastrointestinal Surgery

Outcome Measures

Primary Outcomes (1)

• Length of stay (LOS)

  Measured in days from surgery to discharge.

  Up to 30 days after surgery

Secondary Outcomes (10)

• Intraoperative fluid use

  Intraoperative

• Surgical Complications

  Up to 30 days after surgery

• Hospital readmission

  Up to 30 days after surgery

• Intraoperative opioid use

  Intraoperative

• Postoperative opioid use

  Up to 30 days after surgery

Study Arms (3)

ENRICH-US Implementation- early

ACTIVE COMPARATOR

Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery) data collection. This phase involves abstraction of existing electronic health records data by the Site Coordinator about current, standard perioperative care received by patients. Patients and parents will complete web-based HRQoL assessments preoperatively, and 5 days and 4-6 weeks post-operatively. Site-specific barriers and facilitators to implementation will be assessed by semi-structured, telephone interviews, conducted by each Site's PI and Coordinator. Intervention phase will span 12 months with an implementation curriculum. Sites will be randomized to this implementation phase based on stepped-wedge cluster assignment. A sustainability phase will collect post intervention data.

Procedure: Perioperative surgical care

ENRICH-US Implementation- mid

ACTIVE COMPARATOR

Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery) data collection. This phase involves abstraction of existing electronic health records data by the Site Coordinator about current, standard perioperative care received by patients. Patients and parents will complete web-based HRQoL assessments preoperatively, and 5 days and 4-6 weeks post-operatively. Site-specific barriers and facilitators to implementation will be assessed by semi-structured, telephone interviews, conducted by each Site's PI and Coordinator. Intervention phase will span 12 months with an implementation curriculum. Sites will be randomized to this implementation phase based on stepped-wedge cluster assignment. A sustainability phase will collect post intervention data.

Procedure: Perioperative surgical care

ENRICH-US Implementation- late

ACTIVE COMPARATOR

Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery) data collection. This phase involves abstraction of existing electronic health records data by the Site Coordinator about current, standard perioperative care received by patients. Patients and parents will complete web-based HRQoL assessments preoperatively, and 5 days and 4-6 weeks post-operatively. Site-specific barriers and facilitators to implementation will be assessed by semi-structured, telephone interviews, conducted by each Site's PI and Coordinator. Intervention phase will span 12 months with an implementation curriculum. Sites will be randomized to this implementation phase based on stepped-wedge cluster assignment. A sustainability phase will collect post intervention data.

Procedure: Perioperative surgical care

Interventions

Perioperative surgical care PROCEDURE

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.

ENRICH-US Implementation- early; ENRICH-US Implementation- late; ENRICH-US Implementation- mid

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Balbale SN, Schafer WLA, Davis TL, Blake SC, Close S, Sullivan GA, Reiter AJ, Hu AJ, Smith CJ, Wilberding MJ, Johnson JK, Holl JL, Raval MV. A mixed-method approach to generate and deliver rapid-cycle evaluation feedback: lessons learned from a multicenter implementation trial in pediatric surgery. Implement Sci Commun. 2023 Jul 18;4(1):82. doi: 10.1186/s43058-023-00463-x.

  PMID: 37464448 DERIVED

• 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.

  PMID: 33198767 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery and Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 19, 2019
• Study Start: July 1, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)