ENhancing Recovery in CHildren Undergoing Surgery (ENRICH-US)

• ClinicalTrials.gov Identifier: NCT04060303
• Recruitment Status: Recruiting
• First Posted: August 19, 2019
• Last Update Posted: July 10, 2020
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Mehul Raval, Northwestern University

Study Description

Brief Summary:

Initiated in the 1990s, perioperative Enhanced Recovery Protocols (ERPs) have progressively gained traction in a wide range of adult surgical disciplines and have decreased hospital length of stay (LOS), in-hospital costs, complications, and result in a markedly improved patient care experience that mitigates the physiologic stress of surgery and hastens recovery. Implementation of ERPs in pediatric surgery is lagging and concerted efforts to demonstrate both clinical effectiveness and to examine obstacles to implementation are needed. Specifically, pediatric patients with inflammatory bowel disease (IBD) undergoing elective abdominal surgery represent an ideal population in which to study the implementation of ERPs. Almost one third of patients with Crohn's disease (CD) and a quarter of patients with Ulcerative Colitis (UC) present before age 20. Up to three-quarters of CD patients require GI surgery for medically refractory disease and all patients with UC require colectomy to either manage severe disease or to mitigate cancer risks. Over the past four years, investigators modified existing adult ERPs to meet the needs of pediatric patients undergoing elective GI surgery. Based on the positive results of a pilot study, the investigators propose to conduct a multicenter, prospective, pragmatic, study using a stepped-wedge, cluster, randomized controlled trial design to evaluate the effectiveness of ERPs while assessing implementation fidelity, sustainability, and site-specific adaptations. The cluster randomized trial design is ideally suited for this type of pragmatic intervention implementation. The National Implementation Research Network's five Active Implementation Frameworks (AIFs), which identifies competency, organization, and leadership as drivers of implementation, empowers team collaboration, and facilitates rapid-cycle evaluation, will be used to optimize implementation. The investigators propose to conduct the ENhancing Recovery In CHildren Undergoing Surgery (ENRICH-US) Study in 18 US hospitals participating in the Pediatric Surgical Research Collaborative (PedSRC) by implementing and evaluating the effectiveness of the Pediatric ERP in GI Surgery on clinical outcomes for pediatric IBD patients and by measuring by fidelity and sustainability of the intervention while identifying organizational, leadership, and competency-based drivers of improved ERP implementation and sustainability.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis	Procedure: Perioperative surgical care	Not Applicable

Detailed Description:

This application proposes to implement an ERP for pediatric patients with inflammatory bowel disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), and undergoing elective abdominal surgery. They represent an ideal population in which to study the implementation of ERPs because almost one third of patients with CD present before age 20 and up to three-quarters of CD patients require gastrointestinal (GI) surgery for medically refractory disease. A quarter of UC patients present before age 20 and all patients with UC require colectomy to either manage severe disease or mitigate cancer risks. The GI surgical procedures performed in children with IBD are similar to the adult procedures for which ERPs have been well tested and validated.

The study team has previously modified existing adult ERPs to meet the needs of pediatric patients undergoing elective GI surgery, primarily for IBD, by conducting (a) a systematic literature review, (b) a national survey to assess readiness for implementation, and (c) an expert panel adjudication of ERP elements. The investigators also conducted a pilot study to assess the feasibility, safety, and preliminary effectiveness of the pediatric ERP in 79 pediatric patients who underwent elective GI surgery. Patient and provider education materials were created, a learning collaborative explored drivers and obstacles to implementation, patient advocates were engaged to enhance the quality improvement process, and data were routinely fed back to the implementation team members. The pilot study demonstrated a 50% decrease in LOS, from 5 to 3 days, near elimination of intraoperative and post-operative opioid use, and a 30% decrease in perioperative fluid administration, without any increase in post-surgical complications or re-hospitalization.

Based on these promising results, the investigators propose the ENhancing Recovery In CHildren Undergoing Surgery (ENRICH-US) Study in 18 US hospitals that participate in the Pediatric Surgical Research Collaborative (PedSRC). This multicenter study will use a stepped-wedge, cluster-randomized, pragmatic clinical trial design to evaluate the effectiveness of ENRICH-US while also assessing implementation fidelity, sustainability, and site-specific adaptations. The investigators 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1260 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children With Inflammatory Bowel Disease
• Actual Study Start Date: September 1, 2019
• Estimated Primary Completion Date: December 1, 2023
• Estimated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ENRICH-US Implementation- early; Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery for IBD) 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; 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.
Active Comparator: ENRICH-US Implementation- mid; Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery for IBD) 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; 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.
Active Comparator: ENRICH-US Implementation- late; Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery for IBD) 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Length of stay (LOS) [ Time Frame: Up to 30 days after surgery ]
   Measured in days from surgery to discharge.

Secondary Outcome Measures :

1. Intraoperative fluid use [ Time Frame: Intraoperative ]
   intravenous fluids given during surgery (measured in mL/kg)
2. Surgical Complications [ Time Frame: Up to 30 days after surgery ]
   wound infections, pneumonia, urinary tract infections within 30 days of surgery
3. Hospital readmission [ Time Frame: Up to 30 days after surgery ]
   Post discharge hospital readmission within 30 days of surgery.
4. Intraoperative opioid use [ Time Frame: Intraoperative ]
   opioids used during surgery measured in morphine equivalents mg/kg
5. Postoperative opioid use [ Time Frame: Up to 30 days after surgery ]
   opioids from surgery until discharge measured in morphine equivalents mg/kg
6. Post-discharge opioid prescribed [ Time Frame: Up to 30 days after surgery ]
   Opioids prescribed at discharge measured in morphine equivalents mg/kg
7. Time to regular diet [ Time Frame: Up to 30 days after surgery ]
   Time from intestinal surgery to resumption of regular diet (measured in days)
8. Preoperative Quality of Life assessment [ Time Frame: Baseline (prior to surgery) ]
   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.
9. Immediate post-operative Quality of Life assessment [ Time Frame: 48 hours after surgery ]
   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
10. Long-term post-operative Quality of Life assessment [ Time Frame: 2 weeks after surgery ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Pediatric patients ages 10-18
• Clinical diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
• Undergoing elective gastrointestinal/colorectal surgical procedures

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Mehul Raval, MD, MS; 3122274210; mraval@luriechildrens.org

Locations

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Contact: Mehul Raval, MD, MS

Sponsors and Collaborators

Northwestern University

More Information

• Responsible Party: Mehul Raval, Associate Professor of Surgery and Pediatrics, Northwestern University
• ClinicalTrials.gov Identifier: NCT04060303
• Other Study ID Numbers: ENRICH-US 2019
• First Posted: August 19, 2019
• Last Update Posted: July 10, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: All data collected during the study will be made available such that further advancement of ERP principles will be made possible by building upon these data. In addition to the peer-reviewed publication of study results and the dissemination of findings through publicly available websites, blogs, and newsletters, the PI and Biostatistics Director will create a patient-deidentified data set that will be made publicly available to researchers. We have included a request for funds to curate this dataset for public use. It will include clinical data and outcomes collected through REDCap for the complete ENRICH-US study, as well as, raw data for the PedsQL health-related quality of life surveys. All data will be fully de-identified. A copy of the study protocol, data definition dictionary, and public use file with instructions will also be generated for ease of use. Data will be made available in a format that will easily be used in mainstream software analysis packages (e.g., ASCII, SAS).

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mehul Raval, Northwestern University:

Pediatric Surgery; Implementation; Quality Improvement; Enhanced Recovery Protocols

Additional relevant MeSH terms:

Crohn Disease; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Colonic Diseases