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ENhanced Recovery in CHildren Undergoing Surgery (ENRICH-US)

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ClinicalTrials.gov Identifier: NCT04060303
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Mehul Raval, Northwestern University

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.

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

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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 Undergoing Gastrointestinal Surgery
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


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) 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) 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) 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.




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.



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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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060303


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

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Mehul Raval, MD, MS         
Sponsors and Collaborators
Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mehul Raval, Associate Professor of Surgery and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT04060303    
Other Study ID Numbers: Pro00039201
R01HD099344 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
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).

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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
Gastrointestinal Surgery
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases