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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD099344 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
Clinicians, staff, and patient advocates participated only as part of the implementation Learning Collaborative and interviews. These individuals were not enrolled as study participants and therefore do not appear in enrollment, Participant Flow, Baseline Characteristics, or Outcome Measures.
Clarification of Study Participants: ENRICH-US used a stepped-wedge, cluster-randomized design in which clinical sites (18) were the units of assignment. Participants are counted under the study phase active at their site at the time of surgery; thus Baseline (248), Implementation (156), and Sustainability (193) reflect exposure groups rather than cluster membership. All 597 pediatric patients who completed consent/assent were enrolled. Learning Collaborative clinicians, staff, and patient advocates participated only in implementation activities/interviews, were not enrolled research participants, were not randomized, and did not contribute demographic, clinical, or PRO data. Therefore, they are not included in Enrollment, Participant Flow, Baseline Characteristics, Outcome Measures, or Adverse Events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| ENRICH-US Implementation- late | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay (LOS) | Measured in days from surgery to discharge | During hospitalization, up to a maximum of 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged LOS (>6 Days) | Binary variable derived from LOS; > 6 days = Yes. | Up to 30 days postoperatively. Baseline (Pre-Implementation) Phase: January 2019 - February 2021. Implementation Phase: March 2021 - October 2022. Sustainability Phase: November 2022 - December 2023. |
| Time to Regular Diet |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42126839 | Derived | Raval MV, Tian Y, Schafer W, Balbale SN, Perez MN, Ingram ME, Lehane A, Smith CJ, Sullivan GA, Reiter AJ, Hu A, Borst JM, Blake SC, Close S, Davis TL, Essner BS, Heiss KF, Huang LW, Wymore E, Paniagua-Perez D, Engelhardt KM, Graffy PM, Johnson JK, Lillehei CW, Gray BW, Goldstein SD, Short SS, Pandya SR, Taylor JA, Gayer C, Goldin AB, Boelig MM, Rialon KL, Jancelewicz T, Lipskar AM, Jafri M, Tracy ET, Harting MT, Sulkowski JP, Ham PB 3rd, Vali K, Cina RA, Schindel DT, Islam S, Teeple EA, Shah SR, Gosain A, Rothstein DH, Brockel MA, Chown J, Holl JL. Implementation and Effectiveness of an Enhanced Recovery Protocol for Children Undergoing Surgery: The ENRICH-US Stepped-Wedge Cluster-Randomized Trial. JAMA Surg. 2026 Jul 1;161(7):670-680. doi: 10.1001/jamasurg.2026.1382. | |
| 39167901 |
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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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Sites (clusters) were randomized into 3 sequences (6 sites/sequence) and crossed from Baseline to Implementation to Sustainability per the prespecified roll-out. Participants were enrolled continuously according to surgery dates.
This was a stepped-wedge, cluster-randomized trial with 18 clinical sites assigned to 3 randomized sequences (6 sites per seq.). Each sequence progressed through Baseline (usual care), Implementation and Sustainability phases at different calendar times according to the prespecified roll-out. Participants reported by the phase active at their site at time of surgery. Learning Collaborative personnel were not research participants and do not contribute to Participant Flow, Outcome Measures or AEs
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 (Early Implementation Sites) | Clinical sites (clusters) were randomized by the data coordinating team into three sequences for the stepped-wedge design, stratified to include two lower-volume and four higher-volume sites per sequence. Sites in this sequence initiated the ENRICH-US protocol in the first step. Sites contributed data according to the study schedule: Baseline (pre-implementation) 6 months, Implementation 12 months, and Sustainability 24 months. During baseline, sites provided standard care. During implementation and sustainability, sites implemented the 21-element ENRICH-US protocol supported by a structured implementation toolkit, learning collaborative curriculum, ERP adherence data feedback, and implementation report cards. |
| FG001 | Sequence 2 (Mid Implementation Sites) | Clinical sites (clusters) were randomized by the data coordinating team into three sequences for the stepped-wedge design, stratified to include two lower-volume and four higher-volume sites per sequence. Sites in this sequence initiated the ENRICH-US protocol in the second step. Sites contributed data according to the study schedule: Baseline (pre-implementation) 12 months, Implementation 12 months, and Sustainability 18 months. During baseline, sites provided standard care. During implementation and sustainability, sites implemented the 21-element ENRICH-US protocol supported by a structured implementation toolkit, learning collaborative curriculum, ERP adherence data feedback, and implementation report cards. |
| FG002 | Sequence 3 (Late Implementation Sites) | Clinical sites (clusters) were randomized by the data coordinating team into three sequences for the stepped-wedge design, stratified to include two lower-volume and four higher-volume sites per sequence. Sites in this sequence initiated the ENRICH-US protocol in the third step. Sites contributed data according to the study schedule: Baseline (pre-implementation) 18 months, Implementation 12 months, and Sustainability 12 months. During baseline, sites provided standard care. During implementation and sustainability, sites implemented the 21-element ENRICH-US protocol supported by a structured implementation toolkit, learning collaborative curriculum, ERP adherence data feedback, and implementation report cards. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Pre-Implementation) |
| |||||||||||||
| Implementation |
| |||||||||||||
| Sustainability |
|
Baseline characteristics include all 597 enrolled participants and reflect demographic and clinical data collected at the time of surgery. Participants are pooled across study periods and sequences for descriptive purposes only. Baseline characteristics are not restricted to the baseline period of the stepped-wedge design.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline (Pre-Implementation) | Participants enrolled prior to implementation of the ENRICH-US enhanced recovery protocol at their site, reflecting usual perioperative care. |
| BG001 | Implementation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was collected at the time of surgery from the medical record and is reported in years. For this study, eligible participants were 10-18 years old. Age is summarized as median and interquartile range (IQR) by study phase. No participants outside this age range were enrolled. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Stay (LOS) | Measured in days from surgery to discharge | All participants with available LOS data are included. Numbers analyzed match the total enrolled in each study phase. No participants were excluded from LOS analysis. | Posted | Median | Inter-Quartile Range | Days | During hospitalization, up to a maximum of 14 days. |
|
Assessed from the date of surgery through 30 days post-operation. Participants were enrolled across three stepped-wedge phases with site-specific durations: Baseline Phase (minimum 9 months), Implementation Phase (12 months), and Sustainability Phase (12-24 months depending on site).
All adverse event data collected during the study are reported. No deaths or serious adverse events occurred. Postoperative complications were collected prospectively from electronic health records by trained site coordinators using MedDRA terminology. All complications collected are reported; only those meeting the ≥5% frequency threshold are displayed in the "Other (Not Including Serious) Adverse Events" table, per ClinicalTrials.gov requirements.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline (Pre-Implementation) | Participants whose surgery occurred during the baseline (pre-implementation) phase at their site, prior to implementation of the ENRICH-US protocol. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus (requiring NG tube placement or delay of oral intake) | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment | Postoperative ileus requiring NG tube placement or delayed oral intake. |
This study is limited by challenges inherent to measuring implementation quality and variability across sites. COVID-19-related disruptions, staffing turnover, and delays in site activation affected implementation timelines. Results may not generalize to all pediatric surgical populations or care settings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehul Raval | Northwestern University | 312-227-4210 | mehul.raval@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 | Oct 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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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.
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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.
|
|
Days from surgery until first documented tolerance of regular diet in EHR |
| Up to 30 days postoperatively. Baseline (Pre-Implementation) Phase: January 2019 - February 2021. Implementation Phase: March 2021 - October 2022. Sustainability Phase: November 2022 - December 2023. |
| Intraoperative Fluid Use | Total volume of intraoperative crystalloid fluid administered, as abstracted from the anesthesia record. | During surgery (intraoperative period). |
| Opioid Use During Hospitalization (MME/Day) | Average daily opioid use during hospitalization, converted to morphine milligram equivalents (MME/day). | During the index hospitalization, from admission through discharge. |
| Opioid Prescribed at Discharge | Number of participants who were prescribed an opioid medication at the time of hospital discharge. | At hospital discharge. |
| Post-discharge Opioid Prescribed | Prescription of opioids at discharge (yes/no). Data from EHR discharge med lists. | Up to 30 days postoperatively. Baseline (Pre-Implementation) Phase: January 2019 - February 2021. Implementation Phase: March 2021 - October 2022. Sustainability Phase: November 2022 - December 2023. |
| Surgical Complications (Any) | Composite of surgical, infectious, pulmonary, vascular, neurologic, and renal complications; each participant counted once per category. | During hospitalization, up to a maximum of 14 days. |
| Multiple Complications (> 1) | Participants experiencing > 1 distinct postoperative complication. | During hospitalization, up to a maximum of 14 days. |
| 30-day Readmission | Any unplanned hospital readmission within 30 days of discharge after index surgery. Events were abstracted from medical records and categorized as yes/no. Values are reported by study phase as number and percentage of participants readmitted. | Up to 30 days postoperatively. Baseline (Pre-Implementation) Phase: January 2019 - February 2021. Implementation Phase: March 2021 - October 2022. Sustainability Phase: November 2022 - December 2023. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health Scale (Preoperative) | Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health T-score before surgery. The PROMIS Pediatric Global Health Scale (PGH-7) is a validated, standardized patient-reported outcome measure assessing overall physical, mental, and social health in children and adolescents. Scores are reported as T-scores standardized to the U.S. pediatric population, with a mean of 50 and standard deviation of 10. Possible scores typically range from approximately 20 to 80. Higher T-scores indicate better global health. The PROMIS Pediatric Global Health T-score was assessed preoperatively within 30 days prior to surgery and summarized by study phase. | Preoperative assessment within 30 days before surgery. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (Postoperative) | The PROMIS Pediatric Global Health Scale (PGH-7) is a validated, standardized patient-reported outcome measure assessing overall physical, mental, and social health in children and adolescents. Scores are reported as T-scores standardized to the U.S. pediatric population, with a mean of 50 and standard deviation of 10, and a typical range of approximately 20 to 80. Higher T-scores indicate better global health. The PROMIS Pediatric Global Health T-score was assessed postoperatively at 2-4 weeks after surgery and summarized by study phase. | Postoperative assessment at 2-4 weeks after surgery. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference (Preoperative) | The PROMIS Pediatric Pain Interference Scale is a validated patient-reported outcome measure assessing the extent to which pain interferes with physical, emotional, and social functioning in children and adolescents. Scores are reported as standardized T-scores with a mean of 50 and standard deviation of 10, with a typical range of approximately 30 to 80. Higher T-scores indicate greater pain interference (worse outcome). Pain interference T-scores were assessed preoperatively within 30 days prior to surgery and summarized by study phase. | Preoperative assessment within 30 days before surgery. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference (Postoperative) | The PROMIS® Pediatric Pain Interference Scale is a validated patient-reported outcome measure assessing the extent to which pain interferes with physical, emotional, and social functioning in children and adolescents. Scores are reported as standardized T-scores with a mean of 50 and standard deviation of 10, with a typical range of approximately 30 to 80. Higher T-scores indicate greater pain interference (worse outcome). Pain interference T-scores were assessed postoperatively at 2-4 weeks after surgery and summarized by study phase. | Postoperative assessment at 2-4 weeks after surgery. |
| Derived |
| Smith CJ, Schafer WLA, Wilberding MJ, Reiter A, Sullivan GA, Hu A, Holl JL, Balbale SN, Blake SC, Close S, Davis TL, Johnson JK, Raval MV. Fidelity of Enhanced Recovery Protocol Implementation With Assessment of Hospital-Specific Materials. J Surg Res. 2024 Oct;302:469-475. doi: 10.1016/j.jss.2024.07.087. Epub 2024 Aug 20. |
| 37464448 | Derived | 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. |
| 33198767 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Participants enrolled during active implementation of the ENRICH-US enhanced recovery protocol at their site, when protocol elements were being introduced.
| BG002 | Sustainability | Participants enrolled after ENRICH-US enhanced recovery protocol implementation was established and maintained at their site. |
| BG003 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| Years |
|
| Sex: Female, Male | Sex was collected as Female or Male, consistent with NIH/OMB reporting standards. Information was obtained from medical records or participant self-report at enrollment. "Unknown/Not Reported" was used when sex data were unavailable. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race and ethnicity were abstracted from the medical record and/or participant self-report and are reported using study-defined categories (Black or African American, Hispanic, Non-Hispanic White, Other [Asian, multiracial, unknown]) to match the source dataset and manuscript tables. | Count of Participants | Participants |
|
| Age at surgery (years) | Age in years at the time of surgery. | Mean | Standard Deviation | Years |
|
| OG002 | Sustainability | Participants enrolled during the sustainability phase following implementation of the ENRICH-US protocol. |
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| Secondary | Prolonged LOS (>6 Days) | Binary variable derived from LOS; > 6 days = Yes. | All patients with LOS data. | Posted | Count of Participants | Participants | Up to 30 days postoperatively. Baseline (Pre-Implementation) Phase: January 2019 - February 2021. Implementation Phase: March 2021 - October 2022. Sustainability Phase: November 2022 - December 2023. |
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| Secondary | Time to Regular Diet | Days from surgery until first documented tolerance of regular diet in EHR | All patients with postoperative diet data; n = 248, 156, 193 | Posted | Median | Inter-Quartile Range | Days | Up to 30 days postoperatively. Baseline (Pre-Implementation) Phase: January 2019 - February 2021. Implementation Phase: March 2021 - October 2022. Sustainability Phase: November 2022 - December 2023. |
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| Secondary | Intraoperative Fluid Use | Total volume of intraoperative crystalloid fluid administered, as abstracted from the anesthesia record. | Intraoperative crystalloid fluid volume (mL) was collected from anesthesia records for all participants. The dataset was 100% complete; no participants were excluded due to missing or invalid data. Approximately 1% of participants had a recorded value of 0 mL, which was retained in the analysis as explicitly documented in the anesthesia record. | Posted | Median | Inter-Quartile Range | mL | During surgery (intraoperative period). |
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| Secondary | Opioid Use During Hospitalization (MME/Day) | Average daily opioid use during hospitalization, converted to morphine milligram equivalents (MME/day). | Opioid data were collected from medication administration records (MAR) throughout the hospitalization. Doses were converted to MME using standard CDC conversion factors and calculated as average daily MME (MME/day). The dataset was 100% complete; all enrolled participants were included (Baseline n=248, Implementation n=156, Sustainability n=193). Data do not distinguish between intraoperative and postoperative administration but represent average use throughout the entire hospitalization. | Posted | Median | Inter-Quartile Range | MME/day | During the index hospitalization, from admission through discharge. |
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| Secondary | Opioid Prescribed at Discharge | Number of participants who were prescribed an opioid medication at the time of hospital discharge. | Participants discharged after the index surgery were included. Due to lack of documented duration for discharge prescriptions, opioid use is reported as a binary indicator (prescribed vs. not prescribed) rather than morphine milligram equivalents (MME). All participants with available discharge medication records are included (Baseline n=248, Implementation n=156, Sustainability n=193). | Posted | Count of Participants | Participants | At hospital discharge. |
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| Secondary | Post-discharge Opioid Prescribed | Prescription of opioids at discharge (yes/no). Data from EHR discharge med lists. | All discharged participants; n = 248, 156, 193. | Posted | Count of Participants | Participants | Up to 30 days postoperatively. Baseline (Pre-Implementation) Phase: January 2019 - February 2021. Implementation Phase: March 2021 - October 2022. Sustainability Phase: November 2022 - December 2023. |
|
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| Secondary | Surgical Complications (Any) | Composite of surgical, infectious, pulmonary, vascular, neurologic, and renal complications; each participant counted once per category. | All patients undergoing surgery. | Posted | Count of Participants | Participants | During hospitalization, up to a maximum of 14 days. |
|
|
|
| Secondary | Multiple Complications (> 1) | Participants experiencing > 1 distinct postoperative complication. | All participants; n = 248, 156, 193 | Posted | Count of Participants | Participants | During hospitalization, up to a maximum of 14 days. |
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|
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| Secondary | 30-day Readmission | Any unplanned hospital readmission within 30 days of discharge after index surgery. Events were abstracted from medical records and categorized as yes/no. Values are reported by study phase as number and percentage of participants readmitted. | All discharged participants; n = 248, 156, 193. | Posted | Count of Participants | Participants | Up to 30 days postoperatively. Baseline (Pre-Implementation) Phase: January 2019 - February 2021. Implementation Phase: March 2021 - October 2022. Sustainability Phase: November 2022 - December 2023. |
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| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health Scale (Preoperative) | Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health T-score before surgery. The PROMIS Pediatric Global Health Scale (PGH-7) is a validated, standardized patient-reported outcome measure assessing overall physical, mental, and social health in children and adolescents. Scores are reported as T-scores standardized to the U.S. pediatric population, with a mean of 50 and standard deviation of 10. Possible scores typically range from approximately 20 to 80. Higher T-scores indicate better global health. The PROMIS Pediatric Global Health T-score was assessed preoperatively within 30 days prior to surgery and summarized by study phase. | Participants with completed PROMIS Pediatric Global Health questionnaires at the preoperative assessment for each study phase (Baseline n=211; Implementation n=138; Sustainability n=148). | Posted | Mean | Standard Deviation | PROMIS T-scores | Preoperative assessment within 30 days before surgery. |
|
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|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (Postoperative) | The PROMIS Pediatric Global Health Scale (PGH-7) is a validated, standardized patient-reported outcome measure assessing overall physical, mental, and social health in children and adolescents. Scores are reported as T-scores standardized to the U.S. pediatric population, with a mean of 50 and standard deviation of 10, and a typical range of approximately 20 to 80. Higher T-scores indicate better global health. The PROMIS Pediatric Global Health T-score was assessed postoperatively at 2-4 weeks after surgery and summarized by study phase. | Participants with completed PROMIS Pediatric Global Health questionnaires at the postoperative assessment (2-4 weeks after surgery) within each study phase. | Posted | Mean | Standard Deviation | T-Score | Postoperative assessment at 2-4 weeks after surgery. |
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| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference (Preoperative) | The PROMIS Pediatric Pain Interference Scale is a validated patient-reported outcome measure assessing the extent to which pain interferes with physical, emotional, and social functioning in children and adolescents. Scores are reported as standardized T-scores with a mean of 50 and standard deviation of 10, with a typical range of approximately 30 to 80. Higher T-scores indicate greater pain interference (worse outcome). Pain interference T-scores were assessed preoperatively within 30 days prior to surgery and summarized by study phase. | Participants with completed PROMIS Pediatric Pain Interference questionnaires at the preoperative assessment for each phase. | Posted | Mean | Standard Deviation | T-score | Preoperative assessment within 30 days before surgery. |
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| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference (Postoperative) | The PROMIS® Pediatric Pain Interference Scale is a validated patient-reported outcome measure assessing the extent to which pain interferes with physical, emotional, and social functioning in children and adolescents. Scores are reported as standardized T-scores with a mean of 50 and standard deviation of 10, with a typical range of approximately 30 to 80. Higher T-scores indicate greater pain interference (worse outcome). Pain interference T-scores were assessed postoperatively at 2-4 weeks after surgery and summarized by study phase. | Participants with completed PROMIS Pediatric Pain Interference questionnaires at the postoperative assessment (2-4 weeks after surgery) for each phase. | Posted | Mean | Standard Deviation | T-score | Postoperative assessment at 2-4 weeks after surgery. |
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|
|
| 0 |
| 248 |
| 0 |
| 248 |
| 24 |
| 248 |
| EG001 | Implementation | Participants whose surgery occurred during the implementation phase at their site, when the ENRICH-US protocol was being introduced and used. | 0 | 156 | 0 | 156 | 19 | 156 |
| EG002 | Sustainability | Participants whose surgery occurred during the sustainability phase at their site, after ENRICH-US protocol implementation was established and maintained. | 0 | 193 | 0 | 193 | 20 | 193 |
|
Not provided
Not provided
| D003092 | Colitis |
| D003108 | Colonic Diseases |