Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT03364933
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2017-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Intensivists and Primary Nurses to Decrease Pediatric ICU Length of Stay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009726', 'term': 'Nurses'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PICU length of stay', 'timeFrame': 'Up to 2 years', 'description': 'Total number of days in which an individual stays in the PICU'}], 'secondaryOutcomes': [{'measure': 'Family satisfaction', 'timeFrame': 'Up to 2 years', 'description': 'In order to assess family satisfaction, families of all PICU patients (with PICU lengths of stay \\> 10 days) will be asked to complete a short anonymous questionnaire (Likert Scale) at the time of ICU discharge or within a few days when the patient is still hospitalized, if discharged late at night or over a weekend.'}, {'measure': 'Provider satisfaction', 'timeFrame': 'Up to 2 years', 'description': 'In order assess provider satisfaction, all PICU attendings, fellows, and nurses will be verbally consented and asked to complete a short anonymous questionnaire (Likert Scale) at one of two time points-1) at the end of the study or 2) before the staff member leaves'}, {'measure': 'Percentage of family meetings attended by a primary nurse', 'timeFrame': 'Up to 2 years', 'description': 'Number of meetings a nurse participated in divided by the number of meetings'}, {'measure': 'Duration of invasive mechanical ventilation in those patients without chronic respiratory failure and who are on invasive mechanical ventilation from the time of enrollment', 'timeFrame': 'Up to 2 years', 'description': 'Measured in days.'}, {'measure': 'Time to tracheotomy in those who undergo a tracheotomy', 'timeFrame': 'Up to 2 years', 'description': 'Measured in days.'}, {'measure': 'Incidence of nursing-related KEEPSAFE reports recorded after enrollment', 'timeFrame': 'Up to 2 years', 'description': 'total number of reports that are recorded.'}, {'measure': 'Timing of involvement of Patient Care Services', 'timeFrame': 'Up to 2 years', 'description': 'Measured in days.'}, {'measure': 'Incidence of ICU-acquired infections after enrollment', 'timeFrame': 'Up to 2 years', 'description': 'Total number of ICU-acquired infections'}, {'measure': 'Number of documented family meetings', 'timeFrame': 'Up to 2 years', 'description': 'Total number of family meetings.'}, {'measure': 'Incidence of unplanned re-admissions to a PICU within 48 hours of PICU discharge', 'timeFrame': 'Up to 2 years', 'description': 'Total number of unplanned re-admissions to a PICU.'}, {'measure': 'Percentage of primary intensivists who meet with families', 'timeFrame': 'Up to 2 years', 'description': 'Measured by total number of meeting divided by the number of weeks after enrollment.'}, {'measure': 'Total number of shifts that are not being covered by a primary nurse,', 'timeFrame': 'Up to 2 years', 'description': 'The Bice-Boxerman Continuity of Care Index will be used to measure continuity compliance in terms of the total number of shifts not covered by a primary nurse.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child', 'Critical Illness', 'Length of Stay', 'Satisfaction'], 'conditions': ['ICU Length of Stay']}, 'descriptionModule': {'briefSummary': 'This is a randomized control trial of PICU patients admitted for 7 days and expected to remain for at least another 3 days and who have a complex chronic condition. Patients will be randomized to usual care or usual care plus a primary intensivist and group of primary nurses (to facilitate passing of important patient information and informed, expedited decision-making). The primary research question is whether having a primary intensivist and nurses decreases PICU length of stay.', 'detailedDescription': "Long-stay intensive care unit (ICU) patients, or children who require prolonged hospitalization in the pediatric ICU (PICU), represent a minority of PICU patients but have a disproportionate impact on hospital resources and unfavorable outcomes, including morbidity, mortality, and repeated critical illness. These patients and their families have multifaceted needs (eg, tailored communication) that pose unique challenges to PICU providers and the parent-provider relationship. These experiences and needs are compounded and complicated by the transitory care that is typically provided by PICU. This transitory care may contribute to 1) patient/family dissatisfaction; 2) ineffective passing of important information day to day and week to week; and 3) delayed decision-making. These latter two potential consequences may, in turn, contribute to prolonged length of stay (LOS).\n\nFor these reasons, the investigators propose a randomized control trial to test whether primary intensivists and primary nurses can decrease PICU LOS for long-stay patients. A primary intensivist is one that remains a consistent physician-presence for the patient/family and PICU team throughout the child's PICU stay, despite changes in the intensivist(s) who orchestrates day-to-day management. Primary nurses are a team of PICU nurses who provide the all/most of the bedside care to the child. The investigators hypothesize that the long-stay PICU patients who are randomized to receive primary intensivists and nurses will have a statistically lower LOS than those patients who do not."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PICU patients of any age who\n\n * have a complex chronic condition\n * have been admitted to the PICU for one week and are predicted by the PICU attending to continue to be admitted for at least another 3 days.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03364933', 'acronym': 'PIPRNs', 'briefTitle': 'Primary Intensivists and Primary Nurses to Decrease Pediatric ICU Length of Stay', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Primary Intensivists and Primary Nurses to Decrease Pediatric ICU Length of Stay', 'orgStudyIdInfo': {'id': 'AAAR5445'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primary intensivist and nurses', 'description': 'Patients randomized to the experimental arm will have a primary intensivist and a team of primary nurses assigned to them.', 'interventionNames': ['Behavioral: Primary intensivist and nurses']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients who are randomized to the control group will receive usual care and not be assigned a primary intensivist or nurses.'}], 'interventions': [{'name': 'Primary intensivist and nurses', 'type': 'BEHAVIORAL', 'description': 'Primary intensivist will have no active role in the daily management of patients. The primary intensivist should facilitate decision-making, be a liaison between the patient/family and PICU team, and be a resource of information for all. Responsibilities of primary intensivist:\n\n* Weekly check-in with and availability to patient/family\n* Attendance at family meetings\n* Availability to PICU team\n\nPrimary nurses will be a team of up to 7 ICU nurses who will provide as much of the bedside care as possible. Responsibilities of primary nurses:\n\n* Maintain a primary nurse binder (paper format) for on-going communication about the patient among the team members; it will be their discretion what is information is communicated.\n* The Primary Nurse or delegate will be involved in all team/family meetings and will be expected/given an opportunity to speak during these meetings.', 'armGroupLabels': ['Primary intensivist and nurses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeffrey Edwards, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Jeffrey D. Edwards', 'investigatorAffiliation': 'Columbia University'}}}}