Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02277535
Status:
COMPLETED
Last Update Posted:
2017-02-02
First Post:
2014-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Email Intervention to Prevent Iatrogenic Malnutrition in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2014-10-28', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients started on nutrition within 72 h of ICU admission', 'timeFrame': 'After completing the intervention for each ICU (2 months)', 'description': "The ICU admission date and EN initiation date will be collected in a data base which will later be analyzed to assess the percentange of patients initiated on EN within 72 hours of admission to the ICU. This will be reported as rates and will be compared amongst intervention and no-intervention arms using Fisher's Exact test or Chi-sq Test"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Malnutrition in the ICU (caloric deficit >4000 kcal or 150 g protein deficit) or >48hrs of admission without receiving nutrition'], 'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'This is a quality improvement research project evaluating if a targeted feedback email to clinicians impacts their nutrition delivery in the ICU.', 'detailedDescription': 'This prospective study looks to determine if a targeted email to clinicians taking care of critically ill patients will allow reduce malnutrition in the Intensive Care Units (ICU). Four ICUs will be included: medical ICU (MICU), coronary care unit (CCU) and two surgical ICUs. The investigators will rotate a 2 month period intervention amongst the aforementioned participating ICUs and follow simultaneous cohorts to evaluate the effect of our intervention (email feedback to treating clinicians) on nutrition delivery in the ICU. After the completion of the intervention, there will be a six-month follow-up of nutritional adequacy to assess the durability of changes in behavior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinicians taking care of patients admitted to the ICU within the past 48hrs\n* Clinicians taking care of patients in whom enteral nutrition is prescribed\n\nExclusion Criteria:\n\n* Clinicians taking care of patients in whom enteral nutrition is not prescribed.'}, 'identificationModule': {'nctId': 'NCT02277535', 'briefTitle': 'An Email Intervention to Prevent Iatrogenic Malnutrition in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'An Email Intervention to Prevent Iatrogenic Malnutrition in the ICU', 'orgStudyIdInfo': {'id': '2014P001702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-mail intervention', 'description': 'ICU clinicians caring for patients who have not yet been initiated on nutrition 48 hours after ICU admission will receive a reminder email.\n\nICU clinicians caring for patients who accumulate a caloric deficit greater than 4000 calories or 150 g protein deficit will receive a feedback email', 'interventionNames': ['Other: Feedback/Reminder email.']}, {'type': 'NO_INTERVENTION', 'label': 'No E-mail intervention', 'description': 'Nutrition status of patients will be assessed but no reminder or feedback emails will be sent'}], 'interventions': [{'name': 'Feedback/Reminder email.', 'type': 'OTHER', 'armGroupLabels': ['E-mail intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Trauma and Critical Care Surgeon', 'investigatorFullName': 'Daniel Dante Yeh', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}