Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
Study NCT ID:
NCT00635869
Status:
COMPLETED
Last Update Posted:
2008-03-14
First Post:
2008-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advancing Research and Clinical Practice Through Close Collaboration (ARCC): A Pilot Test of an Intervention to Improve Evidence-Based Care and Patient Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-13', 'studyFirstSubmitDate': '2008-03-07', 'studyFirstSubmitQcDate': '2008-03-13', 'lastUpdatePostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EBP beliefs', 'timeFrame': 'baseline, week 5, week 16, week 24'}], 'secondaryOutcomes': [{'measure': 'EBP Implementation', 'timeFrame': 'baseline, week 5, week 16, week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['evidence based practice beliefs', 'evidence based practice implementation', 'evidence based practice knowledge', 'nurse physician collaboration'], 'conditions': ['Evidence-Based Medicine', 'Physician-Nurse Relations']}, 'descriptionModule': {'briefSummary': 'The primary aim of this pilot study is to evaluate the effects of two variations of the ARCC Intervention Program on nursing processes and outcomes (job satisfaction, group cohesion, EBP knowledge, EBP implementation, EBP beliefs), patient/family outcomes (e.g. pt/family satisfaction with care), and institutional processes and outcomes (e.g. nurse-physician collaboration, cost, RN turnover, incidence frequency relevant to the topic). Secondary aims are to test the feasibility of study methods and reliability and validity of questionnaires.\n\nThis study is designed as a three-group randomized clinical trial with repeated measures. Three inpatient units (medicine, surgery, surgical intensive care) will be randomly assigned to one of three interventions: ARCC enhanced (didactic content presentations, use of an EBP tool kit which will stay on the unit, environmental EBP prompts, availability of an EBP coach on the unit); ARCC standard (all of the above, but without the coach); non-EBP intervention (didactic content and environmental prompts, but not related to EBP; placebo). The interventions will be implemented over an estimated 14 weeks, including a 4-week training period, and an estimated 10 weeks to implement an EBP initiative that the nurses on the two ARCC intervention units will develop.\n\nBaseline information and questionnaires will be collected from nurses at the start of the study, and again at completion of the intervention phase. Outcome data will be collected from nurses approximately 10 weeks after implementation of the ARCC interventions are completed (i.e., 22 weeks after the study is commenced). Nurse-physician collaboration data will be collected from physicians working with study unit nurses as well as from the nurses. Patient satisfaction data will not be separately collected in this study, but will include use of unit-level Press-Ganey scores immediately prior to and over the study time period. Unit level and institutional RN turnover will be tracked monthly during the entire study period and will be compared across units at the same time as well as compared within each study over time (i.e., unit retention during those same months in the previous year). Costs of each EBP intervention will be tracked during the study and compared descriptively. Survey data will be analyzed using analysis of variance statistics. Questionnaires will be tested for reliability and construct validity. Because this is a pilot study, statistically significant differences are not expected, however, effect sizes will be calculated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Registered Nurse staff working on inpatient study units (medicine, surgery, surgical intensive care)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* employed by Upstate\n* working full or part time on study unit\n* able to attend all education sessions\n\nExclusion Criteria:\n\n* employed by temporary agency\n* not able to attend all education sessions'}, 'identificationModule': {'nctId': 'NCT00635869', 'briefTitle': 'Advancing Research and Clinical Practice Through Close Collaboration (ARCC): A Pilot Test of an Intervention to Improve Evidence-Based Care and Patient Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Upstate Medical University'}, 'officialTitle': 'Advancing Research and Clinical Practice Through Close Collaboration (ARCC): A Pilot Test of an Intervention to Improve Evidence-Based Care and Patient Outcomes', 'orgStudyIdInfo': {'id': '5199'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARCC standard', 'description': 'RNs on unit receiving basic ARCC information with staff nurse champion', 'interventionNames': ['Behavioral: ARCC standard information']}, {'label': 'ARCC enhanced', 'description': 'RNs on unit receiving ARCC standard content plus with an EBP mentor', 'interventionNames': ['Behavioral: ARCC enhanced']}, {'label': 'C', 'description': 'RNs on the unit receiving the placebo intervention', 'interventionNames': ['Behavioral: Placebo']}], 'interventions': [{'name': 'ARCC standard information', 'type': 'BEHAVIORAL', 'description': 'EBP didactic education sessions, EBP toolkit, environmental prompts, identification of an EBP champion among unit staff RNs', 'armGroupLabels': ['ARCC standard']}, {'name': 'ARCC enhanced', 'type': 'BEHAVIORAL', 'description': 'same as ARCC standard plus EBP mentor on-site twice each week plus available by e-mail for consultation', 'armGroupLabels': ['ARCC enhanced']}, {'name': 'Placebo', 'type': 'BEHAVIORAL', 'description': 'didactic education sessions on physical assessment', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'University Hospital, SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}], 'overallOfficials': [{'name': 'Priscilla S Worral, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York - Upstate Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Priscilla Sandford Worral, Coordinator of Nursing Research', 'oldOrganization': 'University Hospital, SUNY Upstate Medical University'}}}}