Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-04 @ 8:51 AM
Study NCT ID:
NCT00237757
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
2005-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation Team Functioning and Patient Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-02', 'studyFirstSubmitDate': '2005-10-07', 'studyFirstSubmitQcDate': '2005-10-07', 'lastUpdatePostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional gain as measured by motor FIM score', 'timeFrame': 'One year post team training intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patient Care Team', 'Rehabilitation outcomes', 'Treatment outcomes'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '23101971', 'type': 'BACKGROUND', 'citation': 'Strasser DC, Falconer JA, Uomoto JM. Can quality of care indicators measure quality of care? Arch Phys Med Rehabil. 2012 Nov;93(11):2130-1; author reply 2131-2. doi: 10.1016/j.apmr.2012.04.035. No abstract available.'}, {'pmid': '18247250', 'type': 'BACKGROUND', 'citation': 'Stevens AB, Strasser DC, Uomoto J, Bowen SE, Falconer JA. Utility of Treatment Implementation methods in clinical trial with rehabilitation teams. J Rehabil Res Dev. 2007;44(4):537-46. doi: 10.1682/jrrd.2006.09.0120.'}, {'pmid': '18164351', 'type': 'BACKGROUND', 'citation': 'Strasser DC, Uomoto JM, Smits SJ. The interdisciplinary team and polytrauma rehabilitation: prescription for partnership. Arch Phys Med Rehabil. 2008 Jan;89(1):179-81. doi: 10.1016/j.apmr.2007.06.774.'}, {'pmid': '11926323', 'type': 'BACKGROUND', 'citation': 'Strasser DC, Smits SJ, Falconer JA, Herrin JS, Bowen SE. The influence of hospital culture on rehabilitation team functioning in VA hospitals. J Rehabil Res Dev. 2002 Jan-Feb;39(1):115-25.'}, {'pmid': '15759219', 'type': 'RESULT', 'citation': 'Strasser DC, Falconer JA, Herrin JS, Bowen SE, Stevens AB, Uomoto J. Team functioning and patient outcomes in stroke rehabilitation. Arch Phys Med Rehabil. 2005 Mar;86(3):403-9. doi: 10.1016/j.apmr.2004.04.046.'}, {'pmid': '20826416', 'type': 'RESULT', 'citation': 'Strasser DC, Burridge AB, Falconer JA, Herrin J, Uomoto J. Measuring team process for quality improvement. Top Stroke Rehabil. 2010 Jul-Aug;17(4):282-93. doi: 10.1310/tsr1704-282.'}, {'pmid': '18164324', 'type': 'RESULT', 'citation': 'Strasser DC, Falconer JA, Stevens AB, Uomoto JM, Herrin J, Bowen SE, Burridge AB. Team training and stroke rehabilitation outcomes: a cluster randomized trial. Arch Phys Med Rehabil. 2008 Jan;89(1):10-5. doi: 10.1016/j.apmr.2007.08.127.'}, {'pmid': '13680570', 'type': 'RESULT', 'citation': 'Smits SJ, Falconer JA, Herrin J, Bowen SE, Strasser DC. Patient-focused rehabilitation team cohesiveness in veterans administration hospitals. Arch Phys Med Rehabil. 2003 Sep;84(9):1332-8. doi: 10.1016/s0003-9993(03)00197-7.'}, {'pmid': '25007707', 'type': 'DERIVED', 'citation': 'Strasser DC, Burridge AB, Falconer JA, Uomoto JM, Herrin J. Toward spanning the quality chasm: an examination of team functioning measures. Arch Phys Med Rehabil. 2014 Nov;95(11):2220-3. doi: 10.1016/j.apmr.2014.06.013. Epub 2014 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if 1. Rehabilitation staff can be trained to work better together as a team; and 2. Better team work improves patient outcomes.', 'detailedDescription': 'The benefits of team treatment are widely accepted. Prior research has shown that how rehabilitation teams go about their work makes a difference in the patients they treat. However, there is little information about what, specifically, the team does that results in patients who are able to do more for themselves. The objectives of this clinical trial was to test whether a team training intervention in stroke rehabilitation was associated with improved patient outcomes. We conducted a cluster randomized trial of 31 rehabilitation units comparing stroke outcomes between intervention and control groups. in thirty-one VA medical centers with 237 clinical staff on 16 control teams and 227 staff on 15 intervention teams. There were 487 stroke patients treated by these teams before and after the intervention.\n\nThe intervention consisted of a multiphase, staff training program delivered over six months, including: an off-site workshop emphasizing team dynamics, problem solving, and the use of performance feedback data; and action plans for process improvement; and telephone and videoconference consultations. Control and intervention teams received site- specific team performance profiles with recommendations to use this information to modify team process.\n\nThe main outcomes measures consisted of three patient outcomes: functional improvement as measured by the change in motor items of Function Independence Measure (FIM), community discharge, and length of stay (LOS). For both the primary (stroke only) and secondary analyses (all patients), there was a significant difference in improvement of functional outcome between the two groups, with the percentage of stroke patients gaining more than a median FIM gain of 23 points increasing significantly more in the intervention group (difference in increase = 13.6%, P=0.032). There was no significant difference on LOS or rates of community discharge. Stroke patients treated by staff who participated in a team training program were more likely to make functional gains than those treated by staff receiving information only. This study is a randomized cluster trial which tested used workshops to train rehabilitation staff. Patients treated by trained teams were compared with patients treated by teams that did not have workshop training. Stroke patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Randomized, controlled subjects were VA inpatient rehabilitation teams. Secondary data included telephone surveys from discharged patients treated by the rehabilitation teams.\n\nExclusion Criteria:\n\n* VA sites which did not submit data to the VA-FSOD - the national functional outcomes database'}, 'identificationModule': {'nctId': 'NCT00237757', 'briefTitle': 'Rehabilitation Team Functioning and Patient Outcomes', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Rehabilitation Team Functioning and Patient Outcomes', 'orgStudyIdInfo': {'id': 'O3225-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'The experimental arm consisted of a six month staff training period with an emphasis on effective team functioning to improve patient outcomes. The core of the intervention consisted of a concentrated 2.5 day workshop in Atlanta for 29 rehabilitation team leaders from 15 VA hospitals. Several weeks after the workshop, participants received a custom action plan developed on issues discussed in the workshop. The experimental arm also received a summary of results of the initial survey along with comparative data from all other sites. During the subsequent 5 months after the workshop, research staff maintained regular contact with research participants through telephone and videoconferencing', 'interventionNames': ['Behavioral: Information feedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes. In addition, participants in the comparison arm were invited to contact the research staff for help in interpreting data or to set-up a process improvement initiative.', 'interventionNames': ['Behavioral: Information feedback']}], 'interventions': [{'name': 'Information feedback', 'type': 'BEHAVIORAL', 'description': 'The experimental arm consisted of a six month staff training period. The core of the intervention consisted of a concentrated 2.5 day workshop in Atlanta for 29 rehabilitation team leaders from 15 VA hospitals. Several weeks after the workshop, participants received a custom action plan developed on issues discussed in the workshop. The experimental arm also received a summary of results of the initial survey along with comparative data from all other sites. During the subsequent 5 months after the workshop, research staff maintained regular contact with research participants through telephone and videoconferencing. The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes.', 'armGroupLabels': ['Arm 1']}, {'name': 'Information feedback', 'type': 'BEHAVIORAL', 'description': 'The comparison arm (staff on 16 teams) completed the identical summary of staff, hospital, and team characteristics. The local PIs at the Comparison sites received summaries of the survey findings, comparative data from other participating VA sites, and suggestions on how this information could be used to improve patient outcomes. In addition, participants in the comparison arm were invited to contact the research staff for help in interpreting data or to set-up a process improvement initiative.', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'VA Medical Center, Decatur', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}], 'overallOfficials': [{'name': 'Dale Christian Strasser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center, Decatur'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}