Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT00499161
Status:
COMPLETED
Last Update Posted:
2008-02-18
First Post:
2007-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Patient-Centered Care (PCC) on Patient Satisfaction at Hospital Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-15', 'studyFirstSubmitDate': '2007-07-09', 'studyFirstSubmitQcDate': '2007-07-10', 'lastUpdatePostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure level of overall satisfaction', 'timeFrame': 'day of discharge'}], 'secondaryOutcomes': [{'measure': 'Measure level of quality of care - 1)Length of stay, 2)infection, 3)falls', 'timeFrame': 'day of discharge and 7 days post discharge'}, {'measure': 'measure satisfaction with nursing care', 'timeFrame': 'day of discharge'}, {'measure': 'measure level of quality care (unplanned adverse events)', 'timeFrame': 'approximately 30 days post discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Individualized care', 'Relationship based care', 'Negotiated care', 'Patient focused care'], 'conditions': ['Patient Centered Care']}, 'descriptionModule': {'briefSummary': "The purpose of this randomized clinical trial is to examine the effect of Patient-Centered Care (PCC) on a patient's level of satisfaction on discharge from an acute healthcare setting. Findings from this study will assist in determining if PCC, administered by nurses, should be instituted hospital wide.\n\nSPECIFIC AIMS:\n\n1. To examine the effect of Patient-Centered Care on patient satisfaction.\n2. To examine the effect of Patient-Centered Care on the quality of patient care.\n3. To examine the effect of patient's perception of nursing care on patient satisfaction.", 'detailedDescription': 'Patient-Centered Care (PCC), also known as individualized patient care or negotiated care, focuses on the patient\'s right to have his/her values and beliefs respected as an individual.This respect is viewed as part of a commitment to build a deep understanding of the patient as a thinking and feeling individual with the ability to change and develop. A person-centered model of care requires a nurse to work with an individual\'s beliefs, values, wants, needs and desires.This adaptation to a patient\'s personal needs requires the nurse to be flexible, respectful, and reciprocal when providing patient care. If the patient\'s expectations are not appropriate to the type of care needed to heal or if the patient refuses or denies a specific type of treatment that is known as influencing ones quality of care, the nurse must negotiate with the patient. Negotiation incorporates education, which is believed to increase the patient\'s level of understanding. In addition, negotiation allows the nurse and patient to define a level of treatment that is specific to the patient\'s needs but still seen as a quality indicator.\n\nThe Institute of Medicine (IOM) has listed PCC as one of six national quality aims for improvement. The IOM\'s vision is that all health professionals will be educated to provide and deliver PCC as part of an interdisciplinary team. In 2001, the IOM report "Crossing the Quality Chasm: A New Health System for the 21st Century" recommends a mixture of approaches to achieve their vision . These approaches include an appropriate training environment, research, public reporting and leadership. At present, there is little evidence to support the critical role nurse clinicians\' play in providing PCC and satisfying patient\'s needs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Admitted to the service of Dr.RQ and scheduled for bariatric bypass surgery\n* Expected length of hospital stay ≥ 2 days.\n\nExclusion Criteria:\n\n* Any prior admission to the study unit\n* Bariatric surgery performed by a surgeon other than Dr.RQ\n* Scheduled to have a LAP Band procedure, as this procedure has a different postoperative course.'}, 'identificationModule': {'nctId': 'NCT00499161', 'acronym': 'PCC', 'briefTitle': 'Effect of Patient-Centered Care (PCC) on Patient Satisfaction at Hospital Discharge', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Effect of Patient-Centered Care (PCC) on Patient Satisfaction at Hospital Discharge', 'orgStudyIdInfo': {'id': 'PRO07030017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'Control group received usual care'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Received intervention New model of nursing care', 'interventionNames': ['Behavioral: New model of nursing care']}], 'interventions': [{'name': 'New model of nursing care', 'type': 'BEHAVIORAL', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15237', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC St. Margaret', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Debra M Wolf, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburh, School of Nursing & UPMC St. Margaret'}, {'name': 'Lisa Lehman, BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Robert Quinlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Jodi Miller, BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Debra M. Wolf, PhD, MSN, RN', 'oldOrganization': 'University of PIttsburgh'}}}}