Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 11:55 AM
Study NCT ID:
NCT01773057
Status:
COMPLETED
Last Update Posted:
2018-04-12
First Post:
2012-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of 'NHGDoc' on Quality of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-11', 'studyFirstSubmitDate': '2012-11-22', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prescribing of ACE-inhibitors/Angiotensin II', 'timeFrame': 'One year', 'description': 'Percentage of patients with heart failure that is prescribed ACE-inhibitors/Angiotensin II'}, {'measure': 'Prescribing of beta blockers', 'timeFrame': 'One year', 'description': 'Percentage of heart failure patients that is prescribed beta blockers'}, {'measure': 'Prescribing of diuretics', 'timeFrame': 'One year', 'description': 'Percentage of heart failure patients that is prescribed diuretics'}], 'secondaryOutcomes': [{'measure': 'Hospital admissions', 'timeFrame': 'One year', 'description': 'Number of hospital admissions of patients with heart failure'}, {'measure': 'All cause mortality', 'timeFrame': 'One year', 'description': 'Number of patients with heart failure that die within the hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Computerized Decision Support System', 'Heart failure', 'Effects on quality of care', 'Process of care', 'Patient outcomes'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '26474603', 'type': 'DERIVED', 'citation': 'Lugtenberg M, Pasveer D, van der Weijden T, Westert GP, Kool RB. Exposure to and experiences with a computerized decision support intervention in primary care: results from a process evaluation. BMC Fam Pract. 2015 Oct 16;16:141. doi: 10.1186/s12875-015-0364-0.'}, {'pmid': '25322766', 'type': 'DERIVED', 'citation': 'Lugtenberg M, Westert GP, Pasveer D, van der Weijden T, Kool RB. Evaluating the uptake and effects of the computerized decision support system NHGDoc on quality of primary care: protocol for a large-scale cluster randomized controlled trial. Implement Sci. 2014 Oct 17;9:145. doi: 10.1186/s13012-014-0145-5.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether the computerized decision support system 'NHGDoc' is effective in improving quality of primary care in terms of processes of care (e.g. prescribing behavior of physicians) as well as outcomes of care (e.g. hospital admissions, mortality).", 'detailedDescription': "Computerized decision support systems are regarded as useful tools to improve quality of care, but their effects are still uncertain. In the Netherlands 'NHGDoc' a computerized decision support system supported by the Dutch College of General Practitioners (NHG) is currently being implemented among more than 1.000 general practices in the Netherlands.\n\nThe aim of this study is to evaluate the effects of NHGDoc on quality of care. In addition, we want to gain insight into the barriers and facilitators that affect the systems' impact.\n\nA cluster randomized controlled trial will be conducted among 120 general practices in the Netherlands. Eligible practices will be randomized to receive either the regular NHGDoc modules (control arm) or the regular modules and an additional module on heart failure (intervention arm). The effect evaluation will focus on processes of care (e.g. prescription behavior) as well as on patient outcomes (e.g. hospital admissions, mortality). Additionally, a process evaluation will be conducted, which includes a focus group study and a survey among participating healthcare providers to evaluate the perceived barriers and facilitators to using 'NHGDoc'.\n\nResults of this study will provide insight in the ability of computerized decision support systems and in particular 'NHGDoc' to improve quality of primary care. Whereas the trial focuses on a specific NHGDoc domain - heart failure - we believe our conclusions are relevant to other primary care areas as well, particularly as this study also explores the factors that contribute to the systems' effectiveness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General practices should use the information system MicroHIS X or Promedico ASP\n* NHGDoc should be available in the general practices\n\nExclusion Criteria:\n\n* General practices that do not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01773057', 'acronym': 'NHGDoc', 'briefTitle': "Effects of 'NHGDoc' on Quality of Care", 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': "Effects of the Computerized Decision Support System 'NHGDoc' on Quality of Care: a Cluster Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'NHGDoc 2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active decision support', 'description': 'Regular NHGDoc domains plus NHGDoc domain heart failure', 'interventionNames': ['Other: NHGDoc domain Heart Failure']}, {'type': 'NO_INTERVENTION', 'label': 'Passive decision support', 'description': 'Regular NHGDoc domains'}], 'interventions': [{'name': 'NHGDoc domain Heart Failure', 'type': 'OTHER', 'description': 'Healthcare providers receive patient specific alerts in terms of diagnosing and treatment of patients with heart failure', 'armGroupLabels': ['Active decision support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre, IQ healthcare', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Tijn Kool, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IQ healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Netherlands: Ministry of Health, Welfare and Sports', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}