Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-04 @ 11:55 PM
Study NCT ID:
NCT01634802
Status:
UNKNOWN
Last Update Posted:
2012-07-06
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Use of Clinical Decision Support System in HIV Care in Resource Constrained Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057286', 'term': 'Electronic Health Records'}], 'ancestors': [{'id': 'D016347', 'term': 'Medical Records Systems, Computerized'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1460}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-05', 'studyFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main end-point of the study will be the proportion of patients on treatment who have experienced treatment failure and appropriate clinical action taken according to the guidelines.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Other outcome measures will be the proportion of CD4 cell counts done on time and proportion of pre-ART patient eligible for treatment that are initiated within 30 days of eligibility. The median time taken to clinical action will be measured.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinical Decision Support Systems', 'Electronic Medical Record', 'Resource constrained countries', 'HIV'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '34930228', 'type': 'DERIVED', 'citation': 'Oluoch T, Cornet R, Muthusi J, Katana A, Kimanga D, Kwaro D, Okeyo N, Abu-Hanna A, de Keizer N. A clinical decision support system is associated with reduced loss to follow-up among patients receiving HIV treatment in Kenya: a cluster randomized trial. BMC Med Inform Decis Mak. 2021 Dec 20;21(1):357. doi: 10.1186/s12911-021-01718-0.'}, {'pmid': '26847229', 'type': 'DERIVED', 'citation': 'Oluoch T, Katana A, Kwaro D, Santas X, Langat P, Mwalili S, Muthusi K, Okeyo N, Ojwang JK, Cornet R, Abu-Hanna A, de Keizer N. Effect of a clinical decision support system on early action on immunological treatment failure in patients with HIV in Kenya: a cluster randomised controlled trial. Lancet HIV. 2016 Feb;3(2):e76-84. doi: 10.1016/S2352-3018(15)00242-8. Epub 2015 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of a Computerized Decision Support System (CDSS) in form of alerts to clinicians enhances early detection of immunological treatment failure in HIV patients.', 'detailedDescription': 'We hypothesize that there is no difference in the time to detecting immunological treatment failure among HIV patients in resource poor settings whether the clinicians use an Electronic Medical Record (EMR) system with a Computerized Decision Support (CDSS) or an EMR without a CDSS. In this study, 20 clinics were assigned to the intervention (EMR+CDSS) arm and non-intervention arm (EMR only) and will be followed up for 12 months to assess whether there are any differences in time taken to detect immunological treatment failure based on CD4 cell count.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All HIV patients enrolled in participating clinics'}, 'identificationModule': {'nctId': 'NCT01634802', 'acronym': 'CDSS', 'briefTitle': 'Evaluation of Use of Clinical Decision Support System in HIV Care in Resource Constrained Settings', 'organization': {'class': 'OTHER', 'fullName': 'Kenya Medical Research Institute'}, 'officialTitle': 'Evaluation of Use of Clinical Decision Support System for Early Detection of Immunological Treatment Failure Among HIV Patients in Resource Constrained Settings', 'orgStudyIdInfo': {'id': '2073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'EMR Only', 'description': 'Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system.', 'interventionNames': ['Other: EMR Only']}, {'type': 'EXPERIMENTAL', 'label': 'EMR+CDSS', 'description': 'Clinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making.', 'interventionNames': ['Other: EMR+CDSS']}], 'interventions': [{'name': 'EMR Only', 'type': 'OTHER', 'description': 'Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system.', 'armGroupLabels': ['EMR Only']}, {'name': 'EMR+CDSS', 'type': 'OTHER', 'otherNames': ['Clinical Decision Support Systems', 'Electronic Medical Records'], 'description': 'Clinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making.', 'armGroupLabels': ['EMR+CDSS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'state': 'Nyanza', 'country': 'Kenya', 'contacts': [{'name': 'Patrick Langat, BSc', 'role': 'CONTACT', 'email': 'Plangat@kemricdc.org', 'phone': '+254 722 750 072'}, {'name': 'Daniel Kwaro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'KEMRI/CDC Clinical Research Center', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'centralContacts': [{'name': 'Daniel Kwaro, MD', 'role': 'CONTACT', 'email': 'Dkwaro@kemricdc.org', 'phone': '+254 700 858 288'}, {'name': 'Nicky Okeyo, MSc', 'role': 'CONTACT', 'email': 'Nokeyo@kemricdc.org', 'phone': '+254 721 864 474'}], 'overallOfficials': [{'name': 'Tom Oluoch, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}, {'name': 'Daniel Kwaro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KEMRI-CDC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr.', 'investigatorFullName': 'Tom Oluoch', 'investigatorAffiliation': 'Centers for Disease Control and Prevention'}}}}