Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT03553732
Status:
TERMINATED
Last Update Posted:
2022-08-04
First Post:
2018-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012042', 'term': 'Registries'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011996', 'term': 'Records'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delayed follow-up - Number of days monitoring is delayed past recommended follow-up interval,', 'timeFrame': '2 years', 'description': 'measured from date monitoring (e.g. prostate-specific antigen test or biopsy) is scheduled to date monitoring occurs.'}, {'measure': 'Acceptability and feasibility of intervention - Semi-structured interviews', 'timeFrame': '1 year', 'description': 'Acceptability and feasibility of the intervention among clinicians will be measured using the Technology Acceptance Model (Venkatesh et al). Semi-structured interviews will be conducted to assess usefulness and ease of use.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients lost to follow-up', 'timeFrame': '2 years', 'description': 'The proportion of patients who are lost to follow-up, defined as three subsequent unsuccessful outreach attempts'}, {'measure': 'Proportion of patients that adhere to recommended monitoring', 'timeFrame': '2 years', 'description': 'Adherence to monitoring (e.g. prostate-specific antigen test every 3 months) will be assessed. Monitoring will be considered adherent if it occurs within 30 days of the recommendation.'}, {'measure': 'Proportion of patients that move from active surveillance to active treatment at a cancer stage that is more advanced than the stage recorded upon entry into program.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['active surveillance', 'health information technology', 'patient safety', 'adherence', 'ambulatory', 'outpatient', 'human factors', 'systems engineering', 'vulnerable populations', 'chronic disease'], 'conditions': ['Prostatic Neoplasms']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Venkatesh, Viswanath; Morris, Michael G.; Davis, Gordon B.; and Davis, Fred D.. 2003.'}, {'pmid': '31428442', 'type': 'DERIVED', 'citation': 'Cedars B, Lisker S, Borno HT, Kamal P, Breyer B, Sarkar U. An electronic registry to improve adherence to active surveillance monitoring among men with prostate cancer at a safety-net hospital: protocol for a pilot study. Pilot Feasibility Stud. 2019 Aug 14;5:101. doi: 10.1186/s40814-019-0482-x. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'To implement and evaluate a health information technology platform designed to support the management of patients on active surveillance for prostate cancer in an urban, publicly-funded outpatient setting.', 'detailedDescription': 'We aim to implement and evaluate a health information technology (HIT) registry at an urban, public delivery system. We will use systems engineering methodologies to design, develop, and implement the platform. The platform will be implemented in the Urology clinic that cares for patients with prostate cancer. We are conducting a prospective non-randomized pilot study that will follow men who choose active surveillance as a management strategy for prostate cancer. We aim to assess the impact of the HIT registry on patient monitoring and adherence.\n\nThe HIT platform seeks to improve the monitoring and alerting functionality of existing systems. Specifically, it replaces paper-based or ineffective computer-based systems previously used by the clinic to monitor its active surveillance patients. It will be implemented clinic-wide for all patients being monitored by an active surveillance protocol. The platform is approved for clinical use and research by the San Francisco Health Network and the University of California, San Francisco.\n\nResearch involves materials that are collected for nonresearch purposes, as well as low-risk research employing survey, interview, focus group, program evaluation, and human factors methodologies. We will solicit structured feedback from registry users designed to continuously evaluate and improve performance in a clinical area to reduce patient safety gaps. Patient medical records will be reviewed, but patients monitored on the registry will not be contacted by researchers.\n\nProcedures are in place to monitor the registry. First, quality assurance is performed by the research team, information technology analysts in the San Francisco Health Network, as well as by the third-party software provider. This includes checking that data in the platform matches source data, such as data entered in the electronic health record. In addition, users are audited on a weekly basis. A data dictionary defining variables used in the platform exists and is updated as needed. The HIT platform users include clinicians who are responsible for monitoring patients on active surveillance for prostate cancer. Patients who are enrolled in the active surveillance program will be added to the registry by a clinician. The research team will support the clinicians in data analysis, although this will be performed with population-level, de-identified data. However, if unmediated adverse events are identified by the research team, the research team will alert the clinicians appropriately. The research team will also develop training materials and conduct training sessions to ensure that all clinicians responsible for monitoring patients on active surveillance are provided with up-to-date resources and accessible support. The HIT platform is designed to supplement, but not replace, the existing electronic health record. Data on the registry will be validated with source data and users will still engage with the source data and electronic health record as appropriate clinically and operationally.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Active Surveillance for prostate cancer is recommended as an initial management strategy for men with low- to intermediate-risk prostate cancer. Eligibility criteria at our institution include diagnostic prostate-specific antigen \\<= 10 ng/ml, clinical stage T1 or T2, Gleason scores \\<= 3+4, \\<=33% positive cores, and \\<= 50% tumor in any single core. Men who do not meet these eligibility criteria by elect to be managed by Active Surveillance may also be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who elect to be managed by Active Surveillance for prostate cancer by the Urology Clinic\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT03553732', 'briefTitle': 'An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'An Electronic Registry to Improve Adherence to Active Surveillance Monitoring Among Men With Prostate Cancer at a Safety-net Hospital: A Study Protocol', 'orgStudyIdInfo': {'id': 'P30HS023558-2'}, 'secondaryIdInfos': [{'id': 'P30HS023558', 'link': 'https://reporter.nih.gov/quickSearch/P30HS023558', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active Surveillance Patients', 'description': 'Patients who elect to be monitored by an Active Surveillance protocol for prostate cancer', 'interventionNames': ['Other: Registry']}], 'interventions': [{'name': 'Registry', 'type': 'OTHER', 'description': 'Patients who are diagnosed with prostate cancer and elect to be monitored by an Active Surveillance protocol by the Urology Clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing but suboptimal systems for tracking patients. All Active Surveillance patients monitored by the clinic will be included.', 'armGroupLabels': ['Active Surveillance Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Zuckerberg San Francisco General Hospital and Trauma Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Urmimala Sarkar, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}