Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01241656
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
2010-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2521}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-21', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA test vs. No PSA test', 'timeFrame': '12 month follow-up', 'description': 'We will determine whether a DESI viewing had an impact on testing.'}, {'measure': 'Healthcare utilization and costs', 'timeFrame': '12 month follow-up', 'description': 'All prostate specific health care utilization and cost will be estimate for each group.'}], 'secondaryOutcomes': [{'measure': 'DESI viewing', 'timeFrame': '4 months after mailings', 'description': 'Did the patient view the decision support intervention or not?'}, {'measure': 'Decision specific knowledge', 'timeFrame': '4 months after mailings', 'description': "Patient's knowledge will be assessed with a validated 10-item measure."}, {'measure': 'Discussion with provider', 'timeFrame': '4 months after mailings', 'description': 'Patients will be asked if they discussed prostate cancer screening with a healthcare provider.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Decision support intervention (DESI)', 'Shared medical appointments (SMA)', 'Comparative effectiveness research (CER)'], 'conditions': ['Healthy Men Age 50 Who Are Considering PSA Screening']}, 'referencesModule': {'references': [{'pmid': '25666221', 'type': 'DERIVED', 'citation': 'Lewis CL, Adams J, Tai-Seale M, Huang Q, Knowles SB, Nielsen ME, Pignone MP, Walter LC, Frosch DL. A Randomized Controlled Effectiveness Trial for PSA Screening Decision Support Interventions in Two Primary Care Settings. J Gen Intern Med. 2015 Jun;30(6):810-6. doi: 10.1007/s11606-015-3214-9. Epub 2015 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'In this study we will compare 3 strategies for systematic delivery of prostate cancer screening decision support interventions (DESI) to usual care and examine their impact on screening decisions and subsequent healthcare utilization using a randomized control design.\n\nWe hypothesize men who are given the opportunity to review a DESI by one of the 3 strategies will be less likely to opt for prostate cancer screening, and will have lower subsequent healthcare utilization than men in the control group.', 'detailedDescription': "We will use a randomized experimental design to compare the effects of 3 different strategies to implement a prostate cancer screening decision support intervention (DESI) with a control condition in primary care in 2 clinical systems - PAMF (Palo Alto Medical Foundation) and UNC. The primary outcomes of interest are men's screening decisions and their subsequent healthcare utilization. Secondary outcomes include the likelihood that they review the DESI and their decision-specific knowledge. The 3 strategies selected by the PAMF and UNC health systems are: (1) mailing men a DESI in DVD; (2) inviting men to participate in a shared (group) medical appointment (SMA) to watch and discuss the DESI with a healthcare provider and other men; and (3) providing men options by inviting them to a SMA while also providing them a DESI in DVD which they can use individually if they are unable or choose not to attend a SMA. The 3 groups will be compared to a control condition that does not receive a DESI but will be encouraged to discuss prostate cancer screening with their physician. Because of its significantly larger patient population, the PAMF site will also evaluate these outcomes by targeting screening-naïve patients on their 50th birthday, when they first become guideline eligible to consider prostate cancer screening."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 50 or older\n* do not have a prostate diagnosis\n* have not had a PSA test in the past 10 months\n* have not seen their primary care physicians in the last 3 months\n\nExclusion Criteria:\n\n* Women'}, 'identificationModule': {'nctId': 'NCT01241656', 'briefTitle': 'Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1', 'orgStudyIdInfo': {'id': '10-1317'}, 'secondaryIdInfos': [{'id': '1R18AE000023-01', 'link': 'https://reporter.nih.gov/quickSearch/1R18AE000023-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mail DVD', 'interventionNames': ['Behavioral: DESI for home viewing']}, {'type': 'EXPERIMENTAL', 'label': 'Invite to SMA to view and discuss DESI', 'interventionNames': ['Behavioral: DESI for viewing at Shared Medical Appointment']}, {'type': 'EXPERIMENTAL', 'label': 'SMA and DVD', 'interventionNames': ['Behavioral: Option of SMA and DESI or DESI only']}, {'type': 'NO_INTERVENTION', 'label': 'Encouraged to talk to physician'}], 'interventions': [{'name': 'DESI for home viewing', 'type': 'BEHAVIORAL', 'description': 'Decision support intervention is a 31 minute DVD mailed to the patients in all of the experimental groups. The program explains the function and location of the prostate and the nature of prostate cancer, including its associated mortality. Next, the program describes the different tests that are used to detect prostate cancer including the digital rectal exam, prostate specific antigen (PSA) test and prostate biopsy.', 'armGroupLabels': ['Mail DVD']}, {'name': 'DESI for viewing at Shared Medical Appointment', 'type': 'BEHAVIORAL', 'description': 'Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.', 'armGroupLabels': ['Invite to SMA to view and discuss DESI']}, {'name': 'Option of SMA and DESI or DESI only', 'type': 'BEHAVIORAL', 'description': 'Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.', 'armGroupLabels': ['SMA and DVD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation Research Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Carmen L Lewis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Ming Tai-Seale, Ph.D, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Palo Alto Medical Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Palo Alto Medical Foundation', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Carmen Lewis, MD, MPH', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}