Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-04-11 @ 8:23 AM
Study NCT ID:
NCT01361035
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cervical, breast and colorectal cancer screening rates', 'timeFrame': '0, 12, 24 months', 'description': 'Cervical/Breast/Colorectal cancer screening rates will be measured at baseline and annually for 2 years to assess whether screening rates improve over time'}], 'secondaryOutcomes': [{'measure': 'Change in standardized patient ratings of physician communication behaviors', 'timeFrame': '0, 6, 12 months', 'description': "The mystery shoppers (standardized patients) will rate the physicians' shared decision making and counseling about cancer screening prior to the intervention at baseline and then again at 6-month and 12-month follow up evaluations to assess whether communication behaviors improve over time"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['health literacy', 'cancer screening', 'doctor-patient communication', 'standardized patient', 'continuing medical education'], 'conditions': ['Cervical Cancer', 'Breast Cancer', 'Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '20352506', 'type': 'BACKGROUND', 'citation': 'Price-Haywood EG, Roth KG, Shelby K, Cooper LA. Cancer risk communication with low health literacy patients: a continuing medical education program. J Gen Intern Med. 2010 May;25 Suppl 2(Suppl 2):S126-9. doi: 10.1007/s11606-009-1211-6.'}, {'pmid': '24590734', 'type': 'RESULT', 'citation': 'Price-Haywood EG, Harden-Barrios J, Cooper LA. Comparative effectiveness of audit-feedback versus additional physician communication training to improve cancer screening for patients with limited health literacy. J Gen Intern Med. 2014 Aug;29(8):1113-21. doi: 10.1007/s11606-014-2782-4. Epub 2014 Feb 4.'}, {'pmid': '38726892', 'type': 'DERIVED', 'citation': "Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2."}]}, 'descriptionModule': {'briefSummary': "What's the purpose of this study? This 4-year study is designed: (1) to teach primary care physicians how to recognize low health literacy patients and effectively counsel them on cancer screening using risk communication and shared decision making and (2) to assess the impact of training on changes in physician communication behavior and changes in low health literacy patients' cancer screening behaviors. This study proposal is based on the hypothesis that physician training in cancer screening guidelines, health literacy, and communication skills will improve provider-patient interactions during encounters dealing with preventive health maintenance especially cancer screening.\n\nHow will the proposed study be implemented? Thirty-two physicians in the New Orleans metropolitan area will be recruited and randomly assigned to one of two groups. The unit of randomization will be the health care organization or clinic. The intervention group will receive training in health literacy, cancer screening, risk communication and shared decision-making. The control group will not receive communication training until the end of the study. Physicians in both groups will undergo three clinic visits with standardized patients (actors trained to portray real patients; mystery shoppers) but they will not be aware that they are conducting visits with actors. The visits will occur at study enrollment and at 6 and 12 months. At the end of each clinic visit, the standardized patients will rate the physicians' communication skills. Each physician assigned to the intervention group will receive verbal feedback on communication skills from the standardized patients and complete a web-based tutorial. Physicians in the control group will not have access to the web-based tutorial until the end of the study.\n\nFor each physician, 10-15 patients with limited health literacy will be recruited to the study. Each patient will rate his/her perceived involvement with care and global satisfaction with care at study enrollment and annually for three years. Age and gender-appropriate referral rates for breast, cervical and colorectal cancer screening and patients' receipt of such screening will be assessed annually for three years. All study physicians, regardless of group assignment, will receive performance feedback (report cards) on their cancer screening rates among low health literacy patients in their clinic."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPhysician\n\n* Physicians who practice at these clinic sites at least one half day per week are eligible to participate in this study.\n\nPatient\n\n* Eligible patients include men and women age 40 to 75, individuals enrolled in the clinic practice for at least one year, and individuals identified as having low or inadequate health literacy via the Rapid Estimate of Adult Literacy in Medicine.\n\nExclusion Criteria:\n\nPhysician\n\n* Any provider planning to leave before the end of 12 months will be excluded.\n\nPatient\n\n* Patients will be excluded if they plan to change primary care provider or site of health plan, have resided in the United States for less than five years, or do not speak English'}, 'identificationModule': {'nctId': 'NCT01361035', 'briefTitle': 'Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tulane University'}, 'officialTitle': 'Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients', 'orgStudyIdInfo': {'id': 'RWJF-63523'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No communication training', 'description': 'Physicians enrolled in the control arm do not undergo training in health literacy, cancer screening and shared decision making'}, {'type': 'OTHER', 'label': 'Cancer risk ommunication skills training', 'description': 'Physicians enrolled in the intervention arm undergo training in health literacy, cancer screening and shared decision making', 'interventionNames': ['Other: Cancer risk communication skills training']}], 'interventions': [{'name': 'Cancer risk communication skills training', 'type': 'OTHER', 'description': "Intervention physicians receive training in cancer risk communication and shared decision making (SDM). At the end of each visit with intervention physicians, standardized patients (SPs) reveal themselves as actors and give structured verbal feedback. After baseline SP visits, each intervention physician undergoes academic detailing with a communication expert. Intervention physicians are directed to a web-based communication skills tutorial where SP ratings are hyperlinked to key references for supplemental reading. Both study groups will receive annual reports detailing their patients' cancer screening status and aggregate ratings of their communication style.", 'armGroupLabels': ['Cancer risk ommunication skills training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Communty Health Center at Covenant House', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Faculty Practice', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70114', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'EXCELth - Ida Hymel Community Health Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70117', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'DCSNO St Cecelia Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'DCSNO Carrollton Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Eboni Price-Haywood, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tulane University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Associate Professor of Clinical Medicine', 'investigatorFullName': 'Eboni Price-Haywood', 'investigatorAffiliation': 'Tulane University School of Medicine'}}}}