Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-02 @ 7:10 AM
Study NCT ID:
NCT02915068
Status:
COMPLETED
Last Update Posted:
2017-09-14
First Post:
2016-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Clinician Training Program to Improve Patient-provider Communication in the Presence of Health IT Systems in the Exam Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-13', 'studyFirstSubmitDate': '2016-09-20', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline patient report of physician performance at 3 and 6 months', 'timeFrame': 'baseline, 3 months, 6 months', 'description': "The patient's report of physician performance will be used as the key measure in this study. They will use a validated instrument previously developed by the research group in the PACE trials, focusing on clinical practices of the clinician, especially, use of National Asthma Education and Prevention Program recommended therapies, communication and counseling behaviors specially related to EHR use."}], 'secondaryOutcomes': [{'measure': 'Change from baseline patient satisfaction at 3 and 6 months', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'specific facets of satisfaction with care adapted from the widely used Patient Satisfaction Questionnaire, especially as it relates to interactions with clinicians in the presence of EHRs in the exam room'}, {'measure': 'Change from baseline asthma control at 3 and 6 months', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'the Asthma Control Test (ACT), a valid measure responsive to changes in asthma control over time'}, {'measure': 'Change from baseline asthma-related quality of life at 3 and 6 months', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Mini Asthma Quality of Life Questionnaire (Mini-AQLQ), a 15-item validated instrument that assesses physical, emotional, and social well-being of adults with asthma through four domains (activity limitations, symptoms, emotional function, and exposure to environmental stimuli).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['patient-provider communication', 'Electronic Health Records', 'Provider education'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': "The investigators propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. The investigators will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of best practices for clinicians interacting with patients in the presence of computer systems in the exam room. They will then establish the feasibility and potential impact of EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the intervention on the following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the physician's performance, asthma control, and asthma-related quality of life. Outcomes will be assessed on patients, but physicians will receive the intervention. Patients will not know which arm their doctor was randomized to. The pilot trial will compare two groups of primary care physicians who see patients with asthma in clinics equipped with certified EHRs. It is hypothesized that patients of physicians who receive EHR-PACE training will achieve better outcomes compared to physicians who do not receive EHR-PACE.", 'detailedDescription': "Failure in clinician-patient communication, lack of clarity regarding clinical treatment priorities, and more recently, ineffective use of health IT systems in exam rooms are associated with deficits in achieving chronic disease management goals, and increased healthcare utilization and costs. Strategies for communicating with patients in exam rooms in the presence of electronic health records (EHR) have been described in the literature. Whether such strategies are reaching clinicians and demonstrating positive health outcomes is unclear. The investigators propose to develop and test the feasibility on patient outcomes of an interactive training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs). They propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. The PACE program is based on concepts and skills for strengthening communication and patient-clinician relationships through behavior change principles that are highly applicable to patients with asthma and has potential for specific application to EHR use in clinical practice. The investigators will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of best practices for clinicians interacting with patients in the presence of computer systems in the exam room. They will then establish the feasibility and potential impact of EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the intervention on the following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the physician's performance, asthma control, and asthma-related quality of life. Outcomes will be assessed on patients, but physicians will receive the intervention.Patients will not know which arm their doctor was randomized to.The pilot trial will compare two groups of primary care physicians who see patients with asthma in clinics equipped with certified EHRs. It is hypothesized that patients of physicians who receive EHR-PACE training will achieve better outcomes compared to physicians who do not receive EHR-PACE.\n\nEHR-PACE developed in this study is expected to have a high degree of relevance for improving the patient-provider communication skills of clinicians who see a wide range of patients in a variety of practice settings that have now integrated EHRs. Given that PACE can achieve dramatic outcomes within only two, 2-hour sessions, EHR-PACE has the potential to become an invaluable training tool to busy clinicians if proven feasible and effective. Ultimately, this work has potential for a high degree of impact."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPhysicians:\n\n1. Licensed physician in practice and board certified in primary care or family medicine\n2. Treating adults with asthma\n3. Full-time in a practice at an Integrated Health Associates clinic that has implemented a certified EHR system for at least one year\n4. Consent to participate\n5. Will generate a roster of adult asthma patients for inclusion in the study\n\nPatients:\n\n1. Treated by the participating physician during the study intake period\n2. 18 years of age or older\n3. Have a diagnosis of asthma made by a physician using the National Asthma Education and Prevention Program Guidelines\n4. Have at least one urgent medical care visit for asthma in the previous year\n5. Have access to a telephone\n6. Consent to participate\n\nExclusion Criteria:\n\nPatients:\n\n1\\. Have other chronic disorders that have pulmonary complications\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02915068', 'briefTitle': 'Feasibility of a Clinician Training Program to Improve Patient-provider Communication in the Presence of Health IT Systems in the Exam Room', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Feasibility of a Clinician Training Program to Improve Patient-provider Communication in the Presence of Health IT Systems in the Exam Room', 'orgStudyIdInfo': {'id': 'HUM00100232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Physicians do not receive focused education and training on patient-centered communication with the EHR'}, {'type': 'EXPERIMENTAL', 'label': 'EHR-PACE', 'description': 'participants will receive EHR-PACE, an interactive 1.5 hour training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs).', 'interventionNames': ['Behavioral: EHR-Physician Asthma Care Education Program']}], 'interventions': [{'name': 'EHR-Physician Asthma Care Education Program', 'type': 'BEHAVIORAL', 'description': 'participants will receive EHR-PACE, an interactive 1.5 hour training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs).', 'armGroupLabels': ['EHR-PACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Integrated Health Associates ClinSite Research', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Minal R Patel, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Minal Patel', 'investigatorAffiliation': 'University of Michigan'}}}}