Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-02 @ 5:18 AM
Study NCT ID:
NCT03200535
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2017-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emily.b.schroeder@kp.org', 'phone': '303-636-2478', 'title': 'Dr. Emily Schroeder', 'organization': 'Kaiser Permanente Colorado'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We were unable to analyze the change in BMI and change in A1c due to the low number of individuals who enrolled in diabetes prevention classes'}}, 'adverseEventsModule': {'timeFrame': '4.5 months (6/26/2017-11/10/2017)', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Usual care', 'otherNumAtRisk': 1863, 'deathsNumAtRisk': 1863, 'otherNumAffected': 0, 'seriousNumAtRisk': 1863, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electronic Health Record "Gaps"', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient', 'otherNumAtRisk': 1863, 'deathsNumAtRisk': 1863, 'otherNumAffected': 0, 'seriousNumAtRisk': 1863, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bulk Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent', 'otherNumAtRisk': 1862, 'deathsNumAtRisk': 1862, 'otherNumAffected': 0, 'seriousNumAtRisk': 1862, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Personalized Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent\n\nDietician call: Patients will receive a personalized call by a registered dietitian', 'otherNumAtRisk': 1000, 'deathsNumAtRisk': 1000, 'otherNumAffected': 0, 'seriousNumAtRisk': 1000, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Enrollment in Diabetes Prevention or Weight Management Class (Online)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'OG000'}, {'value': '1863', 'groupId': 'OG001'}, {'value': '1862', 'groupId': 'OG002'}, {'value': '1000', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care'}, {'id': 'OG001', 'title': 'Electronic Health Record "Gaps"', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient'}, {'id': 'OG002', 'title': 'Bulk Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent'}, {'id': 'OG003', 'title': 'Personalized Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent\n\nDietician call: Patients will receive a personalized call by a registered dietitian'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority analysis'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4.5 months (6/26/2017-11/10/2017)', 'description': 'Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Entire population was analyzed'}, {'type': 'SECONDARY', 'title': 'Enrollment in Diabetes Prevention or Weight Management Class (in Person)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'OG000'}, {'value': '1863', 'groupId': 'OG001'}, {'value': '1862', 'groupId': 'OG002'}, {'value': '1000', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care'}, {'id': 'OG001', 'title': 'Electronic Health Record "Gaps"', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient'}, {'id': 'OG002', 'title': 'Bulk Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent'}, {'id': 'OG003', 'title': 'Personalized Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent\n\nDietician call: Patients will receive a personalized call by a registered dietitian'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4.5 months (6/26/2017-11/10/2017)', 'description': 'Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Usual care'}, {'id': 'FG001', 'title': 'Electronic Health Record "Gaps"', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient'}, {'id': 'FG002', 'title': 'Bulk Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent'}, {'id': 'FG003', 'title': 'Personalized Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent\n\nDietician call: Patients will receive a personalized call by a registered dietitian'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1863'}, {'groupId': 'FG001', 'numSubjects': '1863'}, {'groupId': 'FG002', 'numSubjects': '1862'}, {'groupId': 'FG003', 'numSubjects': '1000'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1863'}, {'groupId': 'FG001', 'numSubjects': '1863'}, {'groupId': 'FG002', 'numSubjects': '1862'}, {'groupId': 'FG003', 'numSubjects': '1000'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'BG000'}, {'value': '1863', 'groupId': 'BG001'}, {'value': '1862', 'groupId': 'BG002'}, {'value': '1000', 'groupId': 'BG003'}, {'value': '6588', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Usual care'}, {'id': 'BG001', 'title': 'Electronic Health Record "Gaps"', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient'}, {'id': 'BG002', 'title': 'Bulk Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent'}, {'id': 'BG003', 'title': 'Personalized Outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian\n\nEHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient\n\nBulk outreach: A bulk letter or email will be sent\n\nDietician call: Patients will receive a personalized call by a registered dietitian'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'BG000'}, {'value': '1863', 'groupId': 'BG001'}, {'value': '1862', 'groupId': 'BG002'}, {'value': '1000', 'groupId': 'BG003'}, {'value': '6588', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '59.1', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '58.0', 'spread': '11.1', 'groupId': 'BG002'}, {'value': '58.3', 'spread': '10.9', 'groupId': 'BG003'}, {'value': '58.2', 'spread': '11.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1857', 'groupId': 'BG000'}, {'value': '1856', 'groupId': 'BG001'}, {'value': '1861', 'groupId': 'BG002'}, {'value': '997', 'groupId': 'BG003'}, {'value': '6571', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '999', 'groupId': 'BG000'}, {'value': '1023', 'groupId': 'BG001'}, {'value': '990', 'groupId': 'BG002'}, {'value': '544', 'groupId': 'BG003'}, {'value': '3556', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '858', 'groupId': 'BG000'}, {'value': '833', 'groupId': 'BG001'}, {'value': '871', 'groupId': 'BG002'}, {'value': '453', 'groupId': 'BG003'}, {'value': '3015', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '17 participants had missing data on gender'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'BG000'}, {'value': '1863', 'groupId': 'BG001'}, {'value': '1862', 'groupId': 'BG002'}, {'value': '1000', 'groupId': 'BG003'}, {'value': '6588', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '36.3', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '36.6', 'spread': '5.9', 'groupId': 'BG002'}, {'value': '36.4', 'spread': '5.5', 'groupId': 'BG003'}, {'value': '36.4', 'spread': '5.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'A1c', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'BG000'}, {'value': '1863', 'groupId': 'BG001'}, {'value': '1862', 'groupId': 'BG002'}, {'value': '1000', 'groupId': 'BG003'}, {'value': '6588', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '0.18', 'groupId': 'BG000'}, {'value': '6.3', 'spread': '0.18', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '0.18', 'groupId': 'BG002'}, {'value': '6.3', 'spread': '0.18', 'groupId': 'BG003'}, {'value': '6.3', 'spread': '0.17', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-06', 'size': 102190, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-06T10:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individuals with a body mass index between 25 and 30 are randomized 1:1 to the Usual Care or EHR Gap arms. Individuals with a body mass index \\>=30 are randomized to all 4 arms, with n=1000 for the Personalized Outreach arm and 1:1:1 for the other three arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6588}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2017-06-23', 'resultsFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-21', 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment in Diabetes Prevention or Weight Management Class (Online)', 'timeFrame': '4.5 months (6/26/2017-11/10/2017)', 'description': 'Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period'}], 'secondaryOutcomes': [{'measure': 'Enrollment in Diabetes Prevention or Weight Management Class (in Person)', 'timeFrame': '4.5 months (6/26/2017-11/10/2017)', 'description': 'Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PreDiabetes', 'Obesity']}, 'descriptionModule': {'briefSummary': "Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that programs such weight management classes and one-on-one counseling with registered dieticians can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser Permanente Colorado members in these activities is low. The purpose of this study is to determine which of three outreach methods is most effective in increasing engagement in these activities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kaiser Permanente Member\n* Age 18-75\n* Prediabetes\n* BMI \\>= 25\n* A1c 6.1-6.4%\n* No dietitian visit within the past 3 years\n\nExclusion Criteria:\n\n\\- Pregnancy'}, 'identificationModule': {'nctId': 'NCT03200535', 'briefTitle': 'Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs', 'orgStudyIdInfo': {'id': 'CO-17-2437'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electronic health record "gaps"', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient', 'interventionNames': ['Other: EHR gaps']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bulk outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent', 'interventionNames': ['Other: EHR gaps', 'Other: Bulk outreach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Personalized outreach', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian', 'interventionNames': ['Other: EHR gaps', 'Other: Bulk outreach', 'Other: Dietician call']}], 'interventions': [{'name': 'EHR gaps', 'type': 'OTHER', 'description': 'Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient', 'armGroupLabels': ['Bulk outreach', 'Electronic health record "gaps"', 'Personalized outreach']}, {'name': 'Bulk outreach', 'type': 'OTHER', 'description': 'A bulk letter or email will be sent', 'armGroupLabels': ['Bulk outreach', 'Personalized outreach']}, {'name': 'Dietician call', 'type': 'OTHER', 'description': 'Patients will receive a personalized call by a registered dietitian', 'armGroupLabels': ['Personalized outreach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80014', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente Coloado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Emily Schroeder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Emily Schroeder', 'investigatorAffiliation': 'Kaiser Permanente'}}}}