Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT01653405
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2012-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Anticoagulation Control in VISN 1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arose@rand.org', 'phone': '617-338-2059', 'title': 'Dr. Adam Rose', 'phoneExt': '8672', 'organization': 'Rand Corporation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Adverse events were not monitored or assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'VISN1 (Intervention Group)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Outside VISN1 (Control Group)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Time in Therapeutic Range (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8029', 'groupId': 'OG000'}, {'value': '179979', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Difference in differences', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared TTR after the intervention to before the intervention. We used a difference in differences analysis to compare the absolute percentage change over time in the intervention group vs. the control group.', 'unitOfMeasure': 'percent change', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients receiving care at specified sites. Patient-level analyses were aggregated to the site level.'}, {'type': 'SECONDARY', 'title': 'Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8029', 'groupId': 'OG000'}, {'value': '179979', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'test of differences', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared the rate of 56-day gaps per patient year in the pre-intervention and post-intervention period. We used a difference in differences analysis to compare the intervention and control group. We are reporting absolute change.', 'unitOfMeasure': 'gaps per patient year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8029', 'groupId': 'OG000'}, {'value': '179979', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'difference in differences', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared the percentage of patients with follow-up within 7 days before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.', 'unitOfMeasure': 'percentage change', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8029', 'groupId': 'OG000'}, {'value': '179979', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Difference in differences', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared the percentage of patients before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups. Absolute percentage is reported.', 'unitOfMeasure': 'percentage change', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Mean INR Value Between 2.3 - 2.7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8029', 'groupId': 'OG000'}, {'value': '179979', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'VA patients receiving anticoagulation clinic services at 8 sites within VISN 1. We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'difference in differences', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared the absolute percentage of patients with a mean INR of 2.3 - 2.7 before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.', 'unitOfMeasure': 'percentage change', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VISN1 (Intervention Group)', 'description': 'VA patients receiving care at anticoagulation clinics at 8 sites within VISN 1'}, {'id': 'FG001', 'title': 'Outside VISN1 (Control Group)', 'description': 'VA patients receiving care at anticoagulation clinics at 116 sites outside of VISN 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '11794'}, {'groupId': 'FG001', 'numUnits': '116', 'numSubjects': '1248782'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'These patients had enough data to calculate TTR.', 'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '8029'}, {'comment': 'These patients had enough data to calculate TTR.', 'groupId': 'FG001', 'numUnits': '116', 'numSubjects': '179979'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '3765'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '1068803'}]}]}], 'typeUnitsAnalyzed': 'VA sites'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8029', 'groupId': 'BG000'}, {'value': '179979', 'groupId': 'BG001'}, {'value': '188008', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'VA patients receiving anticoagulation clinic services at 8 sites in VISN 1.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'VA patients receiving anticoagulation clinic services at 116 sites outside of VISN 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77.7', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '75.3', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '75.4', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '4340', 'groupId': 'BG001'}, {'value': '4521', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7848', 'groupId': 'BG000'}, {'value': '175639', 'groupId': 'BG001'}, {'value': '183487', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Average TTR', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '65.9', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '65.9', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of time in target INR range', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percentage of instances where INR<=1.5 was followed by a second INR within 7 days', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants can contribute more than one instance each.', 'unitOfMeasure': 'percentage of instances'}, {'title': 'Percentage of instances where an INR >= 4.0 was followed by a second INR within 7 days', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants can contribute more than one instance each.', 'unitOfMeasure': 'percentage of instances'}, {'title': 'Gaps in monitoring per patient-year', 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '0.15', 'groupId': 'BG000'}, {'value': '0.37', 'spread': '0.18', 'groupId': 'BG001'}, {'value': '0.37', 'spread': '0.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean gaps in monitoring per patient year of therapy', 'unitOfMeasure': 'gaps per patient-year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percentage of patients whose mean INR value was between 2.3 and 2.7', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of patients'}], 'populationDescription': 'Analysis was conducted at the site level and not the patient level.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1260576}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2012-07-06', 'resultsFirstSubmitDate': '2017-09-26', 'studyFirstSubmitQcDate': '2012-07-26', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-14', 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Time in Therapeutic Range (TTR)', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared TTR after the intervention to before the intervention. We used a difference in differences analysis to compare the absolute percentage change over time in the intervention group vs. the control group.'}], 'secondaryOutcomes': [{'measure': 'Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared the rate of 56-day gaps per patient year in the pre-intervention and post-intervention period. We used a difference in differences analysis to compare the intervention and control group. We are reporting absolute change.'}, {'measure': 'Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared the percentage of patients with follow-up within 7 days before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.'}, {'measure': 'Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower)', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared the percentage of patients before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups. Absolute percentage is reported.'}, {'measure': 'Percentage of Patients With Mean INR Value Between 2.3 - 2.7', 'timeFrame': 'Baseline and 4 years', 'description': 'We compared the absolute percentage of patients with a mean INR of 2.3 - 2.7 before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anticoagulants', 'pharmacists', 'quality improvement', 'quality of health care'], 'conditions': ['Anticoagulants', 'Atrial Fibrillation', 'Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '27349472', 'type': 'RESULT', 'citation': 'Rose AJ, McCullough MB. A Practical Guide to Using the Positive Deviance Method in Health Services Research. Health Serv Res. 2017 Jun;52(3):1207-1222. doi: 10.1111/1475-6773.12524. Epub 2016 Jun 28.'}, {'pmid': '28367699', 'type': 'RESULT', 'citation': 'Rose AJ, Park A, Gillespie C, Van Deusen Lukas C, Ozonoff A, Petrakis BA, Reisman JI, Borzecki AM, Benedict AJ, Lukesh WN, Schmoke TJ, Jones EA, Morreale AP, Ourth HL, Schlosser JE, Mayo-Smith MF, Allen AL, Witt DM, Helfrich CD, McCullough MB. Results of a Regional Effort to Improve Warfarin Management. Ann Pharmacother. 2017 May;51(5):373-379. doi: 10.1177/1060028016681030. Epub 2016 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'Over 100,000 VHA patients receive anticoagulants (blood thinners) each year to prevent blood clots (including strokes). Too much anticoagulation increases the risk of serious or even fatal bleeding, and too little anticoagulation fails to protect the patient against blood clots. VHA anticoagulation clinics vary widely on how much time their patients spend in the therapeutic range, the range within which they are protected from clots but not at excessive risk of bleeding. Anticoagulation clinics can improve anticoagulation control by following several relatively simple procedures, including following-up promptly when patients are out of range and focusing on educating and supporting patients with poor control. In this study, the investigators will promote these practices at the anticoagulation clinics of the New England VA region, with a goal of improving anticoagulation control.', 'detailedDescription': 'Background: Over 100,000 VA patients receive oral anticoagulation (AC) each year to prevent blood clots, including strokes. AC is safer and more effective when it is managed skillfully and therefore well-controlled. AC control can be measured using percent time in therapeutic range (TTR), the proportion of time when patients are sufficiently anticoagulated to prevent clots but not excessively anticoagulated (which increases the risk of bleeding). The investigators have shown that the anticoagulation clinics (ACCs) of the VA vary widely on TTR, from 40% (very poor control) to 70% (excellent control). Improving TTR in the VA would prevent thousands of adverse events, including strokes, major hemorrhages, and deaths. The investigators have further investigated the structures and processes of care that contribute to these wide disparities in TTR performance.\n\nObjectives: We applied proven methods to change provider behavior. The goal was to facilitate the adoption of these evidence-based practices in order to improve TTR in VISN 1. We utilized educational outreach, audit and feedback, internal facilitation, and external facilitation to promote improvements in three evidence-based processes of care; namely, follow-up within 7 days after deranged INR values, minimizing loss to follow-up, and use of guideline concordant INR targets.\n\nMethods: Our clinician-focused intervention used a Dashboard to measure site-level TTR and processes of care and an Algorithm for routine AC management. Both the Dashboard and the Algorithm are concrete representations of our main evidence-based recommendations to improve AC management. We promoted their use through quarterly visits to the sites, at which we delivered audit and feedback and educational outreach, and also provided external facilitation to address ways to improve these performance measures. Our main outcome was change in site TTR over time, which was compared between VISN 1 and non-VISN 1 sites using an interrupted time series. Secondary outcomes included site-level changes in processes of anticoagulation care (measured using automated data). We used a difference-in-differences (DID) model to examine changes in anticoagulation control, measured as percent time in target range (TTR), as well as process measures, and compared VISN 1 sites to 116 VA sites located outside VISN 1. The pre-intervention period was from 5/1/10-5/1/13, while the post-intervention period was from 5/2/13-5/10/16.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients receiving long-term oral anticoagulation with warfarin within the VA New England Region ("VISN 1")\n\nExclusion Criteria:\n\n* Patients with valvular heart disease, who may have an INR target range other than 2-3. This usually represents between 10-15% of patients receiving anticoagulation.'}, 'identificationModule': {'nctId': 'NCT01653405', 'briefTitle': 'Improving Anticoagulation Control in VISN 1', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Improving Anticoagulation Control in VISN 1', 'orgStudyIdInfo': {'id': 'SDP 12-249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'VA patients treated at anticoagulation clinics at 8 sites in VISN 1. The intervention included a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.', 'interventionNames': ['Other: Multifaceted behavioral intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'VA patients treated at anticoagulation clinics at 116 sites outside of VISN 1.'}], 'interventions': [{'name': 'Multifaceted behavioral intervention', 'type': 'OTHER', 'description': 'The intervention included access to a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01730', 'city': 'Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA', 'geoPoint': {'lat': 42.49065, 'lon': -71.27617}}], 'overallOfficials': [{'name': 'Ann M. Borzecki, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}