Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT02475850
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2015-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Strategies to Reduce Injuries and Develop Confidence in Elders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erich.greene@yale.edu', 'phone': '203-737-3636', 'title': 'Erich Greene PhD', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Enrollment through death, withdrawal, or end of study (max 44 months)', 'description': 'Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention - Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 2802, 'otherNumAffected': 0, 'seriousNumAtRisk': 2802, 'deathsNumAffected': 235, 'seriousNumAffected': 1139}, {'id': 'EG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 2649, 'otherNumAffected': 0, 'seriousNumAtRisk': 2649, 'deathsNumAffected': 220, 'seriousNumAffected': 1108}], 'seriousEvents': [{'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 34, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 270, 'numAffected': 199}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 259, 'numAffected': 199}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 208, 'numAffected': 161}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 176, 'numAffected': 135}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 194, 'numAffected': 159}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 168, 'numAffected': 152}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 324, 'numAffected': 252}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 298, 'numAffected': 231}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 225, 'numAffected': 187}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 242, 'numAffected': 196}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 35, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 59, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 70, 'numAffected': 55}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 205, 'numAffected': 173}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 182, 'numAffected': 156}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 59, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 58, 'numAffected': 52}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 230, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 192, 'numAffected': 153}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 54, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 67, 'numAffected': 55}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 196, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 156, 'numAffected': 119}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 116, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 135, 'numAffected': 119}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 72, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 91, 'numAffected': 77}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2649, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'First Adjudicated Serious Fall-Related Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2802', 'groupId': 'OG000'}, {'value': '2649', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}], 'classes': [{'categories': [{'measurements': [{'value': '4.87', 'groupId': 'OG000', 'lowerLimit': '4.31', 'upperLimit': '5.43'}, {'value': '5.34', 'groupId': 'OG001', 'lowerLimit': '4.55', 'upperLimit': '6.13'}]}]}], 'analyses': [{'pValue': '0.245', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.06', 'pValueComment': 'p\\<0.05 threshold (primary outcome)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'multistate model accounting for death as a semi-competing risk'}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment through last completed follow-up or death interview (max 44 months)', 'description': 'Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.', 'unitOfMeasure': 'events per 100 person years of follow-up', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'First Self-reported Fall-related Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2802', 'groupId': 'OG000'}, {'value': '2649', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}], 'classes': [{'categories': [{'measurements': [{'value': '25.64', 'groupId': 'OG000', 'lowerLimit': '24.19', 'upperLimit': '27.08'}, {'value': '28.62', 'groupId': 'OG001', 'lowerLimit': '26.53', 'upperLimit': '30.72'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.90', 'ciLowerLimit': '0.83', 'ciUpperLimit': '0.99', 'pValueComment': 'p\\< 0.01 threshold (secondary outcome)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment through last completed follow-up or death interview (max 44 months)', 'description': 'Number of first self-reported fall-related injuries per 100 per years of follow-up', 'unitOfMeasure': 'events per 100 person years of follow-up', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Self-reported Falls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}], 'timeFrame': 'these data were not collected', 'description': '\\*\\* data for this outcome was not collected', 'reportingStatus': 'POSTED', 'populationDescription': 'These data were not collected'}, {'type': 'SECONDARY', 'title': 'Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}], 'classes': [{'categories': [{'measurements': [{'value': '58.45', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '57.73', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.309', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least-squared means across', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.72', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '2.54', 'pValueComment': 'p \\< 0.01 threshold (secondary outcome)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.71', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores', 'description': 'Late Life Function and Disability Instrument (LL-FDI) function score. The scores are on a 0-100 scale, higher score = better function. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'subsample selected for well-being measures with completed baseline LL-FDI'}, {'type': 'SECONDARY', 'title': 'Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}], 'classes': [{'categories': [{'measurements': [{'value': '55.16', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '54.57', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.528', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.59', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '0.93', 'pValueComment': 'p \\< 0.01 threshold (secondary outcome)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores', 'description': 'Late Life Function and Disability Instrument (LL-FDI) disability score. The scores are on a 0-100 scale, higher score = less disability. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'subsample selected for well-being measures with completed baseline LL-FDI'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}], 'classes': [{'categories': [{'measurements': [{'value': '11.63', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '12.53', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.90', 'ciLowerLimit': '-2.00', 'ciUpperLimit': '0.20', 'pValueComment': 'p \\< 0.01 threshold (secondary outcome)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'estimateComment': 'Difference in least-squared means across all follow-up (repeated measures: 12 months/24 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.', 'description': 'Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'subsample selected for well-being measures and with completed baseline PROMIS Anxiety'}, {'type': 'SECONDARY', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}], 'classes': [{'categories': [{'measurements': [{'value': '11.75', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '12.94', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-1.19', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '-0.02', 'pValueComment': 'p\\<0.01 threshold (secondary outcome)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.', 'description': 'PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'subsample selected for well-being measures and with completed baseline PROMIS dep'}, {'type': 'SECONDARY', 'title': 'Fear of Falling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}], 'classes': [{'categories': [{'measurements': [{'value': '16.03', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '16.10', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.897', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.07', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '1.25', 'pValueComment': 'p \\<0.01 threshold (secondary outcome)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'estimateComment': 'Difference in least-squared means across all follow-up (repeated measures: 12 months, 24 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.', 'description': 'Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more fear of falling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'subsample selected for well-being measures and with completed baseline FES'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention - Fall Prevention Standard of Care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'FG001', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2802'}, {'groupId': 'FG001', 'numSubjects': '2649'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2209'}, {'groupId': 'FG001', 'numSubjects': '2165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '593'}, {'groupId': 'FG001', 'numSubjects': '484'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '155'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2649', 'groupId': 'BG000'}, {'value': '2802', 'groupId': 'BG001'}, {'value': '5451', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Usual fall prevention care\n\nUsual care'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach\n\nEvidence-based tailored fall prevention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79.5', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '79.9', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '79.7', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1629', 'groupId': 'BG000'}, {'value': '1752', 'groupId': 'BG001'}, {'value': '3381', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1020', 'groupId': 'BG000'}, {'value': '1050', 'groupId': 'BG001'}, {'value': '2070', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2428', 'groupId': 'BG000'}, {'value': '2592', 'groupId': 'BG001'}, {'value': '5020', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2394', 'groupId': 'BG000'}, {'value': '2571', 'groupId': 'BG001'}, {'value': '4965', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Positive on Fall Risk Screening Questions', 'classes': [{'title': 'Fallen 2 or more times in past year', 'categories': [{'measurements': [{'value': '896', 'groupId': 'BG000'}, {'value': '1015', 'groupId': 'BG001'}, {'value': '1911', 'groupId': 'BG002'}]}]}, {'title': 'Fallen and hurt yourself in past year', 'categories': [{'measurements': [{'value': '1031', 'groupId': 'BG000'}, {'value': '1089', 'groupId': 'BG001'}, {'value': '2120', 'groupId': 'BG002'}]}]}, {'title': 'Fear of falling because of balance or walking problems', 'categories': [{'measurements': [{'value': '2274', 'groupId': 'BG000'}, {'value': '2405', 'groupId': 'BG001'}, {'value': '4679', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Educational Level', 'classes': [{'categories': [{'title': 'High school graduate or less', 'measurements': [{'value': '643', 'groupId': 'BG000'}, {'value': '602', 'groupId': 'BG001'}, {'value': '1245', 'groupId': 'BG002'}]}, {'title': 'Some college or equivalent', 'measurements': [{'value': '659', 'groupId': 'BG000'}, {'value': '697', 'groupId': 'BG001'}, {'value': '1356', 'groupId': 'BG002'}]}, {'title': 'College graduate or higher', 'measurements': [{'value': '1343', 'groupId': 'BG000'}, {'value': '1502', 'groupId': 'BG001'}, {'value': '2845', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic coexisting conditions - number per participant', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number chronic conditions per subject', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinically significant cognitive impairment', 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Four or more errors on 6-item Callahan cognitive screener OR the interview was completed entirely by proxy', 'unitOfMeasure': 'Participants'}, {'title': 'Use of mobility aid or inability to ambulate', 'classes': [{'categories': [{'measurements': [{'value': '909', 'groupId': 'BG000'}, {'value': '972', 'groupId': 'BG001'}, {'value': '1881', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of positive responses to screening questions regarding fall injuries', 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '1571', 'groupId': 'BG000'}, {'value': '1634', 'groupId': 'BG001'}, {'value': '3205', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '605', 'groupId': 'BG000'}, {'value': '629', 'groupId': 'BG001'}, {'value': '1234', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '473', 'groupId': 'BG000'}, {'value': '539', 'groupId': 'BG001'}, {'value': '1012', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of fracture other than of the hip after 50 yr of age', 'classes': [{'categories': [{'measurements': [{'value': '876', 'groupId': 'BG000'}, {'value': '918', 'groupId': 'BG001'}, {'value': '1794', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of hip fracture after 50 years of age', 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-25', 'size': 997550, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-01T08:52', 'hasProtocol': False}, {'date': '2019-12-31', 'size': 989114, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-01T10:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5451}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2015-06-01', 'resultsFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-02', 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First Adjudicated Serious Fall-Related Injury', 'timeFrame': 'Enrollment through last completed follow-up or death interview (max 44 months)', 'description': 'Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.'}], 'secondaryOutcomes': [{'measure': 'First Self-reported Fall-related Injury', 'timeFrame': 'Enrollment through last completed follow-up or death interview (max 44 months)', 'description': 'Number of first self-reported fall-related injuries per 100 per years of follow-up'}, {'measure': 'Time to Self-reported Falls', 'timeFrame': 'these data were not collected', 'description': '\\*\\* data for this outcome was not collected'}, {'measure': 'Physical Function', 'timeFrame': 'measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores', 'description': 'Late Life Function and Disability Instrument (LL-FDI) function score. The scores are on a 0-100 scale, higher score = better function. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment'}, {'measure': 'Disability', 'timeFrame': 'measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores', 'description': 'Late Life Function and Disability Instrument (LL-FDI) disability score. The scores are on a 0-100 scale, higher score = less disability. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment'}, {'measure': 'Anxiety', 'timeFrame': 'Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.', 'description': 'Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.'}, {'measure': 'Depression', 'timeFrame': 'Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.', 'description': 'PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.'}, {'measure': 'Fear of Falling', 'timeFrame': 'Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.', 'description': 'Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more fear of falling.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Accidental Falls', 'Wounds and Injuries']}, 'referencesModule': {'references': [{'pmid': '38740298', 'type': 'DERIVED', 'citation': 'Esserman D, Greene EJ, Latham NK, Kane M, Lu C, Peduzzi PN, Gill TM, Ganz DA. Assessing readiness to use electronic health record data for outcome ascertainment in clinical trials - A case study. Contemp Clin Trials. 2024 Jul;142:107572. doi: 10.1016/j.cct.2024.107572. Epub 2024 May 11.'}, {'pmid': '37533073', 'type': 'DERIVED', 'citation': 'Ganz DA, Gill TM, Reuben DB, Bhasin S, Latham NK, Peduzzi P, Greene EJ. Costs of fall injuries in the STRIDE study: an economic evaluation of healthcare system heterogeneity and heterogeneity of treatment effect. Cost Eff Resour Alloc. 2023 Aug 2;21(1):49. doi: 10.1186/s12962-023-00459-3.'}, {'pmid': '35932279', 'type': 'DERIVED', 'citation': 'Ganz DA, Yuan AH, Greene EJ, Latham NK, Araujo K, Siu AL, Magaziner J, Gurwitz JH, Wu AW, Alexander NB, Wallace RB, Greenspan SL, Rich J, Volpi E, Waring SC, Dykes PC, Ko F, Resnick NM, McMahon SK, Basaria S, Wang R, Lu C, Esserman D, Dziura J, Miller ME, Travison TG, Peduzzi P, Bhasin S, Reuben DB, Gill TM. Effect of the STRIDE fall injury prevention intervention on falls, fall injuries, and health-related quality of life. J Am Geriatr Soc. 2022 Nov;70(11):3221-3229. doi: 10.1111/jgs.17964. Epub 2022 Aug 6.'}, {'pmid': '33678038', 'type': 'DERIVED', 'citation': 'Esserman DA, Gill TM, Miller ME, Greene EJ, Dziura JD, Travison TG, Meng C, Peduzzi PN. A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial. Clin Trials. 2021 Apr;18(2):207-214. doi: 10.1177/1740774520980070. Epub 2021 Mar 7.'}, {'pmid': '33037632', 'type': 'DERIVED', 'citation': 'Gill TM, Bhasin S, Reuben DB, Latham NK, Araujo K, Ganz DA, Boult C, Wu AW, Magaziner J, Alexander N, Wallace RB, Miller ME, Travison TG, Greenspan SL, Gurwitz JH, Rich J, Volpi E, Waring SC, Manini TM, Min LC, Teresi J, Dykes PC, McMahon S, McGloin JM, Skokos EA, Charpentier P, Basaria S, Duncan PW, Storer TW, Gazarian P, Allore HG, Dziura J, Esserman D, Carnie MB, Hanson C, Ko F, Resnick NM, Wiggins J, Lu C, Meng C, Goehring L, Fagan M, Correa-de-Araujo R, Casteel C, Peduzzi P, Greene EJ. Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study. J Am Geriatr Soc. 2021 Jan;69(1):173-179. doi: 10.1111/jgs.16854. Epub 2020 Oct 9.'}, {'pmid': '32640131', 'type': 'DERIVED', 'citation': 'Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S, Storer TW, Gazarian P, Miller ME, Travison TG, Esserman D, Carnie MB, Goehring L, Fagan M, Greenspan SL, Alexander N, Wiggins J, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace RB, Casteel C, Resnick NM, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Meng C, Allore H, Brawley BF, Eder R, McGloin JM, Skokos EA, Duncan PW, Baker D, Boult C, Correa-de-Araujo R, Peduzzi P; STRIDE Trial Investigators. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. N Engl J Med. 2020 Jul 9;383(2):129-140. doi: 10.1056/NEJMoa2002183.'}, {'pmid': '32408769', 'type': 'DERIVED', 'citation': 'Esserman D. From screening to ascertainment of the primary outcome using electronic health records: Challenges in the STRIDE trial. Clin Trials. 2020 Aug;17(4):346-350. doi: 10.1177/1740774520920898. Epub 2020 May 14.'}, {'pmid': '32212395', 'type': 'DERIVED', 'citation': 'Gill TM, McGloin JM, Shelton A, Bianco LM, Skokos EA, Latham NK, Ganz DA, Nyquist LV, Wallace RB, Carnie MB, Dykes PC, Goehring LA, Doyle M, Charpentier PA, Greene EJ, Araujo KL. Optimizing Retention in a Pragmatic Trial of Community-Living Older Persons: The STRIDE Study. J Am Geriatr Soc. 2020 Jun;68(6):1242-1249. doi: 10.1111/jgs.16356. Epub 2020 Mar 25.'}, {'pmid': '31245263', 'type': 'DERIVED', 'citation': 'Ganz DA, Siu AL, Magaziner J, Latham NK, Travison TG, Lorenze NP, Lu C, Wang R, Greene EJ, Stowe CL, Harvin LN, Araujo KLB, Gurwitz JH, Agrawal Y, Correa-De-Araujo R, Peduzzi P, Gill TM; STRIDE Investigators. Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study. Inj Epidemiol. 2019 Apr 15;6:14. doi: 10.1186/s40621-019-0190-2. eCollection 2019.'}, {'pmid': '30020415', 'type': 'DERIVED', 'citation': 'Gill TM, McGloin JM, Latham NK, Charpentier PA, Araujo KL, Skokos EA, Lu C, Shelton A, Bhasin S, Bianco LM, Carnie MB, Covinsky KE, Dykes P, Esserman DA, Ganz DA, Gurwitz JH, Hanson C, Nyquist LV, Reuben DB, Wallace RB, Greene EJ. Screening, Recruitment, and Baseline Characteristics for the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Study. J Gerontol A Biol Sci Med Sci. 2018 Oct 8;73(11):1495-1501. doi: 10.1093/gerona/gly076.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy in community dwelling older adults at risk of falls recruited from 86 primary care practices around the U.S.', 'detailedDescription': 'Objective: To determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy implemented within primary care practices using usual health care resources\n\nDesign: This study is a cluster randomized, parallel group superiority trial with practices stratified by healthcare system and patients nested within practices. The unit of randomization is the practice.\n\nStudy Duration: The total study duration is 5 years. Recruitment will take place over 20 months, with follow-up taking place for 24 months - 44 months depending on date of enrollment.\n\nTrial Sites: 86 primary care practices that are part of 10 trial sites located around the U.S.: The Partners\' Health Care System; Essentia; Hopkins Health Care System; HealthCare Partners; Reliant Health Care System; Mount Sinai Health Care System; University of Pittsburgh Health Care System; University of Texas Medical Branch Health Care System; University of Iowa Health Care System; University of Michigan Health Care System.\n\nNumber of Subjects: The original target sample size was 6,000 participants enrolled in 86 practices to provide 90% power to detect a 20% reduction in the rate of the primary outcome with intervention relative to control. The study was originally designed for a study duration of 36 months with 18 months of recruitment and a minimum of 18 months of follow-up. The study was extended to a 44 month study (20 months of recruitment and a minimum 24 month of follow-up). For a 44 month trial, it was estimated that a sample size of 5,322 subjects would provide 90% power to detect a 20% reduction in the rate of the primary outcome with the intervention relative to control.\n\nMain Inclusion Criteria Community-living persons, 70 years or older, who are at increased risk for serious fall injuries.\n\nIntervention: An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the Center for Disease Control\'s (CDC\'s) "STEADI" toolbox (Stopping Elderly Accidents, Disability and Injury) and the joint American Geriatrics Society/British Geriatrics Society guidelines, and Assessing Care of Vulnerable Elders (ACOVE) practice change approach. The fall prevention strategies will be systematically implemented into clinical practice using: delivery system design to improve quality (Co-management); decision support (algorithms); information systems (software); self-management support (patient/caregiver engagement and activation); and linkage to community-based resources.\n\nPrimary Outcome: The primary outcome is adjudicated serious fall injuries, operationalized as a fall resulting in: (1) (fracture other than thoracic/lumbar vertebral; joint dislocation; or cut requiring closure) AND any medical attention; OR (2) (head injury; sprain or strain; bruising or swelling; or other) requiring hospitalization.\n\nPrimary Analysis: The risk of any serious fall injury (i.e., time to first event) will be analyzed using a survival model that incorporates competing risks (due to death) and clustering. In this analysis, participants who are lost to follow-up without a prior serious fall-related injury will be censored at their date last seen. In a sensitivity analysis, the investigators will adjust for the pre-specified set of baseline covariates to examine their influence on the intervention effect.\n\nSecondary Outcomes: All self-reported falls, all self-reported fall-related injuries, and measures of well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient is at least 70 years of age.\n* The patient must answer 'yes' to one or more of the following questions:\n* Have you fallen and hurt yourself in the past year?\n* Have you fallen 2 or more times in the past year?\n* Are you afraid that you might fall because of balance or walking problems?\n\nExclusion Criteria:\n\n* The patient is enrolled in hospice.\n* The patient resides in a nursing home.\n* The patient is not capable of providing informed consent (or assent), and a proxy is not available.\n* The patient does not speak English or Spanish"}, 'identificationModule': {'nctId': 'NCT02475850', 'acronym': 'STRIDE', 'briefTitle': 'Strategies to Reduce Injuries and Develop Confidence in Elders', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Randomized Trial of a Multifactorial Fall Injury Prevention Strategy', 'orgStudyIdInfo': {'id': 'U01AG048270', 'link': 'https://reporter.nih.gov/quickSearch/U01AG048270', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1U01AG048270-01', 'link': 'https://reporter.nih.gov/quickSearch/1U01AG048270-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fall prevention standard of care', 'description': 'An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC\'s "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach', 'interventionNames': ['Other: Evidence-based tailored fall prevention']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Usual fall prevention care', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Evidence-based tailored fall prevention', 'type': 'OTHER', 'armGroupLabels': ['Fall prevention standard of care']}, {'name': 'Usual care', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Healthcare Partners', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Health Alliance', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medicine', 'geoPoint': {'lat': 39.29038, 'lon': 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