Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-30 @ 6:06 AM
Study NCT ID:
NCT01251757
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'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': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.vollmer@kpchr.org', 'phone': '503-335-2400', 'title': 'William M Vollmer, PhD', 'organization': 'Kaiser Permanente Center for Health Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months post randomization', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care (UC)', 'description': 'usual medical care', 'otherNumAtRisk': 7255, 'deathsNumAtRisk': 7255, 'otherNumAffected': 0, 'seriousNumAtRisk': 7255, 'deathsNumAffected': 141, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'usual care plus automated phone calls', 'otherNumAtRisk': 7247, 'deathsNumAtRisk': 7247, 'otherNumAffected': 0, 'seriousNumAtRisk': 7247, 'deathsNumAffected': 146, 'seriousNumAffected': 21}, {'id': 'EG002', 'title': 'Enhanced IVR (IVR+)', 'description': 'usual care plus automated phone calls plus educational mailings and mail follow-up for persistent nonadherence', 'otherNumAtRisk': 7250, 'deathsNumAtRisk': 7250, 'otherNumAffected': 0, 'seriousNumAtRisk': 7250, 'deathsNumAffected': 140, 'seriousNumAffected': 22}], 'seriousEvents': [{'term': 'potential ACEI/ARB related hospitalization', 'notes': 'organ system categorization is incomplete. this includes hospitalization for acute renal failure, angioedema, anaphylactic shock, and anaphylactic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4330, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 4370, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 4323, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'potential statin related hospitalization', 'notes': 'specifically includes hospitalizations for liver failure or cirrhosis rhabdomyolysis as a primary discharge diagnosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3980, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3971, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence to Statins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5484', 'groupId': 'OG000'}, {'value': '5453', 'groupId': 'OG001'}, {'value': '5429', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (UC)', 'description': 'statin users in UC arm'}, {'id': 'OG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'statin users in IVR arm'}, {'id': 'OG002', 'title': 'Enhanced IVR (IVR+)', 'description': 'statin users in IVR+ arm'}], 'classes': [{'title': 'overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5484', 'groupId': 'OG000'}, {'value': '5453', 'groupId': 'OG001'}, {'value': '5429', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '0.34', 'groupId': 'OG002'}]}]}, {'title': 'baseline adherence <= 0.40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1880', 'groupId': 'OG000'}, {'value': '1827', 'groupId': 'OG001'}, {'value': '1842', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.36', 'groupId': 'OG002'}]}]}, {'title': 'baseline adherence 0.4-0.75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3165', 'groupId': 'OG000'}, {'value': '3141', 'groupId': 'OG001'}, {'value': '3122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': 'baseline adherence 0.75-0.90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}, {'value': '465', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.022', 'ciLowerLimit': '0.011', 'ciUpperLimit': '0.034', 'estimateComment': 'Adjusted difference in adherence for IVR group versus UC group, calculated as IVR - UC.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.030', 'ciLowerLimit': '0.019', 'ciUpperLimit': '0.042', 'estimateComment': 'Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline statin adherence.'}], 'paramType': 'MEAN', 'timeFrame': '12 months post randomization', 'description': "We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window.\n\nWe used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.", 'unitOfMeasure': 'mMPR as a fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were taking statins at the time of randomization'}, {'type': 'PRIMARY', 'title': 'Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4330', 'groupId': 'OG000'}, {'value': '4370', 'groupId': 'OG001'}, {'value': '4323', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (UC)', 'description': 'ACEI/ARB users in UC arm'}, {'id': 'OG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'ACEI/ARB users in IVR arm'}, {'id': 'OG002', 'title': 'Enhanced IVR (IVR+)', 'description': 'ACEI/ARB users in IVR+ arm'}], 'classes': [{'title': 'overall', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '0.61', 'spread': '0.34', 'groupId': 'OG002'}]}]}, {'title': 'baseline adherence <=0.50', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.36', 'groupId': 'OG002'}]}]}, {'title': 'baseline adherence 0.50-0.75', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '0.29', 'groupId': 'OG002'}]}]}, {'title': 'baseline adherence 0.75-0.90', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.016', 'ciLowerLimit': '0.002', 'ciUpperLimit': '0.029', 'estimateComment': 'Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.037', 'ciLowerLimit': '0.023', 'ciUpperLimit': '0.050', 'estimateComment': 'Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.'}], 'paramType': 'MEAN', 'timeFrame': '12 months post randomization', 'description': 'We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.', 'unitOfMeasure': 'mMPR expressed as a fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were taking an ACEI or an ARB at the time of randomization'}, {'type': 'SECONDARY', 'title': 'Percentage With Good (>80%) Statin Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5484', 'groupId': 'OG000'}, {'value': '5453', 'groupId': 'OG001'}, {'value': '5429', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (UC)', 'description': 'statin users in UC arm'}, {'id': 'OG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'statin users in IVR arm'}, {'id': 'OG002', 'title': 'Enhanced IVR (IVR+)', 'description': 'statin users in IVR+ arm'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '35.9', 'groupId': 'OG001'}, {'value': '35.8', 'groupId': 'OG002'}]}]}, {'title': 'baseline adherence <=0.40', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}, {'value': '21.8', 'groupId': 'OG002'}]}]}, {'title': 'baseline adherence 0.4-0.75', 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000'}, {'value': '39.4', 'groupId': 'OG001'}, {'value': '40.1', 'groupId': 'OG002'}]}]}, {'title': 'baseline adherence 0.75-0.90', 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}, {'value': '63.5', 'groupId': 'OG001'}, {'value': '62.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.24', 'pValueComment': 'Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.', 'estimateComment': 'Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.26', 'pValueComment': 'Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.', 'estimateComment': 'Adjusted odds ratio for good adherence in IVR+ group versus UC group, calculated as IVR+ - UC.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months post randomization', 'description': 'Binary indicator of good statin adherence, defined as an mMPR\\>0.80. 1=yes, 0=no.', 'unitOfMeasure': 'percent with good adherence', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were taking statins at the time of randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage With Good (>80%) ACEI/ARB Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4330', 'groupId': 'OG000'}, {'value': '4370', 'groupId': 'OG001'}, {'value': '4323', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (UC)', 'description': 'ACEI/ARB users in UC arm'}, {'id': 'OG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'ACEI/ARB users in IVR arm'}, {'id': 'OG002', 'title': 'Enhanced IVR (IVR+)', 'description': 'ACEI/ARB users in IVR+ arm'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4330', 'groupId': 'OG000'}, {'value': '4370', 'groupId': 'OG001'}, {'value': '4323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000'}, {'value': '40.3', 'groupId': 'OG001'}, {'value': '41.6', 'groupId': 'OG002'}]}]}, {'title': 'Baseline adherence <=0.50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2111', 'groupId': 'OG000'}, {'value': '2123', 'groupId': 'OG001'}, {'value': '2155', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '27.0', 'groupId': 'OG001'}, {'value': '28.2', 'groupId': 'OG002'}]}]}, {'title': 'Baseline adherence 0.50-0.75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'OG000'}, {'value': '1059', 'groupId': 'OG001'}, {'value': '1058', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '51.1', 'groupId': 'OG001'}, {'value': '52.0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline adherence 0.75-0-.90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '723', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}, {'value': '657', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000'}, {'value': '62.0', 'groupId': 'OG001'}, {'value': '66.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.23', 'pValueComment': 'adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence', 'estimateComment': 'Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.32', 'pValueComment': 'Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.', 'estimateComment': 'Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months post randomization', 'description': 'Binary indicator of good ACEI/ARB adherence, defined as an mMPR\\>0.80. 1=yes, 0=no.', 'unitOfMeasure': 'Percent with good adherence', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were taking an ACEI or an ARB at the time of randomization'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3980', 'groupId': 'OG000'}, {'value': '3980', 'groupId': 'OG001'}, {'value': '3971', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (UC)', 'description': 'ACEI/ARB users in UC arm'}, {'id': 'OG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'ACEI/ARB users in IVR arm .'}, {'id': 'OG002', 'title': 'Enhanced IVR (IVR+)', 'description': 'ACEI/ARB users in IVR+ arm'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3980', 'groupId': 'OG000'}, {'value': '3980', 'groupId': 'OG001'}, {'value': '3971', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '129.2', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '128.6', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '129.0', 'spread': '13.2', 'groupId': 'OG002'}]}]}, {'title': 'Baseline SBP<=130mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2111', 'groupId': 'OG000'}, {'value': '2123', 'groupId': 'OG001'}, {'value': '2155', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '123.5', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '122.8', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '123.4', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline SBP 130-140mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'OG000'}, {'value': '1059', 'groupId': 'OG001'}, {'value': '1058', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '132.8', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '132.2', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '132.7', 'spread': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline SBP>140mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '723', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}, {'value': '657', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '140.6', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '140.4', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '140.9', 'spread': '13.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.0', 'pValueComment': 'As noted above, the a priori threshold for statistical significance for this test was .025.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline SBP group.'}, {'pValue': '.93', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-.5', 'ciUpperLimit': '.5', 'pValueComment': 'As noted above, the a priori threshold for statistical significance for this test was .025.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group.'}], 'paramType': 'MEAN', 'timeFrame': '12-months post randomization', 'description': 'Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis sample was restricted to ACEI/ARB users with at least one post intervention SBP measurement recorded in the EMR. We did not impute any missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage With Good (<140/90 mmHg) Blood Pressure Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3980', 'groupId': 'OG000'}, {'value': '3980', 'groupId': 'OG001'}, {'value': '3971', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (UC)', 'description': 'ACEI/ARB users in UC arm'}, {'id': 'OG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'ACEI/ARB users in IVR arm .'}, {'id': 'OG002', 'title': 'Enhanced IVR (IVR+)', 'description': 'ACEI/ARB users in IVR+ arm'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}, {'value': '82.1', 'groupId': 'OG001'}, {'value': '81.3', 'groupId': 'OG002'}]}]}, {'title': 'Baseline SBP<=130 mmHg', 'categories': [{'measurements': [{'value': '93.7', 'groupId': 'OG000'}, {'value': '94.0', 'groupId': 'OG001'}, {'value': '92.9', 'groupId': 'OG002'}]}]}, {'title': 'Baseline SBP 130-140 mmHg', 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000'}, {'value': '78.4', 'groupId': 'OG001'}, {'value': '78.3', 'groupId': 'OG002'}]}]}, {'title': 'Baseline SBP>140 mmHg', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}, {'value': '50.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.404', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.19', 'pValueComment': 'As noted above, the a priori threshold for statistical significance for this test was .025.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group'}, {'pValue': '.54', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.96', 'ciLowerLimit': '.85', 'ciUpperLimit': '1.09', 'pValueComment': 'As noted above, the a priori threshold for statistical significance for this test was .025.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group'}], 'paramType': 'NUMBER', 'timeFrame': '12 months post randomization', 'description': 'Using the mean of last 5 available blood pressure measurements post randomization, we defined BP control as a means systolic BP \\<140 mmHg and a mean diastolic BP \\< 90 mmHg.', 'unitOfMeasure': 'percentage of subjects with good control', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were taking an ACEI or an ARB at the time of randomization and who had at least one post randomization BP recorded in the EMR. Missing data were not imputed.'}, {'type': 'SECONDARY', 'title': 'Post Intervention Low Density Lipoprotein (LDL) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4621', 'groupId': 'OG000'}, {'value': '4610', 'groupId': 'OG001'}, {'value': '4545', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (UC)', 'description': 'statin users in UC arm'}, {'id': 'OG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'statin users in IVR arm'}, {'id': 'OG002', 'title': 'Enhanced IVR (IVR+)', 'description': 'statin users in IVR+ arm'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4621', 'groupId': 'OG000'}, {'value': '4610', 'groupId': 'OG001'}, {'value': '4545', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.4', 'spread': '35.3', 'groupId': 'OG000'}, {'value': '91.8', 'spread': '34.0', 'groupId': 'OG001'}, {'value': '91.3', 'spread': '33.3', 'groupId': 'OG002'}]}]}, {'title': 'Baseline LDL <=80 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1815', 'groupId': 'OG000'}, {'value': '1769', 'groupId': 'OG001'}, {'value': '1734', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.5', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '25.7', 'groupId': 'OG001'}, {'value': '75.6', 'spread': '26.1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline LDL 80-100 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1155', 'groupId': 'OG000'}, {'value': '1224', 'groupId': 'OG001'}, {'value': '1193', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.0', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '91.5', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '90.7', 'spread': '24.9', 'groupId': 'OG002'}]}]}, {'title': 'Baseline LDL>100 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1352', 'groupId': 'OG000'}, {'value': '1329', 'groupId': 'OG001'}, {'value': '1346', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '114.9', 'spread': '37.9', 'groupId': 'OG000'}, {'value': '113.0', 'spread': '37.9', 'groupId': 'OG001'}, {'value': '111.4', 'spread': '36.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.7', 'pValueComment': 'As noted above, the a priori threshold for statistical significance for this test was .025.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL subgroups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.'}, {'pValue': '.019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '-0.2', 'pValueComment': 'As noted above, the a priori threshold for statistical significance for this test was .025.', 'estimateComment': 'MeanLDL levels were sig lower for IVR+ participants than for UC participants. In subgroup analyses this difference was most pronounced in those individuals with baseline LDL levels above 100 mg/dL (adj diff=-3.6 mg/dL, 95%CI= (-5.9, -1.3), p=.002).', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.'}], 'paramType': 'MEAN', 'timeFrame': '12 months post randomization', 'description': 'We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were taking statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.'}, {'type': 'SECONDARY', 'title': 'Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4621', 'groupId': 'OG000'}, {'value': '4610', 'groupId': 'OG001'}, {'value': '4545', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (UC)', 'description': 'statin users in UC arm'}, {'id': 'OG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'statin users in IVR arm'}, {'id': 'OG002', 'title': 'Enhanced IVR (IVR+)', 'description': 'statin users in IVR+ arm'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000'}, {'value': '69.8', 'groupId': 'OG001'}, {'value': '70.4', 'groupId': 'OG002'}]}]}, {'title': 'Baseline LDL <=80 mg/dL', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}, {'value': '88.0', 'groupId': 'OG001'}, {'value': '88.1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline LDL 80-100 mg/dL', 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}, {'value': '74.0', 'groupId': 'OG001'}, {'value': '74.9', 'groupId': 'OG002'}]}]}, {'title': 'Baseline LDL > 100 mg/dL', 'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000'}, {'value': '43.5', 'groupId': 'OG001'}, {'value': '44.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.13', 'pValueComment': 'As noted above, the a priori threshold for statistical significance for this test was .025.', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.'}, {'pValue': '.058', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.22', 'pValueComment': 'As noted above, the a priori threshold for statistical significance for this test was .025.', 'estimateComment': 'Though higher for the IVR+ group, LDL control did not differ significantly between the IVR+ and UC arms. Among those with poor initial control, however, control was sig better for the IVR+ arm (OR = 1.21, 95%CI = (1.04, 1.42), p=.015).', 'groupDescription': 'We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months post randomization', 'description': 'Using the last LDL measurement (fasting or nonfasting) available in the EMR post randomization, we defined good control as an LDL level \\<= 100 mg/dL.', 'unitOfMeasure': 'percentage with controlled LDL', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were taking a statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care (UC)', 'description': 'Participants in this arm had full access to all care they were normally entitled to as part of usual care'}, {'id': 'FG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.\n\nThe calls fell into two basic types: simple refill reminders and "tardy" calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser\'s automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population.'}, {'id': 'FG002', 'title': 'Enhanced IVR (IVR+)', 'description': "Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.\n\nThe educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Separate analyses were done for statin users and ACEI/ARB users. This is the combined N.', 'groupId': 'FG000', 'numSubjects': '7255'}, {'comment': 'Separate analyses were done for statin users and ACEI/ARB users. This is the combined N.', 'groupId': 'FG001', 'numSubjects': '7247'}, {'comment': 'Separate analyses were done for statin users and ACEI/ARB users. This is the combined N.', 'groupId': 'FG002', 'numSubjects': '7250'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'mean (SD) duration of follow-up was 9.7 (2.3) mos, but we computed an adherence score for everyone.', 'groupId': 'FG000', 'numSubjects': '7255'}, {'comment': 'mean (SD) duration of follow-up was 9.6 (2.4) mos, but we computed an adherence score for everyone.', 'groupId': 'FG001', 'numSubjects': '7247'}, {'comment': 'mean (SD) duration of follow-up was 9.6 (2.5) mos, but we computed an adherence score for everyone.', 'groupId': 'FG002', 'numSubjects': '7250'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7255', 'groupId': 'BG000'}, {'value': '7247', 'groupId': 'BG001'}, {'value': '7250', 'groupId': 'BG002'}, {'value': '21752', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care (UC)', 'description': 'Participants in this arm had full access to all care they were normally entitled to as part of usual care'}, {'id': 'BG001', 'title': 'Interactive Voice Recognition (IVR)', 'description': 'In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.\n\nThe calls fell into two basic types: simple refill reminders and "tardy" calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser\'s automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population.'}, {'id': 'BG002', 'title': 'Enhanced IVR (IVR+)', 'description': "Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.\n\nThe educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '12.2', 'groupId': 'BG002'}, {'value': '63.6', 'spread': '12.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3432', 'groupId': 'BG000'}, {'value': '3370', 'groupId': 'BG001'}, {'value': '3415', 'groupId': 'BG002'}, {'value': '10217', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3823', 'groupId': 'BG000'}, {'value': '3877', 'groupId': 'BG001'}, {'value': '3835', 'groupId': 'BG002'}, {'value': '11535', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1270', 'groupId': 'BG000'}, {'value': '1290', 'groupId': 'BG001'}, {'value': '1254', 'groupId': 'BG002'}, {'value': '3814', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '798', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '783', 'groupId': 'BG002'}, {'value': '2400', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1168', 'groupId': 'BG000'}, {'value': '1094', 'groupId': 'BG001'}, {'value': '1109', 'groupId': 'BG002'}, {'value': '3371', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '3403', 'groupId': 'BG000'}, {'value': '3399', 'groupId': 'BG001'}, {'value': '3408', 'groupId': 'BG002'}, {'value': '10210', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '565', 'groupId': 'BG000'}, {'value': '602', 'groupId': 'BG001'}, {'value': '652', 'groupId': 'BG002'}, {'value': '1819', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7255', 'groupId': 'BG000'}, {'value': '7247', 'groupId': 'BG001'}, {'value': '7250', 'groupId': 'BG002'}, {'value': '21752', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ever smokers', 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '3482', 'groupId': 'BG000'}, {'value': '3537', 'groupId': 'BG001'}, {'value': '3560', 'groupId': 'BG002'}, {'value': '10579', 'groupId': 'BG003'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '3773', 'groupId': 'BG000'}, {'value': '3710', 'groupId': 'BG001'}, {'value': '3690', 'groupId': 'BG002'}, {'value': '11173', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'co-morbid diabetes mellitus', 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '5666', 'groupId': 'BG000'}, {'value': '5703', 'groupId': 'BG001'}, {'value': '5626', 'groupId': 'BG002'}, {'value': '16995', 'groupId': 'BG003'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '1589', 'groupId': 'BG000'}, {'value': '1544', 'groupId': 'BG001'}, {'value': '1624', 'groupId': 'BG002'}, {'value': '4757', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'co-morbid cardiovascular disease', 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '2626', 'groupId': 'BG000'}, {'value': '2616', 'groupId': 'BG001'}, {'value': '2661', 'groupId': 'BG002'}, {'value': '7903', 'groupId': 'BG003'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '4629', 'groupId': 'BG000'}, {'value': '4631', 'groupId': 'BG001'}, {'value': '4589', 'groupId': 'BG002'}, {'value': '13849', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'target medication use', 'classes': [{'title': 'statin only', 'categories': [{'measurements': [{'value': '2924', 'groupId': 'BG000'}, {'value': '2870', 'groupId': 'BG001'}, {'value': '2922', 'groupId': 'BG002'}, {'value': '8716', 'groupId': 'BG003'}]}]}, {'title': 'ACEI/ARB only', 'categories': [{'measurements': [{'value': '1770', 'groupId': 'BG000'}, {'value': '1790', 'groupId': 'BG001'}, {'value': '1820', 'groupId': 'BG002'}, {'value': '5380', 'groupId': 'BG003'}]}]}, {'title': 'statin and ACEI/ARB', 'categories': [{'measurements': [{'value': '2561', 'groupId': 'BG000'}, {'value': '2587', 'groupId': 'BG001'}, {'value': '2508', 'groupId': 'BG002'}, {'value': '7656', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21752}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-01', 'studyFirstSubmitDate': '2010-11-30', 'resultsFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2010-11-30', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-07', 'studyFirstPostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to Statins', 'timeFrame': '12 months post randomization', 'description': "We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window.\n\nWe used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications."}, {'measure': 'Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)', 'timeFrame': '12 months post randomization', 'description': 'We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.'}], 'secondaryOutcomes': [{'measure': 'Percentage With Good (>80%) Statin Adherence', 'timeFrame': '12 months post randomization', 'description': 'Binary indicator of good statin adherence, defined as an mMPR\\>0.80. 1=yes, 0=no.'}, {'measure': 'Percentage With Good (>80%) ACEI/ARB Adherence', 'timeFrame': '12 months post randomization', 'description': 'Binary indicator of good ACEI/ARB adherence, defined as an mMPR\\>0.80. 1=yes, 0=no.'}, {'measure': 'Systolic Blood Pressure (SBP)', 'timeFrame': '12-months post randomization', 'description': 'Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.'}, {'measure': 'Percentage With Good (<140/90 mmHg) Blood Pressure Control', 'timeFrame': '12 months post randomization', 'description': 'Using the mean of last 5 available blood pressure measurements post randomization, we defined BP control as a means systolic BP \\<140 mmHg and a mean diastolic BP \\< 90 mmHg.'}, {'measure': 'Post Intervention Low Density Lipoprotein (LDL) Level', 'timeFrame': '12 months post randomization', 'description': 'We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.'}, {'measure': 'Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control', 'timeFrame': '12 months post randomization', 'description': 'Using the last LDL measurement (fasting or nonfasting) available in the EMR post randomization, we defined good control as an LDL level \\<= 100 mg/dL.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'cardiovascular disease', 'randomized clinical trial', 'medication adherence', 'health information technology', 'adult', 'telephone calls', 'IVR'], 'conditions': ['Diabetes Mellitus', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '25811824', 'type': 'RESULT', 'citation': 'Vollmer WM, Owen-Smith AA, Tom JO, Laws R, Ditmer DG, Smith DH, Waterbury AC, Schneider JL, Yonehara CH, Williams A, Vupputuri S, Rand CS. Improving adherence to cardiovascular disease medications with information technology. Am J Manag Care. 2014 Nov;20(11 Spec No. 17):SP502-10.'}, {'pmid': '27021751', 'type': 'RESULT', 'citation': "Smith DH, O'Keeffe-Rosetti M, Owen-Smith AA, Rand C, Tom J, Vupputuri S, Laws R, Waterbury A, Hankerson-Dyson DD, Yonehara C, Williams A, Schneider J, Dickerson JF, Vollmer WM. Improving Adherence to Cardiovascular Therapies: An Economic Evaluation of a Randomized Pragmatic Trial. Value Health. 2016 Mar-Apr;19(2):176-84. doi: 10.1016/j.jval.2015.11.013. Epub 2016 Feb 12."}, {'pmid': '27352409', 'type': 'RESULT', 'citation': 'Owen-Smith AA, Smith DH, Rand CS, Tom JO, Laws R, Waterbury A, Williams A, Vollmer WM. Difference in Effectiveness of Medication Adherence Intervention by Health Literacy Level. Perm J. 2016 Summer;20(3):15-200. doi: 10.7812/TPP/15-200. Epub 2016 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized clinical trial is to determine whether two low-intensity, technology based interventions, when compared to each other and to usual care, improve adherence to selected medications that are used to treat people with cardiovascular disease (CVD) and diabetes.', 'detailedDescription': 'The frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. Many studies have linked medication non-adherence to treatment failure; unnecessary and dangerous intensification of therapy; and excess health care costs, hospitalizations, and deaths. Although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. Simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. The proposed PATIENT study will use health information technology (automated phone calls and access to an electronic medical record) to test two such interventions and compare them to each other and to usual care alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 40 years or older as of time of randomization.\n* Flagged in KP\'s databases as having either diabetes or atherosclerotic cardiovascular disease(defined as coronary artery disease, peripheral vascular disease, or a history of atherosclerotic stroke) at the time of randomization\n* At least one dispensing of an ACEI, ARB, or statin from a Kaiser Permanente (KP) outpatient pharmacy during the baseline year.\n* Suboptimal adherence ((MPR\\<0.9) to either statins or ACEI/ARBs during the baseline year\n* Continuous membership in KP for the 12 months prior to randomization.\n* Qualified for an intervention call at the time of randomization.\n\nExclusion Criteria:\n\n* Evidence in the electronic medical record (EMR) of allergy or intolerance to statins or ACE inhibitors/ARBs\n* medical conditions that would contraindicate use of statins or ACEI/ARBs\n* Absence of either a phone number or mailing address in the EMR\n* for Kaiser Permanente Hawaii, clinics whose patients tend to fill prescriptions primarily at non-KP pharmacies\n* on Kaiser Permanente\'s "do not contact" list or in other research studies that could add undue burden'}, 'identificationModule': {'nctId': 'NCT01251757', 'acronym': 'PATIENT', 'briefTitle': 'Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)', 'orgStudyIdInfo': {'id': 'R01HS019341-01', 'link': 'https://reporter.nih.gov/quickSearch/R01HS019341-01', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care (UC)', 'description': 'Participants in this arm received their usual care with no restrictions.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interactive Voice Recognition (IVR)', 'description': 'automated phone calls', 'interventionNames': ['Other: Interactive Voice Recognition (IVR) phone calls']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced IVR (IVR+)', 'description': 'automated phone calls \\& Educational mailings and follow-up for nonadherence', 'interventionNames': ['Other: Interactive Voice Recognition (IVR) phone calls', 'Other: Educational mailings and follow-up for nonadherence']}], 'interventions': [{'name': 'Interactive Voice Recognition (IVR) phone calls', 'type': 'OTHER', 'otherNames': ['automated phone calls'], 'description': 'The IVR intervention consisted of automated phone calls designed to educate participants about their medications and to assist them in refilling their prescriptions. The calls fell into two basic types: simple refill reminders and "tardy" calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the electronic medical record (EMR). Call features included the ability to transfer individuals to Kaiser\'s automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population.', 'armGroupLabels': ['Enhanced IVR (IVR+)', 'Interactive Voice Recognition (IVR)']}, {'name': 'Educational mailings and follow-up for nonadherence', 'type': 'OTHER', 'otherNames': ['mail follow-up for nonadherence', 'educational mailings'], 'description': "Participants received bimonthly educational materials by mail. In addition, patients received mailed refill reminder letters and their providers were notified electronically if the patients failed to refill in response to the automated calls. The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as frequently asked questions (FAQs) about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers.", 'armGroupLabels': ['Enhanced IVR (IVR+)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30305', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Center for Health Research, Kaiser Permanente Southeast', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Center for Health Research, Kaiser Permanente Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Center for Health Research, Kaiser Permanente Northwest', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'William M Vollmer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Health Research, Kaiser Permanente Northwest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At the request of AHRQ we did not create a formal public data release.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiser Foundation Hospitals, Center for Health Research', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}