Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 6:11 PM
Study NCT ID:
NCT00495794
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2007-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adherence and Intensification of Medications (AIM) Implementation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mheisler@umich.edu', 'phone': '734-845-3504', 'title': 'Dr. Michele Heisler', 'organization': 'VA Center for Clinical Management Research; University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'In the intervention arm, only 53% of subjects had a pharmacist encounter. Higher rates of participation might have led to a more substantial initial improvement and a detectable longer term effect.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pharmacist Management', 'description': 'Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)\n\nClinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms', 'otherNumAtRisk': 2319, 'otherNumAffected': 0, 'seriousNumAtRisk': 2319, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Eligible patients receive usual care', 'otherNumAtRisk': 2303, 'otherNumAffected': 0, 'seriousNumAtRisk': 2303, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1693', 'groupId': 'OG000'}, {'value': '2162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacist Management', 'description': 'Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)\n\nClinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Eligible patients receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.9', 'groupId': 'OG000', 'lowerLimit': '-9.5', 'upperLimit': '-8.4'}, {'value': '-9.0', 'groupId': 'OG001', 'lowerLimit': '-9.6', 'upperLimit': '-8.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months prior to 6 months after the intervention period', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'A1c Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1477', 'groupId': 'OG000'}, {'value': '1920', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacist Management', 'description': 'Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)\n\nClinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Eligible patients receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after intervention period', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only participants with an A1c in the 12 months after the intervention period.'}, {'type': 'SECONDARY', 'title': 'LDL Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1410', 'groupId': 'OG000'}, {'value': '1824', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacist Management', 'description': 'Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)\n\nClinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Eligible patients receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '89.1', 'spread': '31.1', 'groupId': 'OG000'}, {'value': '87.8', 'spread': '32.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after invention period', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only participants with a LDL in the 12 months after the intervention period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pharmacist Management', 'description': 'Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)\n\nClinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Eligible patients receive usual care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2319'}, {'groupId': 'FG001', 'numSubjects': '2303'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1797'}, {'groupId': 'FG001', 'numSubjects': '2303'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '522'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Pharmacist did not activate patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '522'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1797', 'groupId': 'BG000'}, {'value': '2303', 'groupId': 'BG001'}, {'value': '4100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pharmacist Management', 'description': 'Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)\n\nClinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Eligible patients receive usual care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '65.3', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '65.3', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '547', 'groupId': 'BG000'}, {'value': '721', 'groupId': 'BG001'}, {'value': '1268', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1250', 'groupId': 'BG000'}, {'value': '1582', 'groupId': 'BG001'}, {'value': '2832', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1797', 'groupId': 'BG000'}, {'value': '2303', 'groupId': 'BG001'}, {'value': '4100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4622}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2007-06-29', 'resultsFirstSubmitDate': '2014-09-03', 'studyFirstSubmitQcDate': '2007-07-02', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-03', 'studyFirstPostDateStruct': {'date': '2007-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': '6 months prior to 6 months after the intervention period'}], 'secondaryOutcomes': [{'measure': 'A1c Control', 'timeFrame': '12 months after intervention period'}, {'measure': 'LDL Control', 'timeFrame': '12 months after invention period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'hypertension', 'adherence', 'implementation', 'medications', 'organization of care'], 'conditions': ['Diabetes', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '20939913', 'type': 'RESULT', 'citation': 'Heisler M, Hofer TP, Klamerus ML, Schmittdiel J, Selby J, Hogan MM, Bosworth HB, Tremblay A, Kerr EA. Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study. Trials. 2010 Oct 12;11:95. doi: 10.1186/1745-6215-11-95.'}, {'pmid': '23892775', 'type': 'RESULT', 'citation': 'Klamerus ML, Kerr EA, Bosworth HB, Schmittdiel JA, Heisler M. Characteristics of diabetic patients associated with achieving and maintaining blood pressure targets in the Adherence and Intensification of Medications program. Chronic Illn. 2014 Mar;10(1):60-73. doi: 10.1177/1742395313496590. Epub 2013 Jul 26.'}, {'pmid': '22570370', 'type': 'RESULT', 'citation': 'Heisler M, Hofer TP, Schmittdiel JA, Selby JV, Klamerus ML, Bosworth HB, Bermann M, Kerr EA. Improving blood pressure control through a clinical pharmacist outreach program in patients with diabetes mellitus in 2 high-performing health systems: the adherence and intensification of medications cluster randomized, controlled pragmatic trial. Circulation. 2012 Jun 12;125(23):2863-72. doi: 10.1161/CIRCULATIONAHA.111.089169. Epub 2012 May 8.'}, {'pmid': '22909303', 'type': 'RESULT', 'citation': 'Meddings J, Kerr EA, Heisler M, Hofer TP. Physician assessments of medication adherence and decisions to intensify medications for patients with uncontrolled blood pressure: still no better than a coin toss. BMC Health Serv Res. 2012 Aug 21;12:270. doi: 10.1186/1472-6963-12-270.'}, {'pmid': '22928756', 'type': 'RESULT', 'citation': 'Sussman JB, Zulman DM, Hayward R, Hofer TP, Kerr EA. Cardiac risk is not associated with hypertension treatment intensification. Am J Manag Care. 2012 Aug;18(8):414-20.'}, {'pmid': '22747998', 'type': 'RESULT', 'citation': 'Selby JV, Schmittdiel JA, Fireman B, Jaffe M, Ransom LJ, Dyer W, Uratsu CS, Reed ME, Kerr EA, Hsu J. Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial. BMC Health Serv Res. 2012 Jul 2;12:183. doi: 10.1186/1472-6963-12-183.'}]}, 'descriptionModule': {'briefSummary': "Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control.\n\nObjectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.", 'detailedDescription': "Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control.\n\nObjectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.\n\nMethods: In this cluster randomized implementation trial, we will proactively identify, using clinical automated data, all diabetes patients within 3 VA sites who have poor blood pressure control and either poor refill adherence or insufficient medication intensification. (NIDDK R18 funds 2 non-VA sites.) Adherence and treatment intensification patterns will also be evaluated for glycemia and lipids if either of these risk factors is poorly controlled. Clinical pharmacists, trained in motivational interviewing techniques and guided by computerized adherence modules, will identify barriers to medication adherence and provide adherence counseling. They will also be authorized to change and titrate medications following site-specific algorithms. Patients in the non-intervention (control) teams will receive usual care. Blood pressure control and refill adherence will be assessed 6-months after the end of the intervention period. We will also conduct a formative evaluation during the course of the study and assess implementation attainment and potential for dissemination.\n\nStatus: Data analysis complete. (Enrollment numbers are for VA and non-VA sites \\[control and intervention\\].)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVA inclusion criteria\n\n1. Must be a veteran at a study site;\n2. Have a diagnosis of diabetes;\n3. Meet blood pressure, medication adherence and intensification requirements (as determined by the study team)\n\nExclusion Criteria:\n\nVA Exclusion\n\n1. Dementia\n2. Traumatic brain injury\n3. Pregnancy\n4. Age \\<18 or \\>100'}, 'identificationModule': {'nctId': 'NCT00495794', 'briefTitle': 'Adherence and Intensification of Medications (AIM) Implementation Study', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Adherence and Intensification of Medications: A Population-Based Clinical Pharmacists Implementation Study Among Hypertensive Diabetes Patients', 'orgStudyIdInfo': {'id': 'SDP 06-128'}, 'secondaryIdInfos': [{'id': 'R18DK076622-01', 'link': 'https://reporter.nih.gov/quickSearch/R18DK076622-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmacist management', 'description': 'Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)', 'interventionNames': ['Behavioral: Clinical pharmacist-based intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Eligible patients receive usual care'}], 'interventions': [{'name': 'Clinical pharmacist-based intervention', 'type': 'BEHAVIORAL', 'description': 'Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms', 'armGroupLabels': ['Pharmacist management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'M. E. Michele Heisler, MD MPA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}