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Sponsors and Collaborators: |
Department of Veterans Affairs National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00495794 |
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.
Objectives: 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.
Condition | Intervention |
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Diabetes Hypertension |
Behavioral: Clinical pharmacist-based intervention |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Adherence and Intensification of Medications: A Population-Based Clinical Pharmacists Implementation Study Among Hypertensive Diabetes Patients |
Estimated Enrollment: | 219 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Patients with diabetes identified as having poor BP control AND (adherence or intensification problems)
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Behavioral: Clinical 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
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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.
Objectives: 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.
Methods: 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. 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 12-month intervention period. We will also conduct a formative evaluation during the course of the study and assess implementation attainment and potential for dissemination.
Status: Recruiting
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mandi L Klamerus, MPH BS | mandi.klamerus@med.va.gov | |
Contact: Mary M Hogan, BS MS PhD | Mary.Hogan@med.va.gov |
United States, Michigan | |
VA Ann Arbor Healthcare System | Recruiting |
Ann Arbor, Michigan, United States, 48113-0170 | |
Contact: Janet G Adams-Watson, MHSA BA (734) 845-3604 jan.adams-watson@va.gov | |
Contact: Julie C Lowery, PhD MHSA (734) 845-3619 Julie.Lowery@va.gov | |
Sub-Investigator: Sarah L. Krein, PhD RN | |
Sub-Investigator: John D. Piette, PhD | |
Principal Investigator: M.E. Michele Heisler, MD MPA | |
Sub-Investigator: Thomas A. Stavenger, BS RPh | |
Sub-Investigator: Jane H. Forman, AB MHS ScD | |
Sub-Investigator: Pamela J Reeves, MD | |
Sub-Investigator: Eve A. Kerr, MD MPH | |
Sub-Investigator: Timothy P. Hofer, MD MSc | |
Sub-Investigator: Steven J. Bernstein, MD MPH | |
John D. Dingell VA Medical Center, Detroit | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Mandi Klamerus, MPH 734-845-3618 mandi.klamerus@va.gov |
Principal Investigator: | M.E. Michele Heisler, MD MPA | VA Ann Arbor Healthcare System |
Responsible Party: | Department of Veterans Affairs ( Heisler, M.E. - Principal Investigator ) |
Study ID Numbers: | SDP 06-128, R18DK076622-01 |
Study First Received: | June 29, 2007 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00495794 |
Health Authority: | United States: Federal Government |
diabetes hypertension adherence |
implementation medications organization of care |
Metabolic Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypertension |
Cardiovascular Diseases |