Improving Adherence to Blood Pressure Guidelines
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Improving Adherence to Blood Pressure Guidelines|
- Adherence to hypertension guidelines [ Time Frame: Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study ] [ Designated as safety issue: No ]
- Blood pressure control [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
- Physician knowledge [ Time Frame: Measured prior to the start of the study and at the end of the study ] [ Designated as safety issue: No ]
- Patient medication adherence [ Time Frame: Measured at the time of enrollment and when the participant completes the study ] [ Designated as safety issue: No ]
- Physician-pharmacist relationship [ Time Frame: Measured prior to the start of the study and at the end of the study ] [ Designated as safety issue: No ]
|Study Start Date:||August 2003|
|Study Completion Date:||July 2009|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Active intervention participants receive a physician-pharmacist collaborative intervention.
Behavioral: Physician-pharmacist collaborative intervention
Participants receive assessment and medication and lifestyle recommendations from a clinical pharmacist.
No Intervention: 2
Control participants do not receive recommendations from a clinical pharmacist.
No Intervention: 3
Passive intervention participants receive care by the same physicians caring for participants in the active intervention arm but are not seen by a clinical pharmacist. They are not actively enrolled in the study and do not have study visits for measuring blood pressure.
Hypertension is a prevalent chronic condition that, if left untreated, can lead to significant cardiovascular morbidity and premature mortality. There are established, evidence-based guidelines for the treatment of hypertension. However, these guidelines are not routinely adhered to by all providers for reasons that are not well known or understood. In addition, inadequate control of BP nationwide has been well documented. This study will explore barriers to guideline adherence (Phase I) and evaluate, via a randomized controlled trial, a new approach to enhancing guideline adherence and ultimately BP control.
The long-range goal of the principal investigator is to develop and evaluate collaborative relationships between physicians and pharmacists that improve pharmacotherapy. This will be a 5-year, multicenter study to evaluate the impact of physician/pharmacist collaborative teams on adherence to hypertension guidelines (JNC-VI) in six community-based family practice sites. There will be two study phases. Phase I comprises a needs assessment to identify barriers to guideline adherence and design intervention implementation refinement strategies. Phase II will be a prospective, randomized trial to assess the impact of physician/pharmacist collaborative teams on hypertension guideline adherence and BP control. The specific aims of Phase I are (1) to identify the scope and nature of physician and patient variables that may contribute to poor guideline adherence and (2) to refine the intervention implementation strategy and design tools for assessing guideline adherence and barriers to adherence. The specific aims of Phase II are (1) to determine if there is a change in guideline adherence and knowledge of hypertension when physicians are involved in physician/pharmacist teams and 2) to determine if physician/pharmacist teams can achieve better BP control compared to usual care. The investigators expect that the improvement in guideline adherence and reduction in BP with this intervention will significantly impact patients with hypertension. Because there are more than 37 million Americans with uncontrolled hypertension, this model has the potential to become an important strategy to help achieve the BP goals for Healthy People 2010.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201019
|United States, Iowa|
|University of Iowa College of Pharmacy|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Barry L. Carter, PharmD||University of Iowa|