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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL070740 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to evaluate the impact of physician/pharmacist collaborative teams on hypertension guideline adherence for patients with uncontrolled hypertension in six family medicine practice sites in Iowa.
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Active intervention participants receive a physician-pharmacist collaborative intervention. |
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| 2 | No Intervention | Control participants do not receive recommendations from a clinical pharmacist. | |
| 3 | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician-pharmacist collaborative intervention | Behavioral | Participants receive assessment and medication and lifestyle recommendations from a clinical pharmacist. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence to hypertension guidelines | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure control | Measured at baseline, 3 months, and 6 months | |
| Physician knowledge | Measured prior to the start of the study and at the end of the study | |
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Inclusion Criteria for Phase II:
Exclusion Criteria for Phase II:
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| Name | Affiliation | Role |
|---|---|---|
| Barry L. Carter, PharmD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa College of Pharmacy | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15381676 | Background | Milchak JL, Carter BL, James PA, Ardery G. Measuring adherence to practice guidelines for the management of hypertension: an evaluation of the literature. Hypertension. 2004 Nov;44(5):602-8. doi: 10.1161/01.HYP.0000144100.29945.5e. Epub 2004 Sep 20. | |
| 16543909 | Background | Milchak JL, Carter BL, Ardery G, Black HR, Bakris GL, Jones DW, Kreiter CD. Development of explicit criteria to measure adherence to hypertension guidelines. J Hum Hypertens. 2006 Jun;20(6):426-33. doi: 10.1038/sj.jhh.1002005. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Patient medication adherence |
| Measured at the time of enrollment and when the participant completes the study |
| Physician-pharmacist relationship | Measured prior to the start of the study and at the end of the study |
| 16849901 | Background | Carter BL, Hartz A, Bergus G, Dawson JD, Doucette WR, Stewart JJ, Xu Y. Relationship between physician knowledge of hypertension and blood pressure control. J Clin Hypertens (Greenwich). 2006 Jul;8(7):481-6. doi: 10.1111/j.1524-6175.2006.05601.x. |
| 16982966 | Background | Carter BL. Antihypertensive prescribing: do we have reason to celebrate? Hypertension. 2006 Nov;48(5):816-7. doi: 10.1161/01.HYP.0000240978.77934.3a. Epub 2006 Sep 18. No abstract available. |
| 17268216 | Background | Ardery G, Carter BL, Milchak JL, Bergus GR, Dawson JD, James PA, Franciscus C, Kim Y. Explicit and implicit evaluation of physician adherence to hypertension guidelines. J Clin Hypertens (Greenwich). 2007 Feb;9(2):113-9. doi: 10.1111/j.1524-6175.2007.06112.x. |
| 17877445 | Background | Carter BL, Sica DA. Strategies to improve the cardiovascular risk profile of thiazide-type diuretics as used in the management of hypertension. Expert Opin Drug Saf. 2007 Sep;6(5):583-94. doi: 10.1517/14740338.6.5.583. |
| 19858431 | Background | Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009 Oct 26;169(19):1748-55. doi: 10.1001/archinternmed.2009.316. |
| 19933962 | Derived | Carter BL, Ardery G, Dawson JD, James PA, Bergus GR, Doucette WR, Chrischilles EA, Franciscus CL, Xu Y. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med. 2009 Nov 23;169(21):1996-2002. doi: 10.1001/archinternmed.2009.358. |