title: Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.
abstract: Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, NC 27710, USA. Electronic address: george.l.jackson@duke.edu.
authors.forename: George L
authors.initials: GL
authors.lastname: Jackson
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.
authors.forename: Morris
authors.initials: M
authors.lastname: Weinberger
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
authors.forename: Miriam A
authors.initials: MA
authors.lastname: Kirshner
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
authors.forename: Karen M
authors.initials: KM
authors.lastname: Stechuchak
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
authors.forename: Stephanie D
authors.initials: SD
authors.lastname: Melnyk
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, NC 27710, USA.
authors.forename: Hayden B
authors.initials: HB
authors.lastname: Bosworth
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Biostatistics & Bioinformatics, Duke University, Durham, NC 27710, USA.
authors.forename: Cynthia J
authors.initials: CJ
authors.lastname: Coffman
authors.affiliation: Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC 29425, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Neelon
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, NC 27710, USA.
authors.forename: Courtney
authors.initials: C
authors.lastname: Van Houtven
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, NC 27710, USA.
authors.forename: Pamela W
authors.initials: PW
authors.lastname: Gentry
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
authors.forename: Isis J
authors.initials: IJ
authors.lastname: Morris
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, NC 27710, USA.
authors.forename: Cynthia M
authors.initials: CM
authors.lastname: Rose
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
authors.forename: Jennifer P
authors.initials: JP
authors.lastname: Taylor
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
authors.forename: Carrie L
authors.initials: CL
authors.lastname: May
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
authors.forename: Byungjoo
authors.initials: B
authors.lastname: Han
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
authors.forename: Christi
authors.initials: C
authors.lastname: Wainwright
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, NC 27710, USA.
authors.forename: Aviel
authors.initials: A
authors.lastname: Alkon
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
authors.forename: Lesa
authors.initials: L
authors.lastname: Powell
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, NC 27710, USA.
authors.forename: David
authors.initials: D
authors.lastname: Edelman
mesh_terms: D000293:Adolescent; D000328:Adult; D001741:Black or African American; D000367:Age Factors; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001521:Behavior Therapy / Q000379:methods; D018660:Blood Pressure Monitoring, Ambulatory; D019468:Disease Management; D015444:Exercise; D005260:Female; D015438:Health Behavior; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D054539:Medication Therapy Management / Q000458:organization & administration; D008875:Middle Aged; D010348:Patient Care Team / Q000458:organization & administration; D012107:Research Design; D012737:Sex Factors; D014481:United States; D014493:United States Department of Veterans Affairs; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents
keywords: Hypertension; Randomized controlled trial; Veterans