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Study to Lower Veterans BP: Patient/Physician Intervention
This study has been completed.
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105716
  Purpose

This four and a half year trial is evaluating both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient health education and behavioral intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.


Condition Intervention
Hypertension
Behavioral: Telephone behavioral education
Behavioral: Computer behavioral education

MedlinePlus related topics: High Blood Pressure
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title: Study to Lower Veterans Blood Pressure: Patient/Physician Intervention

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge and perceived risks associated with hypertension and ability to continue hypertension regimen will be assessed at baseline and via telephone 6 and 24 months after baseline; Medication adherence will be assessed from pharmacy records [ Designated as safety issue: No ]

Estimated Enrollment: 544
Study Start Date: March 2002
Study Completion Date: April 2005
Arms Assigned Interventions
1 Behavioral: Telephone behavioral education Behavioral: Computer behavioral education

Detailed Description:

Background:

There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension, yet only 31% have their blood pressure (BP) under effective control. Uncontrolled hypertension greatly increases the risk of stroke, CAD, renal failure, CHF, and mortality.

Objectives:

This four year study evaluated simultaneously both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses were: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient behavioral/education intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.

Methods:

This was a randomized controlled trial with a split-plot design. Thirty primary care providers in the Durham VAMC Primary Care Clinic were randomly assigned to receive either the provider intervention or basic patient information; 588 of their hypertensive patients were randomized to the patient intervention or usual care. The provider intervention (ATHENA study (IIR 99-275) included an electronically generated hypertension decision support system (DSS) delivered to the provider at each hypertensive patient's visit. The provider intervention was designed to improve guideline concordant therapy. The patient intervention was a tailored behavioral/education intervention administered at periodic telephone contacts. The intervention included support and reminders, information on hypertension and on health behaviors. Patients received feedback about their recent BP values, continuous patient education, and were monitored and supported to enhance adherence. The control group was usual care.

Status:

Complete. Major activities completed in the past 12 months include submission of a manuscript describing the study, the interventions, and baseline and follow-up analyses. Secondary analyses are being completed which will be included in additional manuscripts.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >1 ICD9 Diagnosis 401.0, 401.1, 401.9
  2. Designated Primary Care Provider
  3. >1 Primary Care visit between 1/01/01-12/31/01
  4. Restricted to NC and VA addresses
  5. >1 Medication CV100, CV150, CV200, CV490, CV701, CV702, CV704, CV800, CV805

Exclusion Criteria:

  1. Dialysis patient
  2. Hospitalization for stroke in prior 3 months
  3. Myocardial infarction in prior 3 months
  4. Coronary artery revascularization in prior 3 months
  5. Metastatic cancer diagnosis in prior 3 months
  6. Transplant of: kidney; liver; lung; pancreas; peripheral stem cells; bone; bone marrow; heart; intestine; stem cells; tissue V42.9; complications of transplants
  7. Nursing home resident
  8. Documented diagnosis of dementia
  9. Difficulty hearing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105716

Locations
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Hayden B. Bosworth, PhD Department of Veterans Affairs
  More Information

Publications of Results:
Powers BJ, Oddone EZ, Grubber JM, Olsen MK, Bosworth HB. Perceived and actual stroke risk among men with hypertension. J Clin Hypertens (Greenwich). 2008 Apr;10(4):287-94.
Olsen MK, Delong ER, Oddone EZ, Bosworth HB. Strategies for analyzing multilevel cluster-randomized studies with binary outcomes collected at varying intervals of time. Stat Med. 2008 Sep 29; [Epub ahead of print]
Walsh JM, Sundaram V, McDonald K, Owens DK, Goldstein MK. Implementing effective hypertension quality improvement strategies: barriers and potential solutions. J Clin Hypertens (Greenwich). 2008 Apr;10(4):311-6. Review.
Lin ND, Martins SB, Chan AS, Coleman RW, Bosworth HB, Oddone EZ, Shankar RD, Musen MA, Hoffman BB, Goldstein MK. Identifying barriers to hypertension guideline adherence using clinician feedback at the point of care. AMIA Annu Symp Proc. 2006;:494-8.
Cho AH, Voils CI, Yancy WS Jr, Oddone EZ, Bosworth HB. Does participatory decision making improve hypertension self-care behaviors and outcomes? J Clin Hypertens (Greenwich). 2007 May;9(5):330-6.
Hong TB, Oddone EZ, Dudley TK, Bosworth HB. Subjective and objective evaluations of health among middle-aged and older veterans with hypertension. J Aging Health. 2005 Oct;17(5):592-608.
Bosworth HB, Olsen MK, Gentry P, Orr M, Dudley T, McCant F, Oddone EZ. Nurse administered telephone intervention for blood pressure control: a patient-tailored multifactorial intervention. Patient Educ Couns. 2005 Apr;57(1):5-14.
Bosworth HB, Olsen MK, Goldstein MK, Orr M, Dudley T, McCant F, Gentry P, Oddone EZ. The veterans' study to improve the control of hypertension (V-STITCH): design and methodology. Contemp Clin Trials. 2005 Apr;26(2):155-68.
Lowry KP, Dudley TK, Oddone EZ, Bosworth HB. Intentional and unintentional nonadherence to antihypertensive medication. Ann Pharmacother. 2005 Jul-Aug;39(7-8):1198-203. Epub 2005 Jun 14.
Bosworth HB, Oddone EZ. A model of psychosocial and cultural antecedents of blood pressure control. J Natl Med Assoc. 2002 Apr;94(4):236-48.
Steinman MA, Fischer MA, Shlipak MG, Bosworth HB, Oddone EZ, Hoffman BB, Goldstein MK. Clinician awareness of adherence to hypertension guidelines. Am J Med. 2004 Nov 15;117(10):747-54.
Chan AS, Coleman RW, Martins SB, Advani A, Musen MA, Bosworth HB, Oddone EZ, Shlipak MG, Hoffman BB, Goldstein MK. Evaluating provider adherence in a trial of a guideline-based decision support system for hypertension. Medinfo. 2004;11(Pt 1):125-9.
Bosworth HB, Dudley T, Olsen MK, Voils CI, Powers B, Goldstein MK, Oddone EZ. Racial differences in blood pressure control: potential explanatory factors. Am J Med. 2006 Jan;119(1):70.e9-15.

Responsible Party: Department of Veterans Affairs ( Bosworth, Hayden - Principal Investigator )
Study ID Numbers: IIR 20-034
Study First Received: March 16, 2005
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00105716  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hypertension
adherence
cardiovascular diseases

Study placed in the following topic categories:
Vascular Diseases
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009