Study to Lower Veterans BP: Patient/Physician Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105716
First received: March 16, 2005
Last updated: October 25, 2013
Last verified: April 2006

March 16, 2005
October 25, 2013
March 2002
Not Provided
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 ]
Not Provided
Complete list of historical versions of study NCT00105716 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
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Study to Lower Veterans BP: Patient/Physician Intervention
Study to Lower Veterans Blood Pressure: Patient/Physician Intervention

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Hypertension
  • Behavioral: Telephone behavioral education
  • Behavioral: Computer behavioral education
Arm 1
Interventions:
  • Behavioral: Telephone behavioral education
  • Behavioral: Computer behavioral education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
544
April 2005
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105716
IIR 20-034
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Hayden B. Bosworth, PhD Department of Veterans Affairs
Principal Investigator: Eugene Z. Oddone, MD MHSc Department of Veterans Affairs
Department of Veterans Affairs
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP