Study to Lower Veterans BP: Patient/Physician Intervention

NCT00105716 | Completed

• 1 other identifier: IIR 20-034
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

hypertension; adherence; cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.

Secondary Outcomes (1)

• 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

Study Arms (1)

Arm 1

OTHER

Behavioral: Telephone behavioral education; Behavioral: Computer behavioral education

Interventions

Telephone behavioral education BEHAVIORAL

Arm 1

Computer behavioral education BEHAVIORAL

Arm 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Dialysis patient
• Hospitalization for stroke in prior 3 months
• Myocardial infarction in prior 3 months
• Coronary artery revascularization in prior 3 months
• Metastatic cancer diagnosis in prior 3 months
• Transplant of: kidney; liver; lung; pancreas; peripheral stem cells; bone; bone marrow; heart; intestine; stem cells; tissue V42.9; complications of transplants
• Nursing home resident
• Documented diagnosis of dementia
• Difficulty hearing

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (18)

• Datta SK, Oddone EZ, Olsen MK, Orr M, McCant F, Gentry P, Bosworth HB. Economic analysis of a tailored behavioral intervention to improve blood pressure control for primary care patients. Am Heart J. 2010 Aug;160(2):257-63. doi: 10.1016/j.ahj.2010.05.024.

  PMID: 20691830 RESULT

• Powers BJ, Olsen MK, Oddone EZ, Bosworth HB. The effect of a hypertension self-management intervention on diabetes and cholesterol control. Am J Med. 2009 Jul;122(7):639-46. doi: 10.1016/j.amjmed.2008.12.022.

  PMID: 19559166 RESULT

• Thorpe CT, Bryson CL, Maciejewski ML, Bosworth HB. Medication acquisition and self-reported adherence in veterans with hypertension. Med Care. 2009 Apr;47(4):474-81. doi: 10.1097/mlr.0b013e31818e7d4d.

  PMID: 19330891 RESULT

• Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.

  PMID: 19249414 RESULT

• Powers BJ, Olsen MK, Oddone EZ, Thorpe CT, Bosworth HB. Literacy and blood pressure--do healthcare systems influence this relationship? A cross-sectional study. BMC Health Serv Res. 2008 Oct 23;8:219. doi: 10.1186/1472-6963-8-219.

  PMID: 18947408 RESULT

• 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 Dec 20;27(29):6055-71. doi: 10.1002/sim.3446.

  PMID: 18825655 RESULT

• 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. doi: 10.1111/j.1751-7176.2008.07425.x.

  PMID: 18401229 RESULT

• 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. doi: 10.1111/j.1524-6175.2007.06489.x.

  PMID: 17485968 RESULT

• 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. doi: 10.1111/j.1751-7176.2008.07797.x.

  PMID: 18401226 RESULT

• 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;2006:494-8.

  PMID: 17238390 RESULT

• 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. doi: 10.1345/aph.1E594. Epub 2005 Jun 14.

  PMID: 15956238 RESULT

• 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. doi: 10.1016/j.cct.2004.12.006.

  PMID: 15837438 RESULT

• 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.

  PMID: 11991336 RESULT

• 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. Stud Health Technol Inform. 2004;107(Pt 1):125-9.

  PMID: 15360788 RESULT

• 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. doi: 10.1016/j.amjmed.2004.03.035.

  PMID: 15541324 RESULT

• 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. doi: 10.1016/j.amjmed.2005.08.019.

  PMID: 16431192 RESULT

• 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. doi: 10.1177/0898264305279780.

  PMID: 16177452 RESULT

• 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. doi: 10.1016/j.pec.2004.03.011.

  PMID: 15797147 RESULT

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Hayden B. Bosworth, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• Eugene Z. Oddone, MD MHSc

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2005
• First Posted: March 17, 2005
• Study Start: March 1, 2002
• Study Completion: April 1, 2005
• Last Updated: April 7, 2015

Record last verified: 2006-04

Locations

US (1)