Interventions to Improve Hypertension Control and Reduce Cardiovascular Disease Risk (HIP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laura Svetkey, Duke University
ClinicalTrials.gov Identifier:
NCT00201136
First received: September 12, 2005
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

This study will test the separate and combined effects of a continuous quality improvement (CQI) intervention for physicians (MDs) and a behavioral intervention for patients on blood pressure control.


Condition Intervention Phase
Hypertension
Behavioral: Lifestyle interventions to lower blood pressure for patients
Behavioral: MD CQI-type intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypertension Improvement Project (HIP)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in systolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in diastolic BP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in BP at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Patient and MD adherence to intervention [ Time Frame: 6 and 18 months ] [ Designated as safety issue: No ]

Enrollment: 574
Study Start Date: February 2004
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: MD-C/PT-C
Physician and patient control group.
Experimental: MD-I/PT-C
MD CQI-type intervention; Patient control
Behavioral: MD CQI-type intervention
CQI-type intervention for MD adherence to JNC guidelines for BP management
Experimental: MD-C/Pt-I
MD control; patient behavioral intervention
Behavioral: Lifestyle interventions to lower blood pressure for patients
Weight loss, DASH dietary pattern, increased physical activity, reduced salt intake, moderation of alchohol intake.
Experimental: MD-I/Pt-I
MD CQI-type intervention; Patient behavioral intervention
Behavioral: Lifestyle interventions to lower blood pressure for patients
Weight loss, DASH dietary pattern, increased physical activity, reduced salt intake, moderation of alchohol intake.
Behavioral: MD CQI-type intervention
CQI-type intervention for MD adherence to JNC guidelines for BP management

Detailed Description:

BACKGROUND:

Hypertension affects 25% of adults in the United States and remains a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 25% of people with hypertension are at goal blood pressure (BP). The chronic care model suggests that BP control can be achieved by improving patient self-care and the systems through which care is delivered. Patient self-care efforts should be directed at counteracting the effects of obesity, physical inactivity, poor dietary pattern, and non-adherence to prescribed medications on BP. In addition, efforts should be directed at the use of quality improvement systems that can counteract the well-documented non-adherence of primary care MDs to established clinical practice guidelines. In addition to improving BP control, these approaches can also reduce costs associated with hypertension and its consequences. However, given the resources that would be required to implement such approaches, it is critical that their effectiveness be rigorously established. This controlled study will test the separate and combined effects of a behavioral intervention for patients and a CQI intervention for MDs on BP control. The patient intervention will employ proven behavioral methods for promoting a healthy lifestyle and adherence to medication regimens. The MD intervention will use a CQI approach to provide training, motivation, and feedback on performance in a non-threatening way to promote continuous self-improvement and adherence to clinical practice guidelines.

DESIGN NARRATIVE:

The Hypertension Improvement Project (HIP) is a randomized, controlled study that will test the separate and combined effects of a CQI intervention for MDs and a behavioral intervention for patients on BP control. MDs will be selected from practices in the Duke Primary Care Research Consortium that serve low-income and minority populations. Practices will be randomly assigned to the MD intervention or to the MD control condition. Within these practices, all MDs will receive the same intervention and their patients will be individually randomized to the patient intervention or to the patient usual care condition. The MD intervention consists of the following three main elements: 1) on-line training modules; 2) an evaluation and treatment algorithm for use in the clinic; and 3) a CQI procedure involving assessment of clinical performance measures and feedback to MDs on their adherence to guidelines. The performance data will be collected for 18 months and feedback will be provided to MDs every 3 months. Patients from these practices (approximately 50% women, at least 40% African American, and 90% low-income) will be randomly assigned to patient intervention or usual care. The patient intervention consists of a 6-month behavioral intervention aimed at lifestyle changes to lower BP and promote adherence to prescribed BP medications. BP and other follow-up measurements will be performed at the end of the intervention and a year later (at 6 and 18 months post-randomization). The primary outcome will be the proportion of patients in each treatment group that have adequate BP control at 6 months. BP control is defined by the Joint National Committee 6 (JNC-6) goals (systolic BP less than 140 mm Hg and diastolic BP less than 90 mm Hg for most patients; lower goals for patients with cardiovascular or renal disease, or diabetes). Other outcomes of this study will include BP control at 18 months, MD adherence to national guidelines, and patient adherence to lifestyle recommendations and medication regimens. A cost analysis will also be done. The study will enroll 500 patients in 10 practices (approximately 20 MDs), and will have 80% power to detect an effect size of 0.3 for the primary outcome. The HIP study will test practical interventions for improving hypertension control that can be broadly implemented and can reduce CVD risk.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving primary care from participating physicians from practices in the Duke Primary Care Research Consortium
  • Hypertension

Exclusion Criteria:

  • Primary care doctor advises against enrollment
  • Pregnant, nursing, or planning pregnancy
  • Recent CVD event
  • Chronic kidney or liver disease
  • Active cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201136

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Laura P. Svetkey Duke University
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laura Svetkey, Professor of Medicine, Duke University
ClinicalTrials.gov Identifier: NCT00201136     History of Changes
Other Study ID Numbers: Pro00013310, R01HL075373, R01 HL075373
Study First Received: September 12, 2005
Last Updated: February 16, 2012
Health Authority: United States: Federal Government

Keywords provided by Duke University:
Behavioral intervention
Lifestyle modification
Guidelines

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014