Improving Antihypertensive and Lipid-Lowering Therapy

Hypertension Clinical Trial

— CERT2  

Official title:

CERT-HIT: A Multimodal Intervention to Improve Antihypertensive and Lipid-lowering Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00876330
• Other study ID #: 1U18HS016970-01
• Status: Active, not recruiting
• Phase: N/A
• First received: April 3, 2009
• Last updated: September 19, 2012
• Start date: May 2009
• Est. completion date: March 2013

Study information

• Verified date: September 2012
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of electronic health record clinical decision support and automated telephone outreach on antihypertensive and lipid-lowering therapy in ambulatory care.

Description:

The quality of care delivered in physicians' offices is suboptimal. Underuse of proven, potentially life-saving medications, such as anti-hypertensive agents and statins for lipid-lowering, is unfortunately no exception. Data from more than 70 million people collected for the 2005 HEDIS Report Card show that fewer than half of those patients at high risk for myocardial infarction have adequately controlled lipids and fewer than 70% of patients with hypertension have blood pressure controlled; annually this suboptimal treatment accounts for more than 10,000 avoidable deaths, $333 million in avoidable hospital costs, 27.2 million sick days and $4.5 billion in lost productivity.

The "care-gaps" in the management of blood pressure and lipids arise from numerous barriers to optimal practice at the level of the system, the provider, and the patient. Process evaluations of quality improvement efforts have cited several barriers as the most important: inadequate time, resources, and support; limitations in computer technology, including insufficient information management; little use of formal change processes; too many competing priorities; a lack of agreement about the desired changes; and inadequate physician engagement.

Both computerized clinical decision support (CDS) in the context of a robust electronic health record (EHR) and automated telephone outreach to patients with interactive voice recognition (IVR) to patients are promising interventions to overcome the barriers that physicians and patients encounter in treating hypertension and hyperlipidemia. While recent studies have begun to demonstrate the effectiveness of CDS in the ambulatory setting, there is an urgent need to implement and evaluate these systems in the practices of physicians practicing solo or in small groups in the community, outside the extensive HIT infrastructure of academic medical centers and integrated delivery systems.

IVR is a patient-outreach intervention that involves automated telephone calls to patients to patients in a conversation about specific health-related issues. Randomized control trials (RCTs) have shown that IVR monitoring with clinician follow-up can improve self-care, perceived health status, and physiologic outcomes among individuals with diabetes and hypertension.

The specific aim of this project is to evaluate, the effectiveness of CDS alone compared to IVR to improve the use of antihypertensive and lipid-lowering medications in community-based primary care practices.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• MDs, NPs, PAs, or DOs practicing in primary care or medical subspecialties and using eClinical Works EHR

• Patients of eligible physicians who have hypertension or hyperlipidemia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Other:
• Clinical Decision Support for Hypertension
Clinical decision support alerts for antihypertensive therapy
• Automated Telephone Outreach for Antihypertensive Therapy
Automated Telephone Outreach to patients for antihypertensive medication therapy.
• Clinical Decision Support for Lipid-lowering Therapy
Clinical Decision Support alerts for Lipid-lowering medication therapy.
• Automated Telephone Outreach for Lipid-lowering Therapy
Automated telephone outreach to patients for Lipid-lowering medication therapy.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
VA Boston Healthcare System	Agency for Healthcare Research and Quality (AHRQ)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main outcome measure will be the proportion of patients at treatment goal.		Baseline and 6 months	No