Improving Antihypertensive and Lipid-Lowering Therapy

NCT ID: NCT00876330

Last Updated: 2012-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-03-31

Brief 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.

Detailed 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.

Conditions

Hyperlipidemia; Hypertension

Keywords

Clinical Decision Support Systems; Hyperlipidemia; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Receives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support.

Group Type: EXPERIMENTAL

Clinical Decision Support for Hypertension

Intervention Type: OTHER

Clinical decision support alerts for antihypertensive therapy

Automated Telephone Outreach for Antihypertensive Therapy

Intervention Type: OTHER

Automated Telephone Outreach to patients for antihypertensive medication therapy.

2

Receives Hypertension and Hyperlipidemia Intervention with automated telephone outreach.

Group Type: EXPERIMENTAL

Clinical Decision Support for Lipid-lowering Therapy

Intervention Type: OTHER

Clinical Decision Support alerts for Lipid-lowering medication therapy.

Automated Telephone Outreach for Lipid-lowering Therapy

Intervention Type: OTHER

Automated telephone outreach to patients for Lipid-lowering medication therapy.

Interventions

Clinical Decision Support for Hypertension

Clinical decision support alerts for antihypertensive therapy

Intervention Type: OTHER

Automated Telephone Outreach for Antihypertensive Therapy

Automated Telephone Outreach to patients for antihypertensive medication therapy.

Intervention Type: OTHER

Clinical Decision Support for Lipid-lowering Therapy

Clinical Decision Support alerts for Lipid-lowering medication therapy.

Intervention Type: OTHER

Automated Telephone Outreach for Lipid-lowering Therapy

Automated telephone outreach to patients for Lipid-lowering medication therapy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

VA Boston Healthcare System

FED

Sponsor Role: lead

Responsible Party

Steven Simon

Site Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven R Simon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

David W Bates, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Other Identifiers

1U18HS016970-01

Identifier Type: AHRQ

Identifier Source: org_study_id

View Link