Improving Antihypertensive and Lipid-Lowering Therapy (CERT2)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Hyperlipidemia
• Intervention / Treatment: Other: Clinical Decision Support for Hypertension; Other: Automated Telephone Outreach for Antihypertensive Therapy; Other: Clinical Decision Support for Lipid-lowering Therapy; Other: Automated Telephone Outreach for Lipid-lowering Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 6000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Receives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support.	Other: Clinical Decision Support for Hypertension; Clinical decision support alerts for antihypertensive therapy; Other: Automated Telephone Outreach for Antihypertensive Therapy; Automated Telephone Outreach to patients for antihypertensive medication therapy.
Experimental: 2; Receives Hypertension and Hyperlipidemia Intervention with automated telephone outreach.	Other: Clinical Decision Support for Lipid-lowering Therapy; Clinical Decision Support alerts for Lipid-lowering medication therapy.; Other: Automated Telephone Outreach for Lipid-lowering Therapy; Automated telephone outreach to patients for Lipid-lowering medication therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The main outcome measure will be the proportion of patients at treatment goal.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: VA Boston Healthcare System
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Steven R Simon, MD, MPH, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 3, 2009
• First Posted (Estimate): April 6, 2009

Study Record Updates

• Last Update Posted (Estimate): September 20, 2012
• Last Update Submitted That Met QC Criteria: September 19, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Hyperlipidemia; Clinical Decision Support Systems
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypertension; Hyperlipidemias; Hyperlipoproteinemias; Antihypertensive Agents
• Other Study ID Numbers: 1U18HS016970-01 (U.S. AHRQ Grant/Contract)