Improving Antihypertensive and Lipid-Lowering Therapy (CERT2)
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|ClinicalTrials.gov Identifier: NCT00876330|
Recruitment Status : Unknown
Verified September 2012 by Steven Simon, VA Boston Healthcare System.
Recruitment status was: Active, not recruiting
First Posted : April 6, 2009
Last Update Posted : September 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipidemia Hypertension||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||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||6000 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||CERT-HIT: A Multimodal Intervention to Improve Antihypertensive and Lipid-lowering Therapy|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
Receives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support.
Other: Clinical Decision Support for Hypertension
Clinical decision support alerts for antihypertensive therapyOther: Automated Telephone Outreach for Antihypertensive Therapy
Automated Telephone Outreach to patients for antihypertensive medication therapy.
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.
- The main outcome measure will be the proportion of patients at treatment goal. [ Time Frame: Baseline and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876330
|Principal Investigator:||Steven R Simon, MD, MPH||Brigham and Women's Hospital|
|Principal Investigator:||David W Bates, MD, MSc||Brigham and Women's Hospital|