Improving Antihypertensive and Lipid-Lowering Therapy (CERT2)

V

Veterans Affairs (VA) Boston Healthcare System

Status

Unknown

Conditions

Hypertension
Hyperlipidemia

Treatments

Other: Automated Telephone Outreach for Antihypertensive Therapy
Other: Automated Telephone Outreach for Lipid-lowering Therapy
Other: Clinical Decision Support for Lipid-lowering Therapy
Other: Clinical Decision Support for Hypertension

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00876330
1U18HS016970-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

6,000 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

6,000 participants in 2 patient groups

1
Experimental group
Description:
Receives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support.
Treatment:
Other: Clinical Decision Support for Hypertension
Other: Automated Telephone Outreach for Antihypertensive Therapy
2
Experimental group
Description:
Receives Hypertension and Hyperlipidemia Intervention with automated telephone outreach.
Treatment:
Other: Clinical Decision Support for Lipid-lowering Therapy
Other: Automated Telephone Outreach for Lipid-lowering Therapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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