Improving Antihypertensive and Lipid-Lowering Therapy (CERT2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Simon, VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT00876330
First received: April 3, 2009
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CERT-HIT: A Multimodal Intervention to Improve Antihypertensive and Lipid-lowering Therapy

Resource links provided by NLM:


Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • The main outcome measure will be the proportion of patients at treatment goal. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: May 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876330

Sponsors and Collaborators
VA Boston Healthcare System
Investigators
Principal Investigator: Steven R Simon, MD, MPH Brigham and Women's Hospital
Principal Investigator: David W Bates, MD, MSc Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Steven Simon, Site Principal Investigator, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT00876330     History of Changes
Other Study ID Numbers: 1U18HS016970-01
Study First Received: April 3, 2009
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by VA Boston Healthcare System:
Clinical Decision Support Systems
Hyperlipidemia
Hypertension

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014