Improving Antihypertensive and Lipid-Lowering Therapy (CERT2)
Primary Purpose
Hyperlipidemia, Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical Decision Support for Hypertension
Automated Telephone Outreach for Antihypertensive Therapy
Clinical Decision Support for Lipid-lowering Therapy
Automated Telephone Outreach for Lipid-lowering Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia focused on measuring Clinical Decision Support Systems, Hyperlipidemia, Hypertension
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Receives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support.
Receives Hypertension and Hyperlipidemia Intervention with automated telephone outreach.
Outcomes
Primary Outcome Measures
The main outcome measure will be the proportion of patients at treatment goal.
Secondary Outcome Measures
Full Information
NCT ID
NCT00876330
First Posted
April 3, 2009
Last Updated
September 19, 2012
Sponsor
VA Boston Healthcare System
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT00876330
Brief Title
Improving Antihypertensive and Lipid-Lowering Therapy
Acronym
CERT2
Official Title
CERT-HIT: A Multimodal Intervention to Improve Antihypertensive and Lipid-lowering Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Boston Healthcare System
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Hypertension
Keywords
Clinical Decision Support Systems, Hyperlipidemia, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Receives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support.
Arm Title
2
Arm Type
Experimental
Arm Description
Receives Hypertension and Hyperlipidemia Intervention with automated telephone outreach.
Intervention Type
Other
Intervention Name(s)
Clinical Decision Support for Hypertension
Intervention Description
Clinical decision support alerts for antihypertensive therapy
Intervention Type
Other
Intervention Name(s)
Automated Telephone Outreach for Antihypertensive Therapy
Intervention Description
Automated Telephone Outreach to patients for antihypertensive medication therapy.
Intervention Type
Other
Intervention Name(s)
Clinical Decision Support for Lipid-lowering Therapy
Intervention Description
Clinical Decision Support alerts for Lipid-lowering medication therapy.
Intervention Type
Other
Intervention Name(s)
Automated Telephone Outreach for Lipid-lowering Therapy
Intervention Description
Automated telephone outreach to patients for Lipid-lowering medication therapy.
Primary Outcome Measure Information:
Title
The main outcome measure will be the proportion of patients at treatment goal.
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Simon, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David W Bates, MD, MSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Improving Antihypertensive and Lipid-Lowering Therapy
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