search
Back to results

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
VA Boston Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Clinical Decision Support Systems, Hyperlipidemia, Hypertension

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 3, 2009
    Last Updated
    September 19, 2012
    Sponsor
    VA Boston Healthcare System
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)
    search

    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

    We'll reach out to this number within 24 hrs