AzTrials
AzTrials

HyperlipidemiaCERT2NCT00876330

Improving Antihypertensive and Lipid-Lowering Therapy

A study testing Clinical Decision Support for Hypertension, Automated Telephone Outreach for Antihypertensive Therapy and Clinical Decision Support for Lipid-lowering Therapy in people with Hyperlipidemia and Hypertension, run by VA Boston Healthcare System.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Hyperlipidemia, Hypertension
What is being tested?
Clinical Decision Support for Hypertension, Automated Telephone Outreach for Antihypertensive Therapy and Clinical Decision Support for Lipid-lowering Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,000 participants
Where
No sites listed yet
Study dates
May 2009to Mar 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

About this study

Official title: CERT-HIT: A Multimodal Intervention to Improve Antihypertensive and Lipid-lowering Therapy

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.

Read the 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.

Being tested
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
Keywords
Clinical Decision Support Systems, Hyperlipidemia, Hypertension
Medical subject headings
Hyperlipidemias, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical Decision Support for HypertensionOther

    Clinical decision support alerts for antihypertensive therapy

  • Automated Telephone Outreach for Antihypertensive TherapyOther

    Automated Telephone Outreach to patients for antihypertensive medication therapy.

  • Clinical Decision Support for Lipid-lowering TherapyOther

    Clinical Decision Support alerts for Lipid-lowering medication therapy.

  • Automated Telephone Outreach for Lipid-lowering TherapyOther

    Automated telephone outreach to patients for Lipid-lowering medication therapy.

Study groups in NCT00876330
Study groupRoleWhat they receive
1ExperimentalReceives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support.
Receives: Other: Clinical Decision Support for Hypertension; Other: Automated Telephone Outreach for Antihypertensive Therapy
2ExperimentalReceives Hypertension and Hyperlipidemia Intervention with automated telephone outreach.
Receives: Other: Clinical Decision Support for Lipid-lowering Therapy; Other: Automated Telephone Outreach for Lipid-lowering Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The main outcome measure will be the proportion of patients at treatment goal.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2012 (estimated)
  4. Study completionMar 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00876330
Sponsor's protocol ID
1U18HS016970-01
Acronym
CERT2
Status last verified
Sep 2012
First submitted
3 Apr 2009
Last updated
20 Sep 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Decision Support for Hypertension, Automated Telephone Outreach for Antihypertensive Therapy and Clinical Decision Support for Lipid-lowering Therapy in people with Hyperlipidemia and Hypertension, run by VA Boston Healthcare System.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The main outcome measure will be the proportion of patients at treatment goal. (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2012.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in