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.
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.
- Conditions
- Hyperlipidemia, Hypertension
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Receives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support. Receives: Other: Clinical Decision Support for Hypertension; Other: Automated Telephone Outreach for Antihypertensive Therapy |
| 2 | Experimental | Receives 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.
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.
- First posted6 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Steven Simon, VA Boston Healthcare System
- Investigators
- Steven R Simon, MD, MPH, Principal investigator, Brigham and Women's HospitalDavid W Bates, MD, MSc, Principal investigator, Brigham and Women's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CERT-HIT: A Multimodal Intervention to Improve Antihypertensive and Lipid-lowering Therapy
- ClinicalTrials.gov ID
- NCT00876330
- Acronym / sponsor ID
- CERT2 / 1U18HS016970-01
- Conditions
- Hyperlipidemia, Hypertension
- Keywords
- Clinical Decision Support Systems, Hyperlipidemia, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- May 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 6 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Clinical Decision Support for Hypertension, Other: Automated Telephone Outreach for Antihypertensive TherapyReceives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support. |
| 2 | Experimental | Other: Clinical Decision Support for Lipid-lowering Therapy, Other: Automated Telephone Outreach for Lipid-lowering TherapyReceives Hypertension and Hyperlipidemia Intervention with automated telephone outreach. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support for HypertensionClinical decision support alerts for antihypertensive therapy | Other | 1 |
| Automated Telephone Outreach for Antihypertensive TherapyAutomated Telephone Outreach to patients for antihypertensive medication therapy. | Other | 1 |
| Clinical Decision Support for Lipid-lowering TherapyClinical Decision Support alerts for Lipid-lowering medication therapy. | Other | 2 |
| Automated Telephone Outreach for Lipid-lowering TherapyAutomated telephone outreach to patients for Lipid-lowering medication therapy. | Other | 2 |
Primary outcome
The main outcome measure will be the proportion of patients at treatment goal.
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Simon, MD, MPH principal investigator
Brigham and Women's Hospital
David W Bates, MD, MSc principal investigator
Brigham and Women's Hospital
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.