HypertensionNCT00265044
Improving Practice Patterns for the Treatment of Hypertension
A study testing Provider Education, Hypertension Alert and Patient Education in people with Hypertension, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
To improve the quality of hypertension care in our facility, while concurrently, examining the relative contribution of each aspect of a multi-factorial intervention designed to improve hypertension care. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Provider Education, Hypertension Alert and Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2004
- 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 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients were eligible for inclusion if they were aged 21- 90 years and filled their medications with the VA pharmacies. Seen in 2003 and had a primary care visit coded as hypertension using International Classification of Diseases Ninth Revision; Clinical Modification (ICD 9-CM) (24) of 401.1 or 401.9 and who were prescribed only one antihypertensive medication
Who cannot join
- More than one antihypertensive medication Refuse consent to review medical record Pregnant Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
About this study
Official title: Innovations to Implementing Evidence-based Clinical Practice
To improve the quality of hypertension care in our facility, while concurrently, examining the relative contribution of each aspect of a multi-factorial intervention designed to improve hypertension care.
Read the detailed description
This project was a randomized trial designed to examine the relative contribution of three quality improvement interventions of increasing intensity on BP control in veterans. Providers in each stratum and their eligible patients were randomized to one of three study arms. The providers randomized to the first arm received education alone, and were considered the controls. Providers randomized to the second arm received both provider education and a hypertension alert. The third arm included provider education, a hypertension alert, and patient education. Patients were eligible for inclusion if they were aged 21- 90 years and filled their medications with the VA pharmacies. Between July and December 2003, we determined patient eligibility using a search strategy using data from the Mid South Quality Improvement Data warehouse, which is downloaded monthly from Veterans' Health Information System and Technology Architecture (VistA).
- Conditions
- Hypertension
- Being tested
- Provider Education, Hypertension Alert, Patient Education
- Keywords
- Behavior Change, patient Education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider EducationBehavioural
Hypertension AlertBehavioural
Patient EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Provider Education; Behavioral: Hypertension Alert; Behavioral: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching Systolic BP goal 6 months after intervention
Secondary outcomes (1)
Reaching Diastolic BP goal 6 months after intervention Any additional prescriptions of antihypertensive medications.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startJan 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Theodore Speroff, PhD, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TNChristianne L Roumie, BA MD MPH, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TNVincent Alvarez, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265044
- Sponsor's protocol ID
- IMV 04-091
- Status last verified
- May 2006
- First submitted
- 12 Dec 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Roumie CL, Elasy TA, Greevy R, Griffin MR, Liu X, Stone WJ, Wallston KA, Dittus RS, Alvarez V, Cobb J, Speroff T. Patient education adds critical boost to hypertension management. [Editorial]. VA Research Currents. 2006 Sep 1; 7-8.
Roumie CL, Elasy TA, Greevy R, Griffin MR, Liu X, Stone WJ, Wallston KA, Dittus RS, Alvarez V, Cobb J, Speroff T. Improving blood pressure control through provider education, provider alerts, and patient education: a cluster randomized trial. Ann Intern Med. 2006 Aug 1;145(3):165-75. doi: 10.7326/0003-4819-145-3-200608010-00004.
PubMed 16880458
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovations to Implementing Evidence-based Clinical Practice
- ClinicalTrials.gov ID
- NCT00265044
- Acronym / sponsor ID
- IMV 04-091
- Conditions
- Hypertension
- Keywords
- Behavior Change, patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2004
- Study completion
- Dec 2004 (actual)
- First posted
- 13 Dec 2005 (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.
To improve the quality of hypertension care in our facility, while concurrently, examining the relative contribution of each aspect of a multi-factorial intervention designed to improve hypertension care.
Detailed description
This project was a randomized trial designed to examine the relative contribution of three quality improvement interventions of increasing intensity on BP control in veterans. Providers in each stratum and their eligible patients were randomized to one of three study arms. The providers randomized to the first arm received education alone, and were considered the controls. Providers randomized to the second arm received both provider education and a hypertension alert. The third arm included provider education, a hypertension alert, and patient education. Patients were eligible for inclusion if they were aged 21- 90 years and filled their medications with the VA pharmacies. Between July and December 2003, we determined patient eligibility using a search strategy using data from the Mid South Quality Improvement Data warehouse, which is downloaded monthly from Veterans' Health Information System and Technology Architecture (VistA).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Provider Education, Behavioral: Hypertension Alert, Behavioral: Patient Education |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were eligible for inclusion if they were aged 21- 90 years and filled their medications with the VA pharmacies. Seen in 2003 and had a primary care visit coded as hypertension using International Classification of Diseases Ninth Revision; Clinical Modification (ICD 9-CM) (24) of 401.1 or 401.9 and who were prescribed only one antihypertensive medication
Key exclusion criteria (1 listed)
- More than one antihypertensive medication Refuse consent to review medical record Pregnant Prisoners
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 |
|---|---|---|
| Provider Education | Behavioural | Arm 1 |
| Hypertension Alert | Behavioural | Arm 1 |
| Patient Education | Behavioural | Arm 1 |
Primary outcome
Reaching Systolic BP goal 6 months after intervention
1 secondary outcome
Reaching Diastolic BP goal 6 months after intervention Any additional prescriptions of antihypertensive medications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publicationRoumie CL, Elasy TA, Greevy R, Griffin MR, Liu X, Stone WJ, Wallston KA, Dittus RS, Alvarez V, Cobb J, Speroff T. Patient education adds critical boost to hypertension management. [Editorial]. VA Research Currents. 2006 Sep 1; 7-8.
- Results publication: PubMed 16880458Roumie CL, Elasy TA, Greevy R, Griffin MR, Liu X, Stone WJ, Wallston KA, Dittus RS, Alvarez V, Cobb J, Speroff T. Improving blood pressure control through provider education, provider alerts, and patient education: a cluster randomized trial. Ann Intern Med. 2006 Aug 1;145(3):165-75. doi: 10.7326/0003-4819-145-3-200608010-00004.
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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.
Theodore Speroff, PhD principal investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Christianne L Roumie, BA MD MPH principal investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Vincent Alvarez principal investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Education, Hypertension Alert and Patient Education in people with Hypertension, run by US Department of Veterans Affairs at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reaching Systolic BP goal 6 months after intervention. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00265044, which also lists 2 linked publications.
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 7 Apr 2015.