HypertensionPhase 3NCT00122161
Guidelines for Drug Therapy of Hypertension: Multi-Site Implementation
A Phase 3 study testing ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers and Profiling performance in people with Hypertension, run by US Department of Veterans Affairs at 3 sites in United States.
Trial summary
Clinical trial of implementation of clinical practice guidelines for managing hypertension in primary care clinics. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers and Profiling performance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Sep 2005
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary care clinicians at participating study sites. That is physicians, nurse practitioners and physician assistants who have their own panel of patients to whom they provide direct patient care.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
About this study
Clinical trial of implementation of clinical practice guidelines for managing hypertension in primary care clinics.
Read the detailed description
Background:
Hypertension, the most commonly reported medical problem in veterans, is a major risk factor for heart disease and stroke. Lowering blood pressure decreases the risk of these adverse clinical outcomes. Widely promoted evidence-based clinical practice guidelines set target blood pressures for adequate control, yet most hypertensives, including VA patients, do not meet the targets. Guidelines also call for use of specific drugs depending on the patient's pattern of comorbid characteristics; yet, clinicians often prescribe drugs that are not guideline-concordant.
Objectives:
The long term objective of this work is to contribute to the VA's ability to respond flexibly to rapidly evolving medical knowledge by establishing a system guidelines that can be used throughout the VA nationally for implementing multiple different clinical practice. In collaboration with Stanford Medical Informatics we developed an automated decision support system for hypertension management, known as ATHENA DSS built with EON technology for guideline-based decision support. ATHENA DSS incorporates hundreds of knowledge rules to operationalize guidelines for hypertension.
Methods:
ATHENA DSS combines patient information from VistA with an automated knowledge base of hypertension to generate patient-specific recommendations for management of hypertension that are displayed to primary care clinicians in pop-up windows in the VA�s Computerized Patient Record System (CPRS) when the record for appropriate patients is opened on the day of scheduled primary care clinic visits. The ATHENA DSS pop-up provides advice on adequacy of control of blood pressure and specific recommendations for drug therapy of hypertension, a visual display of the patient�s medication history and concurrent blood pressures, evidence supporting the main recommendations, and other information. We deployed the system at three VA medical centers--Durham, San Francisco, and Palo Alto�and conducted a clinician-randomized trial. We logged data on use of the system, monitored comments entered by clinicians, and conducted a questionnaire survey of clinicians. We planned analyses of impact on clinician prescribing and patient blood pressures. We planned preparation for dissemination of the system to additional VA medical centers.
Status:
Project work is ongoing at time of preparing this report. We recently received notice of funding for a VISN collaborative that will use the ATHENA DSS in five medical centers in VISN 1 (New England).
- Conditions
- Hypertension
- Being tested
- ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers, Profiling performance
- Keywords
- Drug therapy, Practice guidelines, Reminder systems, Ambulatory care, Hypertension, Clinical protocols, Quality Assurance, Health Care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care ProvidersBehavioural
Profiling performanceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers; Behavioral: Profiling performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary care clinicians adherence to hypertension guidelines and blood pressure control in their panels of patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary K. Goldstein, MD MS, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122161
- Sponsor's protocol ID
- CPI 99-275
- Status last verified
- Oct 2007
- First submitted
- 18 Jul 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Siegel D, Lopez J, Meier J, Goldstein MK, Lee S, Brazill BJ, Matalka MS. Academic detailing to improve antihypertensive prescribing patterns. Am J Hypertens. 2003 Jun;16(6):508-11. doi: 10.1016/s0895-7061(03)00060-8.
PubMed 12799103Bosworth HB, Dudley T, Olsen MK, Voils CI, Powers B, Goldstein MK, Oddone EZ. Racial differences in blood pressure control: potential explanatory factors. Am J Med. 2006 Jan;119(1):70.e9-15. doi: 10.1016/j.amjmed.2005.08.019.
PubMed 16431192Szeto HC, Coleman RK, Gholami P, Hoffman BB, Goldstein MK. Accuracy of computerized outpatient diagnoses in a Veterans Affairs general medicine clinic. Am J Manag Care. 2002 Jan;8(1):37-43.
PubMed 11814171Chan AS, Shankar RD, Coleman RW, Matins SB, Hoffman BB, Goldstein MK. Leveraging point-of-care clinician feedback to study barriers to guideline adherence. AMIA Annu Symp Proc. 2005;2005:915.
PubMed 16779202Steinman MA, Fischer MA, Shlipak MG, Bosworth HB, Oddone EZ, Hoffman BB, Goldstein MK. Clinician awareness of adherence to hypertension guidelines. Am J Med. 2004 Nov 15;117(10):747-54. doi: 10.1016/j.amjmed.2004.03.035.
PubMed 15541324Tu SW, Musen MA, Shankar R, Campbell J, Hrabak K, McClay J, Huff SM, McClure R, Parker C, Rocha R, Abarbanel R, Beard N, Glasgow J, Mansfield G, Ram P, Ye Q, Mays E, Weida T, Chute CG, McDonald K, Molu D, Nyman MA, Scheitel S, Solbrig H, Zill DA, Goldstein MK. Modeling guidelines for integration into clinical workflow. Stud Health Technol Inform. 2004;107(Pt 1):174-8.
PubMed 15360798Advani A, Jones N, Shahar Y, Goldstein MK, Musen MA. An intelligent case-adjustment algorithm for the automated design of population-based quality auditing protocols. Stud Health Technol Inform. 2004;107(Pt 2):1003-7.
PubMed 15360963Shankar RD, Tu SW, Martins SB, Fagan LM, Goldstein MK, Musen MA. Integration of textual guideline documents with formal guideline knowledge bases. Proc AMIA Symp. 2001:617-21.
PubMed 11825260Chan AS, Coleman RW, Martins SB, Advani A, Musen MA, Bosworth HB, Oddone EZ, Shlipak MG, Hoffman BB, Goldstein MK. Evaluating provider adherence in a trial of a guideline-based decision support system for hypertension. Stud Health Technol Inform. 2004;107(Pt 1):125-9.
PubMed 15360788Goldstein MK, Coleman RW, Tu SW, Shankar RD, O'Connor MJ, Musen MA, Martins SB, Lavori PW, Shlipak MG, Oddone E, Advani AA, Gholami P, Hoffman BB. Translating research into practice: organizational issues in implementing automated decision support for hypertension in three medical centers. J Am Med Inform Assoc. 2004 Sep-Oct;11(5):368-76. doi: 10.1197/jamia.M1534. Epub 2004 Jun 7.
PubMed 15187064Shankar RD, Martins SB, Tu SW, Goldstein MK, Musen MA. Building an explanation function for a hypertension decision-support system. Stud Health Technol Inform. 2001;84(Pt 1):538-42.
PubMed 11604798Lin ND, Martins SB, Chan AS, Coleman RW, Bosworth HB, Oddone EZ, Shankar RD, Musen MA, Hoffman BB, Goldstein MK. Identifying barriers to hypertension guideline adherence using clinician feedback at the point of care. AMIA Annu Symp Proc. 2006;2006:494-8.
PubMed 17238390Bosworth HB, Olsen MK, Goldstein MK, Orr M, Dudley T, McCant F, Gentry P, Oddone EZ. The veterans' study to improve the control of hypertension (V-STITCH): design and methodology. Contemp Clin Trials. 2005 Apr;26(2):155-68. doi: 10.1016/j.cct.2004.12.006.
PubMed 15837438Tu SW, Hrabak KM, Campbell JR, Glasgow J, Nyman MA, McClure R, McClay J, Abarbanel R, Mansfield JG, Martins SM, Goldstein MK, Musen MA. Use of declarative statements in creating and maintaining computer-interpretable knowledge bases for guideline-based care. AMIA Annu Symp Proc. 2006;2006:784-8.
PubMed 17238448Peralta CA, Shlipak MG, Wassel-Fyr C, Bosworth H, Hoffman B, Martins S, Oddone E, Goldstein MK. Association of antihypertensive therapy and diastolic hypotension in chronic kidney disease. Hypertension. 2007 Sep;50(3):474-80. doi: 10.1161/HYPERTENSIONAHA.107.088088. Epub 2007 Jul 30.
PubMed 17664397
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
- Guidelines for Drug Therapy of Hypertension: Multi-Site Implementation
- ClinicalTrials.gov ID
- NCT00122161
- Acronym / sponsor ID
- CPI 99-275
- Conditions
- Hypertension
- Keywords
- Drug therapy, Practice guidelines, Reminder systems, Ambulatory care, Hypertension, Clinical protocols, Quality Assurance, Health Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Sep 2005 (actual)
- First posted
- 21 Jul 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.
Clinical trial of implementation of clinical practice guidelines for managing hypertension in primary care clinics.
Detailed description
Background:
Hypertension, the most commonly reported medical problem in veterans, is a major risk factor for heart disease and stroke. Lowering blood pressure decreases the risk of these adverse clinical outcomes. Widely promoted evidence-based clinical practice guidelines set target blood pressures for adequate control, yet most hypertensives, including VA patients, do not meet the targets. Guidelines also call for use of specific drugs depending on the patient's pattern of comorbid characteristics; yet, clinicians often prescribe drugs that are not guideline-concordant.
Objectives:
The long term objective of this work is to contribute to the VA's ability to respond flexibly to rapidly evolving medical knowledge by establishing a system guidelines that can be used throughout the VA nationally for implementing multiple different clinical practice. In collaboration with Stanford Medical Informatics we developed an automated decision support system for hypertension management, known as ATHENA DSS built with EON technology for guideline-based decision support. ATHENA DSS incorporates hundreds of knowledge rules to operationalize guidelines for hypertension.
Methods:
ATHENA DSS combines patient information from VistA with an automated knowledge base of hypertension to generate patient-specific recommendations for management of hypertension that are displayed to primary care clinicians in pop-up windows in the VA�s Computerized Patient Record System (CPRS) when the record for appropriate patients is opened on the day of scheduled primary care clinic visits. The ATHENA DSS pop-up provides advice on adequacy of control of blood pressure and specific recommendations for drug therapy of hypertension, a visual display of the patient�s medication history and concurrent blood pressures, evidence supporting the main recommendations, and other information. We deployed the system at three VA medical centers--Durham, San Francisco, and Palo Alto�and conducted a clinician-randomized trial. We logged data on use of the system, monitored comments entered by clinicians, and conducted a questionnaire survey of clinicians. We planned analyses of impact on clinician prescribing and patient blood pressures. We planned preparation for dissemination of the system to additional VA medical centers.
Status:
Project work is ongoing at time of preparing this report. We recently received notice of funding for a VISN collaborative that will use the ATHENA DSS in five medical centers in VISN 1 (New England).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers, Behavioral: Profiling performance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care clinicians at participating study sites. That is physicians, nurse practitioners and physician assistants who have their own panel of patients to whom they provide direct patient care.
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 |
|---|---|---|
| ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers | Behavioural | Arm 1 |
| Profiling performance | Behavioural | Arm 1 |
Primary outcome
Primary care clinicians adherence to hypertension guidelines and blood pressure control in their panels of patients.
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 publication: PubMed 12799103Siegel D, Lopez J, Meier J, Goldstein MK, Lee S, Brazill BJ, Matalka MS. Academic detailing to improve antihypertensive prescribing patterns. Am J Hypertens. 2003 Jun;16(6):508-11. doi: 10.1016/s0895-7061(03)00060-8.
- Results publication: PubMed 16431192Bosworth HB, Dudley T, Olsen MK, Voils CI, Powers B, Goldstein MK, Oddone EZ. Racial differences in blood pressure control: potential explanatory factors. Am J Med. 2006 Jan;119(1):70.e9-15. doi: 10.1016/j.amjmed.2005.08.019.
- Results publication: PubMed 11814171Szeto HC, Coleman RK, Gholami P, Hoffman BB, Goldstein MK. Accuracy of computerized outpatient diagnoses in a Veterans Affairs general medicine clinic. Am J Manag Care. 2002 Jan;8(1):37-43.
- Results publication: PubMed 16779202Chan AS, Shankar RD, Coleman RW, Matins SB, Hoffman BB, Goldstein MK. Leveraging point-of-care clinician feedback to study barriers to guideline adherence. AMIA Annu Symp Proc. 2005;2005:915.
- Results publication: PubMed 15541324Steinman MA, Fischer MA, Shlipak MG, Bosworth HB, Oddone EZ, Hoffman BB, Goldstein MK. Clinician awareness of adherence to hypertension guidelines. Am J Med. 2004 Nov 15;117(10):747-54. doi: 10.1016/j.amjmed.2004.03.035.
- Results publication: PubMed 15360798Tu SW, Musen MA, Shankar R, Campbell J, Hrabak K, McClay J, Huff SM, McClure R, Parker C, Rocha R, Abarbanel R, Beard N, Glasgow J, Mansfield G, Ram P, Ye Q, Mays E, Weida T, Chute CG, McDonald K, Molu D, Nyman MA, Scheitel S, Solbrig H, Zill DA, Goldstein MK. Modeling guidelines for integration into clinical workflow. Stud Health Technol Inform. 2004;107(Pt 1):174-8.
- Results publication: PubMed 15360963Advani A, Jones N, Shahar Y, Goldstein MK, Musen MA. An intelligent case-adjustment algorithm for the automated design of population-based quality auditing protocols. Stud Health Technol Inform. 2004;107(Pt 2):1003-7.
- Results publication: PubMed 11825260Shankar RD, Tu SW, Martins SB, Fagan LM, Goldstein MK, Musen MA. Integration of textual guideline documents with formal guideline knowledge bases. Proc AMIA Symp. 2001:617-21.
- Results publication: PubMed 15360788Chan AS, Coleman RW, Martins SB, Advani A, Musen MA, Bosworth HB, Oddone EZ, Shlipak MG, Hoffman BB, Goldstein MK. Evaluating provider adherence in a trial of a guideline-based decision support system for hypertension. Stud Health Technol Inform. 2004;107(Pt 1):125-9.
- Results publication: PubMed 15187064Goldstein MK, Coleman RW, Tu SW, Shankar RD, O'Connor MJ, Musen MA, Martins SB, Lavori PW, Shlipak MG, Oddone E, Advani AA, Gholami P, Hoffman BB. Translating research into practice: organizational issues in implementing automated decision support for hypertension in three medical centers. J Am Med Inform Assoc. 2004 Sep-Oct;11(5):368-76. doi: 10.1197/jamia.M1534. Epub 2004 Jun 7.
- Results publication: PubMed 11604798Shankar RD, Martins SB, Tu SW, Goldstein MK, Musen MA. Building an explanation function for a hypertension decision-support system. Stud Health Technol Inform. 2001;84(Pt 1):538-42.
- Results publication: PubMed 17238390Lin ND, Martins SB, Chan AS, Coleman RW, Bosworth HB, Oddone EZ, Shankar RD, Musen MA, Hoffman BB, Goldstein MK. Identifying barriers to hypertension guideline adherence using clinician feedback at the point of care. AMIA Annu Symp Proc. 2006;2006:494-8.
- Click here for more information about this study: Guidelines for Drug Therapy of Hypertension: Multi-Site ImplementationLink provided by the sponsor.
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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.
Mary K. Goldstein, MD MS principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers and Profiling performance in people with Hypertension, run by US Department of Veterans Affairs at 3 sites 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 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: 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 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary care clinicians adherence to hypertension guidelines and blood pressure control in their panels of patients.. 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 NCT00122161, which also lists 16 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.