HypertensionHTNNCT00374452
VISN Collaborative for Improving Hypertension Management With ATHENA-HTN
A study testing ATHENA-CDS-HTN plus Guideline Link and Guideline Link Only in people with Hypertension, run by VA Office of Research and Development at 7 sites in United States.
Trial summary
This project is a VA HSR\&D-funded Quality Enhancement Research Initiative (QUERI) project to translate into practice evidence about clinical management of primary hypertension. The project aims to contribute to quality improvement of care for patients with primary hypertension. 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-CDS-HTN plus Guideline Link and Guideline Link Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2007to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must be primary care clinicians (for example, physician or nurse practitioner) at one of the participating VA medical centers. This study is NOT recruiting patients.
- The primary care clinician must have a panel of patients for whom he or she provides direct care.
Who cannot join
- Anyone who does not meet inclusion criteria.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, 01730
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
VA Medical Center, Manchester
Manchester, New Hampshire, 03104
VA Connecticut Health Care System (Newington)
Newington, Connecticut, 06111
VA Palo Alto Health Care System
Palo Alto, California, 94304
VA Medical Center, Providence
Providence, Rhode Island, 02908
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
This project is a VA HSR\&D-funded Quality Enhancement Research Initiative (QUERI) project to translate into practice evidence about clinical management of primary hypertension. The project aims to contribute to quality improvement of care for patients with primary hypertension. The project implemented a clinical decision support (CDS) system for primary care clinicians and evaluated the implementation by studying the following: impact on the clinicians' prescribing and their patients' blood pressures; the clinician satisfaction with the CDS; and organizational factors in the implementation.
Read the detailed description
Background / Rationale:
Despite the existence of evidence-based guidelines, there is a gap between evidence-based recommended best medical practice and actual practice. In previous work, we used hypertension as a model to study the translation of research regarding clinical blood pressure targets and drug choice into primary care practice through computer-based implementation of clinical practice guidelines. In collaboration with experts in guideline-automation at Stanford Center for Biomedical Informatics Research (BMIR) (formerly known as Stanford Medical Informatics, SMI), we developed an innovative clinical decision support system: ATHENA-CDS-HTN (hypertension) also known as ATHENA-HTN. ATHENA-HTN is a knowledge-based CDS that uses knowledge bases (KBs) of clinical knowledge of hypertension encoded into computable formats. Clinical data from an electronic health records system is processed with the knowledge in the KB by an execution engine (also known as a guideline interpreter) that generates patient-specific outputs with conclusions about the current state of the patient with respect to the guidelines as shown in the patient's electronic health record data and also generates detailed recommendations for next steps in clinical management of the patient's hypertension. The system is designed to take account of multiple data elements in the patients' clinical data including co-morbid diagnoses that are relevant to hypertension and its treatment, other medications currently prescribed, history of adverse drug reactions/events, and selected laboratory values relevant to hypertension and its management. In previous work, we had demonstrated that deploying this CDS system in VA primary care clinics was feasible and that clinicians found the system usable and useful, as shown by their actual extensive use of the system and their response to a questionnaire survey. The current project was funded by the Department of Veterans Affairs Health Services Research and Development (HSR\&D), under a special funding initiative for Quality Enhancement Initiative (QUERI) projects designed to improve care for hypertension by collaboration with a Veterans Integrated Service Network (VISN) to implement programs to encourage use of established best-practices for managing hypertension according to evidence-based guidelines available at the time of the study. These studies were known as "VISN Collaboratives". The studies did not involve any new drugs or new uses of established drugs, but rather encouraging use of established drugs recommended in standard evidence-based guidelines for care. The focus of the study was implementation of existing known best practices in managing hypertension, using the CDS as a vehicle to bring information to the point-of-care, with detailed individualized recommendations about patients presented to the primary care provider at the time the provider sees patients in scheduled outpatient primary care clinic visits.
Objective(s):
Our objectives in this VISN Implementation Collaborative included: (1) implement evidence-based guidelines for hypertension in a CDS system by upgrading the ATHENA-HTN knowledge-base (KB) to the most recent guidelines; (2) deploy the CDS system in 5 medical centers within VISN 1 to generate individualized recommendations to primary care clinicians caring for patients in outpatient clinics; (3) evaluate the implementation including the organizational aspects.
Methods:
In Phase 1 we plan to update the KB and conduct offline testing; to revise the M (formerly known as MUMPS) program that extracts patient data daily from VistA to extract additional data elements; to streamline the system architecture to make it easier to implement in multiple sites; to work with the site-PIs to obtain IRB approval at 5 implementation sites in VISN 1 plus the coordinating site at VA Palo Alto; to improve the user interface design; to identify and resolve issues in implementing new information technology in multiple different VA medical centers (VAMC) with different Computerized Patient Record System (CPRS) implementations and different methods of distributing computer access to clinicians; to train the site PIs in use of the system; and perform baseline data analysis to inform the randomization. In Phase 2 we plan to recruit primary care providers from the participating 5 medical centers in VISN 1; randomize clinics to ATHENA-HTN intervention or usual care; deploy the system for intervention providers; train intervention providers in use of the system; and conduct a 12-month clinical trial of the system.
Status:
The project has been completed. We completed Institutional Review Board (IRB) approvals at all five medical centers. We updated the knowledge base of computable knowledge regarding hypertension and conducted offline testing. Our system was deployed to all five medical centers. While we were preparing for deployment of the CDS, one site changed from a rich-client environment to a thin-client environment for the medical center computers; we developed new code to run the system in a thin client environment. The previous programming computed recommendations of the CDS based on clinical data available the night before the clinic visit (in order to pre-compute advisories for faster display during clinic); in this project we developed software code to obtain automatic blood pressure updates for the day of visit if these were entered by clinical staff at the time of the visit. VA Palo Alto staff worked with staff at each VAMC to validate clinical data extraction at each site. We developed code for a clinician to select, optionally, for blood pressure write-back to VA VistA so that if clinicians entered to our CDS a blood pressure measurement that they had just taken so they could view updated recommendations based on the repeat blood pressure they would not also have to enter that blood pressure separately to electronic health record. We recruited primary care providers (clinicians) at each of 5 medical centers to participate in the project. One of the 5 medical centers completed the installation of the ATHENA-HTN system, but did not continue with the intervention period, so the intervention included 4 rather than 5 medical centers. Our site-principal investigators and project coordinator trained intervention providers on use of the system by offering short phone calls for training or in-person introduction, and by making the system available for a short period of time for familiarity. Records of patients seen by the clinicians in this training period were excluded from analyses. We completed a 6-8 month intervention period for the clinical trial at the 4 participating medical centers. Our random allocation was at clinic level, where a clinic is a substation of a medical center (station). Before initiating data analyses, we prepared a detailed data analysis plan.
- Conditions
- Hypertension
- Being tested
- ATHENA-CDS-HTN plus Guideline Link, Guideline Link Only
- Keywords
- hypertension, practice guidelines, quality of health care, decision support systems, evidence-based medicine, medical informatics
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATHENA-CDS-HTN plus Guideline LinkOther
ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.
Guideline Link OnlyOther
Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines.
| Study group | Role | What they receive |
|---|---|---|
| ATHENA-CDS-HTN plus Guideline Link | Experimental | ATHENA-CDS-HTN plus Guideline Link. ATHENA-CDS-HTN display on the cover sheet of electronic health record, plus link to the guidelines Receives: Other: ATHENA-CDS-HTN plus Guideline Link |
| Guideline Link Only | Other | Guideline Link Only. Link to The Seventh Report of the Joint National Committee on Prevention Detection and Treatment of High Blood Pressure (JNC7) and to VA-Department of Defense (DoD) hypertension guidelines Receives: Other: Guideline Link Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentages of Events After Index Visit to Primary Care by Patient
The outcome measure was mean percentages of Events after index visit to primary care by patients. The Events were the first event in the patient record after the index clinic visit for the patient, as follows. Event 1 is intensification of pharmacotherapy for hypertension. Event 2 is patient achieves below-target blood pressure (BP). Event 3 is patient does not achieve below-target BP nor is there intensification of pharmacotherapy for hypertension. Event 4 is patient does not achieve BP target, does not have intensified pharmacotherapy, and does not return for further BP measurements. Each patient was assigned one and only one Event. If a patient has pharmacotherapy intensified and also achieved BP below-target, the patient was assigned to whichever happened first. An initial model fitting all 4 events did not detect a difference by study arm for mean percentage of Event 4; final findings are based on a denominator of Events 1 - 3.
Measured: up to one year after index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startJan 2007
- Primary completionMay 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary K. Goldstein, MD MS, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374452
- Sponsor's protocol ID
- IMV 04-062
- Acronym
- HTN
- Status last verified
- Mar 2018
- First submitted
- 8 Sep 2006
- Last updated
- 29 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Martins SB, Lai S, Tu S, Shankar R, Hastings SN, Hoffman BB, Dipilla N, Goldstein MK. Offline testing of the ATHENA Hypertension decision support system knowledge base to improve the accuracy of recommendations. AMIA Annu Symp Proc. 2006;2006:539-43.
PubMed 17238399Chan 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 16779202Trafton J, Martins S, Michel M, Lewis E, Wang D, Combs A, Scates N, Tu S, Goldstein MK. Evaluation of the acceptability and usability of a decision support system to encourage safe and effective use of opioid therapy for chronic, noncancer pain by primary care providers. Pain Med. 2010 Apr;11(4):575-85. doi: 10.1111/j.1526-4637.2010.00818.x. Epub 2010 Mar 1.
PubMed 20202142Michel M, Trafton J, Martins S, Wang D, Tu S, Johnson N, Goldstein MK. Improving Patient Safety Using ATHENA-Decision Support System Technology: The Opioid Therapy for Chronic Pain Experience. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 4: Technology and Medication Safety). Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK43756/
PubMed 21249951Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.
PubMed 19249414Goldstein MK. Using health information technology to improve hypertension management. Curr Hypertens Rep. 2008 Jun;10(3):201-7. doi: 10.1007/s11906-008-0038-6.
PubMed 18765090Cucciare MA, Ketroser N, Wilbourne P, Midboe AM, Cronkite R, Berg-Smith SM, Chardos J. Teaching motivational interviewing to primary care staff in the Veterans Health Administration. J Gen Intern Med. 2012 Aug;27(8):953-61. doi: 10.1007/s11606-012-2016-6. Epub 2012 Feb 28.
PubMed 22370769Steinman MA, Goldstein MK. When tight blood pressure control is not for everyone: a new model for performance measurement in hypertension. Jt Comm J Qual Patient Saf. 2010 Apr;36(4):164-72. doi: 10.1016/s1553-7250(10)36028-4.
PubMed 20402373
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISN Collaborative for Improving Hypertension Management With ATHENA-HTN
- ClinicalTrials.gov ID
- NCT00374452
- Acronym / sponsor ID
- HTN / IMV 04-062
- Conditions
- Hypertension
- Keywords
- hypertension, practice guidelines, quality of health care, decision support systems, evidence-based medicine, medical informatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Posted 18 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a VA HSR\&D-funded Quality Enhancement Research Initiative (QUERI) project to translate into practice evidence about clinical management of primary hypertension. The project aims to contribute to quality improvement of care for patients with primary hypertension. The project implemented a clinical decision support (CDS) system for primary care clinicians and evaluated the implementation by studying the following: impact on the clinicians' prescribing and their patients' blood pressures; the clinician satisfaction with the CDS; and organizational factors in the implementation.
Detailed description
Background / Rationale:
Despite the existence of evidence-based guidelines, there is a gap between evidence-based recommended best medical practice and actual practice. In previous work, we used hypertension as a model to study the translation of research regarding clinical blood pressure targets and drug choice into primary care practice through computer-based implementation of clinical practice guidelines. In collaboration with experts in guideline-automation at Stanford Center for Biomedical Informatics Research (BMIR) (formerly known as Stanford Medical Informatics, SMI), we developed an innovative clinical decision support system: ATHENA-CDS-HTN (hypertension) also known as ATHENA-HTN. ATHENA-HTN is a knowledge-based CDS that uses knowledge bases (KBs) of clinical knowledge of hypertension encoded into computable formats. Clinical data from an electronic health records system is processed with the knowledge in the KB by an execution engine (also known as a guideline interpreter) that generates patient-specific outputs with conclusions about the current state of the patient with respect to the guidelines as shown in the patient's electronic health record data and also generates detailed recommendations for next steps in clinical management of the patient's hypertension. The system is designed to take account of multiple data elements in the patients' clinical data including co-morbid diagnoses that are relevant to hypertension and its treatment, other medications currently prescribed, history of adverse drug reactions/events, and selected laboratory values relevant to hypertension and its management. In previous work, we had demonstrated that deploying this CDS system in VA primary care clinics was feasible and that clinicians found the system usable and useful, as shown by their actual extensive use of the system and their response to a questionnaire survey. The current project was funded by the Department of Veterans Affairs Health Services Research and Development (HSR\&D), under a special funding initiative for Quality Enhancement Initiative (QUERI) projects designed to improve care for hypertension by collaboration with a Veterans Integrated Service Network (VISN) to implement programs to encourage use of established best-practices for managing hypertension according to evidence-based guidelines available at the time of the study. These studies were known as "VISN Collaboratives". The studies did not involve any new drugs or new uses of established drugs, but rather encouraging use of established drugs recommended in standard evidence-based guidelines for care. The focus of the study was implementation of existing known best practices in managing hypertension, using the CDS as a vehicle to bring information to the point-of-care, with detailed individualized recommendations about patients presented to the primary care provider at the time the provider sees patients in scheduled outpatient primary care clinic visits.
Objective(s):
Our objectives in this VISN Implementation Collaborative included: (1) implement evidence-based guidelines for hypertension in a CDS system by upgrading the ATHENA-HTN knowledge-base (KB) to the most recent guidelines; (2) deploy the CDS system in 5 medical centers within VISN 1 to generate individualized recommendations to primary care clinicians caring for patients in outpatient clinics; (3) evaluate the implementation including the organizational aspects.
Methods:
In Phase 1 we plan to update the KB and conduct offline testing; to revise the M (formerly known as MUMPS) program that extracts patient data daily from VistA to extract additional data elements; to streamline the system architecture to make it easier to implement in multiple sites; to work with the site-PIs to obtain IRB approval at 5 implementation sites in VISN 1 plus the coordinating site at VA Palo Alto; to improve the user interface design; to identify and resolve issues in implementing new information technology in multiple different VA medical centers (VAMC) with different Computerized Patient Record System (CPRS) implementations and different methods of distributing computer access to clinicians; to train the site PIs in use of the system; and perform baseline data analysis to inform the randomization. In Phase 2 we plan to recruit primary care providers from the participating 5 medical centers in VISN 1; randomize clinics to ATHENA-HTN intervention or usual care; deploy the system for intervention providers; train intervention providers in use of the system; and conduct a 12-month clinical trial of the system.
Status:
The project has been completed. We completed Institutional Review Board (IRB) approvals at all five medical centers. We updated the knowledge base of computable knowledge regarding hypertension and conducted offline testing. Our system was deployed to all five medical centers. While we were preparing for deployment of the CDS, one site changed from a rich-client environment to a thin-client environment for the medical center computers; we developed new code to run the system in a thin client environment. The previous programming computed recommendations of the CDS based on clinical data available the night before the clinic visit (in order to pre-compute advisories for faster display during clinic); in this project we developed software code to obtain automatic blood pressure updates for the day of visit if these were entered by clinical staff at the time of the visit. VA Palo Alto staff worked with staff at each VAMC to validate clinical data extraction at each site. We developed code for a clinician to select, optionally, for blood pressure write-back to VA VistA so that if clinicians entered to our CDS a blood pressure measurement that they had just taken so they could view updated recommendations based on the repeat blood pressure they would not also have to enter that blood pressure separately to electronic health record. We recruited primary care providers (clinicians) at each of 5 medical centers to participate in the project. One of the 5 medical centers completed the installation of the ATHENA-HTN system, but did not continue with the intervention period, so the intervention included 4 rather than 5 medical centers. Our site-principal investigators and project coordinator trained intervention providers on use of the system by offering short phone calls for training or in-person introduction, and by making the system available for a short period of time for familiarity. Records of patients seen by the clinicians in this training period were excluded from analyses. We completed a 6-8 month intervention period for the clinical trial at the 4 participating medical centers. Our random allocation was at clinic level, where a clinic is a substation of a medical center (station). Before initiating data analyses, we prepared a detailed data analysis plan.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATHENA-CDS-HTN plus Guideline Link | Experimental | Other: ATHENA-CDS-HTN plus Guideline LinkATHENA-CDS-HTN plus Guideline Link. ATHENA-CDS-HTN display on the cover sheet of electronic health record, plus link to the guidelines |
| Guideline Link Only | Other | Other: Guideline Link OnlyGuideline Link Only. Link to The Seventh Report of the Joint National Committee on Prevention Detection and Treatment of High Blood Pressure (JNC7) and to VA-Department of Defense (DoD) hypertension guidelines |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be primary care clinicians (for example, physician or nurse practitioner) at one of the participating VA medical centers. This study is NOT recruiting patients.
- The primary care clinician must have a panel of patients for whom he or she provides direct care.
Key exclusion criteria (1 listed)
- Anyone who does not meet inclusion criteria.
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-CDS-HTN plus Guideline LinkATHENA display provides guideline-based recommendations to clinicians at the time of patient care. | Other | ATHENA-CDS-HTN plus Guideline Link |
| Guideline Link OnlyPrimary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines. | Other | Guideline Link Only |
Primary outcome
Mean Percentages of Events After Index Visit to Primary Care by Patient
Time frame: up to one year after index visit
The outcome measure was mean percentages of Events after index visit to primary care by patients. The Events were the first event in the patient record after the index clinic visit for the patient, as follows. Event 1 is intensification of pharmacotherapy for hypertension. Event 2 is patient achieves below-target blood pressure (BP). Event 3 is patient does not achieve below-target BP nor is there intensification of pharmacotherapy for hypertension. Event 4 is patient does not achieve BP target, does not have intensified pharmacotherapy, and does not return for further BP measurements. Each patient was assigned one and only one Event. If a patient has pharmacotherapy intensified and also achieved BP below-target, the patient was assigned to whichever happened first. An initial model fitting all 4 events did not detect a difference by study arm for mean percentage of Event 4; final findings are based on a denominator of Events 1 - 3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17238399Martins SB, Lai S, Tu S, Shankar R, Hastings SN, Hoffman BB, Dipilla N, Goldstein MK. Offline testing of the ATHENA Hypertension decision support system knowledge base to improve the accuracy of recommendations. AMIA Annu Symp Proc. 2006;2006:539-43.
- 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 20202142Trafton J, Martins S, Michel M, Lewis E, Wang D, Combs A, Scates N, Tu S, Goldstein MK. Evaluation of the acceptability and usability of a decision support system to encourage safe and effective use of opioid therapy for chronic, noncancer pain by primary care providers. Pain Med. 2010 Apr;11(4):575-85. doi: 10.1111/j.1526-4637.2010.00818.x. Epub 2010 Mar 1.
- Results publication: PubMed 21249951Michel M, Trafton J, Martins S, Wang D, Tu S, Johnson N, Goldstein MK. Improving Patient Safety Using ATHENA-Decision Support System Technology: The Opioid Therapy for Chronic Pain Experience. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 4: Technology and Medication Safety). Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK43756/
- Results publication: PubMed 19249414Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.
- Results publication: PubMed 18765090Goldstein MK. Using health information technology to improve hypertension management. Curr Hypertens Rep. 2008 Jun;10(3):201-7. doi: 10.1007/s11906-008-0038-6.
- Results publication: PubMed 22370769Cucciare MA, Ketroser N, Wilbourne P, Midboe AM, Cronkite R, Berg-Smith SM, Chardos J. Teaching motivational interviewing to primary care staff in the Veterans Health Administration. J Gen Intern Med. 2012 Aug;27(8):953-61. doi: 10.1007/s11606-012-2016-6. Epub 2012 Feb 28.
- Results publication: PubMed 20402373Steinman MA, Goldstein MK. When tight blood pressure control is not for everyone: a new model for performance measurement in hypertension. Jt Comm J Qual Patient Saf. 2010 Apr;36(4):164-72. doi: 10.1016/s1553-7250(10)36028-4.
- Individual participant dataSharing planned: No
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATHENA-CDS-HTN plus Guideline Link and Guideline Link Only in people with Hypertension, run by VA Office of Research and Development at 7 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 2 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percentages of Events After Index Visit to Primary Care by Patient (time frame: up to one year after index visit). 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 NCT00374452, which also lists 8 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 29 Mar 2018.