HypertensionPhase 1NCT01640704
Impact of Computerized Reminders on Blood Pressure Documentation and Control
A Phase 1 study testing Computerized reminders about treatment guidelines to providers who care for hypertensive patients in people with Hypertension, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial summary
Numerous studies have examined potential causes for the racial differences in HTN prevalence and severity including baseline insulin levels, sympathetic nervous activity, intracellular calcium levels and intracellular sodium levels.[21-23] However, to our knowledge, there have been no studies examining the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Computerized reminders about treatment guidelines to providers who care for hypertensive patients
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Feb 2005
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- We examined data obtained from the electronic medical record review of patients older than 20 years with a diagnosis of hypertension, with at least one hypertension-related outpatient visit to one of fourteen general medicine clinics in community health centers, community-based practices, and hospital-based practices affiliated with a large urban academic medical center during the one-year period prior to the beginning of the intervention trial.
Who cannot join
- Patients without documented hypertension-related primary care visits or less than 20 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Numerous studies have examined potential causes for the racial differences in HTN prevalence and severity including baseline insulin levels, sympathetic nervous activity, intracellular calcium levels and intracellular sodium levels.[21-23] However, to our knowledge, there have been no studies examining the relationship of physician adherence to JNC guidelines to racial disparities in outcomes from HTN; nor have there been published studies examining the use of interventions such as computerized decision support tools or case-management to improve JNC adherence with the goal of reducing racial differences in blood pressure control. The aims of this study are: 1) To determine if physician's prescribing practices for HTN medications adhere to JNC guidelines for drug therapy.
- To determine if there are variations in adherence to JNC guidelines based on patient race.
- To determine if adherence to JNC guidelines improves blood pressure control. 4) To determine if the use of computerized medical reminders improves adherence to JNC guidelines.
- Conditions
- Hypertension
- Being tested
- Computerized reminders about treatment guidelines to providers who care for hypertensive patients
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized reminders about treatment guidelines to providers who care for hypertensive patientsBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2003
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, david bates, Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- LeRoi S. Hicks, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640704
- Sponsor's protocol ID
- 3Ui8HS11046
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2012
- Last updated
- 16 Jul 2012
- Results posted
- No
Publications
Gandhi TK, Seger AC, Overhage JM, Murray MD, Hope C, Fiskio J, Teal E, Bates DW. Outpatient adverse drug events identified by screening electronic health records. J Patient Saf. 2010 Jun;6(2):91-6. doi: 10.1097/PTS.0b013e3181dcae06.
PubMed 22130350
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Computerized Reminders on Blood Pressure Documentation and Control
- ClinicalTrials.gov ID
- NCT01640704
- Acronym / sponsor ID
- 3Ui8HS11046
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Jul 2003
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 16 Jul 2012 (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.
Numerous studies have examined potential causes for the racial differences in HTN prevalence and severity including baseline insulin levels, sympathetic nervous activity, intracellular calcium levels and intracellular sodium levels.[21-23] However, to our knowledge, there have been no studies examining the relationship of physician adherence to JNC guidelines to racial disparities in outcomes from HTN; nor have there been published studies examining the use of interventions such as computerized decision support tools or case-management to improve JNC adherence with the goal of reducing racial differences in blood pressure control. The aims of this study are: 1) To determine if physician's prescribing practices for HTN medications adhere to JNC guidelines for drug therapy.
- To determine if there are variations in adherence to JNC guidelines based on patient race.
- To determine if adherence to JNC guidelines improves blood pressure control. 4) To determine if the use of computerized medical reminders improves adherence to JNC guidelines.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We examined data obtained from the electronic medical record review of patients older than 20 years with a diagnosis of hypertension, with at least one hypertension-related outpatient visit to one of fourteen general medicine clinics in community health centers, community-based practices, and hospital-based practices affiliated with a large urban academic medical center during the one-year period prior to the beginning of the intervention trial.
Key exclusion criteria (1 listed)
- Patients without documented hypertension-related primary care visits or less than 20 years of age
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 |
|---|---|---|
| Computerized reminders about treatment guidelines to providers who care for hypertensive patients | Behavioural | – |
Primary outcome
Not reported in the source record.
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 16 Jul 2012.
- Results publication: PubMed 22130350Gandhi TK, Seger AC, Overhage JM, Murray MD, Hope C, Fiskio J, Teal E, Bates DW. Outpatient adverse drug events identified by screening electronic health records. J Patient Saf. 2010 Jun;6(2):91-6. doi: 10.1097/PTS.0b013e3181dcae06.
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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.
LeRoi S. Hicks, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computerized reminders about treatment guidelines to providers who care for hypertensive patients in people with Hypertension, run by Agency for Healthcare Research and Quality (AHRQ) 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 16 Jul 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01640704, which also lists 1 linked publication.
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 16 Jul 2012.