Blood PressureNCT02164331
Blood Pressure (BP) Visit Intensification Study
A study testing JNC guideline training in people with Blood Pressure and Hypertension, run by University of Rochester.
Trial summary
Aim 1: The purpose of the study is to implement the Seventh Joint National Committee on the Diagnosis, Prevention and Treatment of Hypertension (JNC VII) recommendation for monthly visits for hypertensive patients with uncontrolled blood pressure (BP) using a theoretically-informed, empirically grounded, multimodal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension
- What is being tested?
- JNC guideline training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Federally Qualified Health Center in the Clinic Directors Network, Practice Champion, Electronic Medical Record System
Who cannot join
- Clinicians who have been at the practice less than 6 months, Practices planning to change Electronic Medical Record systems within the next 6 months
About this study
Official title: A Multimodal Quality Improvement Intervention Using the JNC Guidelines to Promote Control of Patients' BP in Federally Qualified Health Centers
Aim 1: The purpose of the study is to implement the Seventh Joint National Committee on the Diagnosis, Prevention and Treatment of Hypertension (JNC VII) recommendation for monthly visits for hypertensive patients with uncontrolled blood pressure (BP) using a theoretically-informed, empirically grounded, multimodal quality improvement (QI) intervention.
Aim 2: To improve BP control and reduce disparity in BP through implementation of monthly visits.
Aim 3: To assess potential mediators and moderators of the intervention.
Read the detailed description
This study is a stepped wedged cluster randomized trial designed to improve management of uncontrolled blood pressure among patients in federally qualified health centers through the auspices of the the Clinical Directors Network Practice-Based Research Network (CDN PBRN).
- Conditions
- Blood Pressure, Hypertension
- Being tested
- JNC guideline training
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNC guideline trainingBehavioural
Providers will receive a series of trainings on what the JNC guidelines for treating uncontrolled hypertensives are and strategies for meeting those guidelines.
| Study group | Role | What they receive |
|---|---|---|
| JNC guideline training | Experimental | Providers will receive current JNC guideline training for treating patients with uncontrolled hypertension. Receives: Behavioral: JNC guideline training |
| Control | No intervention | Provider patient panels will be assessed for number of uncontrolled hypertensives before receiving the JNC guidelines training. These baseline characteristics will serve as their control conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of office visits
Increase patient visit intensification for patients with uncontrolled blood pressure (BP) until the BP is under control.
Measured: Baseline and aniticipated at 1 year
Secondary outcomes (1)
Reduction in Blood Pressure
Providers patient panels will be assessed to understand any changes in blood pressure from baseline
Measured: Baseline and anticipated at year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2017
- Study completionDec 2017
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 Blood PressureStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Fiscella, University of Rochester
- Investigators
- Kevin A Fiscella, MD MPH, Principal investigator, University of RochesterJonathan Tobin, PhD, Principal investigator, Clinical Directors Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164331
- Sponsor's protocol ID
- 1R18HL117801
- Status last verified
- Jul 2018
- First submitted
- 7 Apr 2014
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fiscella K, He H, Sanders M, Cassells A, Carroll JK, Williams SK, Cornell J, Holder T, Khalida C, Tobin JN. Blood Pressure Visit Intensification in Treatment (BP-Visit) Findings: a Pragmatic Stepped Wedge Cluster Randomized Trial. J Gen Intern Med. 2022 Jan;37(1):32-39. doi: 10.1007/s11606-021-07016-9. Epub 2021 Aug 11.
PubMed 34379277Fiscella K, Ogedegbe G, He H, Carroll J, Cassells A, Sanders M, Khalida C, D'Orazio B, Tobin JN. Blood Pressure Visit Intensification Study in Treatment: Trial design. Am Heart J. 2015 Dec;170(6):1202-10. doi: 10.1016/j.ahj.2015.08.022. Epub 2015 Sep 12.
PubMed 26678642
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Quality Improvement Intervention Using the JNC Guidelines to Promote Control of Patients' BP in Federally Qualified Health Centers
- ClinicalTrials.gov ID
- NCT02164331
- Acronym / sponsor ID
- 1R18HL117801
- Conditions
- Blood Pressure, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Jun 2014 (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.
Aim 1: The purpose of the study is to implement the Seventh Joint National Committee on the Diagnosis, Prevention and Treatment of Hypertension (JNC VII) recommendation for monthly visits for hypertensive patients with uncontrolled blood pressure (BP) using a theoretically-informed, empirically grounded, multimodal quality improvement (QI) intervention.
Aim 2: To improve BP control and reduce disparity in BP through implementation of monthly visits.
Aim 3: To assess potential mediators and moderators of the intervention.
Detailed description
This study is a stepped wedged cluster randomized trial designed to improve management of uncontrolled blood pressure among patients in federally qualified health centers through the auspices of the the Clinical Directors Network Practice-Based Research Network (CDN PBRN).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNC guideline training | Experimental | Behavioral: JNC guideline trainingProviders will receive current JNC guideline training for treating patients with uncontrolled hypertension. |
| Control | No intervention | –Provider patient panels will be assessed for number of uncontrolled hypertensives before receiving the JNC guidelines training. These baseline characteristics will serve as their control conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Federally Qualified Health Center in the Clinic Directors Network, Practice Champion, Electronic Medical Record System
Key exclusion criteria (1 listed)
- Clinicians who have been at the practice less than 6 months, Practices planning to change Electronic Medical Record systems within the next 6 months
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 |
|---|---|---|
| JNC guideline trainingProviders will receive a series of trainings on what the JNC guidelines for treating uncontrolled hypertensives are and strategies for meeting those guidelines. | Behavioural | JNC guideline training |
Primary outcome
Number of office visits
Time frame: Baseline and aniticipated at 1 year
Increase patient visit intensification for patients with uncontrolled blood pressure (BP) until the BP is under control.
1 secondary outcome
Reduction in Blood Pressure
Time frame: Baseline and anticipated at year
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 31 Jul 2018.
- Derived from this study: PubMed 34379277Fiscella K, He H, Sanders M, Cassells A, Carroll JK, Williams SK, Cornell J, Holder T, Khalida C, Tobin JN. Blood Pressure Visit Intensification in Treatment (BP-Visit) Findings: a Pragmatic Stepped Wedge Cluster Randomized Trial. J Gen Intern Med. 2022 Jan;37(1):32-39. doi: 10.1007/s11606-021-07016-9. Epub 2021 Aug 11.
- Derived from this study: PubMed 26678642Fiscella K, Ogedegbe G, He H, Carroll J, Cassells A, Sanders M, Khalida C, D'Orazio B, Tobin JN. Blood Pressure Visit Intensification Study in Treatment: Trial design. Am Heart J. 2015 Dec;170(6):1202-10. doi: 10.1016/j.ahj.2015.08.022. Epub 2015 Sep 12.
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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.
Kevin A Fiscella, MD MPH principal investigator
University of Rochester
Jonathan Tobin, PhD principal investigator
Clinical Directors Network
Questions about this trial
What is this clinical trial studying?
A study testing JNC guideline training in people with Blood Pressure and Hypertension, run by University of Rochester.
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 31 Jul 2018. 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?
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?
Number of office visits (time frame: Baseline and aniticipated at 1 year). 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 NCT02164331, 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 31 Jul 2018.