Cardiovascular DiseasesNCT00201084
Physician Uncertainty Reduction for Hypertension
A study testing Uncertainty reduction in people with Cardiovascular Diseases and Heart Diseases, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to test the theory that a major factor in poor blood pressure (BP) control is that physicians fail to intensify antihypertensive therapy for their patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- What is being tested?
- Uncertainty reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Kept appointment on index visit day (see patient sampling and recruitment methods below)
- Had one previous visit to the setting within the past year and identified the setting as his/her usual source of care
- Average clinic BP on index visit and one most recent previous visit was equal to or greater than 140 mm Hg systolic or 90 mm Hg diastolic (130/80 mm Hg if diabetic)
- Acknowledges understanding of the study goals and methods and gives informed consent to participate in study measurements and other procedures
Who cannot join
- Cognitive or other functional impairment sufficient to limit patient's ability to give informed consent, keep follow-up appointments, and participate actively in adherence to his or her treatment regimen
- Renal insufficiencies or renal failure based on a recent serum creatinine greater than 2.0 or chart diagnosis
- Planning to leave the Houston area within the next two years
- Severe, life-threatening illness that makes hypertension treatment a secondary priority
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test the theory that a major factor in poor blood pressure (BP) control is that physicians fail to intensify antihypertensive therapy for their patients.
Read the detailed description
BACKGROUND:
A large amount of literature suggests that the majority of "uncontrolled" hypertensives are under medical care, and that lack of control is largely explained by physicians not intensifying treatment to achieve the BP targets recommended in the national guidelines. Traditional physician education, feedback, and reminders have a limited effect in promoting a rapid rate of guideline implementation. The theoretical framework of diffusion of innovations suggests that providing physicians with tools to reduce uncertainty about the attributes of a guideline may accelerate the adoption process. The presumed barriers to treatment intensification for uncontrolled hypertension are: 1) uncertainty over the patient's "true" BP; 2) uncertainty over whether the patient is adherent to medications already prescribed; and 3) uncertainty over the benefits of adding medications when patients express preference for lifestyle modification.
DESIGN NARRATIVE:
This cluster randomized trial in 10 primary care clinics (5 intervention and 5 control) will test the hypothesis that an intervention based on diffusion of innovations theory, and targeting provider treatment actions, will increase the prevalence of BP control to Joint National Committee-7(JNC-7) recommended levels in African American patients (greater than 140/90 mm Hg or greater 130/80 mm Hg if the patient has diabetes). The uncertainty reduction tools in the "Uncertainty Reduction to Accelerate Diffusion (URAD)" practices will include: 24-hour ambulatory BP monitoring, electronic bottle-cap monitoring of medication adherence, and medication and lifestyle counseling. The "Usual Practice (UP)" physicians will receive education about the guidelines and a "placebo" chart form indicating the patient is being followed in a BP control study. The 10 participating clinics represent a large, multi-site private group practice and a public health care system. Sixty-seven patients per clinic (670 total) will be enrolled when the intervention is initiated, and their BP and self-reported medication and lifestyle adherence will be monitored for two years. Sixty percent of the sample will be African American, and the study will have 90% power to detect a difference of 20% in the prevalence of hypertension control in the African Americans as a result of the intervention (50% control in URAD clinics vs. 30% control UP clinics). Secondary endpoints will include BP measurements by study staff under standardized conditions, physician treatment intensification actions, patient adherence, characteristics of doctor-patient communication associated with treatment action, use of the URAD components, and physician knowledge and beliefs about the JNC 7 guidelines and their relationship to BP control. Analysis of secondary endpoints will include race. The research team has collaborated with both health systems in previous studies, and is experienced in conducting hypertension control and behavioral intervention studies in the target population.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Being tested
- Uncertainty reduction
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncertainty reductionBehavioural
At physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Uncertainty reduction tools, at physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling Receives: Behavioral: Uncertainty reduction |
| 2 | No intervention | Usual primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expressed as the proportion of patients with average clinic BP less than 140/90 mm Hg in the previous two visits (130/80 mm Hg if the patient also has diabetes)
Measured: 24 months
Secondary outcomes (3)
Actual measure clinic systolic and diastolic BP, patient physician communication patterns
Measured: 24 months
Patient adherence to medication and healthy lifestyle
Measured: 24 months
Physician knowledge, attitude, and beliefs about JNC-7 goals and barriers to achievement of the treatment goals and cost
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston, Kelsey Research Foundation
- Responsible party
- Principal investigator, David Hyman, Baylor College of Medicine
- Investigators
- David J. Hyman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201084
- Sponsor's protocol ID
- 276
- Other IDs
- R01HL078589
- Status last verified
- Jul 2014
- First submitted
- 16 Sep 2005
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pavlik VN, Greisinger AJ, Pool J, Haidet P, Hyman DJ. Does reducing physician uncertainty improve hypertension control?: rationale and methods. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):257-63. doi: 10.1161/CIRCOUTCOMES.109.849984.
PubMed 20031846Grigoryan L, Pavlik VN, Hyman DJ. Characteristics, drug combinations and dosages of primary care patients with uncontrolled ambulatory blood pressure and high medication adherence. J Am Soc Hypertens. 2013 Nov-Dec;7(6):471-6. doi: 10.1016/j.jash.2013.06.004. Epub 2013 Jul 23.
PubMed 23890931Grigoryan L, Pavlik VN, Hyman DJ. Predictors of antihypertensive medication adherence in two urban health-care systems. Am J Hypertens. 2012 Jul;25(7):735-8. doi: 10.1038/ajh.2012.30. Epub 2012 Mar 22.
PubMed 22441507Hyman DJ, Pavlik VN, Greisinger AJ, Chan W, Bayona J, Mansyur C, Simms V, Pool J. Effect of a physician uncertainty reduction intervention on blood pressure in uncontrolled hypertensives--a cluster randomized trial. J Gen Intern Med. 2012 Apr;27(4):413-9. doi: 10.1007/s11606-011-1888-1. Epub 2011 Oct 27.
PubMed 22033742
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Uncertainty Reduction for Hypertension
- ClinicalTrials.gov ID
- NCT00201084
- Acronym / sponsor ID
- 276
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston, Kelsey Research Foundation
- Study start
- Sep 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Sep 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.
The purpose of this study is to test the theory that a major factor in poor blood pressure (BP) control is that physicians fail to intensify antihypertensive therapy for their patients.
Detailed description
BACKGROUND:
A large amount of literature suggests that the majority of "uncontrolled" hypertensives are under medical care, and that lack of control is largely explained by physicians not intensifying treatment to achieve the BP targets recommended in the national guidelines. Traditional physician education, feedback, and reminders have a limited effect in promoting a rapid rate of guideline implementation. The theoretical framework of diffusion of innovations suggests that providing physicians with tools to reduce uncertainty about the attributes of a guideline may accelerate the adoption process. The presumed barriers to treatment intensification for uncontrolled hypertension are: 1) uncertainty over the patient's "true" BP; 2) uncertainty over whether the patient is adherent to medications already prescribed; and 3) uncertainty over the benefits of adding medications when patients express preference for lifestyle modification.
DESIGN NARRATIVE:
This cluster randomized trial in 10 primary care clinics (5 intervention and 5 control) will test the hypothesis that an intervention based on diffusion of innovations theory, and targeting provider treatment actions, will increase the prevalence of BP control to Joint National Committee-7(JNC-7) recommended levels in African American patients (greater than 140/90 mm Hg or greater 130/80 mm Hg if the patient has diabetes). The uncertainty reduction tools in the "Uncertainty Reduction to Accelerate Diffusion (URAD)" practices will include: 24-hour ambulatory BP monitoring, electronic bottle-cap monitoring of medication adherence, and medication and lifestyle counseling. The "Usual Practice (UP)" physicians will receive education about the guidelines and a "placebo" chart form indicating the patient is being followed in a BP control study. The 10 participating clinics represent a large, multi-site private group practice and a public health care system. Sixty-seven patients per clinic (670 total) will be enrolled when the intervention is initiated, and their BP and self-reported medication and lifestyle adherence will be monitored for two years. Sixty percent of the sample will be African American, and the study will have 90% power to detect a difference of 20% in the prevalence of hypertension control in the African Americans as a result of the intervention (50% control in URAD clinics vs. 30% control UP clinics). Secondary endpoints will include BP measurements by study staff under standardized conditions, physician treatment intensification actions, patient adherence, characteristics of doctor-patient communication associated with treatment action, use of the URAD components, and physician knowledge and beliefs about the JNC 7 guidelines and their relationship to BP control. Analysis of secondary endpoints will include race. The research team has collaborated with both health systems in previous studies, and is experienced in conducting hypertension control and behavioral intervention studies in the target population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Uncertainty reductionUncertainty reduction tools, at physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling |
| 2 | No intervention | –Usual primary care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Kept appointment on index visit day (see patient sampling and recruitment methods below)
- Had one previous visit to the setting within the past year and identified the setting as his/her usual source of care
- Average clinic BP on index visit and one most recent previous visit was equal to or greater than 140 mm Hg systolic or 90 mm Hg diastolic (130/80 mm Hg if diabetic)
- Acknowledges understanding of the study goals and methods and gives informed consent to participate in study measurements and other procedures
Key exclusion criteria (4 listed)
- Cognitive or other functional impairment sufficient to limit patient's ability to give informed consent, keep follow-up appointments, and participate actively in adherence to his or her treatment regimen
- Renal insufficiencies or renal failure based on a recent serum creatinine greater than 2.0 or chart diagnosis
- Planning to leave the Houston area within the next two years
- Severe, life-threatening illness that makes hypertension treatment a secondary priority
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 |
|---|---|---|
| Uncertainty reductionAt physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling | Behavioural | 1 |
Primary outcome
Expressed as the proportion of patients with average clinic BP less than 140/90 mm Hg in the previous two visits (130/80 mm Hg if the patient also has diabetes)
Time frame: 24 months
3 secondary outcomes
Actual measure clinic systolic and diastolic BP, patient physician communication patterns
Time frame: 24 months
Patient adherence to medication and healthy lifestyle
Time frame: 24 months
Physician knowledge, attitude, and beliefs about JNC-7 goals and barriers to achievement of the treatment goals and cost
Time frame: 24 months
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 21 Jul 2014.
- Background: PubMed 20031846Pavlik VN, Greisinger AJ, Pool J, Haidet P, Hyman DJ. Does reducing physician uncertainty improve hypertension control?: rationale and methods. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):257-63. doi: 10.1161/CIRCOUTCOMES.109.849984.
- Results publication: PubMed 23890931Grigoryan L, Pavlik VN, Hyman DJ. Characteristics, drug combinations and dosages of primary care patients with uncontrolled ambulatory blood pressure and high medication adherence. J Am Soc Hypertens. 2013 Nov-Dec;7(6):471-6. doi: 10.1016/j.jash.2013.06.004. Epub 2013 Jul 23.
- Results publication: PubMed 22441507Grigoryan L, Pavlik VN, Hyman DJ. Predictors of antihypertensive medication adherence in two urban health-care systems. Am J Hypertens. 2012 Jul;25(7):735-8. doi: 10.1038/ajh.2012.30. Epub 2012 Mar 22.
- Results publication: PubMed 22033742Hyman DJ, Pavlik VN, Greisinger AJ, Chan W, Bayona J, Mansyur C, Simms V, Pool J. Effect of a physician uncertainty reduction intervention on blood pressure in uncontrolled hypertensives--a cluster randomized trial. J Gen Intern Med. 2012 Apr;27(4):413-9. doi: 10.1007/s11606-011-1888-1. Epub 2011 Oct 27.
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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.
David J. Hyman, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncertainty reduction in people with Cardiovascular Diseases and Heart Diseases, run by Baylor College of Medicine 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 4 inclusion and 4 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 21 Jul 2014. 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?
Expressed as the proportion of patients with average clinic BP less than 140/90 mm Hg in the previous two visits (130/80 mm Hg if the patient also has diabetes) (time frame: 24 months). 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 NCT00201084, which also lists 4 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 21 Jul 2014.