HypertensionNCT00201045
Team Management of High Blood Pressure
A study testing Physician/Pharmacist Collaborative Teams in people with Hypertension, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to test whether blood pressure control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Physician/Pharmacist Collaborative Teams
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Oct 2006
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, age 21-85
- Taking 0-3 antihypertensive medications with no changes in regimen or dose within the past 4 weeks
- Non-diabetic with clinic BP 145-179 / 95-109 or diabetic with BP greater than 135/85
Who cannot join
- Previous 24 hour BP monitoring consult service within the past 6 months
- Stage 3 hypertension greater than 180/110
- Recent MI or stroke within the past 6 months
- Class III or IV congestive heart failure
- Unstable angina
- Uncontrolled atrial fibrillation
Show all 10Show fewer
- Serious renal disease (serum creatinine greater than 3.5)
- Serious hepatic disease (total bilirubin greater than 3.0)
- Pregnancy
- Poor prognosis with less than a 3 year life expectancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collaborative Management of Hypertension
The purpose of this study is to test whether blood pressure control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams.
Read the detailed description
BACKGROUND:
The Healthy People 2010 target calls for controlled BP in 50% of the 50 million Americans with hypertension. BP is currently controlled in only 27% of the population. These population figures are in contrast to data from clinical trials (efficacy) in which BP has been controlled in 70 to 80% of study participants. Poor BP control exists in spite of six sets of guidelines generated over the last 30 years in the United States. While there are many causes for poor control, several studies have found that physicians are frequently satisfied with uncontrolled BPs. Numerous strategies exist to assist physicians with achieving better BP control, but a consistent, effective approach to solving the problem has not been found.
DESIGN NARRATIVE:
The objective of this study is to test whether BP control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams. The rationale for this proposal is generated from studies demonstrating that physician knowledge, quality of prescribing, and attainment of treatment goals can be improved when physicians collaborate with clinical pharmacists. Previous studies have suffered from insufficient sample size and controls and did not include a structured intervention. This study will address these gaps in knowledge by conducting a randomized, prospective study in 5 clinics (2 intervention and 3 control) with 27 physicians who care for 180 patients with uncontrolled BP. The structured intervention will involve clinical pharmacists who evaluate BP therapy and treatment strategies and make specific recommendations to the physician. Patients will be seen at baseline and at 2, 4, 6, 8, and 9 months, at which time random zero BP measurements will be performed. The specific aims of this study are (1) to determine if better BP control can be achieved by the use of physician/pharmacist teams that utilize physician education and feedback when compared to usual care, (2) to determine if improvements in BP control are related to an increase in physician knowledge of and adherence to BP guidelines when they are involved in physician/pharmacist teams, and (3) to determine if changes in BP control are associated with the level and scope of the physician/pharmacist relationships. This model utilizes an innovative system approach to improve BP control. This intervention has the potential to achieve marked improvements in BP control. This model could become one additional strategy to help achieve the BP goals for Healthy People 2010.
- Conditions
- Hypertension
- Being tested
- Physician/Pharmacist Collaborative Teams
- Keywords
- Hypertension management, Pharmacist management, Physician pharmacist collaboration, Blood pressure control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician/Pharmacist Collaborative TeamsOther
The patient's physician collaborates with a clinical pharmacist to improve management of hypertension
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention patients receive care from a clinical pharmacist to improve blood pressure. Receives: Other: Physician/Pharmacist Collaborative Teams |
| Control | No intervention | Control patients receive usual care and do not have a clinical pharmacist included in their care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control
Measured: Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months
Secondary outcomes (3)
Mean number of antihypertensives
Measured: Measured when each patient completed the study.
Side effect score
Measured: Measured when each patient completed the study.
Physician knowledge
Measured: Measured at the beginning and at the end of the study.
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 startJul 2003
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Barry L. Carter, Study chair, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201045
- Sponsor's protocol ID
- 271
- Other IDs
- R01HL069801
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carter BL, Hartz A, Bergus G, Dawson JD, Doucette WR, Stewart JJ, Xu Y. Relationship between physician knowledge of hypertension and blood pressure control. J Clin Hypertens (Greenwich). 2006 Jul;8(7):481-6. doi: 10.1111/j.1524-6175.2006.05601.x.
PubMed 16849901Carter BL. Antihypertensive prescribing: do we have reason to celebrate? Hypertension. 2006 Nov;48(5):816-7. doi: 10.1161/01.HYP.0000240978.77934.3a. Epub 2006 Sep 18. No abstract available.
PubMed 16982966Carter BL, Sica DA. Strategies to improve the cardiovascular risk profile of thiazide-type diuretics as used in the management of hypertension. Expert Opin Drug Saf. 2007 Sep;6(5):583-94. doi: 10.1517/14740338.6.5.583.
PubMed 17877445Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009 Oct 26;169(19):1748-55. doi: 10.1001/archinternmed.2009.316.
PubMed 19858431Carter BL, Bergus GR, Dawson JD, Farris KB, Doucette WR, Chrischilles EA, Hartz AJ. A cluster randomized trial to evaluate physician/pharmacist collaboration to improve blood pressure control. J Clin Hypertens (Greenwich). 2008 Apr;10(4):260-71. doi: 10.1111/j.1751-7176.2008.07434.x.
PubMed 18401223Weber CA, Ernst ME, Sezate GS, Zheng S, Carter BL. Pharmacist-physician comanagement of hypertension and reduction in 24-hour ambulatory blood pressures. Arch Intern Med. 2010 Oct 11;170(18):1634-9. doi: 10.1001/archinternmed.2010.349.
PubMed 20937921
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Management of Hypertension
- ClinicalTrials.gov ID
- NCT00201045
- Acronym / sponsor ID
- 271
- Conditions
- Hypertension
- Keywords
- Hypertension management, Pharmacist management, Physician pharmacist collaboration, Blood pressure control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2003
- Study completion
- Oct 2006 (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 whether blood pressure control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams.
Detailed description
BACKGROUND:
The Healthy People 2010 target calls for controlled BP in 50% of the 50 million Americans with hypertension. BP is currently controlled in only 27% of the population. These population figures are in contrast to data from clinical trials (efficacy) in which BP has been controlled in 70 to 80% of study participants. Poor BP control exists in spite of six sets of guidelines generated over the last 30 years in the United States. While there are many causes for poor control, several studies have found that physicians are frequently satisfied with uncontrolled BPs. Numerous strategies exist to assist physicians with achieving better BP control, but a consistent, effective approach to solving the problem has not been found.
DESIGN NARRATIVE:
The objective of this study is to test whether BP control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams. The rationale for this proposal is generated from studies demonstrating that physician knowledge, quality of prescribing, and attainment of treatment goals can be improved when physicians collaborate with clinical pharmacists. Previous studies have suffered from insufficient sample size and controls and did not include a structured intervention. This study will address these gaps in knowledge by conducting a randomized, prospective study in 5 clinics (2 intervention and 3 control) with 27 physicians who care for 180 patients with uncontrolled BP. The structured intervention will involve clinical pharmacists who evaluate BP therapy and treatment strategies and make specific recommendations to the physician. Patients will be seen at baseline and at 2, 4, 6, 8, and 9 months, at which time random zero BP measurements will be performed. The specific aims of this study are (1) to determine if better BP control can be achieved by the use of physician/pharmacist teams that utilize physician education and feedback when compared to usual care, (2) to determine if improvements in BP control are related to an increase in physician knowledge of and adherence to BP guidelines when they are involved in physician/pharmacist teams, and (3) to determine if changes in BP control are associated with the level and scope of the physician/pharmacist relationships. This model utilizes an innovative system approach to improve BP control. This intervention has the potential to achieve marked improvements in BP control. This model could become one additional strategy to help achieve the BP goals for Healthy People 2010.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Physician/Pharmacist Collaborative TeamsIntervention patients receive care from a clinical pharmacist to improve blood pressure. |
| Control | No intervention | –Control patients receive usual care and do not have a clinical pharmacist included in their care. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females, age 21-85
- Taking 0-3 antihypertensive medications with no changes in regimen or dose within the past 4 weeks
- Non-diabetic with clinic BP 145-179 / 95-109 or diabetic with BP greater than 135/85
Key exclusion criteria (10 listed)
- Previous 24 hour BP monitoring consult service within the past 6 months
- Stage 3 hypertension greater than 180/110
- Recent MI or stroke within the past 6 months
- Class III or IV congestive heart failure
- Unstable angina
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 |
|---|---|---|
| Physician/Pharmacist Collaborative TeamsThe patient's physician collaborates with a clinical pharmacist to improve management of hypertension | Other | Intervention |
Primary outcome
Blood pressure control
Time frame: Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months
3 secondary outcomes
Mean number of antihypertensives
Time frame: Measured when each patient completed the study.
Side effect score
Time frame: Measured when each patient completed the study.
Physician knowledge
Time frame: Measured at the beginning and at the end of the study.
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 27 Mar 2014.
- Background: PubMed 16849901Carter BL, Hartz A, Bergus G, Dawson JD, Doucette WR, Stewart JJ, Xu Y. Relationship between physician knowledge of hypertension and blood pressure control. J Clin Hypertens (Greenwich). 2006 Jul;8(7):481-6. doi: 10.1111/j.1524-6175.2006.05601.x.
- Background: PubMed 16982966Carter BL. Antihypertensive prescribing: do we have reason to celebrate? Hypertension. 2006 Nov;48(5):816-7. doi: 10.1161/01.HYP.0000240978.77934.3a. Epub 2006 Sep 18. No abstract available.
- Background: PubMed 17877445Carter BL, Sica DA. Strategies to improve the cardiovascular risk profile of thiazide-type diuretics as used in the management of hypertension. Expert Opin Drug Saf. 2007 Sep;6(5):583-94. doi: 10.1517/14740338.6.5.583.
- Background: PubMed 19858431Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009 Oct 26;169(19):1748-55. doi: 10.1001/archinternmed.2009.316.
- Results publication: PubMed 18401223Carter BL, Bergus GR, Dawson JD, Farris KB, Doucette WR, Chrischilles EA, Hartz AJ. A cluster randomized trial to evaluate physician/pharmacist collaboration to improve blood pressure control. J Clin Hypertens (Greenwich). 2008 Apr;10(4):260-71. doi: 10.1111/j.1751-7176.2008.07434.x.
- Derived from this study: PubMed 20937921Weber CA, Ernst ME, Sezate GS, Zheng S, Carter BL. Pharmacist-physician comanagement of hypertension and reduction in 24-hour ambulatory blood pressures. Arch Intern Med. 2010 Oct 11;170(18):1634-9. doi: 10.1001/archinternmed.2010.349.
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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.
Barry L. Carter study chair
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician/Pharmacist Collaborative Teams in people with Hypertension, run by University of Iowa 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 3 inclusion and 10 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 27 Mar 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?
Blood pressure control (time frame: Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 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 NCT00201045, which also lists 6 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 27 Mar 2014.