Cardiovascular DiseasesHCTANCT00201149
Clinician Counseling and Cultural Competency to Improve Hypertension Control and Therapy Adherence
A study testing Patient-centered Counseling in people with Cardiovascular Diseases and Heart Diseases, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of clinician counseling and cultural competence training on medication compliance and blood pressure (BP) control in patients with high BP. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- What is being tested?
- Patient-centered Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2015
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting for care at least once in the General Internal Medicine clinic
- Diagnosis of hypertension, as listed on a medical problem list or elsewhere within the medical record
- Already prescribed antihypertensive medications
Who cannot join
- Musculoskeletal problems preventing successful opening of the electronic pill tops
- Cognitive status limitations, including psychiatric disorders such as schizophrenia
- Active alcohol or substance abuse problems
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02113
About this study
Official title: Hypertension Control and Therapy Adherence
The purpose of this study is to test the effect of clinician counseling and cultural competence training on medication compliance and blood pressure (BP) control in patients with high BP.
Read the detailed description
BACKGROUND:
Hypertension affects nearly 50 million people in the U.S. and is related to increased medical morbidity and mortality associated with a range of medical disorders. Despite the availability of effective treatments for BP control, less than 25 percent of patients with hypertension demonstrate such control, and researchers have found this to be related to important patient factors associated with pharmacotherapy adherence. Further, research has demonstrated that this adherence problem is greater among African Americans than among Caucasians. The focus of the study is on improvements in adherence among patients with hypertension. The study is most specifically targeted to reducing racial disparities in medication adherence by including an interventional element that specifically targets African American patients in its approach.
DESIGN NARRATIVE:
To improve patients' adherence with prescribed anti-hypertensive medication, BP control, and doctor-patient communication, and to decrease racial disparities in each area, the investigators will conduct a three-armed randomized controlled study in the general internal medicine clinics of a large urban teaching hospital serving many poor African American and white patients. Proven intervention strategies will be implemented by teaching clinicians to use patient-centered counseling, enhancing skills that are known to help patients change health-related behaviors, and enhancing cultural competency among clinicians, thereby further improving clinician-patient communication. One group of clinicians will implement only the patient-centered counseling program. A second group will implement the patient-centered counseling education program, augmenting it with an established method for cultural competency training. A third group (control group) will provide usual care. To assess outcomes, the study will evaluate pre-intervention patient adherence to prescribed medications through patient self-report and the use of electronic pill top monitoring, clinicians' provision of advice and counseling about anti-hypertensive medications and use of cultural competency skills, and the proportion of patients with controlled BP. Subsequent to the interventions, each of these outcomes will be assessed.
The aims of this study are to: 1) improve patients' adherence to prescribed anti-hypertensive therapy; 1a. examine adherence rates at baseline, and examine whether there are racial differences in adherence; 1b. decrease racial disparities in patient adherence with anti-hypertensive therapy from the baseline to the follow-up assessments; and 1c. evaluate the relative efficacy of the patient-centered counseling intervention compared to patient-centered counseling augmented by cultural competency training on patients' medication adherence; 2) increase the proportion of patients with controlled hypertension; 2a. examine the baseline proportion of patients with controlled hypertension, and whether there are racial differences in rates of control; 2b. decrease racial disparities in the proportion of patients with controlled hypertension from the baseline to the follow-up assessments; and 2c. evaluate the relative efficacy of patient-centered counseling compared to patient-centered counseling augmented by cultural competency training on patients' BP control; and 3) improve clinicians' communication with patients regarding medication use, as measured by increased frequency of clinicians' provision of advice and counseling about anti-hypertensive medications and use of culturally competent communication styles; 3a. examine whether there are racial disparities in clinicians' provision of advice and counseling or culturally competent communication patterns about anti-hypertensive medications at baseline; 3b. examine whether the proposed interventions decrease any observed racial disparities in clinician communication over time; and 3c. evaluate the relative efficacy of the patient-centered counseling intervention compared to patient-centered counseling augmented by cultural competency training on clinicians' communication patterns.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Being tested
- Patient-centered Counseling
- 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.
Patient-centered CounselingBehavioural
To improve patients' adherence with prescribed anti-hypertensive medication, improve blood pressure control and doctor-patient communication, we propose a three-armed randomized controlled trial in the internal medicine clinics of a large metropolitan teaching hospital which serves a large percentage of poor African American and white patients. We will implement an intervention strategy by teaching clinicians to counsel patients about hypertension control through the use of patient-centered counseling and by providing office-based support; critical to facilitating clinicians' use of this strategy. Through this intervention we will provide clinicians with communication skills that are proven to help patients change risk-related behaviors, and which will enhance doctor-patient communication.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | In one team of clinicians we will implement only the patient-centered counseling program. Receives: Behavioral: Patient-centered Counseling |
| 3 | No intervention | The control group will provide usual care |
| 2 | Experimental | In a subset of those clinicians receiving the patient-centered counseling program intervention, we will augment it with cultural competency training. Receives: Behavioral: Patient-centered Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient medication adherence (self-reported at baseline and follow-up visit [6-9 months after initial recruitment]and measured with electronic monitoring caps 90 days after baseline visit and 90 days after follow-up visit)
Measured: September 2004 - May 2008
Proportion of patients with controlled hypertension (measured at baseline and follow-up visit [6-9 months after initial recruitment])
Measured: September 2004 - May 2008
Use of communication strategies by clinicians (measured at baseline and follow-up visit [6-9 months after initial recruitment])
Measured: September 2004 - May 2008
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 startFeb 2004
- Primary completionApr 2008
- Study completionDec 2015
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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 870 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Nancy Kressin, Boston Medical Center
- Investigators
- Dr. Nancy Kressin, Study chair, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201149
- Sponsor's protocol ID
- 255
- Other IDs
- R01HL072814
- Acronym
- HCTA
- Status last verified
- Apr 2016
- First submitted
- 16 Sep 2005
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Manze MG, Orner MB, Glickman M, Pbert L, Berlowitz D, Kressin NR. Brief provider communication skills training fails to impact patient hypertension outcomes. Patient Educ Couns. 2015 Feb;98(2):191-8. doi: 10.1016/j.pec.2014.10.014. Epub 2014 Oct 27.
PubMed 25468397
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension Control and Therapy Adherence
- ClinicalTrials.gov ID
- NCT00201149
- Acronym / sponsor ID
- HCTA / 255
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 870 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2015 (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 effect of clinician counseling and cultural competence training on medication compliance and blood pressure (BP) control in patients with high BP.
Detailed description
BACKGROUND:
Hypertension affects nearly 50 million people in the U.S. and is related to increased medical morbidity and mortality associated with a range of medical disorders. Despite the availability of effective treatments for BP control, less than 25 percent of patients with hypertension demonstrate such control, and researchers have found this to be related to important patient factors associated with pharmacotherapy adherence. Further, research has demonstrated that this adherence problem is greater among African Americans than among Caucasians. The focus of the study is on improvements in adherence among patients with hypertension. The study is most specifically targeted to reducing racial disparities in medication adherence by including an interventional element that specifically targets African American patients in its approach.
DESIGN NARRATIVE:
To improve patients' adherence with prescribed anti-hypertensive medication, BP control, and doctor-patient communication, and to decrease racial disparities in each area, the investigators will conduct a three-armed randomized controlled study in the general internal medicine clinics of a large urban teaching hospital serving many poor African American and white patients. Proven intervention strategies will be implemented by teaching clinicians to use patient-centered counseling, enhancing skills that are known to help patients change health-related behaviors, and enhancing cultural competency among clinicians, thereby further improving clinician-patient communication. One group of clinicians will implement only the patient-centered counseling program. A second group will implement the patient-centered counseling education program, augmenting it with an established method for cultural competency training. A third group (control group) will provide usual care. To assess outcomes, the study will evaluate pre-intervention patient adherence to prescribed medications through patient self-report and the use of electronic pill top monitoring, clinicians' provision of advice and counseling about anti-hypertensive medications and use of cultural competency skills, and the proportion of patients with controlled BP. Subsequent to the interventions, each of these outcomes will be assessed.
The aims of this study are to: 1) improve patients' adherence to prescribed anti-hypertensive therapy; 1a. examine adherence rates at baseline, and examine whether there are racial differences in adherence; 1b. decrease racial disparities in patient adherence with anti-hypertensive therapy from the baseline to the follow-up assessments; and 1c. evaluate the relative efficacy of the patient-centered counseling intervention compared to patient-centered counseling augmented by cultural competency training on patients' medication adherence; 2) increase the proportion of patients with controlled hypertension; 2a. examine the baseline proportion of patients with controlled hypertension, and whether there are racial differences in rates of control; 2b. decrease racial disparities in the proportion of patients with controlled hypertension from the baseline to the follow-up assessments; and 2c. evaluate the relative efficacy of patient-centered counseling compared to patient-centered counseling augmented by cultural competency training on patients' BP control; and 3) improve clinicians' communication with patients regarding medication use, as measured by increased frequency of clinicians' provision of advice and counseling about anti-hypertensive medications and use of culturally competent communication styles; 3a. examine whether there are racial disparities in clinicians' provision of advice and counseling or culturally competent communication patterns about anti-hypertensive medications at baseline; 3b. examine whether the proposed interventions decrease any observed racial disparities in clinician communication over time; and 3c. evaluate the relative efficacy of the patient-centered counseling intervention compared to patient-centered counseling augmented by cultural competency training on clinicians' communication patterns.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Patient-centered CounselingIn one team of clinicians we will implement only the patient-centered counseling program. |
| 3 | No intervention | –The control group will provide usual care |
| 2 | Experimental | Behavioral: Patient-centered CounselingIn a subset of those clinicians receiving the patient-centered counseling program intervention, we will augment it with cultural competency training. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting for care at least once in the General Internal Medicine clinic
- Diagnosis of hypertension, as listed on a medical problem list or elsewhere within the medical record
- Already prescribed antihypertensive medications
Key exclusion criteria (4 listed)
- Musculoskeletal problems preventing successful opening of the electronic pill tops
- Cognitive status limitations, including psychiatric disorders such as schizophrenia
- Active alcohol or substance abuse problems
- Does not speak English
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 |
|---|---|---|
| Patient-centered CounselingTo improve patients' adherence with prescribed anti-hypertensive medication, improve blood pressure control and doctor-patient communication, we propose a three-armed randomized controlled trial in the internal medicine clinics of a large metropolitan teaching hospital which serves a large percentage of poor African American and white patients. We will implement an intervention strategy by teaching clinicians to counsel patients about hypertension control through the use of patient-centered counseling and by providing office-based support; critical to facilitating clinicians' use of this strategy. Through this intervention we will provide clinicians with communication skills that are proven to help patients change risk-related behaviors, and which will enhance doctor-patient communication. | Behavioural | 1, 2 |
Primary outcome
Patient medication adherence (self-reported at baseline and follow-up visit [6-9 months after initial recruitment]and measured with electronic monitoring caps 90 days after baseline visit and 90 days after follow-up visit)
Time frame: September 2004 - May 2008
Proportion of patients with controlled hypertension (measured at baseline and follow-up visit [6-9 months after initial recruitment])
Time frame: September 2004 - May 2008
Use of communication strategies by clinicians (measured at baseline and follow-up visit [6-9 months after initial recruitment])
Time frame: September 2004 - May 2008
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 7 Apr 2016.
- Results publication: PubMed 25468397Manze MG, Orner MB, Glickman M, Pbert L, Berlowitz D, Kressin NR. Brief provider communication skills training fails to impact patient hypertension outcomes. Patient Educ Couns. 2015 Feb;98(2):191-8. doi: 10.1016/j.pec.2014.10.014. Epub 2014 Oct 27.
- 2\. Kressin, NR, Orner, MB, Manze, M, Glickman, ME, Berlowitz, D. (2010). Understanding contributors to racial disparities in blood pressure control. Circulation: Quality and Outcomes: Mar;3(2):173-80.Link provided by the sponsor.
- 3\. Manze, M, Rose, AJ, Orner, MB, Berlowitz, DR, Kressin, NR (2010). Understanding Racial Disparities in Treatment Intensification for Hypertension Management. Journal of General Internal Medicine; 25 (8), 819-25.Link provided by the sponsor.
- 4\. Rose, AJ, Berlowitz, DR, Manze, M, Orner, MB, Kressin, NR (2009). Comparing methods of measuring treatment intensity in hypertension care. Circulation: Quality and Outcomes: 2; 385-391Link provided by the sponsor.
- 5\. Rose, AJ, Berlowitz, DR, Manze, M, Orner, MB, Kressin, NR (2009). Intensifying Therapy for Hypertension Despite Suboptimal Adherence. Hypertension: 54(3): 524-529.Link provided by the sponsor.
- 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.
Dr. Nancy Kressin study chair
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-centered Counseling in people with Cardiovascular Diseases and Heart Diseases, run by Boston Medical Center 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 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 7 Apr 2016. 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?
Patient medication adherence (self-reported at baseline and follow-up visit [6-9 months after initial recruitment]and measured with electronic monitoring caps 90 days after baseline visit and 90 days after follow-up visit) (time frame: September 2004 - May 2008). The study lists 3 primary outcomes in all. 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 NCT00201149, 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 7 Apr 2016.