Clinician Counseling and Cultural Competency to Improve Hypertension Control and Therapy Adherence

NCT00201149 | Completed DMC

• 2 other identifiers: 255R01HL072814
• Study Type: interventional
• Target: 870
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension

Outcome Measures

Primary Outcomes (3)

• 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)

  September 2004 - May 2008

• Proportion of patients with controlled hypertension (measured at baseline and follow-up visit [6-9 months after initial recruitment])

  September 2004 - May 2008

• Use of communication strategies by clinicians (measured at baseline and follow-up visit [6-9 months after initial recruitment])

  September 2004 - May 2008

Study Arms (3)

1

EXPERIMENTAL

In one team of clinicians we will implement only the patient-centered counseling program.

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.

Behavioral: Patient-centered Counseling

Interventions

Patient-centered Counseling BEHAVIORAL

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.

1; 2

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02113, United States

Location

Related Publications (1)

• 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.

  PMID: 25468397 RESULT

Related Links

• 1\. Rose, A, Glickman, ME, D'Amore, MM, Orner, MB, Berlowitz, D, Kressin, NR. (2011). Effects of Daily Adherence to Anti-Hypertensive Medication on Blood Pressure Control. Journal of Clinical Hypertension: Jun; 13(6): 416-21
• 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.
• 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.
• 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; 385-391
• 5\. Rose, AJ, Berlowitz, DR, Manze, M, Orner, MB, Kressin, NR (2009). Intensifying Therapy for Hypertension Despite Suboptimal Adherence. Hypertension: 54(3): 524-529.

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Dr. Nancy Kressin

  Boston University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BMC Investigator

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2015
• Last Updated: April 7, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)