An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01037920
First received: December 18, 2009
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

The objective of the project is a test-of-concept of an intervention to reduce the effects of the perception of discrimination on the care of patients with chronic illness. Perception of discrimination manifests itself as stereotype threat. We hypothesize that stereotype threat impairs communication between minority patients and their physicians because of increased stress and diminished trust, resulting in interactions that are less successful at enhancing patient self-efficacy, in turn resulting in lower rates of adherence with anti-hypertensive medication.

The intervention is a self-affirmation exercise performed prior to a patient-physician visit. A similar intervention has been shown to reduce the racial gap in academic performance in middle school classrooms.

We will explore the mechanistic effects of the intervention by analysis of audiotapes of patient-provider visits following the intervention. We will measure the effect of the intervention on minority hypertensive patients' adherence with antihypertensive medication and blood pressure.

We will enroll 200 African American and Latino patients with hypertension and randomize 100 patients to perform the exercise and 100 patients to perform a null control exercise before the visit. We will assess change in patient's adherence with antihypertensive medications and in blood pressure over the six months following the index visit. In order to better understand the effects of the intervention we will measure subject's mood following the exercise, and self-reported stress levels, trust in the physician, and medication self-efficacy following the visit. We will also assess the quality of the patient-provider interaction from detailed analysis of audiotapes and from patient questionnaires. Following a subsequent patient-physician visit, we will conduct telephone interviews with patients to assess for persistence of any effects of the intervention.


Condition Intervention
Hypertension
Behavioral: Self-affirmation exercise
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Enrollment: 179
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
subjects in the intervention arm will complete a self-affirmation exercise prior to a physician visit
Behavioral: Self-affirmation exercise
The intervention exercise asks subjects to reflect on a list of 11 personal values and to circle 2 or 3 items that are most important to them. Subjects are asked then to write a few sentences to describe why they are important.
Active Comparator: Control
subjects in the intervention arm will complete a sham exercise prior to a physician visit
Behavioral: Control
The control exercise is the same as the intervention exercise except that subjects reflect and write about values important to someone else.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of hypertension
  • age > 21 years
  • use of Denver Health as their usual source of care and pharmacy services
  • self-described race/ethnicity of African American or Latino
  • ability to provide informed consent

Exclusion Criteria:

  • pregnancy-related hypertension
  • end-stage renal disease
  • unable to speak or write English at at least a 6th grade level.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037920

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
  More Information

No publications provided by Denver Health and Hospital Authority

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01037920     History of Changes
Other Study ID Numbers: R21 HL089623
Study First Received: December 18, 2009
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014