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

December 18, 2009
July 11, 2012
January 2010
December 2011   (final data collection date for primary outcome measure)
medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01037920 on ClinicalTrials.gov Archive Site
Blood pressure [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension
An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Hypertension
  • 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.
  • Behavioral: Control
    The control exercise is the same as the intervention exercise except that subjects reflect and write about values important to someone else.
  • Experimental: Intervention
    subjects in the intervention arm will complete a self-affirmation exercise prior to a physician visit
    Intervention: Behavioral: Self-affirmation exercise
  • Active Comparator: Control
    subjects in the intervention arm will complete a sham exercise prior to a physician visit
    Intervention: Behavioral: Control
Havranek EP, Hanratty R, Tate C, Dickinson LM, Steiner JF, Cohen G, Blair IA. The effect of values affirmation on race-discordant patient-provider communication. Arch Intern Med. 2012 Nov 26;172(21):1662-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01037920
R21 HL089623
No
Denver Health and Hospital Authority
Denver Health and Hospital Authority
Not Provided
Not Provided
Denver Health and Hospital Authority
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP