Clinical trial NCT01037920: An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension
Official title: An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 179
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: medication adherence
timeFrame: 6 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
References:
citation: 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. doi: 10.1001/2013.jamainternmed.258.