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

NCT ID: NCT01037920

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

subjects in the intervention arm will complete a self-affirmation exercise prior to a physician visit

Group Type: EXPERIMENTAL

Self-affirmation exercise

Intervention Type: BEHAVIORAL

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.

Control

subjects in the intervention arm will complete a sham exercise prior to a physician visit

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

The control exercise is the same as the intervention exercise except that subjects reflect and write about values important to someone else.

Interventions

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.

Intervention Type: BEHAVIORAL

Control

The control exercise is the same as the intervention exercise except that subjects reflect and write about values important to someone else.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Denver Health Medical Center

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23128568 (View on PubMed)

Other Identifiers

R21HL089623

Identifier Type: NIH

Identifier Source: org_study_id

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