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

NCT01037920 | Completed

• 1 other identifier: R21HL089623
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• medication adherence

  6 months

Secondary Outcomes (1)

• Blood pressure

  3-6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Self-affirmation exercise

Control

ACTIVE COMPARATOR

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

Behavioral: Control

Interventions

Self-affirmation exercise 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.

Intervention

Control BEHAVIORAL

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

Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• pregnancy-related hypertension
• end-stage renal disease
• unable to speak or write English at at least a 6th grade level.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• 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.

  PMID: 23128568 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 23, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 13, 2012

Record last verified: 2012-07

Locations

US (1)