An Intervention to Increase Engagement With Hypertension Care for American Indian Patients

Hypertension Clinical Trial

Official title:

An Intervention to Increase Engagement With Hypertension Care for American Indian Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414982
• Other study ID #: 15-1711
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to reduce the effects of stereotype threat on the adherence of American Indian/Alaska Native patients with hypertension.

The specific aims of this study, which employs a values affirmation intervention, are to:

1. Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.

2. Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.

Description:

American Indians and Alaska Natives (AI/ANs) in the U.S. bear a disproportionate burden of cardiovascular disease. They have a higher prevalence of conditions that predispose to cardiovascular disease and poorer outcomes after developing cardiovascular disease than white Americans. The causes of these differences are complex and multiple, but there are widespread concerns that racial bias contributes to the problem. As concluded over a decade ago in the 2003 Institute of Medicine report, Unequal Treatment, "Racial/ethnic disparities in health care occur in the context of broader historic and contemporary social and economic inequality and evidence of persistent racial and ethnic discrimination… Bias, stereotyping and prejudice on the part of healthcare providers may contribute to racial and ethnic disparities in health care." These concerns persist. Minority group members are well aware of negative stereotypes targeted at them as a group and of the possibility of bias directed at them as individuals. Given the reality of prejudice and their previous experiences with it, it is understandable that minority group members would be apprehensive about the possibility of being judged in light of the stereotype, both outside and inside the healthcare system. Critically, this apprehension may occur in the absence of actual bias. This raises the possibility that interventions directed at patients' perception of discrimination may have an independent and additive effect beyond the effects of interventions directed at provider bias.

Investigators propose to evaluate a novel intervention that reduces the detrimental effects of negative stereotypes on minority patients by reducing stereotype threat through values- affirmation. Stereotype threat is a stressful psychological state that occurs when a person fears being judged in light of negative stereotypes. The stress of this situation and the pressure to avoid confirming negative stereotypes can result in impaired performance and worse outcomes - something of a self-fulfilling prophecy. For example, an American Indian patient fearful of confirming the stereotype of being unintelligent may fail to ask for clarification of changes in antihypertensive medications and, based on misconceptions, persist in taking an old regimen that is ineffective. Values-affirmation is a process in which global sense of personal worth is strengthened in the face of a threat, making individuals better able to cope with psychological threats.

The intervention proposed in this application is based on one found to be effective in alleviating stereotype threat in other contexts such as education and in alleviating more general threats to the self in a health context as well as in a prior study investigators performed with African American patients. Investigators will randomly assign AI/AN patients with hypertension to complete an affirmation exercise or a control exercise prior to a visit with their providers. The affirmation exercise is performed immediately before a clinic visit. It asks patients to reflect on values or self-defining skills that they find important, and to write a few sentences about why one of them is important. The project is innovative in that it is directed against a mechanism, stereotype threat, not generally recognized as important in healthcare settings. Since the intervention is brief and easily applied across a wide range of health conditions, it directly addresses the need for interventions to be generalizable and sustainable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Hypertension diagnosis: primary or secondary ICD-10 code diagnosis in last 24 mo

• SBP >160 mm Hg or DBP >90 mm Hg in last 12 months

• Currently taking antihypertensive medications

• Medications filled within health system's pharmacy

• White or American Indian/Alaska Native, self-reported race

• Upcoming primary care visit

• Ability to read and write English

• History of hypertension defined as having an outpatient visit in the past year with a primary or secondary ICD-9 code diagnosis of hypertension, with the diagnosis of hypertension confirmed by review of the patient's medical record before enrollment.

• Additional inclusion criteria are age >18 years

• Use of Denver Indian Health and Family Services (DIHFS) or Denver Health (DH) as their usual source of care.

• American Indian/Alaska Native as defined by DIHFS uses to define eligibility for no-cost services.

• To define the comparator group at DH we will use self-described race/ethnicity of white/non- Latino.

• All eligible patients must have the ability to provide informed consent.

Exclusion Criteria:

• Pregnancy-related hypertension

• Dialysis-dependent end-stage renal disease

• Patients who cannot speak or write English

• Unable to provide consent

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Intervention Values Affirmation
Participants are asked to circle the two or three values that are MOST important to them. Next, participants are asked to think about times when the values chosen might be important to THEMSELVES and then write a few sentences to describe when and why they might be important.
• Control Values Affirmation
Participants are asked to circle the two or three items that are LEAST important to them. Next, participants are asked to think about times when the values chosen might be important to SOMEONE ELSE and then write a few sentences to describe when and why they might be important.

Locations

Country	Name	City	State
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Denver Indian Health and Family Services	Denver	Colorado

Sponsors (5)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Heart Association, Denver Health and Hospital Authority, Denver Indian Health and Family Services, University of Colorado Centers for American Indian and Alaska Native Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Antihypertensive Medication Adherence using Pharmacy Records	This antihypertensive medication adherence outcome will be a summary measure of adherence which assesses the proportion of days covered (PDC) over the period of observation for which a patient obtains antihypertensive medications. Adherence will be calculated for each antihypertensive drug in the regimen and combined across drugs into a summary measure of adherence for the entire drug regimen.	Baseline, 3 and 6 months
Primary	Change in Antihypertensive Medication Adherence using Self-Reported Adherence	This antihypertensive medication adherence outcome will be a summary measure of self-reported adherence using the validated Voils instrument, which has 3 questions that address adherence over the previous 7 days.	Baseline, 3 and 6 months
Primary	Change in Antihypertensive Medication Adherence using Pill Counts	This antihypertensive medication adherence outcome will be a summary outcome measure of adherence where if x is the number of pills in the bottle, y is the number of pills that would have been in the bottle had all pills been taken since the bottle was filled, and z is the number of pills that should have been taken since the last fill, and adherence is calculated as 1- [(x-y)/z].	Baseline, 3 and 6 months
Secondary	Systolic Blood Pressure	Systolic blood pressure over time.	Baseline, 3 and 6 months
Secondary	Proportion of Time Blood Pressure is Under Control	Defined as the proportion of time over the 6-months of follow-up with a BP = 160/90 mmHg	6 months