An Intervention to Increase Engagement With Hypertension Care for American Indian Patients
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Values Affirmation
Control Values Affirmation
Sponsored by

About this trial
This is an interventional health services research trial for Hypertension focused on measuring Hypertension, Medication Adherence, Values Affirmation, American Indian/Alaska Native
Eligibility Criteria
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
Sites / Locations
- Denver Health and Hospital Authority
- Denver Indian Health and Family Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Values Affirmation
Control Values Affirmation
Arm Description
Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.
Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.
Outcomes
Primary Outcome Measures
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.
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.
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].
Secondary Outcome Measures
Systolic Blood Pressure
Systolic blood pressure over time.
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
Full Information
NCT ID
NCT04414982
First Posted
May 29, 2020
Last Updated
August 28, 2020
Sponsor
University of Colorado, Denver
Collaborators
American Heart Association, University of Colorado Centers for American Indian and Alaska Native Health, Denver Health and Hospital Authority, Denver Indian Health and Family Services
1. Study Identification
Unique Protocol Identification Number
NCT04414982
Brief Title
An Intervention to Increase Engagement With Hypertension Care for American Indian Patients
Official Title
An Intervention to Increase Engagement With Hypertension Care for American Indian Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
American Heart Association, University of Colorado Centers for American Indian and Alaska Native Health, Denver Health and Hospital Authority, Denver Indian Health and Family Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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:
Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.
Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Medication Adherence, Values Affirmation, American Indian/Alaska Native
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
339 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Values Affirmation
Arm Type
Experimental
Arm Description
Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.
Arm Title
Control Values Affirmation
Arm Type
Active Comparator
Arm Description
Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Values Affirmation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Values Affirmation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Antihypertensive Medication Adherence using Pharmacy Records
Description
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.
Time Frame
Baseline, 3 and 6 months
Title
Change in Antihypertensive Medication Adherence using Self-Reported Adherence
Description
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.
Time Frame
Baseline, 3 and 6 months
Title
Change in Antihypertensive Medication Adherence using Pill Counts
Description
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].
Time Frame
Baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
Systolic blood pressure over time.
Time Frame
Baseline, 3 and 6 months
Title
Proportion of Time Blood Pressure is Under Control
Description
Defined as the proportion of time over the 6-months of follow-up with a BP ≤ 160/90 mmHg
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ed Havranek, MD
Organizational Affiliation
University of Colorad, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Denver Indian Health and Family Services
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
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An Intervention to Increase Engagement With Hypertension Care for American Indian Patients
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