Collaboration to Reduce Disparities in Hypertension

Study Overview
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Brief Summary
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A large number of African-American and low socioeconomic patients have poorly controlled high blood pressure because of not being able to take their high blood pressure medications. This puts these patients at higher risk of heart and kidney disease, stroke and death. This study is designed to reduce the barriers that prevent patients from taking their high blood pressure medications.

Detailed Description
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The objective of this study is to determine the effectiveness and cost-effectiveness of two interventions aimed at reducing barriers to blood pressure (BP) control in an indigent and African-American population. Specifically, we will conduct a randomized controlled trial comparing BP control using either: (1) reimbursing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavioral arms (combined arms); or (4) neither. The ultimate goal of this study is to reduce the incidence of HTN-related CVD among these populations thereby reducing cardiovascular health disparities. Specific aims of the study are to: test whether receiving money each time the patient fills a prescription for medications improves BP control by a clinically significant amount. H1: Reimbursing patients for filling prescriptions will significantly improve BP control. test whether a computer-based behavioral intervention improves BP control by a clinically significant amount. H2: A computer-based behavioral intervention will significantly improve BP control. test whether the two interventions are more effective in improving BP control than either alone. H3: The effect of improving BP control of administering both interventions together will be greater than the sum of the individual effects of each intervention alone. examine the relative cost effectiveness of reimbursement for filling prescriptions, a computer-based behavioral intervention, and the combination of the two. H4: Both interventions will be cost-effective relative to other commonly-covered services.

Official Title
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Collaboration to Reduce Disparities in Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Computer
* Behavioral: Reduction in financial barrier
* Behavioral: Computer intervention & reduction of financial barrier
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of the Philadelphia Veterans Administration Hospital Primary Care Clinic, PinnacleHealth Adult Outpatient Clinics and the VA Pittsburgh Healthcare System who have a diagnosis of hypertension; are currently taking antihypertensive medications; and have elevated blood pressure. Exclusion Criteria: Under 21 years of age Have a diagnosis of: Atrial fibrillation; Metastatic cancer; End stage renal disease (ESRD) with dialysis; Dementia; New York Heart Association (NYHA) class IV congestive heart failure (CHF); Blind or deaf; Other reason for life expectancy of less than 1 year. Are currently participating in another experimental study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Control | Behavioral: Control<br>* No intervention<br>|
| Experimental: 2<br>Reduction of financial barrier | Behavioral: Reduction in financial barrier<br>* Copay only<br>|
| Experimental: 3<br>Computer Intervention | Behavioral: Computer<br>* Computer intervention only<br>|
| Experimental: 4<br>Reduction of financial barrier and Computer Intervention | Behavioral: Computer intervention & reduction of financial barrier<br>* computer intervention & copay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost |  | 12 months | 
| Blood pressure |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Blood Pressure, Health Behaviors, Patient Compliance