Collaboration to Reduce Disparities in Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Control; Behavioral: Reduction in financial barrier; Behavioral: Computer; Behavioral: Computer intervention & reduction of financial barrier

Detailed Description

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:

1. 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.

2. 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.

3. 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.

4. 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.

• Study Type: Interventional
• Enrollment (Actual): 802
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • PinnacleHealth Adult Outpatient Clinics
    • Philadelphia, Pennsylvania, United States, 19104
      • Veterans Administration Medical Center
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	12 months
Cost	12 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Pfizer; Pennsylvania Department of Health; Dickinson College
• Investigators: Principal Investigator: Stephen E. Kimmel, MD, MSCE, University of Pennsylvania

Publications and helpful links

General Publications

• Volpp KG, Troxel AB, Long JA, Ibrahim SA, Appleby D, Smith JO, Jaskowiak J, Helweg-Larsen M, Doshi JA, Kimmel SE. A randomized controlled trial of co-payment elimination: the CHORD trial. Am J Manag Care. 2015 Aug;21(8):e455-64.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: August 19, 2005
• First Submitted That Met QC Criteria: August 19, 2005
• First Posted (Estimate): August 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: High Blood Pressure; Patient Compliance; Health Behaviors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 707850