Clinical trial NCT00133068: Collaboration to Reduce Disparities in Hypertension
Official title: Collaboration to Reduce Disparities in Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: High Blood Pressure
Health Behaviors
Patient Compliance
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
name: Dickinson College
name: Pfizer
First posted: 2005-08-22
Enrollment: 802
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Cost
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: PinnacleHealth Adult Outpatient Clinics
state: Pennsylvania
city: Philadelphia
country: United States
facility: Veterans Administration Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Stephen E. Kimmel, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.