SPHERE Hypertension Intervention Study

Overview: This study uses communications strategies delivered through the traditional emergency medical response system to increase the proportion of low-income adults who obtain blood pressure screening and follow-up information for hypertension treatment options. The project will test the effectiveness of source personalization and tailored messaging in motivating potentially high-risk people, identified by 911 responders, to come to a local fire station for hypertension screening.

Specific Aims: The specific aims are:

1. Test the effectiveness of three health marketing approaches to motivate high-risk people, identified via 911 responders, to come to a local fire station for hypertension screening. The mailed marketing approaches vary personalized risk information and personalization of source.
2. Test the effectiveness of two mailing interventions (blood pressure kits with and without promotional gifts) to increase blood pressure monitoring among patients who have come to a fire station for a second blood pressure check.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Personalized brochure; Behavioral: Promotional gift

Detailed Description

Hypertension, if left untreated, is a major risk factor for stroke, heart attack, heart failure or kidney failure. Many people with hypertension don't know they have the disease and/or may be under treated. As such they are at higher risk for health complications than those who are managing their condition.

People who see a regular healthcare provider are more likely to know they have hypertension, and they are more likely to receive appropriate treatment. However, many patients who call 9-1-1 for emergency medical services (EMS) do not have regular health care providers and may be more at risk for undiagnosed or under treated disease.

EMS personnel enter the homes of thousands of residents each year. Emergency medical technicians (EMTs) routinely take patients' blood pressure as part of their standard diagnostic procedures. EMTs and paramedics complete a medical incident report form (MIRF) for each patient, including this information. As recorded on the MIRFs, thousands of patients have high blood pressure (defined by a systolic measurement of 160 or higher and/or a diastolic measurement of 100 or higher) during those visits. Blood pressure may be elevated simply from the stress and anxiety of a 9-1-1 response. But even in light of this potential "white coat" phenomenon, blood pressure readings at these levels are very high and are a cause for concern, especially in cases where patients are not transported to the hospital for further examination.

From February - April, 2007 we are collecting baseline data on patients who have high blood pressure readings (160/100 or higher) at a 9-1-1 response by an EMT (SPHERE Hypertension Baseline Data Study). We want to understand what these patients remember during the 9-1-1 response around their high blood pressure measure, if the patients seek a second reading, and if the patients seek follow-up care as a result of the high blood pressure measure. We are also interested to learn if patients trust EMTs as a provider of preventive health care. This baseline data will also allow us to more accurately measure the success of this proposed intervention study. The baseline data collection is almost completed and we now will proceed with an intervention study.

We propose to conduct an intervention study next, aimed at:

• Motivating subjects to receive a follow-up hypertension assessment from an EMT at a local fire station after receiving a high blood pressure reading from an EMT during a 911 event.
• Motivating subjects to monitor their blood pressure as appropriate.

• Study Type: Interventional
• Enrollment (Anticipated): 8000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington Health Promotion Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Seen by EMTs in one of the four participating fire departments (Bellevue, Kent, Renton, Shoreline)
• Recorded systolic blood pressure >= 160 and/or diastolic blood pressure >= 100
• At least 18 years old

Exclusion Criteria:

• Patient transported by paramedics
• Patient nursing home/adult family home resident
• Patient a prisoner or in custody (in jail or at the Regional Justice Center in Kent, for example)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1
Experimental: 2; photo and blood pressure personalization	Behavioral: Personalized brochure; either photo personalization, blood pressure personalization, both, or no personalization
Experimental: 3; photo personalization only	Behavioral: Personalized brochure; either photo personalization, blood pressure personalization, both, or no personalization
Experimental: 4; blood pressure personalization only	Behavioral: Personalized brochure; either photo personalization, blood pressure personalization, both, or no personalization
Experimental: 5; no personalization	Behavioral: Personalized brochure; either photo personalization, blood pressure personalization, both, or no personalization
Experimental: A; receives gift card in blood pressure (BP) kit	Behavioral: Promotional gift; half of participants who go to a fire station will receive a gift card.
Experimental: B; does not receive gift card in BP kit	Behavioral: Promotional gift; half of participants who go to a fire station will receive a gift card.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effectiveness of three health marketing approaches to motivate high-risk people, identified via 911 responders, to come to a local fire station for hypertension screening.	June 2007-June 2009
The effectiveness of two mailing interventions (blood pressure kits with and without promotional gifts) to increase blood pressure monitoring among patients who have come to a fire station for a second blood pressure check.	June 2007 - June 2009

Secondary Outcome Measures

Outcome Measure	Time Frame
Test if non-responders have lower trust in, and/or lower perceived efficacy of, the fire stations as preventive health care providers than participants who go to the fire station for a blood pressure check.	June 2007 - December 2009
Correlate the resulting health behaviors with existing health disparity indicators (including health literacy, socioeconomic status, and rural residence)	June 2007 - December 2009
Cost analysis	June 2007 - December 2009

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Hendrika Meischke, PhD, University of Washington; Principal Investigator: Mickey Eisenberg, MD, University of Washington

Publications and helpful links

General Publications

• Meischke H, Ike BR, Fahrenbruch C, Kuniyuki A, Hannon P, Parks MR, Forehand M, Weaver M, Harris JR. Hypertension identification via emergency responders: a randomized controlled intervention study. Prev Med. 2013 Dec;57(6):914-9. doi: 10.1016/j.ypmed.2013.05.010. Epub 2013 Jun 1.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 29, 2007
• First Submitted That Met QC Criteria: June 29, 2007
• First Posted (Estimate): July 3, 2007

Study Record Updates

• Last Update Posted (Estimate): June 29, 2010
• Last Update Submitted That Met QC Criteria: June 25, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 32168-E/G; 07-6656-E/G 01