SPHERE Hypertension Intervention Study

NCT ID: NCT00495833

Last Updated: 2010-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-12-31

Brief Summary

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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

photo and blood pressure personalization

Group Type: EXPERIMENTAL

Personalized brochure

Intervention Type: BEHAVIORAL

either photo personalization, blood pressure personalization, both, or no personalization

3

photo personalization only

Group Type: EXPERIMENTAL

Personalized brochure

Intervention Type: BEHAVIORAL

either photo personalization, blood pressure personalization, both, or no personalization

4

blood pressure personalization only

Group Type: EXPERIMENTAL

Personalized brochure

Intervention Type: BEHAVIORAL

either photo personalization, blood pressure personalization, both, or no personalization

5

no personalization

Group Type: EXPERIMENTAL

Personalized brochure

Intervention Type: BEHAVIORAL

either photo personalization, blood pressure personalization, both, or no personalization

A

receives gift card in blood pressure (BP) kit

Group Type: EXPERIMENTAL

Promotional gift

Intervention Type: BEHAVIORAL

half of participants who go to a fire station will receive a gift card.

B

does not receive gift card in BP kit

Group Type: EXPERIMENTAL

Promotional gift

Intervention Type: BEHAVIORAL

half of participants who go to a fire station will receive a gift card.

Interventions

Personalized brochure

either photo personalization, blood pressure personalization, both, or no personalization

Intervention Type: BEHAVIORAL

Promotional gift

half of participants who go to a fire station will receive a gift card.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Hendrika Meischke, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Mickey Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Health Promotion Research Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23732250 (View on PubMed)

Other Identifiers

07-6656-E/G 01

Identifier Type: -

Identifier Source: secondary_id

32168-E/G

Identifier Type: -

Identifier Source: org_study_id