An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— PROMOTION  

Official title:

Reducing Prehospital Delay in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734760
• Other study ID #: RO! NR05323
• Secondary ID: NIH RO! NR05323
• Status: Completed
• Phase: N/A
• First received: August 12, 2008
• Last updated: August 12, 2008
• Start date: February 2001
• Est. completion date: June 2006

Study information

• Verified date: August 2008
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease.

Description:

Delay to treatment from the onset acute coronary syndrome (ACS)continues to be a significant cause of morbidity and mortality. This study was conducted to evaluate a tailored education and counseling program designed for individuals at high risk for a future event. Study Hypothesis: The central hypothesis of this study was that a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of AMI in patients already identified as having ischemic heart disease. Patients were randomized to receive a nurse-administered education and counseling intervention designed to promote early presentation for medical treatment in the face of cardiac symptoms or to usual instructions by their healthcare provider. Primary & Secondary Endpoints: The primary endpoint of this trial was prehospital delay time, i.e., time from onset of symptoms to arrival at the hospital. The secondary endpoints were: use of the emergency medical system; use of aspirin; healthcare resource utilization; and knowledge, attitudes and beliefs about heart disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3522
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• a diagnosis of ischemic heart disease, confirmed by their physician or medical record

• lived independently (i.e., not in an institutional setting).

Exclusion Criteria:

• complicating serious co-morbidity such as a psychiatric illness or untreated malignancy

• neurological disorder with impaired cognition

• inability to read or understand English.

• major uncorrected hearing loss

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Behavioral:
• education
face-to-face education and counseling intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

References & Publications (4)

Aitken LM, Pelter MM, Carlson B, Marshall AP, Cross R, McKinley S, Dracup K. Effective strategies for implementing a multicenter international clinical trial. J Nurs Scholarsh. 2008;40(2):101-8. doi: 10.1111/j.1547-5069.2008.00213.x. — View Citation

Dracup K, McKinley S, Doering LV, Riegel B, Meischke H, Moser DK, Pelter M, Carlson B, Aitken L, Marshall A, Cross R, Paul SM. Acute coronary syndrome: what do patients know? Arch Intern Med. 2008 May 26;168(10):1049-54. doi: 10.1001/archinte.168.10.1049. — View Citation

Dracup K, McKinley S, Riegel B, Mieschke H, Doering LV, Moser DK. A nursing intervention to reduce prehospital delay in acute coronary syndrome: a randomized clinical trial. J Cardiovasc Nurs. 2006 May-Jun;21(3):186-93. — View Citation

Riegel B, McKinley S, Moser DK, Meischke H, Doering L, Dracup K. Psychometric evaluation of the Acute Coronary Syndrome (ACS) Response Index. Res Nurs Health. 2007 Dec;30(6):584-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time from ACS symptom onset to admission to emergency department		two years	No
Secondary	pre-hospital aspirin use		two years	No
Secondary	emergency medical system use		two years	No
Secondary	resource utilization		two years	No