An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome - Full Text View

Purpose

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.

Condition	Intervention
Acute Coronary Syndrome	Behavioral: education

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Reducing Prehospital Delay in Acute Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

time from ACS symptom onset to admission to emergency department [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pre-hospital aspirin use [ Time Frame: two years ] [ Designated as safety issue: No ]
emergency medical system use [ Time Frame: two years ] [ Designated as safety issue: No ]
resource utilization [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment:	3522
Study Start Date:	February 2001
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A a tailored, face-to-face education and counseling intervention with a nurse lasting approximately 45 minutes, followed by a telephonic reinforcement in 30 days	Behavioral: education face-to-face education and counseling intervention Other Name: none applicable
No Intervention: B care-as-usual with data collection at the same time points as the experimental group

Detailed 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.

Eligibility

Ages Eligible for Study:	30 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734760

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Kathleen A Dracup, DNSc

University of California, San Francisco

More Information

Publications:

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.

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.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dracup K, McKinley S, Riegel B, Moser DK, Meischke H, Doering LV, Davidson P, Paul SM, Baker H, Pelter M. A randomized clinical trial to reduce patient prehospital delay to treatment in acute coronary syndrome. Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):524-32. Epub 2009 Oct 6.

Responsible Party:	Kathleen Dracup, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00734760 History of Changes
Other Study ID Numbers:	RO! NR05323, NIH RO! NR05323
Study First Received:	August 12, 2008
Last Updated:	August 12, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

patient education
acute coronary syndrome
prehospital delay to treatment

Additional relevant MeSH terms:

Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013

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