Clinical trial NCT00734760: An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome
Official title: Reducing Prehospital Delay in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: patient education
acute coronary syndrome
prehospital delay to treatment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 3522
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: time from ACS symptom onset to admission to emergency department
timeFrame: two years
Secondary outcomes:
measure: pre-hospital aspirin use
timeFrame: two years
measure: emergency medical system use
timeFrame: two years
measure: resource utilization
timeFrame: two years
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Kathleen A Dracup, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1002/nur.20213.
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. doi: 10.1097/00005082-200605000-00006.
citation: 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. doi: 10.1161/CIRCOUTCOMES.109.852608. Epub 2009 Oct 6.