An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome (PROMOTION)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00734760
First received: August 12, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 26, 2014