Clinical Trials Logo

Clinical Trial Summary

To evaluate the impact of community educational interventions on patient delay time from onset of symptoms and signs of an acute myocardial infarction (AMI) to arrival at a hospital Emergency Department (ED). Also, to study the impact of community educational interventions on use of Emergency Medical Services (EMS) and EDs, on thrombolytic therapy, and on AMI case fatality.


Clinical Trial Description

BACKGROUND:

Since the advent of thrombolytic therapy, early treatment holds particular promise for decreasing mortality from coronary heart disease. Thrombolytic therapy can reduce mortality by 25 percent for patients treated within the first few hours of AMI symptoms, with greater benefit the earlier the treatment. Not everyone who could benefit from receiving thrombolytic therapy receives such therapy. One contributing factor is that many people with symptoms do not seek emergency care in a timely manner. Studies show substantial delay times from AMI symptoms to hospital arrival, with means ranging from 4.6 to 24 hours and medians from 2 to 6.4 hours. EMS transport time is estimated to average 7 to 22 minutes, so a large portion of pre-hospital delay is attributable to patient recognition and action. Several factors have been associated with delay time. Sudden onset pain is associated with shorter delay times, and older age, female gender, African-American race, consultation with others about symptoms, and self-treatment programs are associated with longer delay times. There is a need for educational programs that are effective in decreasing delay times, particularly by focusing on people who are at increased risk of having an AMI and groups more likely to delay seeking treatment.

Community interventions to reduce delay time between AMI symptoms and contact with the medical system have been conducted in Britain, Canada, Sweden, Australia, Germany, King County in Washington, and Jacksonville, Illinois. The interventions have been promising, but the studies suffer from problems that make the reported results difficult to interpret. Almost all the published studies assessed delay time pre-to-post intervention and had no control or comparison group, making the magnitude and significance of impact from the intervention difficult to determine. Most were conducted in countries other than the United States, so applicability to the health-care system in the United States is questionable. Although some examined the effect of a public education program on ambulance and ED utilization, the effects of public education campaigns on use of the EMS or ED remains unanswered.

DESIGN NARRATIVE:

The study was a multicenter, controlled community trial where the community was the unit of assignment and of analysis. Twenty study communities were pair-matched on demographics and one of each pair was randomly assigned to intervention and one to control. The intervention communities received an 18-month community-based intervention to reduce delay time for symptoms and signs of AMI, focusing on decreasing the delay time associated with patient recognition and action. Several methods were used including: educational interventions based on behavior change theory; patient and provider education; public education and community organization. The primary outcome was time from symptom onset to arrival at the emergency department. Data collection and intervention continued until competion of 18 months of intervention. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00000550
Study type Interventional
Source New England Research Institutes
Contact
Status Completed
Phase Phase 3
Start date August 1994
Completion date May 2000

See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06211361 - Cardiac Rehabilitation Program in Patients With Cardiovascular Disease N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)