Cardiovascular DiseasesPhase 3NCT00000550
Rapid Early Action for Coronary Treatment (REACT)
A Phase 3 study testing health education in people with Cardiovascular Diseases and Coronary Disease, run by Carelon Research.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- health education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1994to May 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Men and women with acute MI or unstable angina.
About this study
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.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
- Being tested
- health education
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startAug 1994
- Primary completionMay 2000
- Study completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Henry Feldman, New England Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000550
- Sponsor's protocol ID
- 94
- Other IDs
- U01HL053149
- Status last verified
- Mar 2014
- First submitted
- 27 Oct 1999
- Last updated
- 4 Mar 2014
- Results posted
- No
Publications
Hedges JR, Mann NC, Meischke H, Robbins M, Goldberg R, Zapka J. Assessment of chest pain onset and out-of-hospital delay using standardized interview questions: the REACT Pilot Study. Rapid Early Action for Coronary Treatment (REACT) Study Group. Acad Emerg Med. 1998 Aug;5(8):773-80. doi: 10.1111/j.1553-2712.1998.tb02503.x.
PubMed 9715238Feldman HA, Proschan MA, Murray DM, Goff DC, Stylianou M, Dulberg E, McGovern PG, Chan W, Mann NC, Bittner V. Statistical design of REACT (Rapid Early Action for Coronary Treatment), a multisite community trial with continual data collection. Control Clin Trials. 1998 Aug;19(4):391-403. doi: 10.1016/s0197-2456(98)00014-2.
PubMed 9683313Simons-Morton DG, Goff DC, Osganian S, Goldberg RJ, Raczynski JM, Finnegan JR, Zapka J, Eisenberg MS, Proschan MA, Feldman HA, Hedges JR, Luepker RV. Rapid early action for coronary treatment: rationale, design, and baseline characteristics. REACT Research Group. Acad Emerg Med. 1998 Jul;5(7):726-38. doi: 10.1111/j.1553-2712.1998.tb02492.x.
PubMed 9678398Goff DC Jr, Sellers DE, McGovern PG, Meischke H, Goldberg RJ, Bittner V, Hedges JR, Allender PS, Nichaman MZ. Knowledge of heart attack symptoms in a population survey in the United States: The REACT Trial. Rapid Early Action for Coronary Treatment. Arch Intern Med. 1998 Nov 23;158(21):2329-38. doi: 10.1001/archinte.158.21.2329.
PubMed 9827784Raczynski JM, Finnegan JR Jr, Zapka JG, Meischke H, Meshack A, Stone EJ, Bracht N, Sellers DE, Daya M, Robbins M, McAlister A, Simons-Morton D. REACT theory-based intervention to reduce treatment-seeking delay for acute myocardial infarction. Rapid Early Action for Coronary Treatment. Am J Prev Med. 1999 May;16(4):325-34. doi: 10.1016/s0749-3797(99)00023-9.
PubMed 10493291Goff DC Jr, Feldman HA, McGovern PG, Goldberg RJ, Simons-Morton DG, Cornell CE, Osganian SK, Cooper LS, Hedges JR. Prehospital delay in patients hospitalized with heart attack symptoms in the United States: the REACT trial. Rapid Early Action for Coronary Treatment (REACT) Study Group. Am Heart J. 1999 Dec;138(6 Pt 1):1046-57. doi: 10.1016/s0002-8703(99)70069-4.
PubMed 10577434Luepker RV, Raczynski JM, Osganian S, Goldberg RJ, Finnegan JR Jr, Hedges JR, Goff DC Jr, Eisenberg MS, Zapka JG, Feldman HA, Labarthe DR, McGovern PG, Cornell CE, Proschan MA, Simons-Morton DG. Effect of a community intervention on patient delay and emergency medical service use in acute coronary heart disease: The Rapid Early Action for Coronary Treatment (REACT) Trial. JAMA. 2000 Jul 5;284(1):60-7. doi: 10.1001/jama.284.1.60.
PubMed 10872014Brown AL, Mann NC, Daya M, Goldberg R, Meischke H, Taylor J, Smith K, Osganian S, Cooper L. Demographic, belief, and situational factors influencing the decision to utilize emergency medical services among chest pain patients. Rapid Early Action for Coronary Treatment (REACT) study. Circulation. 2000 Jul 11;102(2):173-8. doi: 10.1161/01.cir.102.2.173.
PubMed 10889127Goldberg R, Goff D, Cooper L, Luepker R, Zapka J, Bittner V, Osganian S, Lessard D, Cornell C, Meshack A, Mann C, Gilliland J, Feldman H. Age and sex differences in presentation of symptoms among patients with acute coronary disease: the REACT Trial. Rapid Early Action for Coronary Treatment. Coron Artery Dis. 2000 Jul;11(5):399-407. doi: 10.1097/00019501-200007000-00004.
PubMed 10895406Siepmann DB, Mann NC, Hedges JR, Daya MR. Association between prepayment systems and emergency medical services use among patients with acute chest discomfort syndrome. For the Rapid Early Action for Coronary Treatment (REACT) Study. Ann Emerg Med. 2000 Jun;35(6):573-8.
PubMed 10828770Hedges JR, Feldman HA, Bittner V, Goldberg RJ, Zapka J, Osganian SK, Murray DM, Simons-Morton DG, Linares A, Williams J, Luepker RV, Eisenberg MS. Impact of community intervention to reduce patient delay time on use of reperfusion therapy for acute myocardial infarction: rapid early action for coronary treatment (REACT) trial. REACT Study Group. Acad Emerg Med. 2000 Aug;7(8):862-72. doi: 10.1111/j.1553-2712.2000.tb02063.x.
PubMed 10958125Finnegan JR Jr, Meischke H, Zapka JG, Leviton L, Meshack A, Benjamin-Garner R, Estabrook B, Hall NJ, Schaeffer S, Smith C, Weitzman ER, Raczynski J, Stone E. Patient delay in seeking care for heart attack symptoms: findings from focus groups conducted in five U.S. regions. Prev Med. 2000 Sep;31(3):205-13. doi: 10.1006/pmed.2000.0702.
PubMed 10964634Osganian SK, Zapka JG, Feldman HA, Goldberg RJ, Hedges JR, Eisenberg MS, Raczynski JM, McGovern PG, Cooper LS, Pandey DK, Linares AC, Luepker RV; REACT Study Group. Rapid Early Action for Coronary Treatment. Use of emergency medical services for suspected acute cardiac ischemia among demographic and clinical patient subgroups: the REACT trial. Rapid Early Action for Coronary Treatment. Prehosp Emerg Care. 2002 Apr-Jun;6(2):175-85. doi: 10.1080/10903120290938517.
PubMed 11962564Meischke H, Mitchell P, Zapka J, Goff DC Jr, Smith K, Henwood D, Mann C, Lovell K, Stone E, Taylor J. The emergency department experience of chest pain patients and their intention to delay care seeking for acute myocardial infarction. Prog Cardiovasc Nurs. 2000 Spring;15(2):50-7. doi: 10.1111/j.0889-7204.2000.080397.x.
PubMed 10804595Zapka JG, Oakes JM, Simons-Morton DG, Mann NC, Goldberg R, Sellers DE, Estabrook B, Gilliland J, Linares AC, Benjamin-Garner R, McGovern P. Missed opportunities to impact fast response to AMI symptoms. Patient Educ Couns. 2000 Apr;40(1):67-82. doi: 10.1016/s0738-3991(99)00065-8.
PubMed 10705066
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Early Action for Coronary Treatment (REACT)
- ClinicalTrials.gov ID
- NCT00000550
- Acronym / sponsor ID
- 94
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1994
- Primary completion
- May 2000 (actual)
- Study completion
- May 2000 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health education | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Background: PubMed 9715238Hedges JR, Mann NC, Meischke H, Robbins M, Goldberg R, Zapka J. Assessment of chest pain onset and out-of-hospital delay using standardized interview questions: the REACT Pilot Study. Rapid Early Action for Coronary Treatment (REACT) Study Group. Acad Emerg Med. 1998 Aug;5(8):773-80. doi: 10.1111/j.1553-2712.1998.tb02503.x.
- Background: PubMed 9683313Feldman HA, Proschan MA, Murray DM, Goff DC, Stylianou M, Dulberg E, McGovern PG, Chan W, Mann NC, Bittner V. Statistical design of REACT (Rapid Early Action for Coronary Treatment), a multisite community trial with continual data collection. Control Clin Trials. 1998 Aug;19(4):391-403. doi: 10.1016/s0197-2456(98)00014-2.
- Background: PubMed 9678398Simons-Morton DG, Goff DC, Osganian S, Goldberg RJ, Raczynski JM, Finnegan JR, Zapka J, Eisenberg MS, Proschan MA, Feldman HA, Hedges JR, Luepker RV. Rapid early action for coronary treatment: rationale, design, and baseline characteristics. REACT Research Group. Acad Emerg Med. 1998 Jul;5(7):726-38. doi: 10.1111/j.1553-2712.1998.tb02492.x.
- Background: PubMed 9827784Goff DC Jr, Sellers DE, McGovern PG, Meischke H, Goldberg RJ, Bittner V, Hedges JR, Allender PS, Nichaman MZ. Knowledge of heart attack symptoms in a population survey in the United States: The REACT Trial. Rapid Early Action for Coronary Treatment. Arch Intern Med. 1998 Nov 23;158(21):2329-38. doi: 10.1001/archinte.158.21.2329.
- Background: PubMed 10493291Raczynski JM, Finnegan JR Jr, Zapka JG, Meischke H, Meshack A, Stone EJ, Bracht N, Sellers DE, Daya M, Robbins M, McAlister A, Simons-Morton D. REACT theory-based intervention to reduce treatment-seeking delay for acute myocardial infarction. Rapid Early Action for Coronary Treatment. Am J Prev Med. 1999 May;16(4):325-34. doi: 10.1016/s0749-3797(99)00023-9.
- Background: PubMed 10577434Goff DC Jr, Feldman HA, McGovern PG, Goldberg RJ, Simons-Morton DG, Cornell CE, Osganian SK, Cooper LS, Hedges JR. Prehospital delay in patients hospitalized with heart attack symptoms in the United States: the REACT trial. Rapid Early Action for Coronary Treatment (REACT) Study Group. Am Heart J. 1999 Dec;138(6 Pt 1):1046-57. doi: 10.1016/s0002-8703(99)70069-4.
- Background: PubMed 10872014Luepker RV, Raczynski JM, Osganian S, Goldberg RJ, Finnegan JR Jr, Hedges JR, Goff DC Jr, Eisenberg MS, Zapka JG, Feldman HA, Labarthe DR, McGovern PG, Cornell CE, Proschan MA, Simons-Morton DG. Effect of a community intervention on patient delay and emergency medical service use in acute coronary heart disease: The Rapid Early Action for Coronary Treatment (REACT) Trial. JAMA. 2000 Jul 5;284(1):60-7. doi: 10.1001/jama.284.1.60.
- Background: PubMed 10889127Brown AL, Mann NC, Daya M, Goldberg R, Meischke H, Taylor J, Smith K, Osganian S, Cooper L. Demographic, belief, and situational factors influencing the decision to utilize emergency medical services among chest pain patients. Rapid Early Action for Coronary Treatment (REACT) study. Circulation. 2000 Jul 11;102(2):173-8. doi: 10.1161/01.cir.102.2.173.
- Background: PubMed 10895406Goldberg R, Goff D, Cooper L, Luepker R, Zapka J, Bittner V, Osganian S, Lessard D, Cornell C, Meshack A, Mann C, Gilliland J, Feldman H. Age and sex differences in presentation of symptoms among patients with acute coronary disease: the REACT Trial. Rapid Early Action for Coronary Treatment. Coron Artery Dis. 2000 Jul;11(5):399-407. doi: 10.1097/00019501-200007000-00004.
- Background: PubMed 10828770Siepmann DB, Mann NC, Hedges JR, Daya MR. Association between prepayment systems and emergency medical services use among patients with acute chest discomfort syndrome. For the Rapid Early Action for Coronary Treatment (REACT) Study. Ann Emerg Med. 2000 Jun;35(6):573-8.
- Background: PubMed 10958125Hedges JR, Feldman HA, Bittner V, Goldberg RJ, Zapka J, Osganian SK, Murray DM, Simons-Morton DG, Linares A, Williams J, Luepker RV, Eisenberg MS. Impact of community intervention to reduce patient delay time on use of reperfusion therapy for acute myocardial infarction: rapid early action for coronary treatment (REACT) trial. REACT Study Group. Acad Emerg Med. 2000 Aug;7(8):862-72. doi: 10.1111/j.1553-2712.2000.tb02063.x.
- Background: PubMed 10964634Finnegan JR Jr, Meischke H, Zapka JG, Leviton L, Meshack A, Benjamin-Garner R, Estabrook B, Hall NJ, Schaeffer S, Smith C, Weitzman ER, Raczynski J, Stone E. Patient delay in seeking care for heart attack symptoms: findings from focus groups conducted in five U.S. regions. Prev Med. 2000 Sep;31(3):205-13. doi: 10.1006/pmed.2000.0702.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Feldman
New England Research Institute, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing health education in people with Cardiovascular Diseases and Coronary Disease, run by Carelon Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000550, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.