Acute Coronary Syndrome and Care-Seeking Delay: A Web Based Behavioral Study

April 1, 2020 updated by: Yale University
The primary aim of this study is to increase our understanding of care-seeking behavior surrounding heart attacks or acute coronary syndromes [ACS]. This study uses an internet based survey to ask individuals how they obtained medical care in the midst of a heart attack. At present, care-seeking delay among individuals stricken with a heart attack prevents them from obtaining the full therapeutic benefit of hospital based medical care in a timely manner to reduce the long term health consequences of a heart attack. By using a self-tailoring survey instrument the study attempts to take into consideration the complex social processes by which the individual and their family make decisions to seek medical care for symptoms of a heart attack. The study is designed to obtain a national sample of ACS care-seeking behavior in the United States.

Study Overview

Status

Completed

Conditions

Detailed Description

The primary aim of this study is to increase our understanding of care-seeking behavior surrounding acute coronary syndromes [ACS] through the application and testing of an integrated self-regulatory care-seeking model [ISCM] and the utilization of a world wide web [WWW] based ISCM survey instrument. At present, care-seeking delay among individuals stricken with ACS [acute myocardial infarction [AMI], unstable angina or sudden cardiac death] prevents many patients from obtaining the full therapeutic benefit of hospital based thrombolytic and/or mechanical reperfusion therapy to reduce the morbid and mortal consequences of acute cardiovascular disease [CVD]. Results from prior studies of ACS care-seeking delay generally rely on measures of time duration from acute symptom onset [ASO] to hospital emergency department [ED] arrival and measures of social demographic and clinical variables, extracted from emergency medical system [EMS] logs and/or ED charts. By relying on such limited data sources, these studies have failed to take into consideration the complexity of the social and behavioral processes by which individuals make decisions to seek medical care for symptoms of ACS.

By applying and testing an integrated self-regulatory care-seeking model [ISCM] to ACS care-seeking, it will be possible to delineate decision points and situations and circumstances that are critical to producing patterns of care-seeking that are efficient and expeditious or are protracted and delayed. The care-seeking process in the ISCM is viewed in terms of five analytic care-seeking phases from warning or premonitory symptoms to ED arrival. By noting the presence or absence of three central phases, it is possible to distinguish patterns of care-seeking and to record the duration of each care-seeking phase and total duration of each care-seeking path to the ED. The ISCM assumes that coping behaviors emerge over time and initially care-seeking behaviors are guided by demographic and structural factors. As the self-regulatory and coping processes emerge over the course of the ACS episode, the influence of these factors diminishes and emergent ACS evaluations, advice from others and health care providers, emerging symptoms and emotions, come to dominate the care-seeking process and directly determine the duration of ACS care-seeking. The study will test and explore the following hypotheses:

  1. Commonly used demographic variables, such as, age, sex, education and race will prove to be only one component, along with social situational and circumstantial, cognitive and emotional variables, that significantly influence the course and duration of ACS care-seeking.
  2. The ISCM will show that decision process variables associated with the care-seeking phases, the Self, Lay and Health Care Provider Phases, as shown in the Figure, are important predictors of time from symptoms onset to ED arrival and in the prediction of the length of time spent in each care-seeking phase.
  3. The ISCM will show differences in the total duration of the 5 most frequently occurring care-seeking paths to the ED and will explain most of the differences by the variables in Hypotheses 1 and 2.
  4. Conditional models of subjects who use key care-seeking phases, namely the Self, Lay and Health Care Provider Phases, will identify unique predictors of time in each phase.
  5. Significant interaction effects [model coefficient differences] will be found for important risk variables and socially important gender, age and racial groups. For example, African-Americans will show differences in model coefficients from Non-African-Americans.

The proposed study utilizes a twice tested pilot ISCM survey instrument placed on two secure dedicated web servers to collect patient care-seeking data. The target sample size for this study is 2,314 patients who have experienced an ACS episode. Subjects will be recruited using: 1] extensive marketing of the study URL on websites of interest to cardiac patients and oriented toward cardiac health and ACS risks, such as, diabetes or hypertension; 2] placement of study information on discussion boards and chat rooms with a cardiac health focus; 3] emailing of a study flyer PDF for posting in public libraries, senior citizen centers, African-American churches, county and municipal health clinics, and HMO web sites; 4] application of a viral marketing strategy; and 5] use of selected print media, for example, AARP publications. Marketing of the study site URL will emphasize the recruitment of women, the elderly and minorities. In the data collection phase of the study, the proportions of myocardial infarction and angina pectoris subjects falling into each cell of the cross classification of age, sex and race will be derived from NHANES 1999-2000 and 2001-2002 studies. These estimates of the population proportions in these cells will be used to determine quotas for each of the cells in an attempt to ensure all risk groups are adequately represented. We will over sample African-Americans. Statistical models will be used to estimate the effects of variables that characterize the decision process on the time delay until ED arrival. Time required to move from one phase of the decision process to the next will also be modeled, as will the different paths chosen by the subjects. Models will also include patient characteristics and other circumstantial and situational variables in the decision process.

Study Type

Observational

Enrollment (Actual)

2381

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06536
        • Yale University School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study is designed to gather detailed information on the care-seeking behavior of ACS patients from a sample of sufficient size to allow testing of study hypotheses and provide points of intervention in the ACS care-seeking process. To obtain these data the study will employ a self-administered, self-tailoring web based survey instrument and a sampling design incorporating sampling quotas calculated from NHANES 1999-2000 and 2001-2002 studies to represent the population of the United States with AMI by age, gender, and race, and 2] over sampling of selected groups to meet calculated sampling quotas.

Description

Inclusion Criteria: Acute myocardial infarction, acute coronary syndrome, unstable angina, men & women, all races & ethnicities

-

Exclusion Criteria: age < 21 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision points and situations and circumstances critical to producing patterns of care-seeking that are efficient and expeditious or are protracted and delayed.
Time Frame: Study participants will be asked to complete a survey of their heart attack care-seeking experiences. The survey will take from 30 minutes to 1 hour to complete depending on their care-seeking activities.
By applying an integrated self-regulatory care-seeking model [ISCM] to ACS care-seeking, we can delineate decision points and circumstances that are critical to producing patterns of care-seeking that are expeditious or delayed. The ISCM model assumes that coping behaviors emerge over time and are initially guided by demographic and structural factors. As the self-regulatory processes emerge, the influence of these factors diminishes and emergent ACS evaluations, advice from others and health care providers, emerging symptoms and emotions, come to determine the duration of ACS care-seeking.
Study participants will be asked to complete a survey of their heart attack care-seeking experiences. The survey will take from 30 minutes to 1 hour to complete depending on their care-seeking activities.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Angelo A Alonzo, PhD, Yale University School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

July 29, 2011

First Posted (Estimate)

August 2, 2011

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 0711003286
  • 5R01HL085328-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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