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| Name | Class |
|---|---|
| The Gertner Institute | OTHER |
| Israel National Institute for Health Policy and Health Services Research | OTHER_GOV |
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The main aim of the study is to determine the effectiveness of an educational intervention designed to increase attendance of coronary artery bypass grafting (CABG) patients at Cardiac Rehabilitation Programs (CRPs) on actual CRP participation rate and; examine patient-related factors (demographic, health, psychosocial, awareness) influencing patients' attendance at CRPs. We hypothesized that the proportion of CABG patients participating in CRPs will increase significantly to 20-30% following the educational intervention employed.
Coronary heart disease (CHD) is a major cause of disability and economic burden in western societies. Ample evidence exists to suggest that participation of these patients in structured Cardiac Rehabilitation Programs (CRPs) is beneficial in terms of improved prognosis and quality of life. Despite inclusion of cardiac rehabilitation (CR) in the Medical Insurance Basket (MIB) as a treatment for patients after an acute myocardial infarction (MI), for those after coronary artery bypass grafting (CABG), and more recently for patients suffering from congestive heart failure, only a small proportion (5%-7.5%) of patients take part in CRPs in Israel. Several factors have been identified as barriers to CRP in Israel, two of which are lack of patients motivation to participate in CRPs stemming, in part, from lack of awareness regarding the importance of CR and its availability and; Lack of motivation of medical staff to refer patients to CR resulting from a unawareness of the importance of CR and its availability across Israel, to name a few. The present study accords with such recommendations, by proposing a simple intervention designed to improve patients' and medical staff's awareness to the importance of CR participation. It is expected that CRP participation will significantly increase to 20-30% following the educational intervention employed.
This intervention will provide the basis for the implementation of an intervention to increase CRP participation in cardiac patients at a national level.
In addition to increasing the proportion of CABG patients attending at CRPs, the study aims to measure the effect of CRP participation on subsequent 1-year health and behavior related outcomes, and 3-year mortality. We expect to find differences in outcome measures between participating patients and those who do not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Explanation on cardiac rehabilitation | Experimental | Intervention: Increasing awareness to cardiac rehabilitation programs: Patients received a written and oral short explanation on the importance and benefits of cardiac rehabilitation (CR) participation, and information on available programs. They were telephoned 2 weeks after hospital discharge to encourage them to enroll at a cardiac rehabilitation program (CRP). In addition, physicians and nurses at the cardiothoracic units participated in a 1-hour seminar on CR. A recommendation to the general physician to refer the patient to CRP was added to the letter of discharge from hospital. |
|
| Usual care with no intervention | No Intervention | Patients recruited to the study received the usual care without any additional explanation on cardiac rehabilitation, and no effort to increase their awareness or the ward's awareness to cardiac rehabilitation was done. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Increasing awareness to cardiac rehabilitation programs | Behavioral | Increasing awareness to cardiac rehabilitation programs: Before coronary artery bypass grafting (CABG) surgery patients received a face-to-face explanation on their right to participate in cardiac rehabilitation programs (CRPs) under the Israeli Basket of Health Services; they were also provided with a brochure on the benefits of CRP participation and the availability of CRPs throughout the country. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups | The number of cardiac patients who participated in cardiac rehabilitation programs during the year following coronary artery bypass grafting surgery in the control and the intervention groups. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument. | MacNew questionnaire (MACNEW). A self-administered heart disease-specific health-related quality of life (HRQL) instrument. The MacNew is a modification of the original interviewer-administered Quality of Life after Myocardial Infarction [QLMI] instrument. It addresses three major HRQL domains, the Emotional, Physical, and Social domains which can be combined to give a Global HRQL score. The MacNew consists of 27 items. The total mean score ranges between 1 and 7, where higher score means better HRQL. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Morbidity | All hospitalizations which occured during the 1 year follow-up and were due to acute myocardial infarction (International Classification of Disease 9th version (ICD-9) codes 410.), angina pectoris (ICD-9 codes 413.9), stroke/ transient ischemic attack (TIA) (ICD-9 codes 436.), and all surgical procedures which occured during the 1 year follow-up: CABG or coronary catheterizations (ICD-9 codes 36.), endarterectomies (ICD-9 codes 38.0 and 39.0). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Dankner, MD MPH | The Gertner Institute for Epidemiology and Health Service Research, Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center, the Gertner institute for epidemiology and health service research | Ramat Gan | 52621 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25183694 | Background | Dankner R, Drory Y, Geulayov G, Ziv A, Novikov I, Zlotnick AY, Moshkovitz Y, Elami A, Schwammenthal E, Goldbourt U. A controlled intervention to increase participation in cardiac rehabilitation. Eur J Prev Cardiol. 2015 Sep;22(9):1121-8. doi: 10.1177/2047487314548815. Epub 2014 Sep 2. | |
| 23367742 | Result | Gendler Y, Geulayov G, Ziv A, Novikov I, Dankner R; Multi-Center Cardiac Rehabilitation Israeli Working Group. [A multicenter intervention study on referral to cardiac rehabilitation after coronary artery bypass graft surgery: a 1-year follow-up of rehabilitation rates among USSR-born and veteran Israeli patients]. Harefuah. 2012 Sep;151(9):511-7, 558, 557. Hebrew. |
| Label | URL |
|---|---|
| THE PSYCHOMETRIC PROPERTIES OF THE RUSSIAN VERSION OF THE MACNEW HEART DISEASE HEALTH-RELATED QUALITY OF LIFE SCALE IN PATIENTS UNDERGOING CORONARY ARTERY BYPASS GRAFTING SURGERY | View source |
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All first 520 recruited participants from the 5 cardiothoracic units belonged to the control arm of the study and received usual care. The following 504 patients recruited in the 5 cardiothoracic units belonged to the intervention arm and received the educational intervention materials of the study regarding cardiac rehabilitation treatment.
All cardiac patients hospitalized in 5 cardiothoracic clinics for coronary artery bypass grafting (CABG) surgery (with or without valve replacement) were offered to participate in the study based on inclusion criteria. Recruitment started on January 2004 and ended on November 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Education (Intervention) Regarding Cardiac Rehabilitation (CR) | Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR. |
| FG001 | No Education (Control) Regarding Cardiac Rehabilitation (CR) | Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Education (Intervention) Regarding Cardiac Rehabilitation (CR) | Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups | The number of cardiac patients who participated in cardiac rehabilitation programs during the year following coronary artery bypass grafting surgery in the control and the intervention groups. | All patients alive at 1-year follow up who gave information on participation in cardiac rehabilitation programs (CRPs) at any time during the year following surgery (and before follow up assessment). This information was obtained via a face-to-face interview or by telephone interview. | Posted | Nov 2010 | Number | participants | 1 year |
|
1-year follow up after baseline interview.
Baseline interview was conducted during hospitalization period before CABG surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Education (Intervention) Regarding Cardiac Rehabilitation (CR) | Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | ICD-9 | Systematic Assessment | Total mortality |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel S Dankner, MD, MPH | The Gertner Institute for Epidemiology and Health Service Research | 972-3-5305390 | RachelD@gertner.health.gov.il |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
| 1 year |
| 1 year |
| Biochemical Markers | glucose, total cholesterol, triglycerides, low density lipoprotein (LDL) cholesterol. Data regarding these biochemical markers was collected from medical available documents at the homes of the patients. In many cases this data was unavailable. Reported values are only available for a subpopulation. | 1 year |
| Medical Service Utilization | Visits to the emergency department during the year following CABG surgery | 1 year |
| Anthropometric Measures | Measurements of body mass index (BMI) | 1 year |
| Lifestyle Habits (i.e. Smoking) | 1 year |
| Employment Status | Number of patients fully employed in each arm | 1 year |
| Depression & Anxiety | Score in the HADS (hospital Anxiety and Depression Scale) screening for anxiety and depression. This is a 14 item scale, 7 items for anxiety and 7 items for depression. Each item can score 0-3 (0=good, 3=bad) and the total score for each scale varies between 0 (no depression/anxiety) to 21 (clinical depression/anxiety requiring medical intervention) | 1 year |
| Physical Activity | Self-reported physical activity using a physical activity questionnaire validated in Hebrew. Details of the study validating the instrument: "Development of a Hebrew questionnaire to be used in epidemiological studies to assess physical fitness--validation against sub maximal stress test and predicted VO2max". Ken-Dror G, Lerman Y, Segev S, Dankner R. Harefuah. 2004 Aug;143(8):566-72, 623. Hebrew. PMID: 15523807 VO2max=maximal oxygen uptake | 1 year |
| Blood Pressure | The pooled mean of 3 blood pressure measurements taken during the interview | 1 year follow up |
| 21982052 | Result | Dankner R, Geulayov G, Ziv A, Novikov I, Goldbourt U, Drory Y. The effect of an educational intervention on coronary artery bypass graft surgery patients' participation rate in cardiac rehabilitation programs: a controlled health care trial. BMC Cardiovasc Disord. 2011 Oct 8;11:60. doi: 10.1186/1471-2261-11-60. |
| 38456874 | Derived | Moshkovitz Y, Orenstein L, Olmer L, Laufer K, Ziv A, Dankner R. Emulated Trial for Discharge Prescription of Guideline-Directed Medical Therapy and 15-Year Survival After Coronary Artery Bypass Graft Surgery. Mayo Clin Proc. 2024 May;99(5):766-779. doi: 10.1016/j.mayocp.2023.06.022. Epub 2024 Mar 7. |
| 29332626 | Derived | Geulayov G, Novikov I, Dankner D, Dankner R. Symptoms of depression and anxiety and 11-year all-cause mortality in men and women undergoing coronary artery bypass graft (CABG) surgery. J Psychosom Res. 2018 Feb;105:106-114. doi: 10.1016/j.jpsychores.2017.11.017. Epub 2017 Dec 1. |
| Validation of the Hebrew Version of the MacNew Heart Disease Healthrelated Quality of Life Questionnaire in Patients Undergoing Coronary Artery Bypass Surgery | View source |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) |
Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Education (Control) Regarding Cardiac Rehabilitation (CR) | Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about CR and were giving the usual care. |
|
|
| Other Pre-specified | Cardiovascular Morbidity | All hospitalizations which occured during the 1 year follow-up and were due to acute myocardial infarction (International Classification of Disease 9th version (ICD-9) codes 410.), angina pectoris (ICD-9 codes 413.9), stroke/ transient ischemic attack (TIA) (ICD-9 codes 436.), and all surgical procedures which occured during the 1 year follow-up: CABG or coronary catheterizations (ICD-9 codes 36.), endarterectomies (ICD-9 codes 38.0 and 39.0). | All patients who were exposed to the educational intervention at baseline and who were contacted a year later and gave information regarding participation in cardiac rehabilitation during the follow up year. | Posted | Number | events | 1 year | hospitalizations | hospitalizations |
|
|
|
| Other Pre-specified | Biochemical Markers | glucose, total cholesterol, triglycerides, low density lipoprotein (LDL) cholesterol. Data regarding these biochemical markers was collected from medical available documents at the homes of the patients. In many cases this data was unavailable. Reported values are only available for a subpopulation. | Posted | Mean | 95% Confidence Interval | mg/dl | 1 year |
|
|
|
| Other Pre-specified | Medical Service Utilization | Visits to the emergency department during the year following CABG surgery | Posted | Number | ER visits | 1 year |
|
|
|
| Other Pre-specified | Anthropometric Measures | Measurements of body mass index (BMI) | Posted | Mean | 95% Confidence Interval | kg/m^2 | 1 year |
|
|
|
| Other Pre-specified | Lifestyle Habits (i.e. Smoking) | Posted | Number | patients | 1 year |
|
|
|
| Other Pre-specified | Employment Status | Number of patients fully employed in each arm | Posted | Number | patients | 1 year |
|
|
|
| Other Pre-specified | Depression & Anxiety | Score in the HADS (hospital Anxiety and Depression Scale) screening for anxiety and depression. This is a 14 item scale, 7 items for anxiety and 7 items for depression. Each item can score 0-3 (0=good, 3=bad) and the total score for each scale varies between 0 (no depression/anxiety) to 21 (clinical depression/anxiety requiring medical intervention) | All patients who completed the Hospital Anxiety and Depression Scale (HADS) | Posted | Mean | Standard Deviation | HADS score | 1 year |
|
|
|
| Other Pre-specified | Physical Activity | Self-reported physical activity using a physical activity questionnaire validated in Hebrew. Details of the study validating the instrument: "Development of a Hebrew questionnaire to be used in epidemiological studies to assess physical fitness--validation against sub maximal stress test and predicted VO2max". Ken-Dror G, Lerman Y, Segev S, Dankner R. Harefuah. 2004 Aug;143(8):566-72, 623. Hebrew. PMID: 15523807 VO2max=maximal oxygen uptake | All patients who were interviewed 1-year after CABG surgery and responded to the physical activity questionnaire | Posted | Number | patients | 1 year |
|
|
|
| Secondary | MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument. | MacNew questionnaire (MACNEW). A self-administered heart disease-specific health-related quality of life (HRQL) instrument. The MacNew is a modification of the original interviewer-administered Quality of Life after Myocardial Infarction [QLMI] instrument. It addresses three major HRQL domains, the Emotional, Physical, and Social domains which can be combined to give a Global HRQL score. The MacNew consists of 27 items. The total mean score ranges between 1 and 7, where higher score means better HRQL. | The N for this outcome is the number of patients for whom there are follow-up data after one year. | Posted | Mean | Standard Deviation | Scores on a scale | 1 year |
|
|
|
| Other Pre-specified | Blood Pressure | The pooled mean of 3 blood pressure measurements taken during the interview | Posted | Mean | 95% Confidence Interval | mm Hg | 1 year follow up |
|
|
|
| 114 |
| 504 |
| 0 |
| 504 |
| EG001 | No Education (Control) Regarding Cardiac Rehabilitation (CR) | Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care. | 159 | 523 | 0 | 523 |
| acute myocardial infarction, unspecified site | Cardiac disorders | 410.9 | Systematic Assessment |
|
| acute, but ill-defined cerebrovascular disease (apoplexy, n.o.s)/transient cerebral ischemia | Vascular disorders | 436, 435 | Systematic Assessment |
|
| other and unspecified angina pectoris | Cardiac disorders | 413.9 | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Angina Pectoris |
|
| Triglycerides |
|
| LDL Cholesterol |
|
| Never smoked |
|