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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The long-term goal of this research is to improve patient-centered outcomes in patients with coronary heart disease (CHD), the leading cause of death in the world. Exercise-based cardiac rehabilitation (CR) programs decrease mortality and improve quality of life in patients with CHD. Published guidelines recommend exercise-based CR following hospitalization for myocardial infarction, coronary artery bypass grafting, or percutaneous coronary revascularization.
Despite these compelling benefits, CR programs are vastly underutilized, with less than a third of eligible patients participating. One promising solution is greater implementation of home-based CR. Both home and center-based CR programs have equal benefits on cardiovascular risk factors and quality of life. However, similar efficacy does not necessarily translate into similar effectiveness. If patients are more likely to participate in home- vs. center-based therapy, then greater participation could lead to greater clinical effectiveness. We are therefore conducting a quasi-experimental, controlled trial at two VA medical centers to determine the comparative effectiveness of referral to home- vs. center-based CR in patients with CHD.
Aim 1: Determine whether automatic referral to home- vs. center-based CR increases patient participation in CR after hospitalization for myocardial infarction or coronary revascularization.
Aim 2: Among patients who choose to participate in CR, compare the effectiveness of home- vs. center-based CR on six-minute walk distance, quality of life, and healthcare expenditures.
Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race, ethnicity, employment, socioeconomic status, social support, comorbid conditions, or patient preference.
Results from this study will (a) help policy makers determine the effect of covering home CR on healthcare expenditures in patients with CHD; (b) help providers understand the potential benefits and harms of home- vs. center-based CR; and (c) help patients answer questions like, "Given my personal circumstances and preferences, which of these options will improve the outcomes most important to me".
The long-term goal of this research is to improve patient-centered outcomes in patients with coronary heart disease (CHD). CHD is the leading cause of death in the world. Exercise-based cardiac rehabilitation (CR) programs decrease mortality and improve quality of life in patients with CHD. Published guidelines recommend exercise-based CR following hospitalization for myocardial infarction, coronary artery bypass grafting, or percutaneous coronary revascularization, and referral to CR is one of nine performance measures established by the American Heart Association and American College of Cardiology for patients with CHD.
Despite these compelling benefits, CR programs are vastly underutilized, with less than a third of eligible patients participating. The largest barrier to patient participation is that CR must be provided in a physician's office or hospital setting to qualify for reimbursement. For this reason, virtually all existing CR programs require that the patient travel to a CR center 3 times per week for 12 to 36 weeks. Unfortunately, many Americans live too far from a CR center to enroll, and even when nearby programs are available, many patients do not have the time, flexibility, transportation, social support, and/or financial resources to attend.
One promising solution to the problem of CR under-utilization is greater implementation of home-based CR. Both home and center-based CR programs have equal benefits on cardiovascular risk factors and quality of life. However, similar efficacy does not necessarily translate into similar effectiveness. If patients are more likely to participate in home- vs. center-based therapy, then greater participation could lead to greater clinical effectiveness. We are therefore conducting a quasi-experimental, controlled trial at two VA medical centers to determine the comparative effectiveness of referral to home- vs. center-based CR in patients with CHD.
Aim 1: Determine whether automatic referral to home- vs. center-based CR increases patient participation in CR after hospitalization for myocardial infarction or coronary revascularization.
Aim 2: Among patients who choose to participate in CR, compare the effectiveness of home- vs. centerbased CR on six-minute walk distance, quality of life, and healthcare expenditures.
Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race, ethnicity, employment, socioeconomic status, social support, comorbid conditions, or patient preference.
Results from this study will (a) help policy makers determine the effect of covering home CR on healthcare expenditures in patients with CHD; (b) help providers understand the potential benefits and harms of home- vs. center-based CR; and (c) help patients answer questions like, "Given my personal circumstances and preferences, which of these options will improve the outcomes most important to me.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based | Experimental | Referral to a home-based cardiac rehabilitation program (intervention). |
|
| Center-based | Active Comparator | Referral to a center-based cardiac rehabilitation program (standard of care). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Referral to home-based cardiac rehab | Behavioral | Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Participation in Cardiac Rehabilitation | Number of eligible patients who participated in at least one cardiac rehabilitation exercise session. | 12 Months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Distance Completed on 6-minute Walk Test | Baseline to 3-month change in 6-minute walk test distance (feet) among subjects who participated in home-based vs. center-based cardiac rehab. | 3 months |
| Change in Distance Completed on 6-minute Walk Test |
Inclusion Criteria:
Post MI, CABG, or PCI Able to speak, read and write in english
Exclusion Criteria:
Class IV CHF Unstable Angina Complex Ventricular Arrythmias EF <35% without AICD AICD candidate Resting SBP >200mmHG Resting DBP>110mmHG Cognitive Impairment by MoCA Score <26 Life expectancy <1 year
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| Name | Affiliation | Role |
|---|---|---|
| Mary Whooley, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Veterans Affairs Medical Center | San Francisco | California | 94116 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32954885 | Derived | Schopfer DW, Whooley MA, Allsup K, Pabst M, Shen H, Tarasovsky G, Duvernoy CS, Forman DE. Effects of Home-Based Cardiac Rehabilitation on Time to Enrollment and Functional Status in Patients With Ischemic Heart Disease. J Am Heart Assoc. 2020 Oct 20;9(19):e016456. doi: 10.1161/JAHA.120.016456. Epub 2020 Sep 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Referral to Home-based Cardiac Rehabilitation | Referral to home-based cardiac rehabilitation (intervention): Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes. |
| FG001 | Referral to Center-based Cardiac Rehabilitation | Referral to center-based cardiac rehabilitation (standard of care): Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis population was as depicted in Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | Home-based | Referral to home-based cardiac rehabilitation (intervention): Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes. |
| BG001 | Center-based |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (years), integer |
| 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 | Participation in Cardiac Rehabilitation | Number of eligible patients who participated in at least one cardiac rehabilitation exercise session. | Posted | Count of Participants | Participants | 12 Months |
|
1 year
Adverse event reporting data was recorded for participants who enrolled in cardiac rehab (231 home-based and 252 facility-based).
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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 | Referral to Home-based Cardiac Rehabilitation | Referral to a home-based cardiac rehabilitation program (intervention). Referral to home-based cardiac rehabilitation: Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes. |
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CR referral process differed across sites: 90% of eligible patients were referred at the San Francisco (home-based CR) site, whereas 56% of eligible patients were referred at the Ann Arbor and Pittsburgh (center-based CR) sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Whooley | San Francisco VA Healthcare System | 415-221-4810 | mary.whooley@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2018 | Jan 3, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Referral to center-based cardiac rehab | Behavioral | Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting. |
|
Baseline to 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based vs. center-based cardiac rehab.
| 6 months |
Referral to center-based cardiac rehabilitation (standard of care): Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
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| Other Pre-specified | Change in Distance Completed on 6-minute Walk Test | Baseline to 3-month change in 6-minute walk test distance (feet) among subjects who participated in home-based vs. center-based cardiac rehab. | This analysis compared 3-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab. Data from participants who completed the 3 month follow up visit are presented. | Posted | Median | Inter-Quartile Range | feet | 3 months |
|
|
|
|
| Other Pre-specified | Change in Distance Completed on 6-minute Walk Test | Baseline to 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based vs. center-based cardiac rehab. | This analysis compares 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based cardiac rehab vs. patients who participated in center-based cardiac rehab. | Posted | Median | Inter-Quartile Range | feet | 6 months |
|
|
|
|
| 0 |
| 231 |
| 0 |
| 231 |
| 0 |
| 231 |
| EG001 | Referral to Center-based Cardiac Rehabilitation | Referral to a center-based cardiac rehabilitation program (standard of care). Referral to center-based cardiac rehabilitation: Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting. | 0 | 252 | 0 | 252 | 0 | 252 |
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