Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Angina, Peripheral Vascular Disease, Cardiology, Rheumatology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 2/27/2019 |
| Start Date: | October 1, 2016 |
| End Date: | March 31, 2020 |
Secondary Event Prevention Using Population Risk Management After PCI
Ischemic heart disease (IHD) and its treatment carry profound public health and economic
implications. Among Veterans, IHD represents one of the most common causes of death and
disability, with over 500,000 affected individuals' annually. Rheumatic disease, though far
less common than IHD can affect multiple organ systems and requires therapies costing in
excess of $50,000 a year. Optimal treatment of Veterans with IHD and rheumatic disease
requires a number of medications to maintain or improve health. Not taking medications as
prescribed, however, is common and increases the risk of subsequent adverse events (cardiac
death and myocardial infarction [MI]).
To improve medication adherence rates and the cardiac health of Veterans with IHD, the
investigators propose to test a medication adherence intervention. Known as VA SEPPRMACI-ARM
(Secondary Event Prevention using Population Risk Management After PCI and for Anti-Rheumatic
Medications), this intervention will consist of: proactive real-time adherence monitoring of
patients and targeting of individuals if they have not refilled their medication a given
number of days after it was due for refill. The intervention will employ a tailored,
escalating-intensity approach which begins with some combination of personalized short
messaging service (SMS) text messages and interactive voice response (IVR) telephone
technology, depending on patient preference. Patients not completing SMS and then IVR by not
refilling their medication (or declining SMS and not completing IVR) escalate to a trained
research interventionalist. The interventionalist will contact the patient and address
adherence barriers based on the dimensions outlined by the World Health Organization (WHO)
that are specific to each patient. The investigators will test the intervention on IHD
patients who have recently undergone PCI-a cardiac procedure commonly used among IHD patients
to improve the heart's blood flow and in patients starting anti-rheumatic medication. The
investigators will test the intervention at four VA Cardiac Catheterization Laboratories
(CCLs) and have 12 sites serving as usual care controls.
implications. Among Veterans, IHD represents one of the most common causes of death and
disability, with over 500,000 affected individuals' annually. Rheumatic disease, though far
less common than IHD can affect multiple organ systems and requires therapies costing in
excess of $50,000 a year. Optimal treatment of Veterans with IHD and rheumatic disease
requires a number of medications to maintain or improve health. Not taking medications as
prescribed, however, is common and increases the risk of subsequent adverse events (cardiac
death and myocardial infarction [MI]).
To improve medication adherence rates and the cardiac health of Veterans with IHD, the
investigators propose to test a medication adherence intervention. Known as VA SEPPRMACI-ARM
(Secondary Event Prevention using Population Risk Management After PCI and for Anti-Rheumatic
Medications), this intervention will consist of: proactive real-time adherence monitoring of
patients and targeting of individuals if they have not refilled their medication a given
number of days after it was due for refill. The intervention will employ a tailored,
escalating-intensity approach which begins with some combination of personalized short
messaging service (SMS) text messages and interactive voice response (IVR) telephone
technology, depending on patient preference. Patients not completing SMS and then IVR by not
refilling their medication (or declining SMS and not completing IVR) escalate to a trained
research interventionalist. The interventionalist will contact the patient and address
adherence barriers based on the dimensions outlined by the World Health Organization (WHO)
that are specific to each patient. The investigators will test the intervention on IHD
patients who have recently undergone PCI-a cardiac procedure commonly used among IHD patients
to improve the heart's blood flow and in patients starting anti-rheumatic medication. The
investigators will test the intervention at four VA Cardiac Catheterization Laboratories
(CCLs) and have 12 sites serving as usual care controls.
Ischemic heart disease (IHD) and rheumatic diseases are both pervasive, expensive, and
results in grave health consequences. IHD affects an estimated 15.4 million Americans 20
years of age-representing 6.4% of the adult population. The direct and indirect cost of IHD
has been estimated at $195.2 billion, with a doubling of cost projected by 2030.5 Similarly,
the direct cost to the U.S. workforce for rheumatoid arthritis alone approaches $5.8 billion
yearly.
Widely-accepted national evidence-based guidelines support the use of cardio-protective
medications to reduce the risk of adverse consequences resulting from IHD and disease
modifying anti-rheumatic medications (DMARDs) to reduce the risk of adverse consequence in
rheumatic diseases. For example, numerous rigorously conducted randomized trials show that
statins improve outcomes and reduce mortality in patients with established cardiovascular
disease (i.e., secondary prevention), including those undergoing percutaneous coronary
interventions (PCI). The use of statins and beta-blockers have been repeatedly demonstrated
to be cost-effective in lowering cardiovascular event (CVE) rates, in part by their effects
on cholesterol, and blood pressure, respectively. Accordingly, the most recent VA performance
measures and American Heart Association guidelines encourage the use of statins in patients
with atherosclerotic disease; beta-blockers in subjects with left ventricular systolic
dysfunction (ejection fraction less than 40%), prior MI, or blood pressure of 140/90 or
greater; and clopidogrel following any acute coronary syndrome (ACS) or PCI with stent. The
rheumatology literature provides similar evidence for the benefit of DMARDs in rheumatic
diseases, and guidelines strongly endorse their use.
Unfortunately, non-adherence to medications is common, and increases the risk of poor
outcomes. The investigators' 2011 national preliminary data from VA cardiac catheterization
laboratories (CCLs) demonstrate that over 6300 patients experienced at least one refill gap
of >= 7 days for statins in the year following PCI. The mean proportion of days covered (PDC)
for these patients was only 75%-below the PDC threshold of 80% that typical defines adherent
patients, based on the empiric evidence for effectiveness of medications at this cut-point.
Non-adherent patients were present at all CCLs without substantial variation in mean PDC by
center, suggesting a global problem.
Systematic problems underlie and contribute to non-adherence to medications. Usual care of
IHD and rheumatic disease patients is encumbered by systematic deficiencies including:
passive monitoring (contact with patients only when initiated by the patient) and
inefficiency (time-consuming patient-by-patient approach, rather than through population
management). The proposed intervention addresses both the complex patient-specific factors
(emphasizing forgetfulness and carelessness) and the systematic inadequacies using a
multi-modal, escalating approach.
Objectives
1. To assess the effectiveness of a multi-faceted patient-centered intervention versus
usual care in improving medication adherence as measured by proportion of days covered
(PDC, primary outcome). This will be tested among IHD patients for statins,
beta-blockers and clopidogrel in the year after PCI and among rheumatology clinic
patients chronically prescribed DMARDs. Hypothesis: The PDC for patients in the
intervention arm will exceed the PDC for the usual care arm by a 10% absolute
difference.
2. (Secondary outcome): To determine the effectiveness of a multi-faceted patient-centered
intervention versus usual care in reducing secondary CVEs (myocardial infarction [MI],
repeat revascularization [PCI or coronary bypass graft], and all-cause mortality) among
IHD patients at 18 months post-PCI and progressive erosive disease demonstrated on plain
film radiographs in patients with rheumatic diseases (i.e. "radiographic progression").
Hypothesis: The rate of CVEs and radiographic progression will be 5% relatively lower
for patients in the intervention arm compared with usual care.
3. (Secondary outcome): To establish the cost to implement and maintain the intervention,
above the cost of usual care, as well as the incremental cost effectiveness (ICE; e.g.
cost to achieve at 10% improvement in PDC; cost per CVE prevented). Hypothesis: This aim
does not posit a hypothesis as the objective is descriptive. The available funding for
this project limits this outcome to IHD patients (no rheumatic disease patients will be
analyzed according to cost).
results in grave health consequences. IHD affects an estimated 15.4 million Americans 20
years of age-representing 6.4% of the adult population. The direct and indirect cost of IHD
has been estimated at $195.2 billion, with a doubling of cost projected by 2030.5 Similarly,
the direct cost to the U.S. workforce for rheumatoid arthritis alone approaches $5.8 billion
yearly.
Widely-accepted national evidence-based guidelines support the use of cardio-protective
medications to reduce the risk of adverse consequences resulting from IHD and disease
modifying anti-rheumatic medications (DMARDs) to reduce the risk of adverse consequence in
rheumatic diseases. For example, numerous rigorously conducted randomized trials show that
statins improve outcomes and reduce mortality in patients with established cardiovascular
disease (i.e., secondary prevention), including those undergoing percutaneous coronary
interventions (PCI). The use of statins and beta-blockers have been repeatedly demonstrated
to be cost-effective in lowering cardiovascular event (CVE) rates, in part by their effects
on cholesterol, and blood pressure, respectively. Accordingly, the most recent VA performance
measures and American Heart Association guidelines encourage the use of statins in patients
with atherosclerotic disease; beta-blockers in subjects with left ventricular systolic
dysfunction (ejection fraction less than 40%), prior MI, or blood pressure of 140/90 or
greater; and clopidogrel following any acute coronary syndrome (ACS) or PCI with stent. The
rheumatology literature provides similar evidence for the benefit of DMARDs in rheumatic
diseases, and guidelines strongly endorse their use.
Unfortunately, non-adherence to medications is common, and increases the risk of poor
outcomes. The investigators' 2011 national preliminary data from VA cardiac catheterization
laboratories (CCLs) demonstrate that over 6300 patients experienced at least one refill gap
of >= 7 days for statins in the year following PCI. The mean proportion of days covered (PDC)
for these patients was only 75%-below the PDC threshold of 80% that typical defines adherent
patients, based on the empiric evidence for effectiveness of medications at this cut-point.
Non-adherent patients were present at all CCLs without substantial variation in mean PDC by
center, suggesting a global problem.
Systematic problems underlie and contribute to non-adherence to medications. Usual care of
IHD and rheumatic disease patients is encumbered by systematic deficiencies including:
passive monitoring (contact with patients only when initiated by the patient) and
inefficiency (time-consuming patient-by-patient approach, rather than through population
management). The proposed intervention addresses both the complex patient-specific factors
(emphasizing forgetfulness and carelessness) and the systematic inadequacies using a
multi-modal, escalating approach.
Objectives
1. To assess the effectiveness of a multi-faceted patient-centered intervention versus
usual care in improving medication adherence as measured by proportion of days covered
(PDC, primary outcome). This will be tested among IHD patients for statins,
beta-blockers and clopidogrel in the year after PCI and among rheumatology clinic
patients chronically prescribed DMARDs. Hypothesis: The PDC for patients in the
intervention arm will exceed the PDC for the usual care arm by a 10% absolute
difference.
2. (Secondary outcome): To determine the effectiveness of a multi-faceted patient-centered
intervention versus usual care in reducing secondary CVEs (myocardial infarction [MI],
repeat revascularization [PCI or coronary bypass graft], and all-cause mortality) among
IHD patients at 18 months post-PCI and progressive erosive disease demonstrated on plain
film radiographs in patients with rheumatic diseases (i.e. "radiographic progression").
Hypothesis: The rate of CVEs and radiographic progression will be 5% relatively lower
for patients in the intervention arm compared with usual care.
3. (Secondary outcome): To establish the cost to implement and maintain the intervention,
above the cost of usual care, as well as the incremental cost effectiveness (ICE; e.g.
cost to achieve at 10% improvement in PDC; cost per CVE prevented). Hypothesis: This aim
does not posit a hypothesis as the objective is descriptive. The available funding for
this project limits this outcome to IHD patients (no rheumatic disease patients will be
analyzed according to cost).
Inclusion Criteria:
Patients will qualify for inclusion if they:
- Undergo PCI or are prescribed a DMARD
- Are prescribed any of the following medications:
- A statin
- Beta-blocker
- Thienopyridines (IHD intervention) and hydroxychloroquine
- Oral methotrexate
- Sulfasalazine
- Azathioprine
- Leflunomide
- Tofacitinib (rheumatic disease intervention)
- [Note: as a study focused on adherence, the investigators will NOT address
the appropriateness of prescribed medications, which is an important, but
separate issue]
- Receive their care from the VA.
- This is defined by the presence of a VA-assigned-PCP in the year prior to PCI or
in the year following PCI (IHD intervention) or in the year prior to or following
index DMARD prescription (rheumatic disease intervention).
Exclusion Criteria:
Patients will be excluded under the following circumstances:
- Undergoing only diagnostic catheterization
- Receive their index medicines (listed in item 2 above) from a non-VA source
- Discharge to nursing home or skilled nursing facility
- Individuals with impaired decision making capacity
- Prisoners
- Pregnant women
- The terminally ill
We found this trial at
5
sites
Aurora, Colorado 80045
Principal Investigator: Liron Caplan, MD PhD
Phone: 720-857-5101
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Baltimore, Maryland 21201
Phone: 410-605-7000
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San Francisco, California 94121
Phone: 415-221-2692
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