Secondary Prevention of Atrial Fibrilation
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | February 1, 2018 |
| End Date: | November 2019 |
Boston Medical Center Secondary Prevention of Atrial Fibrillation Randomized Pilot Study
Atrial fibrillation (AF) is the most common arrhythmia affecting over 3 million Americans and
about 33.5 million individuals globally. The lifetime risk of developing AF is 1 in 4 for
adults over age 40 years. AF is associated with a major medical and socioeconomic burden
including high cost, increased risk of stroke, heart failure, dementia, myocardial
infarction, and death. Numerous studies have demonstrated that modifiable risk factors
including hypertension, obesity, sleep apnea, diabetes, and sedentary lifestyle predict the
development of AF.
Recent studies have reported that secondary prevention interventions through aggressive risk
factor modification can reduce the burden of AF. Structured, physician and nursing-led
interdisciplinary AF programs have been shown to improve patient adherence to guideline
recommendations and improve long term prognosis. Previous data, however, are derived mainly
from white European and Australian cohorts and it is unclear whether such interventions can
be effectively implemented in a racially diverse, safety net hospital in the U.S.
This study is a randomized hybrid implementation-effectiveness study designed to investigate
feasibility and effectiveness of an evidence-based innovative AF program, focusing on risk
factor modification and AF education in a racially mixed population receiving care in a
safety net hospital.
about 33.5 million individuals globally. The lifetime risk of developing AF is 1 in 4 for
adults over age 40 years. AF is associated with a major medical and socioeconomic burden
including high cost, increased risk of stroke, heart failure, dementia, myocardial
infarction, and death. Numerous studies have demonstrated that modifiable risk factors
including hypertension, obesity, sleep apnea, diabetes, and sedentary lifestyle predict the
development of AF.
Recent studies have reported that secondary prevention interventions through aggressive risk
factor modification can reduce the burden of AF. Structured, physician and nursing-led
interdisciplinary AF programs have been shown to improve patient adherence to guideline
recommendations and improve long term prognosis. Previous data, however, are derived mainly
from white European and Australian cohorts and it is unclear whether such interventions can
be effectively implemented in a racially diverse, safety net hospital in the U.S.
This study is a randomized hybrid implementation-effectiveness study designed to investigate
feasibility and effectiveness of an evidence-based innovative AF program, focusing on risk
factor modification and AF education in a racially mixed population receiving care in a
safety net hospital.
The proposed study is designed as a Hybrid Type 3 effectiveness-implementation study. This
study design will enable the investigators to primarily focus on core implementation outcomes
while also assessing the effectiveness of the intervention on clinical outcomes. Since this
is a Type 3 Hybrid trial, there are both effectiveness and implementation evaluation
components, but the primary focus is on the implementation outcomes of feasibility,
acceptability, adoption, and appropriateness. The specific aims, data collection, and
analytic plans are grounded in the Proctor Conceptual Model of Implementation Research that
posits improvements in outcomes are dependent not only on the evidence-based interventions
that are implemented but on the implementation strategies used to implement those
interventions. The model distinguishes between the intervention strategy (evidence-based
practice), different types of implementation strategies (system environment, organizational,
group/learning, supervision, individual providers/consumers), and three levels of outcomes
(implementation, service, and client). The appropriate outcome measures in each category
(implementation, service, client) depend upon the specific evidence-based practice and local
context.
AF patients with a BMI of ≥ 27 kg/m2, who are referred to outpatient cardiology clinic,
inpatient cardiology service, or cardiology consult service at Boston Medical Center (BMC)
will be screened until 50 participants are enrolled. Eligible participants will undergo 1:1
randomization to standard of care (SoC -group 1) or to the interdisciplinary AF program
(intervention- group 2). Randomization will be performed using a computer randomizer
algorithm with 5 blocks of 6 and 5 blocks of 4 in random order for a total of 50
participants. The rational for the randomization design is primarily for the purpose of
feasibility and to establish effect sizes and guide the design of the future trial.
All patients will be enrolled for a total duration of six months. Outcomes will be measured
via 30-minute individual interviews at the end of 6-months. The implementation and service
outcomes will be examined including acceptability, appropriateness, adoption, feasibility,
and patient centeredness, as well as the client outcomes of satisfaction, function and
symptomatology. Data will be collected using both quantitative and qualitative data methods
to determine which aspects of the program achieved good patient adherence and acceptability.
study design will enable the investigators to primarily focus on core implementation outcomes
while also assessing the effectiveness of the intervention on clinical outcomes. Since this
is a Type 3 Hybrid trial, there are both effectiveness and implementation evaluation
components, but the primary focus is on the implementation outcomes of feasibility,
acceptability, adoption, and appropriateness. The specific aims, data collection, and
analytic plans are grounded in the Proctor Conceptual Model of Implementation Research that
posits improvements in outcomes are dependent not only on the evidence-based interventions
that are implemented but on the implementation strategies used to implement those
interventions. The model distinguishes between the intervention strategy (evidence-based
practice), different types of implementation strategies (system environment, organizational,
group/learning, supervision, individual providers/consumers), and three levels of outcomes
(implementation, service, and client). The appropriate outcome measures in each category
(implementation, service, client) depend upon the specific evidence-based practice and local
context.
AF patients with a BMI of ≥ 27 kg/m2, who are referred to outpatient cardiology clinic,
inpatient cardiology service, or cardiology consult service at Boston Medical Center (BMC)
will be screened until 50 participants are enrolled. Eligible participants will undergo 1:1
randomization to standard of care (SoC -group 1) or to the interdisciplinary AF program
(intervention- group 2). Randomization will be performed using a computer randomizer
algorithm with 5 blocks of 6 and 5 blocks of 4 in random order for a total of 50
participants. The rational for the randomization design is primarily for the purpose of
feasibility and to establish effect sizes and guide the design of the future trial.
All patients will be enrolled for a total duration of six months. Outcomes will be measured
via 30-minute individual interviews at the end of 6-months. The implementation and service
outcomes will be examined including acceptability, appropriateness, adoption, feasibility,
and patient centeredness, as well as the client outcomes of satisfaction, function and
symptomatology. Data will be collected using both quantitative and qualitative data methods
to determine which aspects of the program achieved good patient adherence and acceptability.
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of paroxysmal AF (based on 12-lead electrocardiogram or event monitor
showing AF).
- Body mass index of greater than 27 kg/m2
- Eligibility to participate in cardiac rehabilitation with negative exercise stress
test within 6 months.
Exclusion Criteria:
- Permanent AF.
- Undergone catheter ablation of AF in past 6 months.
- Class I or Class III anti-arrhythmic drugs at the time of enrollment
- Unable to participate in cardiac rehabilitation.
- Prognosis of less than 1-year.
- Do not own a smart phone.
- Unable to operate (transmit data) their smart phone.
- Are not fluent in English or Spanish.
- Unable to read in English or Spanish.
- Not able to provide informed consent.
- Women who are pregnant.
- Prisoners.
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