CTTI Project: Electronic Healthcare Data
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Electronic Healthcare Data
Sentinel IMPACT-AFib: Transforming Pragmatic Clinical Trials Using a Nationwide Distributed Claims Database
CTTI Project: Electronic Healthcare Data
Webinar Presenters:
- Chris Granger, MD, FACC, FAHA, Professor of Medicine, Division of Cardiology, Duke University Medical Center
- Sean Pokorney, MD, MBA, Cardiology Fellow, Duke University
Webinar Objective:
This webinar provides an update on the Uses of Electronic Healthcare Data project. Through this project, CTTI is helping the FDA evaluate the use of its Sentinel System as a national resource for generating evidence that can guide medical decision-making. The Sentinel System was designed as a distributed database of claims data for conducting safety surveillance; the data remain in participating partners’ secure environments for analysis.
Using the Sentinel System for clinical trials has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials. This webinar discusses the Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). This proof-of-concept trial will be the first conducted using the Sentinel infrastructure and will serve as a pilot for future intervention studies that address critical public health needs.
IMPACT-AFib will randomize 40,000 patients and providers to test whether a multi-level educational intervention can increase the initiation of oral anticoagulation use among patients with atrial fibrillation meeting guidelines for stroke prevention who have not received such therapy in the preceding year. The trial will also assess outcomes associated with the treatment, including stroke.
Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment
CTTI Project: Electronic Healthcare Data
Webinar Presenters:
- Richard Platt, MD, MS, of Mini-Sentinel
- Patrick Archdeacon, MD of the FDA
*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.
Webinar Objective:
Summarize the work generated by CTTI’s Uses of Electronic Data Project and the resulting, recently released report, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database
CTTI Publication Investigates Use of Preventive Statins among Older Patients with Cardiovascular Disease
A new CTTI publication, published in the Journal of the American Geriatrics Society, investigates the use of preventive, high-intensity statins among patients 75 and older diagnosed with atherosclerotic cardiovascular disease (ASCVD). The study, which used pharmacy and medical claims data from a commercial health plan, found substantial underuse of statins among insured ASCVD patients. Less than half of older adults with ASCVD, who are at the highest risk of vascular events like heart attack or stroke, are taking statins. Only a minority of older patients are taking high-intensity statins, and very few are taking non-statin ASCVD treatments. Notably, women and patients who had a diagnosis of cerebrovascular disease (CeVD) or peripheral arterial disease (PAD) were less likely to be prescribed a statin. This paper was based on exploratory work done by CTTI with Duke and HealthCore to assess patient use of ASCVD therapies, with a focus on high-intensity statins, to identify areas where future clinical trials and/or quality improvement initiatives can be targeted to address treatment gaps between clinical practice and guideline recommendations.
Recent CTTI Publication Explores Educational Strategies for Increasing Use of Anticoagulants Among AFib Patients
A new CTTI publication from collaborators including CTTI investigates the impact of educational mailings in increasing the use of oral blood thinners among patients with atrial fibrillation (AFib). For many of these patients, use of blood thinners can reduce their stroke risk by about 70%. Despite current guideline recommendations, only about half of eligible patients with AFib are routinely taking blood thinners, and patient interviews have revealed that patients are undereducated about stroke risk and the potential benefits of preventative blood thinner use. To explore solutions to this educational gap, the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib) identified and sent educational mailings to a subset of eligible patients enrolled in health plans that participate in the FDA’s Sentinel System. The resulting paper, published in JAMA Network Open, found that these mailings were only minimally successful in increasing blood thinner use among AFib patients. These results indicate that more intensive educational interventions may be needed to address this problem.
This trial was the first ever to leverage the FDA-Catalyst System, which combines data from interactions with patients and/or providers with data from the Sentinel Infrastructure. The collaboration included Aetna, Duke Clinical Research Institute, the Harvard Pilgrim Health Care Institute’s Department of Population Medicine, Harvard Pilgrim Health Care, HealthCore Anthem, Humana, Optum, and the FDA.
Public and Stakeholders Encouraged to Comment on Protocol for Innovative Clinical Trial
SENTINEL IMPACT-AFIB DRAFT PROTOCOL POSTED
The draft protocol for an innovative pragmatic clinical trial examining educational methods for improving medication utilization in patients with atrial fibrillation (AFib) has been posted on Sentinel Initiative website. This draft protocol is now available for public comment and feedback as part of process that seeks to engage all potential stakeholders in study development and implementation.
The Sentinel IMPACT-AFib study grew out of findings from a pilot program in which CTTI, through its Electronic Healthcare Data project, evaluated the feasibility of using data from FDA’s Sentinel System to conduct clinical trials. IMPACT-AFib marks the first time the Sentinel System has been used to support a randomized pragmatic clinical trial—not only by serving as a primary source for study data, but also by helping study organizers to identify potential participants.
Atrial fibrillation affects more than 5 million people in the United States. It is a serious condition in which the upper chambers of the heart beat with an irregular rhythm. More common among persons aged 65 years or older, AFib increases a person’s risk of stroke by up to five times and contributes to an estimated 130,000 deaths annually in the United States alone. Although AFib can be treated effectively with a number of different oral anticoagulant (OAC) medications, many of the people who stand to benefit from these therapies do not receive them.
Find out more about AFib and the background of the Sentinel IMPACT AFib trial by clicking here to access a CTTI webinar and slides.
Recording Now Available: Transforming Pragmatic Clinical Trials with Sentinel IMPACT-AFib
Would you like to learn how FDA’s Sentinel System is being used for the first time to conduct a randomized clinical trial?
A recording is now available of CTTI’s webinar discussing Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). The concept for IMPACT-AFib stemmed from a collaboration between CTTI and Sentinel (formerly Mini-Sentinel) on the Uses of Electronic Healthcare Data Project to evaluate the use of Sentinel for conducting randomized trials. Sentinel has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials.
About 5 million people in the United States have atrial fibrillation, and roughly 1 in 5 strokes are due to this condition, representing a significant health burden. While anticoagulation therapy is effective for stroke prevention in this population, only about half of these patients receive this therapy according to guidelines.
The proof-of-concept IMPACT-AFib trial will use the Sentinel System to assess the ability of an educational intervention to increase anticoagulation use in at-risk patients with atrial fibrillation. The webinar discusses considerations encountered in planning for this pragmatic trial:
- Identifying eligible patients and treatments received using a distributed database with linkage to pharmacy claims
- Conducting a pilot phase
- Engaging data partners, providers, and patients in study development
- Making decisions regarding randomization and informed consent
WE INVITE YOU TO VIEW THE RECORDING, ALONG WITH THE PRESENTATION SLIDES, TO LEARN MORE ABOUT THIS EXCITING TRIAL AND THE USE OF SENTINEL TO IMPROVE CLINICAL TRIALS.
To view recordings of other CTTI webinars, CLICK HERE.