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.
CTTI Publication Investigates Use of Preventive Statins among Patients with Cardiovascular Disease
A new CTTI publication, published in the Journal of the American College of Cardiology, investigates the use of preventive, high-intensity statins among patients 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. Most notably, younger patients and women were among those less likely to be prescribed any statin. In those prescribed a statin, women and older patients were less likely to receive high-intensity statins. This paper was based on exploratory work done by CTTI with Duke and HealthCore as background to inform a potential randomized intervention to improve the use of guideline recommended high-intensity statins.
CTTI Collaborates with Multiple U.S. Organizations on First Successful Embedded Trial Using National Health Plans’ Data
Today, at the ESC Congress 2020 – The Digital Experience, a group of U.S. investigators from several organizations including CTTI announced their collaborative findings from the Implementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib) trial.
CTTI worked with 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, as well as a patient representative, to plan and conduct this ground-breaking, 80,000-patient, randomized clinical study. This trial was the first ever to leverage the FDA-Catalyst System network of electronic health data, which consolidates data from a diverse group of national health plan data partners.
The study involved identifying patients with atrial fibrillation (AF) who were at high risk of stroke and not currently taking any type of oral anticoagulant (OAC). The goal of the study was to learn if mailing educational information to patients and their providers could incentivize patients to initiate important OAC prescribing discussions with their doctors.
“It is imperative to identify all patients with AF who are at risk of stroke, especially because strokes can be prevented with OAC,” said Sean Pokorney, co-principal investigator at Duke Clinical Research Institute, who presented the findings at the event. “The underuse of OAC is a significant public health priority, and also a priority of health plans like those participating in this study, which is why we were so eager to collaborate on IMPACT-AFib.”
Although it had never been done before, the study relied upon administrative health plan data and pharmacy dispensing data from multiple national health plans to identify eligible patients and randomize them to an early or delayed intervention, and to assess clinical outcomes.
The study results showed that it would take more than one educational mailing to achieve the desired outcome. Moreover, the study sets a foundation for future clinical trials in AF and other diseases as an example of how the FDA-Catalyst System can help to conduct trials using new and resourceful methods. The goal is for solutions like this to help clinical trial stakeholders conduct future trials much faster than before.
“CTTI played a key role in the pre-work for this trial, proving the viability of running a large-scale trial using the FDA-Catalyst platform,” added Pamela Tenaerts, executive director at CTTI. “The study is a successful proof of concept of embedding a randomized clinical trial into a claims system, while confirming in a large scale experiment that the use of educational interventional approaches in medicine might be limited. We believe that all future clinical trials should maximally leverage available clinical and nonclinical data to minimize collection of necessary trial specific data, and the IMPACT-AFib trial is a fantastic example of that; it serves as a strong model for future research.”
Read the full press release.