Site selection is stressful. It’s tricky to find and choose research sites that both meet your clinical trial’s qualifications and have the characteristics necessary for success — unless you use data from the Centers for Medicare & Medicaid Services (CMS) to enhance site feasibility by validating a potential site’s applicable patient population size and its ability to recruit research participants.
CMS provides data on Medicare, Medicaid, and the Children’s Health Insurance Program beneficiaries, which, according to Ha & Vermeersch, cover more than one-third of the U.S. population. Medicare, the federal health insurance program for people aged 65 or older, people with disabilities under the age of 65, and people of any age with end stage renal disease, accounts for around 96% of U.S. citizens 65 and older, as reported by “Getting Started with CMS Data.” It is important to note that the CMS’ limited data set (LDS) files contain beneficiary-level health information, but, per the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, they do not contain specific direct identifiers.
The CMS Medicare/Medicaid data available cover a wide variety of variables, but the most important include information on the International Classification of Diseases (ICD) Procedure, Diagnosis, and CPT codes that classify medical diagnoses and procedures to determine healthcare reimbursement in the United States. According to Chute, Huff, Ferguson, Walker, & Halamka, the ICD system’s coding options are specific, allowing for detailed capturing of clinical events that can be used to equivalate a study’s eligibility criteria and identify a patient population.
CMS data also include institutional National Provider Identifier (NPI) numbers, demographic information, and age cohorts. By combining these variables with ICD codes and comparing them to specific inclusion and exclusion (I/E) criteria, the CMS data present a unique — and more accurate — way to assess a site’s potential patient population specific to a clinical study protocol.
CMS Data at Work
One of the most important factors to consider in site selection is a site’s patient population and its ability to recruit. Looking at therapeutic area alone is often not enough, and site feasibility questionnaires and qualification calls alone usually do not supply enough specificity to accurately capture a site’s patient population.
Using CMS data to support patient population analysis for clinical studies is an extremely valuable and untapped resource for site feasibility. By combining de-identified beneficiary keys, procedure and diagnosis codes, and the institution NPI numbers, the LDS datasets provide enough information to select patient populations related to clinical study protocols. Additionally, they offer visibility into and data on potential sites the sponsor has not previously worked with, helping to eliminate the challenges associated with deploying complex protocols at unknown sites.
This site selection method is further enhanced when combined with Avania’s existing site feasibility processes and experience databases, exemplified in a recent project obtaining and using the LDS SAF Inpatient Quarterly File and LDS SAF Outpatient File Quarterly to aid in site feasibility for a study focused on patients undergoing a cardiovascular procedure with a heart valve.
Here’s how we did it:
Avania’s clinical and project management team was then able to explore the tables and interactive heat map to confirm their potential site list and their expected patient populations, thereby accelerating and optimizing feasibility.
The Proof Is in the Results
Avania’s process of I/E analysis of equivalent ICD-10 codes was unique in that it helped identify sites and potential patient populations in a way previous site feasibility processes were not able to. The results from the heat map analysis and summary listings helped confirm our current knowledge of potential sites and helped us identify five new potential sites. Of these five sites identified, three became top recruiters for the study.
Most importantly, the site we identified that had the most related procedure and diagnosis claims related to the study protocol became the number one recruiter by far. While Avania had not previously worked with this site, the identification process and subsequent study forged a relationship that will greatly benefit future trials. The CMS study population dataset could also be used to estimate patient cost and reimbursement, enable protocol development based on eligibility criteria, create safety effectiveness endpoints, and compare competing products, further streamlining the clinical trial process. It also garnered objective expected recruitment rates for potential sites, a great improvement on the often-subjective information obtained from feasibility questionnaires and interviews.
By giving actual data and numbers to feasible patient populations, this analysis helped put real data behind a suggested site, validating Avania’s recommendations to the sponsor and strengthening the accuracy of the site’s predicted performance.
Advance Your Site Selection
The data captured in the CMS LDS datasets for inpatient and outpatient claims files provides enough detail to support clinical research site selection and patient population analysis. Furthermore, using CMS LDS datasets to analyze sites for specific trial protocols creates a more credible site feasibility process and increases integrity in the future performance of the sites selected.
Proven by Avania’s work on site selection for the cardiovascular study, CMS data and SQL queries, when coupled with data visualization and analysis for clinical trial execution, allow for the integration of data informatics and analytics with healthcare information management, aid in the success of clinical studies, and, in turn, help patients gain access to better health solutions.
The strategic consultants at Avania have the experience and expertise needed to use this novel process in the optimization and acceleration of your site selection — reducing stress, saving time, and keeping your trial on track. When you need to find the right sites fast, It Takes Avania.