# Enhancing the Efficiency of Pragmatic Clinical Trials Using Administrative Data: Analysis of the STRIDE Study

> **NIH NIH R01** · YALE UNIVERSITY · 2024 · $524,391

## Abstract

Project Summary & Abstract
Pragmatic clinical trials aim to test interventions within typical healthcare settings to produce generalizable
results. Successfully implementing pragmatic trials requires overcoming a number of challenges, including
acquiring data as efficiently and non-intrusively as possible, so as to encourage maximum study participation
at lowest cost. Administrative data are a potential solution for some pragmatic trials. These data derive from
routine activities in the healthcare system, including clinical care (e.g., billing systems; use of electronic health
records). With administrative data, participants can be passively followed over long time periods, potentially
with decreased participant burden, decreased loss to follow-up from inability to contact a participant and
decreased cost compared to alternatives (e.g., participant interview or review of medical records). All of these
features could enhance both internal and external validity and reduce the overall cost of a trial. Limited
empirical work exists on the comparative value of various data sources for ascertaining outcomes in pragmatic
trials. We are in a unique position to the leverage the Strategies to Reduce Injuries and Develop Confidence in
Elders (STRIDE) trial, a ten-site pragmatic, cluster-randomized trial focused on serious fall injury in community-
dwelling older adults, to determine whether outcome ascertainment in pragmatic clinical trials could be
simplified through automated data collection, without introducing significant imprecision or bias, thus reducing
costs. STRIDE has multiple sources of data including multiple reference standards (adjudicated outcomes;
self-reported outcomes) and two administrative data sources (fee-for-service Medicare data; administrative
data from clinical trial sites). We will be able to couple currently available administrative data with newly
available Medicare Advantage data to have a complete administrative picture of this almost universally
Medicare eligible population. Complete data will give us the opportunity to achieve the overall goal of this
research proposal, which is to develop a framework for determining whether administrative data can be used in
pragmatic clinical trials in a Medicare eligible population to efficiently and accurately ascertain the primary
outcome. To achieve this goal, our project has three aims: (1) develop and validate algorithms for detecting
serious fall injuries from administrative data against the reference standards of STRIDE events; (2) determine
the impact of the algorithms on trial findings; and (3) assess the cost efficiency (savings) of conducting the trial
using administrative data.

## Key facts

- **NIH application ID:** 10778587
- **Project number:** 5R01AG071528-03
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Denise Esserman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $524,391
- **Award type:** 5
- **Project period:** 2022-03-15 → 2026-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10778587

## Citation

> US National Institutes of Health, RePORTER application 10778587, Enhancing the Efficiency of Pragmatic Clinical Trials Using Administrative Data: Analysis of the STRIDE Study (5R01AG071528-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10778587. Licensed CC0.

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