Title
Healthcare Utilization Unchanged in the Control Arm of a Randomized Clinical Trial
Authors
Pratik Gongloor, Saad Nadeem, Xiaoying Yu, Mukaila Raji, Kristina D. Mena, and
Elizabeth M. Vaughan
Journal
Journal of Primary Care & Community Health
Background
In low-income settings, clinical trial participation may influence participant behavior, including among control groups. Increased access to care and heightened health awareness during trial enrollment could lead to altered behaviors, a phenomenon known as the Hawthorne effect, which may obscure true intervention impacts; however, this effect remains
poorly studied in low-income environments. Aim: To conduct a secondary exploratory analysis of healthcare utilization among control
participants of a randomized clinical trial (RCT).
Aim
To conduct a secondary exploratory analysis of healthcare utilization among control participants of a randomized clinical trial (RCT).
Methods
We retrospectively analyzed electronic medical records from the control arm (n=26) of an RCT involving low-income Hispanic adults with type 2 diabetes receiving care at a community clinic. Before randomization to a 12-month diabetes education intervention or usual care (control), participants underwent on-site measurements of HbAic, blood pressure, and weight. Healthcare utilization among control participants was compared during the year before and throughout the study, including all types of exposures: provider visits and other services (eg,orders).
Results
Total healthcare utilization was similar between the pre-period (11.9 exposures/year) and the study-period (11.4 exposures/year; P=.93), with no significant changes across visit types. There were no significant differences in fitted mean monthly visits between the pre- and study- periods (P=.93), nor over time (P=.89).
Conclusion
This exploratory study found no evidence of a Hawthorne effect on healtheare utilization among control participants. While this may suggest consistent healthcare behaviors, it may also highlight an important public health concern: individuals in low-income settings may lack the resources to translate increased awareness into health-related action. Larger studies are
needed to further elucidate behavioral patterns in low-income populations.