Creation of the Novel Interventions Caution (NIC) Measure to Assess Patient Behavior Towards Unregulated Stem Cell Interventions

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Project Summary/Abstract There are over 1,200 clinics in the U.S. marketing scientifically unsubstantiated stem cell interventions (SCIs) outside federal regulation and oversight. One major risk to patients from unregulated SCIs is the harm of being misinformed. This has led tens of thousands of patients to take an unregulated SCI resulting in physical, financial, and emotional harm. Our aging population with chronic diseases is the main target of stem cell commercials and are a unique group of health consumers who actively seek information on the internet for unregulated SCIs, for which misinformation is frequently promulgated. Our exploratory, NIH-supported research aims to evaluate patient beliefs and behaviors towards unregulated SCIs and the factors that influence their views on the credibility of information to create pilot health communication interventions. To date, no research has constructed theory-informed and empirically-robust health communication interventions that correct misinformation and enhance autonomy by infusing an appropriate sense of caution toward risky novel health interventions, particularly those given outside of a clinical trial. The overall goal this proposal is to create and validate a new patient-reported Novel Interventions Caution (NIC) measure to assess the psychosocial and behavioral determinants (e.g., perceived risks/benefits, expected outcomes, behavioral intent) of participation toward novel interventions, including SCIs. This crucial measurement step will position us to test the effectiveness of future health communication interventions aimed at correcting (or inoculating against) misinformation about unregulated SCIs. Our two specific aims are (1) to develop the conceptual framework to define the relationship among constructs that influence participation in unregulated SCIs, generate items for the NIC measure, and assess content validity through a Delphi approach using an expert panel and patient cognitive interviews; and (2) to assess the psychometric properties of the NIC measure examining dimensionality, internal consistency reliability, and convergent validity. The measure will be sent to participants using two national databases, including one we have previously characterized and been able to successfully recruit patients. Our work will be the first to delineate the psychosocial and behavioral determinants that influence older, chronic disease patient decisions about unregulated SCIs. This research is particularly innovative because it applies state-of-the-art survey methodology to a new topic area – novel interventions including SCIs. Upon completion of this proposal, we will have the required prerequisite data on outcome measure distributions and necessary pieces for a pilot pre-post evaluation that will culminate in a larger, prospective randomized trial R01 application. Crafting credible, salient messages that effectively counter misinformation about unregulated SCIs and elicit caution towards risky interventions will serve to address the unmet needs of a growing aging, comorbid group of health care consumers.