The investigators of Nudge, an NIH Collaboratory Demonstration Project, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to Dr. Michael Ho, Dr. Sheana Bull, and the Nudge study team for their excellent work!
Nudge (Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications) is designed to evaluate the effect of text messaging and an artificial intelligent (AI) interactive chat bot with the goal of improving medication adherence and outcomes in patients with chronic cardiovascular conditions. Up to 50% of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs.
“Ideally, if people are doing a better job of refilling their meds, they can stay more adherent to their medications, and ultimately, have better health outcomes.”
—Dr. Sheana Bull, Co-PI of Nudge
NIH Collaboratory Demonstration Projects begin with a 1-year, milestone-driven planning phase. Projects become eligible to move to the implementation phase after an administrative review of progress toward scientific milestones and feasibility requirements. Throughout the process, the project team interacts with Core Working Groups and investigators from the other Demonstration Projects.
We spoke with Dr. Michael Ho, co–principal investigator of Nudge, at the NIH Collaboratory Steering Committee meeting in May about what the study team has learned during the planning phase of the trial.
What is the status of your study?
In the planning phase, we received IRB approval and developed the text message library. In the coming months, the team will continue visiting all the participating clinics and hold a stakeholder panel meeting. In the implementation phase, we will implement the trial to test the effect of nudges on medication refills as a measure of adherence.
Were there surprises during the planning phase of the study?
One of the biggest surprises was the difficulty we had getting data from pharmacies and trying to harmonize the definitions. The process was more challenging and time consuming that I expected. A pleasant surprise was the responses we got from the stakeholder and patient panels: they had great feedback on the content of the messages and were excited to interact with us.
What is an example of a challenge you were able to overcome with the help of the NIH Collaboratory Core Working Groups?
The Biostatistics and Study Design Core helped us think through our primary outcome, which is medication adherence as measured by pharmacy data. We had initially proposed including the average adherence of all medications, but we changed it to focus only on the medications for which they are non-adherent based on the advice of the Core. The Ethics and Regulatory Core also helped us, and we had several discussions about using an “opt out” approach. As a result of these discussions, we will provide all patients with an opt-out survey that the Core provided.
(Editor’s note: For more on opt-out and different approaches to informed consent, read the chapter on Consent, Disclosure, and Non-disclosure.)
What other key challenges have you faced?
Getting pharmacy data from one of our health systems has been particularly challenging because they don’t get data frequently enough; they only get data just prior to a clinic visit. We continue to have conversations about this issue.
What advice do you have for investigators conducting their first embedded pragmatic clinical trial (ePCT)?
My biggest advice to new projects in the Collaboratory is to leverage the expertise of the Cores and the other projects, particularly the ones that are further along. It’s been great to learn from the other projects, and it’s also been very helpful to hear the advice of the Cores.
Nudge is supported by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination in the Office of the NIH Director.