Introduction    It is widely accepted that prevention is far more impactful than curative medicine concerning overall health efficacy. The primary care setting faces the challenges of increasingly important time constraints and conflicting priorities; however, prevention is a priority for improving health outcomes. In a previous pilot study, we investigated the impact of a simple instructional video on patients’ willingness to change in the emergency department setting. The initial intervention was passive, requiring subjects to watch a video without interaction. The current study evaluates the practicality and impact of bringing a brief interactive educational video intervention to patients at their primary care clinic visit.    Materials and methods    This is a randomized, non-blinded prospective study of education for adult patients presenting to the primary care clinic immediately following their primary care appointment.     Patients will be randomized to receive the interactive intervention video during this encounter with the practitioner in the clinic. The video is interactive because it asks the patients to answer simple questions about the content in the video to keep them engaged. For instance, if the participant indicates that they do not smoke, the video will “skip” the smoking cessation education and move directly to the other prevention domains. Afterwards, all patients will be presented with a questionnaire about their readiness and confidence to initiate lifestyle changes (transtheoretical stage of change measured on a “readiness ruler”) and additional survey instruments. Most of these questions will come from existing validated scales, including the Gillespie & Lenz behavior modification tool, the Pittsburgh Sleep Quality Index, and select questions from the US HCAHPS Patient Satisfaction Survey (Appendix B). They will be asked for access to their medical record and their willingness to be contacted for a follow-up survey.   Outcome measures The study's primary outcome will be the results of the Lifestyle Readiness to Change and Confidence to Change questionnaires. Secondary outcomes will include satisfaction with the primary care clinic visit using select questions from HCAHPS (Appendix B) and whether they intend to change any specific lifestyle behavior (dichotomous, yes/no) and, if yes, to specify which one(s), seeking medical care outside of the clinic visit as determined by a review of the patient's medical record at intervals of 30 days and six months. HIV will not be evaluated outside of its inclusion in the Charlson Comorbidity Index (CCI). A follow-up survey at approximately 3-12 months will evaluate new diagnoses related to chest pain and ask about the individual's lifestyle changes.    Statistical Summary Plan Logistical regression analysis will be conducted for the primary outcome variable, controlling for the Charlson Comorbidity Index, sex, age, and other predictive variables. We estimate an approximate sample size of 350 patients.   Discussion    The Lifewise Primary Care trial is the first evaluation of comprehensive preventive education using video to minimize interference with the practitioner’s workflow.   Trial Registration     The study was approved by Trinity Health at Ann Arbor IRB (IRB number: E-24-1117). Trial was prospectively registered in the Clinicaltrials.gov database (registration number: NCT06730737)

The authors have declared no competing interest.

NCT06730737

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by Trinity Health at Ann Arbor IRB (IRB number: E-24-1117).

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