Clinical trial NCT06730737: Lifewise Preventive Video Education in Primary Care
Official title: Brief Lifestyle Medicine Preventive Randomized Prospective Interactive Educational Intervention in the Primary Care Clinic
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prevention Harmful Effects
Health Maintenance
Preventive Health Care
Dietary Habits
Keywords: Prevention
Lifestyle
coronary artery disease
video
video education
video education for adults
preventive health care
Lead sponsor: Trinity Health-Livonia
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial of Interactive Preventive Video Education
Primary purpose: PREVENTION

Brief summary: It is widely accepted that prevention is far more impactful than curative medicine and must be included in primary care. In a previous pilot study, we evaluated passive video preventive lifestyle education in the emergency department. The current study is a randomized prospective trial assessing the practicality and impact of a brief interactive educational video intervention to patients during primary care clinic visits.

Detailed description: Background and Summary of Objectives: 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 regarding the improvement in 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 the primary care clinic visit.

Summary of Study Design This randomized, non-blinded prospective study of "just in time" 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 intervention is an interactive video with a duration of approximately 10-15 minutes. The video is interactive because it asks the patients to answer simple questions about the content in the video to keep them engaged with the content. 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. Before leaving the clinic, 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. 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, and whether they intend to change any specific lifestyle behavior (dichotomous, yes/no) and, if yes, to specific 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.

Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 18 and 80, inclusive.

Exclusion Criteria:

* Non-English-speaking patient
* Unable or unwilling to consent to the study
* Unable or unwilling to hear a video on a smartphone or computer tablet
* The patient is in hospice care
* Patients with advanced dementia, in the opinion of the person administering the survey

Primary outcomes:
measure: Lifestyle Readiness to Change and Confidence to Change questionnaires
timeFrame: Immediately following exposure to the intervention or not (both arms receive the questionnaires)
Secondary outcomes:
measure: Satisfaction, intent to changve lifestyle behavior, follow up clinic visit
timeFrame: 18 months
Other outcomes:
Locations:
city: Livonia
country: United States
facility: Trinity Health-Livonia Hospital and Affiliated Clinics
state: Michigan
Study officials:
affiliation: Trinity Health-Livonia
name: Daniel Keyes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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