Lifewise Preventive Video Education in Primary Care

Not Applicable

Not yet recruiting

• Conditions: Prevention Harmful Effects; Health Maintenance; Preventive Health Care; Dietary Habits

• Registration Number: NCT06730737
• Lead Sponsor: Trinity Health-Livonia

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Study Start: 2025-01
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lifestyle Readiness to Change and Confidence to Change questionnaires	Immediately following exposure to the intervention or not (both arms receive the questionnaires)	The study's primary outcome will be the results of the Lifestyle Readiness to Change and Confidence to Change questionnaires.

Secondary Outcome Measures

Name	Time	Method
Satisfaction, intent to changve lifestyle behavior, follow up clinic visit	18 months	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 within approximately six months. 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.

Trial Locations

Locations (1)

Trinity Health-Livonia Hospital and Affiliated Clinics; 🇺🇸 Livonia, Michigan, United States