Lifewise Preventive Video Education in Primary Care

December 8, 2024 updated by: Daniel Keyes, MD, MPH, Trinity Health-Livonia

Brief Lifestyle Medicine Preventive Randomized Prospective Interactive Educational Intervention in the Primary Care Clinic

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daniel Keyes, MD, MPH
  • Phone Number: 734-931-0734
  • Email: dankeyes@msu.edu

Study Locations

  • United States
    • Michigan
      • Livonia, Michigan, United States, 48154
        • Trinity Health-Livonia Hospital and Affiliated Clinics
        • Contact:
        • Contact:
          • Daniel Keyes, MD, MPH
        • Contact:
          • David Steinberger, MD
        • Contact:
          • Dylan L Arroyo, BSE
        • Contact:
          • Ali Jafri, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video intervention group
The intervention is an interactive preventive education video lasting approximately 10 minutes. 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.
Other: Video preventive education
Interactive video that teaches the subject about the overall importance of prevention, smoking cessation, proper diet, exercise, and sleep.
No Intervention: Control
This arm consists of those randomized to receive no video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lifestyle Readiness to Change and Confidence to Change questionnaires
Time Frame: 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.
Immediately following exposure to the intervention or not (both arms receive the questionnaires)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction, intent to changve lifestyle behavior, follow up clinic visit
Time Frame: 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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trinity Health-Livonia

Investigators

  • Principal Investigator: Daniel Keyes, MD, MPH, Trinity Health-Livonia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 8, 2024

First Submitted That Met QC Criteria

December 8, 2024

First Posted (Estimated)

December 12, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 8, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TrinityHealthLivonia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data contains patient health information (PHI), and currently, there is no plan for public disclosure of the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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