Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
350 participants
INTERVENTIONAL
2025-01-31
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Video preventive education
Interactive video that teaches the subject about the overall importance of prevention, smoking cessation, proper diet, exercise, and sleep.
Control
This arm consists of those randomized to receive no video
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Video preventive education
Interactive video that teaches the subject about the overall importance of prevention, smoking cessation, proper diet, exercise, and sleep.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Trinity Health-Livonia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniel Keyes, MD, MPH
Associate Chair, Academic Affairs, Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Keyes, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Trinity Health-Livonia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Trinity Health-Livonia Hospital and Affiliated Clinics
Livonia, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Laurie McHugh, BS
Role: primary
Daniel Keyes, MD, MPH
Role: backup
David Steinberger, MD
Role: backup
Dylan L Arroyo, BSE
Role: backup
Ali Jafri, DO
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Wood EB, Harrison G, Trickey A, Friesen MA, Stinson S, Rovelli E, McReynolds S, Presgrave K. Evidence-Based Practice: Video-Discharge Instructions in the Pediatric Emergency Department. J Emerg Nurs. 2017 Jul;43(4):316-321. doi: 10.1016/j.jen.2016.11.003. Epub 2017 Mar 28.
Stange KC, Flocke SA, Goodwin MA, Kelly RB, Zyzanski SJ. Direct observation of rates of preventive service delivery in community family practice. Prev Med. 2000 Aug;31(2 Pt 1):167-76. doi: 10.1006/pmed.2000.0700.
Schuling J, de Haan R, Limburg M, Groenier KH. The Frenchay Activities Index. Assessment of functional status in stroke patients. Stroke. 1993 Aug;24(8):1173-7. doi: 10.1161/01.str.24.8.1173.
Rising KL, Padrez KA, O'Brien M, Hollander JE, Carr BG, Shea JA. Return visits to the emergency department: the patient perspective. Ann Emerg Med. 2015 Apr;65(4):377-386.e3. doi: 10.1016/j.annemergmed.2014.07.015. Epub 2014 Aug 27.
Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.
Prochaska JO, DiClemente CC. Stages of change in the modification of problem behaviors. Prog Behav Modif. 1992;28:183-218. No abstract available.
Pickens GT, Moore B, Smith MW, McDermott KW, Mummert A, Karaca Z. Methods for estimating the cost of treat-and-release emergency department visits. Health Serv Res. 2021 Oct;56(5):953-961. doi: 10.1111/1475-6773.13709. Epub 2021 Aug 5.
Pathak S, Summerville G, Kaplan CP, Nouri SS, Karliner LS. Patient-Reported Use of the After Visit Summary in a Primary Care Internal Medicine Practice. J Patient Exp. 2020 Oct;7(5):703-707. doi: 10.1177/2374373519879286. Epub 2019 Oct 4.
Park H, Roubal AM, Jovaag A, Gennuso KP, Catlin BB. Relative Contributions of a Set of Health Factors to Selected Health Outcomes. Am J Prev Med. 2015 Dec;49(6):961-9. doi: 10.1016/j.amepre.2015.07.016.
Papa L, Seaberg DC, Rees E, Ferguson K, Stair R, Goldfeder B, Meurer D. Does a waiting room video about what to expect during an emergency department visit improve patient satisfaction? CJEM. 2008 Jul;10(4):347-54. doi: 10.1017/s1481803500010356.
McCarthy DM, Engel KG, Buckley BA, Huang A, Acosta F, Stancati J, Schmidt MJ, Adams JG, Cameron KA. Talk-time in the emergency department: duration of patient-provider conversations during an emergency department visit. J Emerg Med. 2014 Nov;47(5):513-9. doi: 10.1016/j.jemermed.2014.06.056. Epub 2014 Sep 8.
Hood CM, Gennuso KP, Swain GR, Catlin BB. County Health Rankings: Relationships Between Determinant Factors and Health Outcomes. Am J Prev Med. 2016 Feb;50(2):129-35. doi: 10.1016/j.amepre.2015.08.024. Epub 2015 Oct 31.
Hirabayashi KJ, Pomerantz M, Radell JE, Chadha N, Thomas S, Serle JB. The Efficacy of the After-visit Summary in Medication Recall Among Glaucoma Patients. J Glaucoma. 2020 Jul;29(7):529-535. doi: 10.1097/IJG.0000000000001518.
Goodacre R, Karim A, Kaderbhai MA, Kell DB. Rapid and quantitative analysis of recombinant protein expression using pyrolysis mass spectrometry and artificial neural networks: application to mammalian cytochrome b5 in Escherichia coli. J Biotechnol. 1994 May 15;34(2):185-93. doi: 10.1016/0168-1656(94)90088-4.
Colby SM, Monti PM, O'Leary Tevyaw T, Barnett NP, Spirito A, Rohsenow DJ, Riggs S, Lewander W. Brief motivational intervention for adolescent smokers in medical settings. Addict Behav. 2005 Jun;30(5):865-74. doi: 10.1016/j.addbeh.2004.10.001. Epub 2004 Nov 10.
Dhawan N, Saeed O, Gupta V, Desai R, Ku M, Bhoi S, Verma S. Utilizing video on myocardial infarction as a health educational intervention in patient waiting areas of the developing world: A study at the emergency department of a major tertiary care hospital in India. Int Arch Med. 2008 Jul 29;1(1):14. doi: 10.1186/1755-7682-1-14.
Ding R, McCarthy ML, Desmond JS, Lee JS, Aronsky D, Zeger SL. Characterizing waiting room time, treatment time, and boarding time in the emergency department using quantile regression. Acad Emerg Med. 2010 Aug;17(8):813-23. doi: 10.1111/j.1553-2712.2010.00812.x.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TrinityHealthLivonia
Identifier Type: -
Identifier Source: org_study_id