Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Increasing Mens Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy
Sponsor:
Randy Vince MD
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Increasing Mens Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to understand if offering a high touch engagement with healthcare center catered to men and bedside vaccine access in a birthing center increases mens engagement in preventive healthcare The main questions it aims to answer are
Does access to vaccinations and overall health education for men lead to increased uptake of vaccines Does access to vaccinations and overall health education for men lead to increased engagement in overall healthcare of male identifying support persons
Researchers will compare three arms one that receives an offer of vaccines at bedside in the birthing clinic one that receives an information flyer about the importance of preventive care in addition to the offer of vaccines and a third one that receives higher level of engagement from patient liaisons as well as the offer of vaccines at bedside to see if there is a difference in vaccine uptake and engagement in healthcare
Participants will complete two survey and one interview
Does access to vaccinations and overall health education for men lead to increased uptake of vaccines Does access to vaccinations and overall health education for men lead to increased engagement in overall healthcare of male identifying support persons
Researchers will compare three arms one that receives an offer of vaccines at bedside in the birthing clinic one that receives an information flyer about the importance of preventive care in addition to the offer of vaccines and a third one that receives higher level of engagement from patient liaisons as well as the offer of vaccines at bedside to see if there is a difference in vaccine uptake and engagement in healthcare
Participants will complete two survey and one interview
Detailed Description:
The goal of this project is to understand whether the combination of vaccination access and connection to services tailored for men improves vaccination rates among men and engagement in healthcare Additionally this project aims to understand variations in effectiveness between low-touch and high-touch approaches To achieve these goals the project has two specific aims
Aim 1 Assess the effectiveness of cocoon vaccination interventions on a continuum of minimum to high-touch in terms of vaccination completion and healthcare engagement After refinement of the intervention materials and study materials based on engagement with community members representatives of the priority population interested parties including birthing parents the initiative will roll out in three randomly timed clusters one that includes bedside vaccinations another that includes bedside vaccinations in addition to low-touch informational flyer and a third that includes bedside vaccinations and high-touch connection to the UH Cutler Center for Men through the Joe Team Vaccination completion will be assessed utilizing records from the Pharmacy department delivering the vaccinations Male-identifying individuals will also be recruited and enrolled to complete two surveys one at baseline and another four weeks after enrollment to assess healthcare engagement
Aim 2 Examine the factors that impact uptake of vaccination and healthcare engagement after a cocoon vaccination intervention Factors that impact intervention uptake will be assessed through the two surveys and semi-structured interviews with a subsample of survey participants Additionally contextual factors related to the implementation of the intervention such as hours of operation for high touch connectionsvaccine distribution will be assessed By understanding the factors that impact intervention uptake we will assess the barriers and facilitators of this strategy
Hypothesis This pilot study will examine whether implementing a cocoon vaccination strategy that provides access to vaccinations and overall health education for men leads to increased uptake of vaccines and engagement in overall healthcare of male identifying support persons Additionally it will assess the factors that impact intervention uptake We anticipate that vaccination rates and engagement with healthcare will be highest among male visitors at the Ahuja Medical Center who receive the vaccination offer at bedside and the high-touch healthcare navigation information relative to those who are only offered offered bedside vaccines only
Aim 1 Assess the effectiveness of cocoon vaccination interventions on a continuum of minimum to high-touch in terms of vaccination completion and healthcare engagement After refinement of the intervention materials and study materials based on engagement with community members representatives of the priority population interested parties including birthing parents the initiative will roll out in three randomly timed clusters one that includes bedside vaccinations another that includes bedside vaccinations in addition to low-touch informational flyer and a third that includes bedside vaccinations and high-touch connection to the UH Cutler Center for Men through the Joe Team Vaccination completion will be assessed utilizing records from the Pharmacy department delivering the vaccinations Male-identifying individuals will also be recruited and enrolled to complete two surveys one at baseline and another four weeks after enrollment to assess healthcare engagement
Aim 2 Examine the factors that impact uptake of vaccination and healthcare engagement after a cocoon vaccination intervention Factors that impact intervention uptake will be assessed through the two surveys and semi-structured interviews with a subsample of survey participants Additionally contextual factors related to the implementation of the intervention such as hours of operation for high touch connectionsvaccine distribution will be assessed By understanding the factors that impact intervention uptake we will assess the barriers and facilitators of this strategy
Hypothesis This pilot study will examine whether implementing a cocoon vaccination strategy that provides access to vaccinations and overall health education for men leads to increased uptake of vaccines and engagement in overall healthcare of male identifying support persons Additionally it will assess the factors that impact intervention uptake We anticipate that vaccination rates and engagement with healthcare will be highest among male visitors at the Ahuja Medical Center who receive the vaccination offer at bedside and the high-touch healthcare navigation information relative to those who are only offered offered bedside vaccines only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None