Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05275582
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2022-03-02
Brief Title:
Developing a Team-Delivered Intervention for Smoking and Hazardous Drinking for Primary Care Veterans With Cardiovascular Diseases
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Developing a Team-Delivered Intervention for Smoking and Hazardous Drinking for Primary Care Veterans With Cardiovascular Diseases CDA 18-006
Status:
COMPLETED
Status Verified Date:
2024-06
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:
CARE
Brief Summary:
In this study the investigators are interested in learning how patients feel about and are impacted by a new approach for the primary care team to use to talk to patients about heart disease and health behaviors The investigators are looking to recruit around 40 Veterans from Buffalo and Syracuse to be in this study What it will entail is being randomly assigned to one of two conditions If patients are assigned to the first condition their upcoming primary care appointment will be extended by about 5 minutes because a Health Educator will join the end of that appointment If they are assigned to the second condition they would have their typical primary care appointment Beyond that both conditions are quite similar They will have an individual meeting following the primary care appointment with the Health Educator two phone booster meetings at 2 and 4 weeks and information about an optional app that they have the choice to use to help them track some health behaviors
Detailed Description:
Many Veterans 304 with cardiovascular diseases CVDs continue to engage in behaviors that increase risk of cardiovascular events and early mortality such as smoking or hazardous drinking While the VA has several programs designed to help Veterans quit smoking or quitreduce drinking there is a gap in service for Veterans who are not ready for change-based treatments but continue to smoke or drink hazardously VA Patient Aligned Care Teams PACTs screen all patients annually for alcohol and tobacco use and thus the PACT platform is an ideal way to reach Veterans with CVDs who smoke andor drink hazardously Through the Primary Care Mental Health Integration PCMHI initiative mental and behavioral health providers are embedded to provide effective evidence-based Veteran-centered behavioral health interventions for a variety of co-occurring behavioral health concerns and medical problems Educational and self-monitoring interventions are evidence-based and increase substance users intentions to make a behavior change and additionally improve patient factors including engagement willingness to accept behavioral health referrals and self-management strategies This research proposal focuses on adapting elements of these evidence-based interventions specifically for a PACT-based VA setting to appeal to Veterans not yet ready to change smoking andor drinking This intervention aims to increase intention to change and may improve rates of cessation and engagement with change-based programs The intervention will fill a gap in care and potentially improve the health and longevity of Veterans seen in PACT The intervention called CARE will be piloted in two formats 1 that includes a conjoint meeting between a PACT medical provider and a behavioral health provider and 2 only with a behavioral health provider
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IK2HX002610 | NIH | VA HSRD | httpsreporternihgovquickSearchIK2HX002610 |
| CDA 18-006 | OTHER_GRANT | None | None |