- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05671380
A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Steven Fu, MD, MSCE
- Phone Number: (612) 467-1979
- Email: stevefu@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Minneapolis, Minnesota, United States, 55415
- Recruiting
- Hennepin Healthcare
-
Rochester, Minnesota, United States, 55902
- Recruiting
- Mayo Clinic Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English or Spanish-speaking BIPOC patients within the Hennepin Healthcare or MCHS system. BIPOC patients are any patients with a chart identified race that is not White, and will be verified by self-report from the baseline survey.
- Currently smoke >1 cigarette over the past 30 days
- Must have address or telephone number in the electronic health record
Exclusion Criteria:
- Electronic health record documented cognitive impairment or legal guardianship
- Patients who have opted out of reserach studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Enhanced Usual Care: Ask-Advice-Connect (AAC)
AAC participants will receive care through their primary care provider as usual (with the caveat that providers in the clinics will be trained to provide AAC).
AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.
|
Licensed Practical Nurses will be trained to ask all patients if they smoke, document smoking status in the EHR, advise patients to stop smoking, and complete an electronic referral to Quit Partner or the smoking cessation clinic.
AAC will be designed to connect participants to Quit Partner Minnesota to receive tobacco cessation counseling.
Quit Partner™ is a family of programs available to help Minnesota residents quit commercial tobacco, administered by the Minnesota Department of Health (MDH).
Quit Partner programs are provided by National Jewish Health (NJH).
Any Minnesota resident can access a free 2-week supply of Nicotine Replacement Therapy (NRT).
Uninsured and underinsured residents can access the full Quit Partner programs, including free one-on- one coaching, more NRT, and additional supports.
Quit Partner also offers four population- specific programs and calls are available in several languages.
|
Experimental: AAC + Longitudinal Proactive Outreach (LPO)
AAC+LPO participants will receive AAC plus an MI tailored outreach call at baseline and at 3, 6, and 9 months post-enrollment.
AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.
|
Licensed Practical Nurses will be trained to ask all patients if they smoke, document smoking status in the EHR, advise patients to stop smoking, and complete an electronic referral to Quit Partner or the smoking cessation clinic.
AAC will be designed to connect participants to Quit Partner Minnesota to receive tobacco cessation counseling.
Quit Partner™ is a family of programs available to help Minnesota residents quit commercial tobacco, administered by the Minnesota Department of Health (MDH).
Quit Partner programs are provided by National Jewish Health (NJH).
Any Minnesota resident can access a free 2-week supply of Nicotine Replacement Therapy (NRT).
Uninsured and underinsured residents can access the full Quit Partner programs, including free one-on- one coaching, more NRT, and additional supports.
Quit Partner also offers four population- specific programs and calls are available in several languages.
All participants will receive personalized invitation materials (in their preferred language) with messages culturally and linguistically tailored to BIPOC communities, guided by the literature on culturally adapting evidence-based interventions.
The study team will tailor these resources in collaboration with the CE core.
The tailored mailed packet will include an invitation letter and a brochure describing the types of tobacco treatment services available from their health system and from Quit Partner.
One week after the written materials are sent, participants assigned to this condition will receive LPO by a MI-trained coach.
The MI outreach call protocol will consist of 6 contact attempts over two weeks.The MI outreach call protocol will be repeated at 3, 6, and 9 months for a total of four outreach cycles because participants may not have quit or may have relapsed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-day point-prevalence smoking abstinence at 18 months
Time Frame: 18 months
|
7-day point prevalence abstinence from combustible tobacco will be verified at 18 months post-enrollment. Surveys to self-report abstinence will be provided at 6, 12, and 18 months. Self-reported smoking abstinence will be verified using expired carbon monoxide as the primary method with salivary cotinine as an alternative method at the 18-month follow-up. Participants with a CO of < 6 ppm will be considered abstinent. Participants with a salivary cotinine < 10 ng/ml will be considered abstinent. |
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Treatment utilization.
Time Frame: 6, 12, and 18 months
|
Self-reported utilization of evidence-based cessation treatment (EBCT) will be assessed during the 18-month follow-up from any source.
The main treatment outcome will be initiation of counseling with Quit Partner or the participant's healthcare provider, combined with medication treatment utilization.
Initiation of counseling treatment with the Quit Partner will be defined as completion of a warm transfer or electronic referral to the quitline.
Initiation of medication treatment will be defined as using one or more tobacco dependence medications (e.g., NRT, bupropion or varenicline) in the 18-month follow-up period.
Additional treatment utilization outcomes include individual use of counseling or medication and use of any form of EBCT.
|
6, 12, and 18 months
|
Change in Overall Quality of Life
Time Frame: 0, 6, 12, and 18 months
|
Overall quality of life will be assessed using a single-item numerical linear analogue self-assessment from 0 (as bad as it can be) to 10 (as good as it can be) via survey through 18 months post-enrollment.
|
0, 6, 12, and 18 months
|
Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score
Time Frame: 0, 6, 12, and 18 months
|
The TPB-Q is a commonly used and thoroughly validated instrument that maps onto the three predictors of health behavior change in the Theory of Planned Behavior: attitudes about the behavior, perceived subjective norms about the behavior, and perceived control over the behavior.
The TPB-Q items have common wording tapping into those three domains, but the scale was developed such that the items are customized to the specific behavioral goal of an intervention, and thus still comparable across behaviors.
|
0, 6, 12, and 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven Fu, MD, MSCE, Minneapolis Veterans Affairs Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00013870
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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