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A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities

Primary Purpose

Tobacco Use Cessation, Cardiovascular Diseases, Tobacco Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Longitudinal Proactive Outreach (LPO).
Ask-Advice-Connect (AAC)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Use Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hennepin HealthcareRecruiting
  • University of MinnesotaRecruiting
  • Mayo Clinic Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enhanced Usual Care: Ask-Advice-Connect (AAC)

AAC + Longitudinal Proactive Outreach (LPO)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

7-day point-prevalence smoking abstinence at 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.

Secondary Outcome Measures

Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score
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.
Change in Treatment utilization.
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.
Change in Overall Quality of Life
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.

Full Information

First Posted
January 2, 2023
Last Updated
July 10, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05671380
Brief Title
A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
Official Title
A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
March 24, 2026 (Anticipated)
Study Completion Date
June 24, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Few evidence-based cessation treatments (EBCTs) have been specifically developed, evaluated, or implemented for BIPOC populations. Moreover, uptake of EBCT (e.g. medication, counseling) is lower among BIPOC populations. Reasons for the failure to engage BIPOC patients in EBCTs are complex and multi-level (e.g., patient, provider, healthcare system). To address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect BIPOC adults with EBCT. The proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to EBCT. The proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Cardiovascular Diseases, Tobacco Use, Smoking, Smoking Cessation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care: Ask-Advice-Connect (AAC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
AAC + Longitudinal Proactive Outreach (LPO)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Longitudinal Proactive Outreach (LPO).
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ask-Advice-Connect (AAC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
7-day point-prevalence smoking abstinence at 18 months
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score
Description
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.
Time Frame
0, 6, 12, and 18 months
Title
Change in Treatment utilization.
Description
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.
Time Frame
6, 12, and 18 months
Title
Change in Overall Quality of Life
Description
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.
Time Frame
0, 6, 12, and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Fu, MD, MSCE
Phone
(612) 467-1979
Email
stevefu@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Fu, MD, MSCE
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Health System
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities

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