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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06350643
Other study ID # 287064
Secondary ID P50MD017319-03S1
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date December 2024

Study information

Verified date March 2024
Source University of Arkansas
Contact Mignonne Guy, PhD
Phone 804-828-1731
Email mguy@vcu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Black Health Block Quit and Screen Project seeks to engage Black health care providers in helping Black smokers quit tobacco use, including menthol cigarettes and flavored cigars, and screen for lung cancer early as strategies to reduce multiple chronic disease disparities. The goal of this clinical trial is to test the feasibility and impact of the Black Health Block Culturally Tailored Training alone versus the Health Disparities and Lung Cancer Screening Training + the Black Health Block Culturally Tailored training modules on changes in knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition. Participants will complete the training modules and complete pre- and post-tests to assess these outcomes.


Description:

This clinical trial tests the feasibility and impact of the Black Health Block Culturally Tailored Training alone versus the Health Disparities and Lung Cancer Screening Training + the Black Health Block Culturally Tailored training modules on changes in knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition. In partnership with the National Medical Association, investigators will recruit 300 healthcare providers who provide clinical services to Black individuals who smoke smoke. Interested providers will be screened; if eligible, the will complete informed consent. Providers who complete the online consent and agree to enroll in the training study will be individually randomized to one of 2 conditions: The Black Health Block Culturally Tailored + the HDLCS or Black Health Block Culturally Tailored control condition alone. After randomization, providers will complete a pre-test assessing their knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography. Providers will then complete an online training. Providers will then complete a post-test assessing their 1) knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography and 2) preferences for the online materials and satisfaction with the training. Feasibility will be assessed using data on provider interest in the training and training reach.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 85 Years
Eligibility Inclusion Criteria: - Current National Medical Association (NMA) member - Serves a Black patient clientele who smokes - At least 20% of time (1 day per week) devoted to clinical care - Currently screens clients for tobacco use in the clinic - Have the capacity to refer smokers to a patient navigator - Willing to provide informed consent - Will provide contact email, address and phone. Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Black Health Block Culturally Tailored training
This online course will be developed for healthcare providers and will fill gaps in knowledge and attitudes toward lung cancer screening and smoking not covered by Health Disparities and Lung Cancer Screening (HDLCS) training.
Health Disparities and Lung Cancer Screening training
The Health Disparities and Lung Cancer Screening training is an online course that covers disparities in lung cancer and smoking, patient barriers to lung cancer screening, and provider resources for addressing common barriers.

Locations

Country Name City State
United States Virginia Commonwealth Univesity Richmond Virginia

Sponsors (5)

Lead Sponsor Collaborator
University of Arkansas Coalition for a Tobacco Free Arkansas, National Institute on Minority Health and Health Disparities (NIMHD), National Medical Association, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Familiarity with treatment guidelines for tobacco and nicotine treatment Familiarity with treatment guidelines was assessed using an modified question from the Healthcare Provider Survey published by Primary Care Development Corporation in 2008. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Weaver et al. 2012 Provider Attitudes and Perceptions about smoking cessation These questions assessed providers perceptions about the benefits of smoking cessation and the benefits of providers advising patients to quit smoking. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Weaver et al. 2012 Provider Perceptions about provider barriers to providing smoking cessation interventions to patients Perceptions about provider barriers to addressing smoking cessation with patient were assessed using modified questions from a questions published in Weaver et al. 2012, Carter-Harris et al. (2017), and Raz et al. 2019. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Provider Perceptions about patient barriers to smoking cessation Perceptions about patient barriers to smoking cessation were assessed using modified questions from a questions published in Weaver et al. 2012, Carter-Harris et al. (2017), and Raz et al. 2019. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Behavioral intentions to screen and advise patients about smoking cessation A set of questions based on the Theory of Planned Behavior assessed provider's intention to screen patients for tobacco use and provide them interventions and referrals for treatment. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Familiarity with lung cancer screening guidelines Familiarity with treatment guidelines was assessed using an modified question from the Healthcare Provider Survey published by Primary Care Development Corporation in 2008. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Knowledge about low dose computed tomography for lung cancer screening Familiarity with treatment guidelines was assessed using an modified question from the questions published by Kota et al. 2022, Carter-Bawa et al. 2022, and the National Cancer Institute National Survey of Primary Care Physicians' Recommendations & Practices for Breast, Cervical, Lung, & Colorectal Cancer Screening. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Perceptions about shared decision-making for low dose computed tomography for lung cancer screening Questions were modified from the questions published by Forcino et al. in 2018. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Perceptions about provider barriers to referring patients to low dose computed tomography for lung cancer screening Questions were modified from questions published by Coughlin et al. 2020. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Provider Perceptions about patient barriers to get screened for lung cancer Perceptions about patient barriers to getting screened for lung cancer were assessed using modified questions from a questions published in Weaver et al. 2012, Carter-Harris et al. (2017), and Raz et al. 2019. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Primary Behavioral intentions to advise patients to get screened for lung cancer via low dose computed tomography A set of questions based on the Theory of Planned Behavior assessed provider's intention to advise patients who smoke to get screened for lung cancer via low dose computed tomography. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Secondary Diversity of enrolled healthcare providers Study process tracking metrics will be used to assess the demographic, training, and clinical practice characteristics of providers who enroll in the training. This is pre-post design. This outcome will be measured during the pre-test immediately before participants complete the 30-60 minute online training.
Secondary Retention: Percent of providers complete the training after enrolling Study process tracking metrics will be used to assess retention of providers who enroll in the training. This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Secondary Adherence to completing training modules: Percent of modules completed Study process tracking metrics and training completion data will be used to assess the percent of training modules completed (i.e., the number of modules completed divided by the total available modules). This is pre-post design where participants will complete a pre-test immediately before completing a 30-60 minute online training and then a post-test immediately after completing training.
Secondary Preferences regarding training Questions will assess provider feedback on the online training module. This is pre-post design. This outcome will be measured during the post-test immediately after they complete the 30-60 minute online training.
Secondary Satisfaction with training Questions will assess provider satisfaction on the online training module. This is pre-post design. This outcome will be measured during the post-test immediately after they complete the 30-60 minute online training.
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