304 Clinical Trials for Various Conditions
The goal of this pragmatic, multilevel Type III Hybrid Effectiveness-Implementation trial is to increase the reach of existing evidence-based interventions (EBIs) for tobacco cessation and to mitigate the impact of adverse Social Drivers of Health (SDOH) among safety-net healthcare system patients who live in persistent poverty (PP) census tracts. Aim 1: Test the ability of patient-level Conversational Agents (CA) \& Patient Navigation (PN) dissemination strategies to increase the Reach (primary outcome) of evidence-based tobacco cessation treatment delivered via the Utah Tobacco and Nicotine Quit Services (Quit Services) among Community Health Center (CHC) patients who use tobacco and live in persistent poverty census tracts. Secondary analyses will examine the outcome of Reach of services for SDOH among these patients and will evaluate both 1) patient-level CA and PN dissemination strategies and 2) a clinic-level implementation strategy using a pre-post design. Aim 2: Explore contextual factors (e.g., clinic size, patient composition, rurality, patient demographics) related to the Reach, Adoption, Implementation, and potential Maintenance of strategies. Aim 3: Determine the cost-effectiveness of clinic and patient-level strategies based on Quit Services enrollment and service receipt for SDOH. This trial implements a clinic-level implementation strategy, Ask-Advise-Connect (AAC), to address tobacco cessation and needs around social drivers of health for patients in all participating clinics. Eligible patients who are not enrolled in Quit Services four weeks after the clinical encounter, will receive text messages from a chatbot offering information and connections to the Quit Services and patient navigation support from a Community Health Worker.
The Cessation Clinical Trial will investigate the effectiveness of a digital quit tobacco program in promoting abstinence from tobacco product use compared to usual care.
The Healthy Futures: Alternative-to-Suspension Curriculum is a free, online curriculum developed to educate students and provide them with resources to quit tobacco/nicotine use. The investigation aims to estimate the extent to which Healthy Futures: Alternative-to-Suspension changes high school student's knowledge of, attitudes towards, intentions to use, and actual use of tobacco/nicotine.
This study seeks to develop and test an internet video series aimed at helping individuals reduce cigarette smoking. Participants (daily smokers) will be asked to watch a series of six videos (approximately 6.5 minutes each) which cover various empirically-supported smoking cessation strategies and tools. Examples of strategies included in the videos include noticing smoking cues and consequences and relaxation training. Participants' demographic information, motivation to change, reactions to the video series alliance with video therapist, and confidence in avoiding smoking will all be measured. Additionally, participants will be asked to report their smoking behavior at study baseline and follow-up.
Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Federally Qualified Health Centers (FQHCs), which generally provide healthcare services to low income and Medicaid insured patients, are more likely to serve individuals who use tobacco and are required to report tobacco use screening rates and their delivery of cessation interventions. Thus, FQHCs are an ideal community-partner to reach low-income smokers, particularly smokers who are not currently seeking treatment. To address this gap, the investigators developed a pharmacist-delivered smoking cessation intervention to help facilitate nicotine replacement therapy medication adherence among smokers. The proposed study aims to examine the feasibility of delivering the pharmacist-delivered smoking cessation intervention to FQHC patients who are ready to quit, and expanding the intervention for smokers not ready to quit by adding 2 pre-quit sessions focused on rate reduction. The investigators will also determine facilitators and barriers to adopting and implementing the program in FQHCs.
The purpose of this research study is to learn how best to incorporate tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers.
This research study is being conducted to test the effectiveness of the Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use (EMPACT-Us), an innovative suite of tobacco cessation services designed in partnership with patients, providers, and other community stakeholders during a pilot study. We hypothesize that EMPACT-Us will be more effective than the newly-enhanced usual care on improving engagement in tobacco treatments, quit attempts and biochemically verified cessation at 6-and 12-months post initial offerings.
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.
This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.
Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based youth brief tobacco intervention for 9th grade students. This study will use a sequential, multi-method research design beginning with qualitative roundtable discussions with 9th grade students to adapt an existing young adult brief tobacco intervention for youth. Roundtable discussions with students will identify salient intervention themes and strategies for targeting the intervention and developing the text messages. The second phase of the study evaluates the brief intervention, UP2UTobacco, through a cluster randomized controlled trial that compares UP2UTobacco to a no treatment control. It is hypothesized that the UP2UTobacco will produce greater abstinence at the 6-month follow-up compared to the no treatment control. Roughly 90% of daily smokers started before the age of 18, and 2,000 youth smoke a cigarette for the first time each day in the U.S. Additionally, e-cigarette use is on the rise among youth, and is linked to cigarette initiation among tobacco naïve youth. In order to curb the rise of tobacco use among youth, interventions that are easily implemented and easily disseminated need to be developed for youth addressing currently available products and contemporary patterns of use. If the interventions in the current study are proven efficacious, they can easily be disseminated to other schools to continue reducing youth tobacco use.
Disseminating an evidence-based tobacco control intervention for School Teachers
The investigators are implementing a stepwise approach to cessation with a public health focus to improve health outcomes for the investigators' pediatric patients. The investigators are focusing on addressing caregiver smoking as a modifiable risk factor during time of child's hospitalization as a window of opportunity to provide counseling and education to families on secondhand and third hand smoke exposure as well as information on NRT products to heighten caregiver contemplation for quitting. One of the central goals of the investigators' project is to increase immediate access to Nicotine Replacement Therapy (NRT) resources for families during hospitalization which pediatric providers could potentially dose and prescribe to caregivers who are screened positive for smoking. Long-term cessation care is provided by referrals to both the MD Quitline and the John Hopkins Tobacco Treatment Clinic. Both are provided to allow participants options that the participants would find preferable from an insurance and provider perspective.
The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 16-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge (or gum, based on preference) on quit date (week 4), consistent with recommended guidelines based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge (or gum, based on preference), initiated on quit date. The investigators will examine dependence, urge to smoke and self-efficacy for quitting prior to and following quit date. The investigators will also examine differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8, 12, and 16.
The over-arching research question is: Does message (Advise) and referral approach (Refer) influence a patient's willingness to "opt-in" to receive a call from an Illinois Tobacco Quitline (ITQL) smoking cessation coach in patients at MSHC. Primary UH3 study aim: Compare the effect of the portal-delivered Choice message (Arm 1) to the Information-only message (Arm 3) on linkage to the Illinois Tobacco Quitline (i.e., spoke to a Quitline coach). Secondary UH3 aims are to: Examine the reach of the patient portal for delivering "Advise" and "Refer" at 4 weeks. Reach is defined as a patient opening the portal-delivered provider message across all three Arms. Compare the effect of the Quit message (Quit, Arm 2) to Information-only (Arm 3) on linkage to ITQL. Compare the effect of the Facilitated-referral messages (opt-in link in the message: Arm 1 \& 2) vs. Self-referral (Information-only, Arm 3) on linkage to the ITQL (speaking to an ITQL coach) at four weeks. Compare the effect of the portal-message content of the Choice message (Arm 1) vs. the Quit message (Arm 2) on linkage acceptance (opting in to be called by the ITQL) at 4 weeks. Compare the effectiveness of re-engagement message 1 to message 2 for linkage to the ITQL among patients who opted-in to an ITQL call but who were not reached after 3 attempts. Evaluate the cost-effectiveness of using a patient portal to advise patients to change their smoking behavior and refer them to the ITQL. We will compare the costs associated with our project to the costs associated with advising and referring patients during clinical appointments.
Many people living with HIV (PLWH) smoke. Smoking in these individuals is often undertreated. This study plans to assess the ability of various clinical pathways involving tobacco treatment medications and contingency management (paying smokers for not smoking) to improve smoking cessation in a group of PLWH.
In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation.
This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.
This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.
Assess the feasibility and acceptability of delivering an mHealth tobacco intervention among state quitline enrollees.
Smoking can increase the risk of complications around the time of surgery. Researchers are trying to see if a text messaging program can help smokers stay off cigarettes around the time of surgery.
The existing tobacco cessation best practice advisory (BPA) fires for providers (physicians, residents, fellows, midwives, nurse practitioners, physician assistants) during outpatient encounters when a patient is identified as a current tobacco user in the Social History section of their chart. The BPA was designed to help facilitate tobacco cessation interventions; it is part of the The Centers for Medicare \& Medicaid Services (CMS) Quality Payment Program (QPP). The purpose of the project is to optimize this BPA utilization and improve patient outcomes by comparing multiple versions of the tobacco cessation BPA.
This study seeks to evaluate ways to improve outcomes for low-education, uninsured or Medicaid-eligible smokers who do not successfully quit with standard telephone quit line treatment. The study will use an efficient factorial study design to evaluate four evidence-based strategies to improve follow-up care offered by the Wisconsin Tobacco Quit Line (WTQL) to socioeconomically disadvantaged callers who report smoking four months following initial WTQL treatment comprising a single counseling call and 2-week supply of a single nicotine replacement therapy. These strategies include: increasing the intensity of nicotine replacement medication (among those medically cleared to use such medications), increasing the intensity of WTQL counseling, helping callers enroll in an evidence-based smoking cessation texting support program (SmokefreeTXT), and offering moderate financial incentives for engagement in counseling and SmokefreeTXT.
Precision Care (PC) interventions, developed with guidance from a Community Advisory Board (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible, consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to make a quit attempt with medication and who reside in TN or MS. Participants will be randomized 1:1:1 to 1 of 3 groups; (1) group one informs selection of medication with information on nicotine metabolism; (2) group two offers a genetically-informed lung cancer risk score, and (3) group 3 is Guideline-Based Care (GBC). All groups will be followed for 6 months. All RCT participants will receive FDA-approved smoking cessation medication, be referred to the shared TN/MS state quitline, and be offered the NCI "Clearing the Air" standard intervention. The primary outcome is feasibility of delivering the precision interventions in the SCCS population, as evidenced by ability to recruit, engage, and retain participants through end of study. Secondary outcomes, for which the study is not powered, will include risk perceptions, use of quit aids, lung cancer screening among those who are eligible, and smoking cessation.
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers.
Investigators will assess the feasibility of implementing a randomized control trial of a behavioral intervention that uses smartwatch technology to monitor smoking behavior with texts aimed at reducing smoking in pregnant women who smoke. Investigators will compare the cessation rate of pregnant women who receive usual care through programs aimed at reducing smoking with pregnant women who receive usual care and are using the SmokeBeat app with a smartwatch.
In an attempt to reduce smoking-related health disparities, investigators will implement a text messaging-based smoking cessation intervention in collaboration with state quit lines. The approach is based on the successful STOMP (STOp smoking by Mobile Phone) program, a text messaging-based smoking cessation intervention among young Maori adults in New Zealand. Investigators will adapt the STOMP intervention, which will result in a new intervention known as AI STOMP (American Indians STOp smoking by Mobile Phone).The primary aim of the study is to determine the effectiveness of the AI-STOMP intervention in smoking cessation among American Indians.
This study proposes to test the value of a culturally specific program for African American smokers to quit smoking.
This study is designed to assess whether completely electronic, HIPAA-compliant, EHR-based, closed-loop referrals for tobacco cessation from primary care clinics to a state telephone tobacco quitline service can increase the number/percentage of adult tobacco users receiving evidence-based tobacco dependence treatment when compared to paper-based fax referrals. This study also will survey clinic staff to evaluate satisfaction with the referral process.
The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.
The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.