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The goal of this clinical trial is to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (medication therapy management) approach, called QuitAid, to quitting cigarette smoking in rural Appalachia.
The main questions it aims to answer are:
Treatment:
All participants will be given at least 4 weeks of the nicotine patch.
Some participants will be randomized (like the flip of a coin) to receive additional treatments (listed below).
These groups will be compared to each other to see which combination works best to help them quit smoking.
The proposed study uses a mixed-method design to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (Medication Therapy Management) approach, called QuitAid, to smoking cessation in rural Appalachia. Aim 1 of this project will evaluate the effectiveness of QuitAid and standard, evidence-based tobacco treatments on cessation within an MTM pharmacist-delivered approach. Aim 2 will assess implementation, including relative cost of QuitAid, as well as standard, evidence-based tobacco treatments through an ask-advise-connect model, in community pharmacies, and will examine facilitators and barriers to reach, adoption, and maintenance of QuitAid as well as standard, evidence-based tobacco treatments through an ask-advise-connect method in community pharmacies.
Smokers (n=768) recruited through 14 community pharmacies in rural Appalachia will be randomized in a 2x2x2x2x2 full factorial experiment to the following five treatments: (1) QuitAid Intervention (Yes vs. No), (2) tobacco quitline (Yes vs. No), (3) SmokefreeTXT through the National Cancer Institute's (NCI) Smokefree.gov initiative (Yes vs. No), (4) Combination NRT Lozenge + NRT Patch (vs. NRT patch alone), and/or (5) 8 weeks of NRT (vs. standard 4 weeks). Following the experimental trial, we will use an implementation science approach to assess implementation, including relative cost, as well as facilitators and barriers of reach, adoption, and maintenance of QuitAid and standard, evidence-based tobacco treatments through an ask-advise-connect method in community pharmacies (Aim 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QuitAid, 4 weeks, Patch + Lozenge | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge. |
|
| QuitAid, 8 weeks, Patch + Lozenge | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge. |
|
| QuitAid, 4 weeks, Patch + Lozenge, QuitLine | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention |
|
| QuitAid, 8 weeks, Patch + Lozenge, QuitLine | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 weeks of Nicotine lozenge | Drug | All participants will receive at least 4 weeks of the NRT Patch. Some will be randomized to receive 4 weeks of lozenge in addition to the NRT Patch. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco Abstinence | The primary outcome is biochemically verified point prevalence (verified through a CO test via Smokerlyzer at endpoint of participation in trial) abstinence defined as no smoking (even a puff) within the past 7 days. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Tobacco Abstinence | Self-reported point prevalence abstinence defined as no smoking (even a puff) within the past 7 days | 1, 2, and 3 months |
| Adherence to assigned treatment components |
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Study participants will be rural cigarette smokers from Virginia, Tennessee, Kentucky and North Carolina who visit one of the participating study pharmacies. Pharmacies will be located in rural geographic areas of the Central and South Central subregions of Appalachia that include Virginia, Tennessee, Kentucky and North Carolina, as defined by the USDA Rural-Urban Continuum Codes (RUCC) 4-9, Rural-Urban Commuting Area (RUCA) codes 4-10, or Frontier and Remote (FAR) areas level 4. No exclusionary criteria are based on race, gender, or age.
Inclusion Criteria include:
Exclusion Criteria include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Little, PhD, MPH | Contact | 434-924-1935 | mal7uj@virginia.edu | |
| Leslie Gladney, MA | Contact | lag3z@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Little, PhD, MPH | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37730197 | Derived | Fahey MC, Krukowski RA, Anderson RT, Cohn WF, Porter KJ, Reid T, Wiseman KP, You W, Wood CH, Rucker TW, Little MA. Reaching adults who smoke cigarettes in rural Appalachia: Rationale, design & analysis plan for a mixed-methods study disseminating pharmacy-delivered cessation treatment. Contemp Clin Trials. 2023 Nov;134:107335. doi: 10.1016/j.cct.2023.107335. Epub 2023 Sep 18. |
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No plans to share data at the individual level
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2x2x2x2x2
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|
| QuitAid, 4 weeks, Patch | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch. |
|
| QuitAid, 8 weeks, Patch | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch. |
|
| QuitAid, 8 weeks, Patch, QuitLine | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention |
|
| QuitAid, 4 weeks, Patch, QuitLine | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention |
|
| QuitAid, 4 weeks, Patch, SmokeFree Txt | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking. |
|
| QuitAid, 8 weeks, Patch, SmokeFree Txt | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking. |
|
| QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking. |
|
| QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking. |
|
| QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention. |
|
| QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention. |
|
| QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention. |
|
| QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine | Experimental | Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention. |
|
| 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine | Experimental | Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention. |
|
| 8 weeks, Patch, SmokeFree Txt, QuitLine | Experimental | Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention. |
|
| 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine | Experimental | Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention. |
|
| 4 weeks, Patch, SmokeFree Txt, QuitLine | Experimental | Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention. |
|
| 8 weeks, Patch + Lozenge, QuitLine | Experimental | Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention. |
|
| 8 weeks, Patch, QuitLine | Experimental | Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention. |
|
| 4 weeks, Patch + Lozenge, QuitLine | Experimental | Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention. |
|
| 4 weeks, Patch, QuitLine | Experimental | Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention. |
|
| 8 weeks, Patch + Lozenge, SmokeFree Txt | Experimental | Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking. |
|
| 8 weeks, Patch, SmokeFree Txt | Experimental | Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking. |
|
| 4 weeks, Patch + Lozenge, SmokeFree Txt | Experimental | Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking. |
|
| 4 weeks, Patch, SmokeFree Txt | Experimental | Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking. |
|
| 8 weeks, Patch + Lozenge | Experimental | Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge. |
|
| 8 weeks, Patch | Experimental | Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch. |
|
| 4 weeks, Patch + Lozenge | Experimental | Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge. |
|
| 4 weeks, Patch | Experimental | Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch. |
|
|
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| 8 weeks of Nicotine Replacement Therapy Patch | Drug | All participants will receive at least 4 weeks of the NRT Patch. Some will also be randomized to receive an additional 4 weeks of the NRT Patch |
|
|
| QuitAid | Behavioral | All participants will receive at least 4 weeks of the NRT Patch. Some participants will also be randomized to receive the QuitAid intervention, based on a medication adherence intervention, addresses perceptions (e.g., motivation, self-efficacy, beliefs) and practicalities of using NRT (e.g., monitoring NRT use, establishing a reminder system). QuitAid includes 1 in-person session and 5 follow-up telephonic sessions with the participant's local pharmacist/technician. |
|
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| Smokefree TXT | Behavioral | All participants will receive at least 4 weeks of the NRT Patch. Some participants will also be randomized to receive the SmokefreeTXT is a text-messaging program offered through the National Cancer Institute's Smokefree.gov initiative, which sends pre-programmed messages timed around a quit date. Participants will receive 3-5 messages a day for 7 weeks. The first week of messages focus on preparation and the remaining 6 weeks of messages focus on post-cessation strategies (e.g., relapse prevention), all timed relative to the quit date set at enrollment. |
|
| Tobacco Quitline | Behavioral | All participants will receive at least 4 weeks of the NRT Patch. Some participants will also be randomized to receive a 4-session proactive tobacco quitline, with each session lasting 20-30 minutes and occurring on days 7, 14, 21 and 28.The quitline intervention incorporates 3 phases: (1) preparing to quit, (2) quitting process, and (3) relapse prevention. |
|
| 4 weeks of Nicotine Replacement Therapy Patch | Drug | All participants will receive at least 4 weeks of the NRT Patch. |
|
|
| 8 Weeks Nicotine Lozenge | Drug | All participants will receive at least 4 weeks of the NRT Patch. Some will be randomized to receive 8 weeks of lozenge in addition to the NRT Patch. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms. |
|
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Assess adherence to assigned treatment regimen as the percentage of sessions completed if the participant was assigned to QuitAid and/or the quitline treatments, the frequency of opt-out from SmokefreeTXT (e.g., texting "STOP"), and the percent of NRT used. Adherence to NRT (both patch and/or lozenge) will be collected from participants at the 1-, 2-, and 3-month follow-ups.
| 1, 2, and 3 months |
| Quit Attempts | Assess the number of times that participants have made a quit attempt since the previous contact at the 1-, 2-, 3- and 6-month follow-ups. A "quit attempt" will be defined as cigarette abstinence for ≥ 24 hours not due to involuntary or forced cessation (i.e., hospitalization) | 1, 2, and 3 months |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000073865 | Cigarette Smoking |
| D000074264 | Smoking Reduction |
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D054539 | Medication Therapy Management |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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