Nicotine Dependence, Nicotine Dependence, Cigarettes, Nicotine Dependence Tobacco Product, Nicotine Use Disorder, Smoking, Smoking Cessation, Smoking, Cigarette, Smoking, Pipe, Smoking, Tobacco, Smoking (Tobacco) Addiction, Tobacco Dependence, Tobacco Smoking, Tobacco Use, Tobacco Use Cessation, Tobacco; Use, Rehabilitation
Conditions
Brief summary
Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.
Detailed description
2-1-1 information specialists will deliver standard service, then ask a random number of callers per day if they would be willing to answer a few health questions as part of a new 2-1-1 service. Callers eligible to receive the invitation to screen for study eligibility will be: Missouri residents, calling for themselves, English-speaking, and not in acute crisis. Eligible smokers will then be asked if they are willing to share their contact information with a research team conducting a study to help smokers quit. Smokers who agree to share their contact information will be considered enrolled. Trained 2-1-1 operators will record all recruitment screening data in a secure electronic database that is shared with research staff. Research staff will attempt to reach enrolled smokers by phone by the next business day. Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.
Interventions
BEHAVIORALSpecialized Quitline
Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access.
BEHAVIORALBasic Needs Navigator
Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years and older * Missouri resident * English speaking * Not in crisis * Smoke cigarettes every day of the week * Planning to quit smoking in the next 30 days * Comfortable receiving calls from smoking expert and project team * Willing to provide phone numbers to be reached
Exclusion criteria
* Pregnant or planning to become pregnant in the next 3 months * Currently breastfeeding * Insurance through employer * Currently enrolled in smoking quitline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence 6-months | 6 months post-baseline | Report 7-day point prevalence abstinence measured at 6-months post --baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence 3-months | 3 months post-baseline | Report 7-day point prevalence abstinence measured at 3-months post-baseline |
| 24hr Quit Attempt | 6 months post-baseline | Report quitting smoking for at least 24 hours during intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Quitline Participants will receive standard Missouri quitline services | 485 |
| Specialized Quitline Participants will receive an enhanced version of the standard quitline services
Specialized Quitline: Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access. | 485 |
| Standard Quitline With Basic Needs Navigator Participants receive standard quitline services with navigator
Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. | 484 |
| Specialized Quitline With Basic Needs Navigator Participants receive Specialized quitline services (see previous description) with navigator.
Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. | 490 |
| Total | 1,944 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 168 | 196 | 174 | 186 |
| Overall Study | Withdrawal by Subject | 24 | 27 | 7 | 22 |
Baseline characteristics
| Characteristic | Standard Quitline | Specialized Quitline | Standard Quitline With Basic Needs Navigator | Specialized Quitline With Basic Needs Navigator | Total |
|---|---|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 12.1 | 49.0 years STANDARD_DEVIATION 12.5 | 48.6 years STANDARD_DEVIATION 12.2 | 47.8 years STANDARD_DEVIATION 12.1 | 48.4 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 13 Participants | 13 Participants | 14 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 466 Participants | 470 Participants | 465 Participants | 471 Participants | 1872 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants | 5 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 6 Participants | 8 Participants | 5 Participants | 28 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 268 Participants | 278 Participants | 275 Participants | 290 Participants | 1111 Participants |
| Race (NIH/OMB) More than one race | 25 Participants | 29 Participants | 25 Participants | 28 Participants | 107 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 10 Participants | 6 Participants | 24 Participants |
| Race (NIH/OMB) White | 179 Participants | 164 Participants | 166 Participants | 157 Participants | 666 Participants |
| Sex: Female, Male Female | 349 Participants | 357 Participants | 334 Participants | 356 Participants | 1396 Participants |
| Sex: Female, Male Male | 136 Participants | 128 Participants | 150 Participants | 134 Participants | 548 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 485 | 1 / 485 | 1 / 484 | 1 / 490 |
| other Total, other adverse events | 0 / 485 | 0 / 485 | 0 / 484 | 0 / 490 |
| serious Total, serious adverse events | 0 / 485 | 0 / 485 | 0 / 484 | 0 / 490 |
Outcome results
Primary
Abstinence 6-months
Report 7-day point prevalence abstinence measured at 6-months post --baseline
Time frame: 6 months post-baseline
Population: Intention-to-treat sample
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Quitline | Abstinence 6-months | 101 Participants |
| Specialized Quitline | Abstinence 6-months | 90 Participants |
| Standard Quitline With Basic Needs Navigator | Abstinence 6-months | 74 Participants |
| Specialized Quitline With Basic Needs Navigator | Abstinence 6-months | 103 Participants |
Secondary
24hr Quit Attempt
Report quitting smoking for at least 24 hours during intervention
Time frame: 6 months post-baseline
Population: Intention-to-treat sample
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Quitline | 24hr Quit Attempt | 241 Participants |
| Specialized Quitline | 24hr Quit Attempt | 219 Participants |
| Standard Quitline With Basic Needs Navigator | 24hr Quit Attempt | 248 Participants |
| Specialized Quitline With Basic Needs Navigator | 24hr Quit Attempt | 235 Participants |
Secondary
Abstinence 3-months
Report 7-day point prevalence abstinence measured at 3-months post-baseline
Time frame: 3 months post-baseline
Population: Intention-to-treat sample
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Quitline | Abstinence 3-months | 97 Participants |
| Specialized Quitline | Abstinence 3-months | 104 Participants |
| Standard Quitline With Basic Needs Navigator | Abstinence 3-months | 80 Participants |
| Specialized Quitline With Basic Needs Navigator | Abstinence 3-months | 105 Participants |