Trial Outcomes & Findings for Helping Poor Smokers Quit (NCT NCT03194958)
NCT ID: NCT03194958
Last Updated: 2023-12-26
Results Overview
Report 7-day point prevalence abstinence measured at 6-months post --baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1944 participants
Primary outcome timeframe
6 months post-baseline
Results posted on
2023-12-26
Participant Flow
Participant milestones
| Measure |
Standard Quitline
Participants will receive standard Missouri quitline services
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
485
|
485
|
484
|
490
|
|
Overall Study
COMPLETED
|
293
|
261
|
302
|
281
|
|
Overall Study
NOT COMPLETED
|
192
|
224
|
182
|
209
|
Reasons for withdrawal
| Measure |
Standard Quitline
Participants will receive standard Missouri quitline services
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
24
|
27
|
7
|
22
|
|
Overall Study
Lost to Follow-up
|
168
|
196
|
174
|
186
|
Baseline Characteristics
Helping Poor Smokers Quit
Baseline characteristics by cohort
| Measure |
Standard Quitline
n=485 Participants
Participants will receive standard Missouri quitline services
|
Specialized Quitline
n=485 Participants
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.
|
Standard Quitline With Basic Needs Navigator
n=484 Participants
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.
|
Specialized Quitline With Basic Needs Navigator
n=490 Participants
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.
|
Total
n=1944 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
48.4 years
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
349 Participants
n=5 Participants
|
357 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
356 Participants
n=4 Participants
|
1396 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
548 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
466 Participants
n=5 Participants
|
470 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
471 Participants
n=4 Participants
|
1872 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
268 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
290 Participants
n=4 Participants
|
1111 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
179 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
666 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 months post-baselinePopulation: Intention-to-treat sample
Report 7-day point prevalence abstinence measured at 6-months post --baseline
Outcome measures
| Measure |
Standard Quitline
n=485 Participants
Participants will receive standard Missouri quitline services
|
Specialized Quitline
n=485 Participants
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.
|
Standard Quitline With Basic Needs Navigator
n=484 Participants
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.
|
Specialized Quitline With Basic Needs Navigator
n=490 Participants
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.
|
|---|---|---|---|---|
|
Abstinence 6-months
|
101 Participants
|
90 Participants
|
74 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: 3 months post-baselinePopulation: Intention-to-treat sample
Report 7-day point prevalence abstinence measured at 3-months post-baseline
Outcome measures
| Measure |
Standard Quitline
n=485 Participants
Participants will receive standard Missouri quitline services
|
Specialized Quitline
n=485 Participants
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.
|
Standard Quitline With Basic Needs Navigator
n=484 Participants
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.
|
Specialized Quitline With Basic Needs Navigator
n=490 Participants
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.
|
|---|---|---|---|---|
|
Abstinence 3-months
|
97 Participants
|
104 Participants
|
80 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: 6 months post-baselinePopulation: Intention-to-treat sample
Report quitting smoking for at least 24 hours during intervention
Outcome measures
| Measure |
Standard Quitline
n=485 Participants
Participants will receive standard Missouri quitline services
|
Specialized Quitline
n=485 Participants
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.
|
Standard Quitline With Basic Needs Navigator
n=484 Participants
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.
|
Specialized Quitline With Basic Needs Navigator
n=490 Participants
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.
|
|---|---|---|---|---|
|
24hr Quit Attempt
|
241 Participants
|
219 Participants
|
248 Participants
|
235 Participants
|
Adverse Events
Specialized Quitline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Quitline With Basic Needs Navigator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Specialized Quitline With Basic Needs Navigator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Quitline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place