Trial Outcomes & Findings for A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline (NCT NCT01502306)
NCT ID: NCT01502306
Last Updated: 2020-02-13
Results Overview
At a given point in time (in this case, 7 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3816 participants
Primary outcome timeframe
7 months post enrollment
Results posted on
2020-02-13
Participant Flow
Recruitment was between July 2012 and May 2013
Participant milestones
| Measure |
Telephone Counseling
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
|
Phone Counseling & Nicotine Patches
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.
|
Phone Counseling, NRT and Incentives
One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).
Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1004
|
1405
|
1407
|
|
Overall Study
COMPLETED
|
1004
|
1405
|
1407
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline
Baseline characteristics by cohort
| Measure |
Phone Counseling & Nicotine Patches
n=1405 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.
|
Telephone Counseling
n=1004 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
|
Phone Counseling, NRT and Incentives
n=1407 Participants
One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).
Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.
|
Total
n=3816 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-24
|
67 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
63 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
|
Age, Customized
25-44
|
515 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
499 Participants
n=5 Participants
|
1369 Participants
n=4 Participants
|
|
Age, Customized
45-64
|
743 Participants
n=7 Participants
|
550 Participants
n=5 Participants
|
761 Participants
n=5 Participants
|
2054 Participants
n=4 Participants
|
|
Age, Customized
>=65
|
80 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
84 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
955 Participants
n=7 Participants
|
675 Participants
n=5 Participants
|
953 Participants
n=5 Participants
|
2583 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
450 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
454 Participants
n=5 Participants
|
1233 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
819 Participants
n=7 Participants
|
616 Participants
n=5 Participants
|
819 Participants
n=5 Participants
|
2254 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
275 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
283 Participants
n=5 Participants
|
717 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
142 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
138 Participants
n=5 Participants
|
371 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
38 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
31 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
103 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
114 Participants
n=5 Participants
|
316 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Education
<= 12
|
844 Participants
n=7 Participants
|
590 Participants
n=5 Participants
|
823 Participants
n=5 Participants
|
2257 Participants
n=4 Participants
|
|
Education
>12
|
561 Participants
n=7 Participants
|
414 Participants
n=5 Participants
|
584 Participants
n=5 Participants
|
1559 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 months post enrollmentPopulation: Number of participants analyzed reflects the number of participants the quitline was able to reach at 7-months
At a given point in time (in this case, 7 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.
Outcome measures
| Measure |
Telephone Counseling
n=639 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
|
Phone Counseling & Nicotine Patches
n=919 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.
|
Phone Counseling, NRT and Incentives
n=958 Participants
One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).
Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.
|
|---|---|---|---|
|
30-day Abstinence
|
168 Participants
|
237 Participants
|
302 Participants
|
SECONDARY outcome
Timeframe: 2 months post enrollmentPopulation: Number of participants analyzed reflects the number of participants the quitline was able to reach at 2-months
At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they made a quit attempt (attempt at quitting smoking) and how long they made it.
Outcome measures
| Measure |
Telephone Counseling
n=789 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
|
Phone Counseling & Nicotine Patches
n=1093 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.
|
Phone Counseling, NRT and Incentives
n=1143 Participants
One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).
Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.
|
|---|---|---|---|
|
Percentage of Smokers Making a 24-hour Quit Attempt
|
546 Participants
|
847 Participants
|
962 Participants
|
SECONDARY outcome
Timeframe: 7-months post enrollmentPopulation: Number of participants analyzed reflects the number of participants the quitline was able to reach at 7-months
Not smoking since the quit date
Outcome measures
| Measure |
Telephone Counseling
n=639 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
|
Phone Counseling & Nicotine Patches
n=919 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.
|
Phone Counseling, NRT and Incentives
n=958 Participants
One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).
Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.
|
|---|---|---|---|
|
Continuous Abstinence Rates for Those Who Made Quit Attempts
|
90 Participants
|
145 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: 7-months post enrollmentPopulation: Number of participants analyzed reflects the number of participants the quitline was able to reach at 7-months
Seven-day point prevalence abstinence is a measure of, in this case, tobacco cessation outcomes for quitlines. At a given point in time (in this case, 7 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 7 days.
Outcome measures
| Measure |
Telephone Counseling
n=639 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling begins immediately after intake, if the client is available for a 30-minute session or by appointment at the clients' convenience. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls. The follow-up calls (about 10 minutes) will be scheduled as follows: a reminder call if the quit date is more than one week out for the initial counseling, on the quit date, 4-7 days after the quit date, and 10-14 days after the quit date.
|
Phone Counseling & Nicotine Patches
n=919 Participants
One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.
|
Phone Counseling, NRT and Incentives
n=958 Participants
One-on-one, proactive telephone counseling to quit smoking; The counseling addresses behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.
Nicotine patches (four weeks' worth) are sent directly to clients. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking \<6 per day.
Gift cards (to one of 4 major chains) are $20 for the first counseling session and $10 for each additional one (up to five sessions total).
Incentive: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.
|
|---|---|---|---|
|
7-day Prevalence.
|
162 Participants
|
231 Participants
|
298 Participants
|
Adverse Events
Telephone Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phone Counseling & Nicotine Patches
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phone Counseling, NRT and Incentives
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