Smoking Cessation
Conditions
Keywords
Smoking cessation, Telephone, Self-help, Smoking abstinence, Incentives, Nicotine-replacement therapy, Medi-Cal, Medicaid
Brief summary
California Smokers' Helpline will conduct a randomized trial to evaluate 3 strategies of services and/or incentives on smoking cessation rates. This project has the following specific aims: 1. To increase tobacco cessation among Medi-Cal beneficiaries who currently smoke, and to improve the management of diabetes and other chronic disease by means of tobacco cessation. 2. Demonstrate that tobacco cessation benefits that are well promoted and barrier free and include modest incentives, are effective in reducing smoking prevalence, lowering Medi-Cal health care costs, and improving health outcomes for diabetes management in particular.
Detailed description
The mission of the California Department of Health Care Services (DHCS), California's single State Medicaid Agency, is to preserve and improve the health status of all Californians by operating and financing programs delivering effective health care services to eligible individuals. Medi-Cal (California's Medicaid Program) is the largest purchaser of health care in the state, serving over 7.5 million beneficiaries. Approximately half of all Medi-Cal beneficiaries receive their health care through managed care plans, while the other half receive care on a fee-for-service basis. DHCS programs are designed to emphasize prevention-oriented health care measures (such as quitting smoking) that improve health and well-being, and ensure effective expenditure of public resources to serve those with the greatest health care needs. This study (MIPCD) aligns with the goals and objectives of the DHCS Strategic Plan, which states, DHCS supports and values healthy lifestyle behaviors, and aims to promote the use of preventive, health improvement, and wellness services/activities. The primary intervention in this study will be the internationally recognized, California Smokers' Helpline (Helpline) operated by the University of California, San Diego (UCSD). Established in 1992, more than 50% of the Helpline's clients are Medi-Cal members. In this study, the Helpline will: operate a fully functioning quitline call center with trained personnel and live capabilities in English, Spanish, Mandarin, Cantonese, Korean and Vietnamese; assess eligibility for the randomized trial; obtain consent for participation in the trial; send individually tailored self-help materials to registered participants; provide one-on-one telephone counseling, including a comprehensive, pre-quit planning session and up to four relapse-prevention sessions; evaluate the services provided; maintain detailed, confidential records of each beneficiary's cessation activity and receipt of incentives and services. Callers with a valid Medi-Cal ID who have diabetes or other eligible condition(s) and provide consent for the study will be randomized into one of the three arms of the trial. The arms of the trial are detailed below: 1. Group 1 (Policy A) - current policy: beneficiaries who call the Helpline will get free counseling and a certificate of enrollment, which is required in order for them to obtain free nicotine replacement therapy (NRT) from their pharmacy, four weeks' worth at a time. Beneficiaries can receive two courses of treatment per year. 2. Group 2 (Policy B1) - a new policy in which beneficiaries who call the Helpline get free counseling and have free nicotine patches shipped directly to their home, with no limit on the number of quit attempts they can make in a year. 3. Group 3 (Policy B2) - a variant of B1 in which beneficiaries will get free counseling and free nicotine patches shipped directly to their home, with no annual limit on quit attempts. Participants will also get an added incentive to adhere to the counseling program, in the form of gift cards worth $20 for their initial counseling call and $10 for each additional follow-up counseling call (up to five sessions total, or $60).
Interventions
BEHAVIORALTelephone counseling
Telephone counseling is conducted in the appropriate language (Spanish and English) by counselors at the California Smokers' Helpline. Counselors use a structured protocol and there is a record for each call. Quantitative information that will be available for analysis include: timing, length, and frequency of counseling calls.
DRUGNicotine 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.
BEHAVIORALIncentive
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.
Sponsors
Centers for Medicare and Medicaid Services
University of California, San Francisco
California Department of Public Health
California Department of Health Services
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Medi-Cal beneficiary with valid Medi-Cal beneficiary ID * Willing to link Helpline data with Medi-Cal utilization data * English or Spanish speaking * Valid phone number * Valid address * Gave consent to participate in study and evaluation
Exclusion criteria
* Contraindication(s) to nicotine patches and no MD approval * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day Abstinence | 7 months post enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Smokers Making a 24-hour Quit Attempt | 2 months post enrollment | 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. |
| Continuous Abstinence Rates for Those Who Made Quit Attempts | 7-months post enrollment | Not smoking since the quit date |
| 7-day Prevalence. | 7-months post enrollment | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment was between July 2012 and May 2013
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,004 |
| 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. | 1,405 |
| 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. | 1,407 |
| Total | 3,816 |
Baseline characteristics
| Characteristic | Telephone Counseling | Phone Counseling & Nicotine Patches | Phone Counseling, NRT and Incentives | Total |
|---|---|---|---|---|
| Age, Customized 18-24 | 53 Participants | 67 Participants | 63 Participants | 183 Participants |
| Age, Customized 25-44 | 355 Participants | 515 Participants | 499 Participants | 1369 Participants |
| Age, Customized 45-64 | 550 Participants | 743 Participants | 761 Participants | 2054 Participants |
| Age, Customized >=65 | 46 Participants | 80 Participants | 84 Participants | 210 Participants |
| Education <= 12 | 590 Participants | 844 Participants | 823 Participants | 2257 Participants |
| Education >12 | 414 Participants | 561 Participants | 584 Participants | 1559 Participants |
| Race/Ethnicity, Customized American Indian | 19 Participants | 38 Participants | 31 Participants | 88 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 19 Participants | 24 Participants | 16 Participants | 59 Participants |
| Race/Ethnicity, Customized Black | 159 Participants | 275 Participants | 283 Participants | 717 Participants |
| Race/Ethnicity, Customized Hispanic | 91 Participants | 142 Participants | 138 Participants | 371 Participants |
| Race/Ethnicity, Customized Multi-Racial | 99 Participants | 103 Participants | 114 Participants | 316 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 4 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 616 Participants | 819 Participants | 819 Participants | 2254 Participants |
| Sex: Female, Male Female | 675 Participants | 955 Participants | 953 Participants | 2583 Participants |
| Sex: Female, Male Male | 329 Participants | 450 Participants | 454 Participants | 1233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,004 | 0 / 1,405 | 0 / 1,407 |
| serious Total, serious adverse events | 0 / 1,004 | 0 / 1,405 | 0 / 1,407 |
Outcome results
Primary
30-day Abstinence
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.
Time frame: 7 months post enrollment
Population: Number of participants analyzed reflects the number of participants the quitline was able to reach at 7-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telephone Counseling | 30-day Abstinence | 168 Participants |
| Phone Counseling & Nicotine Patches | 30-day Abstinence | 237 Participants |
| Phone Counseling, NRT and Incentives | 30-day Abstinence | 302 Participants |
Secondary
7-day Prevalence.
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.
Time frame: 7-months post enrollment
Population: Number of participants analyzed reflects the number of participants the quitline was able to reach at 7-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telephone Counseling | 7-day Prevalence. | 162 Participants |
| Phone Counseling & Nicotine Patches | 7-day Prevalence. | 231 Participants |
| Phone Counseling, NRT and Incentives | 7-day Prevalence. | 298 Participants |
Secondary
Continuous Abstinence Rates for Those Who Made Quit Attempts
Not smoking since the quit date
Time frame: 7-months post enrollment
Population: Number of participants analyzed reflects the number of participants the quitline was able to reach at 7-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telephone Counseling | Continuous Abstinence Rates for Those Who Made Quit Attempts | 90 Participants |
| Phone Counseling & Nicotine Patches | Continuous Abstinence Rates for Those Who Made Quit Attempts | 145 Participants |
| Phone Counseling, NRT and Incentives | Continuous Abstinence Rates for Those Who Made Quit Attempts | 185 Participants |
Secondary
Percentage of Smokers Making a 24-hour Quit Attempt
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.
Time frame: 2 months post enrollment
Population: Number of participants analyzed reflects the number of participants the quitline was able to reach at 2-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telephone Counseling | Percentage of Smokers Making a 24-hour Quit Attempt | 546 Participants |
| Phone Counseling & Nicotine Patches | Percentage of Smokers Making a 24-hour Quit Attempt | 847 Participants |
| Phone Counseling, NRT and Incentives | Percentage of Smokers Making a 24-hour Quit Attempt | 962 Participants |