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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,816
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.
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.
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.
University of California, San Diego; California Smokers' Helpline
San Diego, California, United States
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
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
Continuous Abstinence Rates for Those Who Made Quit Attempts
Not smoking since the quit date
Time frame: 7-months post enrollment
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
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