A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline
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:
- 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.
- 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.
Behavioral: Telephone counseling
Drug: Nicotine patches
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- 30-day abstinence [ Time Frame: 7 months post enrollment ] [ Designated as safety issue: No ]
- Percentage of smokers making a 24-hour quit attempt [ Time Frame: 7 months post enrollment ] [ Designated as safety issue: No ]
- Continuous abstinence rates for those who made quit attempts [ Time Frame: 7-months post enrollment ] [ Designated as safety issue: No ]
- 7-day prevalence. [ Time Frame: 7-months post enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: Telephone counseling||
Behavioral: Telephone counseling
Telephone counseling is conducted in the appropriate language (Spanish and English) by veteran counselors at the California Smokers' Helpline. The counseling protocol is similar to that used by the Helpline in previous efficacy studies. Counseling is proactive so after the smoker calls in subsequent calls are made by the counselor, a process that reduces attrition. The counseling group will receive proactive sessions initiated by quitline staff with a total of up to 6 individualized telephone counseling sessions that extend to two months from initial screening call. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors will use a structured protocol so that there will be a record for each counseling call. Quantitative information that will be available for analysis include: timing, length, and frequency of counseling calls.
|Experimental: Telephone counseling and nicotine patches||
Drug: Nicotine patches
Nicotine Patch: 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. Subjects randomized into the group 2 or 3 will receive 4 weeks of nicotine patches directly to their home. If the participant smokes 11 or more cigarettes per day they will be sent 21 mg patches. If the participant smokes 6-10 cigarettes per day they will be sent 14 mg patches. If the participant smokes 5 or less cigarettes per day they will be sent 7 mg patches.
|Experimental: Telephone counseling, nicotine patches and incentive||
Incentive: Participants randomized into Group 3 will get an added incentive to adhere to the counseling program, in the form of gift cards worth $20 for their first counseling session and $10 for each additional one (up to five sessions total, or $60). 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).
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:
- 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.
- 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.
- 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).
|Contact: Sharon E. Cummins, Ph.D.||email@example.com|
|Contact: Carrie A. Kirby, M.S.||firstname.lastname@example.org|
|United States, California|
|University of California, San Diego; California Smokers' Helpline||Recruiting|
|San Diego, California, United States, 92111|
|Contact: Prudimar (Dee) Segui, M.B.A. 858-300-1018 email@example.com|
|Contact: Christopher Anderson 858-300-1032 firstname.lastname@example.org|
|Principal Investigator: Shu-Hong Zhu, Ph.D.|
|Principal Investigator: Sharon E. Cummins, Ph.D.|
|Principal Investigator:||Shu-Hong Zhu, Ph.D.||University of California, San Diego|