A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Telephone counseling
* Drug: Nicotine patches
* Behavioral: Incentive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone counseling<br>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. | Behavioral: Telephone counseling<br>* 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.<br>|
| Experimental: Phone counseling & nicotine patches<br>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. | Drug: Nicotine patches<br>* 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.<br>* Other names: Habitrol;|
| Experimental: Phone counseling, NRT and incentives<br>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). | Behavioral: Incentive<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months post enrollment | 
| Continuous Abstinence Rates for Those Who Made Quit Attempts | Not smoking since the quit date | 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. | 7-months post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Telephone, Self-help, Smoking abstinence, Incentives, Nicotine-replacement therapy, Medi-Cal, Medicaid