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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502306
• Other study ID #: CMS NOA # 1B1CMS330882-01-00
• Status: Completed
• Phase: Phase 3
• Start date: June 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3816
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Telephone 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.

Drug:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego; California Smokers' Helpline	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Diego	California Department of Health Services, California Department of Public Health, Centers for Medicare and Medicaid Services, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (4)

Anderson CM, Zhu SH. Tobacco quitlines: looking back and looking ahead. Tob Control. 2007 Dec;16 Suppl 1:i81-6. Review. — View Citation

Lynagh MC, Sanson-Fisher RW, Bonevski B. What's good for the goose is good for the gander. Guiding principles for the use of financial incentives in health behaviour change. Int J Behav Med. 2013 Mar;20(1):114-20. doi: 10.1007/s12529-011-9202-5. Review. — View Citation

Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutiérrez-Terrell E. Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002 Oct 3;347(14):1087-93. — View Citation

Zhu SH, Stretch V, Balabanis M, Rosbrook B, Sadler G, Pierce JP. Telephone counseling for smoking cessation: effects of single-session and multiple-session interventions. J Consult Clin Psychol. 1996 Feb;64(1):202-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	7 months post enrollment
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.	2 months post enrollment
Secondary	Continuous Abstinence Rates for Those Who Made Quit Attempts	Not smoking since the quit date	7-months post enrollment
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.	7-months post enrollment