Clinical trial NCT01502306: A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline
Official title: A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: Smoking cessation
Telephone
Self-help
Smoking abstinence
Incentives
Nicotine-replacement therapy
Medi-Cal
Medicaid
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
name: University of California, San Francisco
name: California Department of Public Health
name: California Department of Health Services
First posted: 2011-12-30
Enrollment: 3816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: 30-day Abstinence
timeFrame: 7 months post enrollment
Secondary outcomes:
measure: Percentage of Smokers Making a 24-hour Quit Attempt
timeFrame: 2 months post enrollment
measure: Continuous Abstinence Rates for Those Who Made Quit Attempts
timeFrame: 7-months post enrollment
measure: 7-day Prevalence.
timeFrame: 7-months post enrollment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego; California Smokers' Helpline
state: California
Study officials:
affiliation: University of California, San Diego
name: Shu-Hong Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1037//0022-006x.64.1.202.
citation: Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutierrez-Terrell E. Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002 Oct 3;347(14):1087-93. doi: 10.1056/NEJMsa020660.
citation: Anderson CM, Zhu SH. Tobacco quitlines: looking back and looking ahead. Tob Control. 2007 Dec;16 Suppl 1(Suppl 1):i81-6. doi: 10.1136/tc.2007.020701.
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.
citation: Anderson CM, Cummins SE, Kohatsu ND, Gamst AC, Zhu SH. Incentives and Patches for Medicaid Smokers: An RCT. Am J Prev Med. 2018 Dec;55(6 Suppl 2):S138-S147. doi: 10.1016/j.amepre.2018.07.015.