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

NCT01502306 | Completed Phase 3 Results

• 1 other identifier: CMS NOA # 1B1CMS330882-01-00
• Study Type: interventional
• Target: 3,816
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Smoking Cessation

Keywords

Smoking cessation; Telephone; Self-help; Smoking abstinence; Incentives; Nicotine-replacement therapy; Medi-Cal; Medicaid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Smokers Making a 24-hour Quit Attempt

  2 months post enrollment

• Continuous Abstinence Rates for Those Who Made Quit Attempts

  7-months post enrollment

• 7-day Prevalence.

  7-months post enrollment

Study Arms (3)

Telephone counseling

EXPERIMENTAL

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

Phone counseling & nicotine patches

EXPERIMENTAL

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

Phone counseling, NRT and incentives

EXPERIMENTAL

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

Interventions

Telephone counseling BEHAVIORAL

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.

Telephone counseling

Nicotine patches DRUG

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.

Also known as: Habitrol

Phone counseling & nicotine patches

Incentive BEHAVIORAL

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.

Phone counseling, NRT and incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication(s) to nicotine patches and no MD approval
• Pregnant

Sponsors & Collaborators

• University of California, San Diego: lead
• Centers for Medicare and Medicaid Services: collaborator
• University of California, San Francisco: collaborator
• California Department of Public Health: collaborator
• California Department of Health Services: collaborator

Study Sites (1)

University of California, San Diego; California Smokers' Helpline

San Diego, California, 92111, United States

Location

Related Publications (5)

• 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.

  PMID: 8907100 BACKGROUND

• 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.

  PMID: 12362011 BACKGROUND

• 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.

  PMID: 18048638 BACKGROUND

• 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.

  PMID: 22094998 BACKGROUND

• 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.

  PMID: 30454668 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Principal Investigator
• Organization: UCSD

szhu@ucsd.edu

8583001056

Study Officials

• Shu-Hong Zhu, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Family and Preventive Medicine

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: December 30, 2011
• Study Start: June 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 13, 2020
• Results First Posted: October 1, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)