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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Centers for Medicare and Medicaid Services
University of California, San Francisco
California Diabetes Program
California Department of Public Health
California Department of Health Care Services
Information provided by (Responsible Party):
Shu-Hong Zhu, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01502306
First received: December 23, 2011
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.

Condition Intervention Phase
Smoking Cessation
Behavioral: Telephone counseling
Drug: Nicotine patches
Behavioral: Incentive
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 30-day abstinence [ Time Frame: 7 months post enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3819
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone counseling
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
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.
Experimental: Phone counseling & nicotine patches

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
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.
Other Name: Habitrol
Experimental: Phone counseling, NRT and incentives

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
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502306

Locations
United States, California
University of California, San Diego; California Smokers' Helpline
San Diego, California, United States, 92111
Sponsors and Collaborators
University of California, San Diego
Centers for Medicare and Medicaid Services
University of California, San Francisco
California Diabetes Program
California Department of Public Health
California Department of Health Care Services
Investigators
Principal Investigator: Shu-Hong Zhu, Ph.D. University of California, San Diego
  More Information

Publications:
Responsible Party: Shu-Hong Zhu, Professor, Department of Family and Preventive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01502306     History of Changes
Other Study ID Numbers: CMS NOA # 1B1CMS330882-01-00
Study First Received: December 23, 2011
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, San Diego:
Smoking cessation
Telephone
Self-help
Smoking abstinence
Incentives
Nicotine-replacement therapy
Medi-Cal
Medicaid

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014