View Clinical Trial (Medical Research Study)
A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline
| City: |
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San Diego |
| State: |
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California |
| Zip Code: |
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92111 |
| Conditions: |
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Smoking Cessation |
| Purpose: |
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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:
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.
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| Study Summary: |
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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:
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).
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| 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
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| NCT ID: |
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NCT01502306 |
| Primary Contact: |
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Principal Investigator
Shu-Hong Zhu, Ph.D.
University of California, San Diego
Sharon E. Cummins, Ph.D.
Phone: 858-300-1046
Email: scummins@ucsd.edu
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| Backup Contact: |
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Email: ckirby@ucsd.edu
Carrie A. Kirby, M.S.
Phone: 858-300-1054
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| Location Contact: |
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San Diego, California 92111
United States
Prudimar (Dee) Segui, M.B.A.
Phone: 858-300-1018
Email: psegui@ucsd.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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