RCT of tobacco dependence treatment benefits in an HMO & PPO
Abstracts
Initial Award Abstract |
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The overall objective of the proposed experiment is to study the impact of first-dollar coverage of a comprehensive smoking cessation benefit for the 2001 benefit year for smokers enrolled in Blue Shield of California’s HMO and PPO plans. The research will have direct policy relevance for increasing access to tobacco dependence treatments for approximately 75% of California’s insured population who receive their health care through HMOs and PPOs. The goal of the research is to define health insurance benefits that remove barriers to access to the most effective smoking cessation treatments and help smokers to quit.
The smoking cessation treatments that will be covered include a smoking cessation telephone counseling service and Federal Food and Drug Administration (FDA) approved pharmacotherapy, including nicotine gum and patch, and Zyban (bupropion/Wellbutrin).
The specific research questions to be answered include:
1. Does the benefit increase use of specific smoking cessation treatments in HMOs and PPOs?
2. Does the benefit increase quit attempts in HMOs and PPOs?
3. Does the benefit increase quit rates at 6 and 12 months in HMOs and PPOs ?
4. Does the benefit increase provider advice to quit and referrals to tobacco dependence treatments in HMOs and PPOs?
5. What is the cost-effectiveness of the benefit in HMOs and PPOs?
6. What is the total annual cost of the benefit per member per month (pmpm) in HMOs and PPOs?
Blue Shield of California has agreed to participate in the research. Using a list of members provided by the health plan, participants in the research will be recruited by telephone. Prior to recruitment, potential participants in Blue Shield’s HMO and PPO will be randomly assigned to either the treatment or control group. The treatment group will receive full coverage for the comprehensive smoking cessation treatment benefit and their primary care physicians will be notified that they have been selected to receive the benefit. At the time of recruitment, the baseline survey will be administered and all participants will be sent a smoking cessation self-help kit, an informed consent letter, and a $5 incentive to return the consent letter.
Two follow-up phone interviews will be conducted at 6 and 12 months with all study members to ask if they used the telephone counseling, used the drug benefits tried to quit, and successfully quit smoking. The final number of participants completing all interviews is estimated to be 1,600 or 800 smokers per group (400 HMO control/400 PPO control, and 400 HMO treatment/400 PPO treatment). All orders for nicotine gum and patch and Zyban will be tracked through the plans' pharmacy mail order system.
The effects of the benefit for smokers in HMOs and PPOs will be measured in two ways:
1. Estimating the differences in the effects for the treatment and control groups at 6 and 12 months;
2. The cost per benefit user who quits will be estimated from the health plan’s perspective based on the total cost of providing the benefit and the number of smokers in the treatment group who successfully quit. In addition, the cost per member per month (pmpm) will be estimated for smokers in HMOs and PPOs. |
Final Report |
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The overall objective of the randomized controlled trial is to assess the impact of full coverage of a comprehensive tobacco dependence treatment benefit for the 2001 benefit year for smokers enrolled in Blue Shield of California’s individual and family PPO plan. The findings will have direct policy relevance for increasing access to nicotine dependence treatments for California’s insured population who receive their health care through PPOs. The research seeks to define health insurance benefits that remove barriers to access to the most effective tobacco dependence treatments and help smokers to quit.
The tobacco dependence treatments that will be covered include a smoking cessation telephone counseling service that meets the guidelines established by PHS for effective tobacco dependence treatment interventions, and Federal Food and Drug Administration (FDA) approved pharmacoptherapy, including nicotine patch, nasal spray and inhaler, and bupropion (Zyban/Wellbutrin).
The specific research questions to be answered include:
1) Does the benefit increase use of tobacco dependence treatments in PPOs?
2) Does the benefit increase quit attempts in PPOs?
3) Does the benefit increase quit rates at 12 months in PPOs?
4) Does the benefit increase provider advice to quit and referrals to tobacco dependence treatments in PPOs?
5) What is the cost per user of the benefit who quits in PPOs?
6) What is the total annual cost of the benefit per member and the cost per member per month (pmpm) in PPOs?
Blue Shield of California agreed to participate in the research with their population enrolled in Individual and Family PPO plans. Using a membership database provided by the health plan, participants in the research were recruited by telephone and by mail. Prior to recruitment, potential participants in Blue Shield’s PPO were randomly assigned to one of three treatment groups. One treatment group received full coverage for Free and Clear’s proactive telephone counseling and pharmacotherapy conditional on enrollment in the counseling program. The second treatment group received full coverage of pharmacotherapy (unconditionally) and the Free and Clear telephone counseling. The third treatment group received coverage only for pharmacotherapy. At the time of recruitment, the baseline survey was administered, and all participants were sent a smoking cessation self-help kit, an informed consent letter, and a $5 incentive to return the consent letter. The benefit began on May 1 and ended on December 31, 2001 (8 months). Those smokers recruited by phone and who completed the baseline survey but did not return their consent form to participate in an experimental group were followed as a control group with no treatment benefits. The final number of participants completing follow-up interviews is 127 for drugs conditional on counseling, 134 for drugs and counseling, 125 for drugs only, and 391 in the control group. All orders for nicotine gum and patch and bupropion were tracked through the plan’s pharmacy system. Participation in the Free and Clear program was tracked by that program. |
